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Journal articles on the topic 'Indirect treatment comparison'

Author: Grafiati

Published: 4 June 2021

Last updated: 15 February 2022

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1

Miladinovic, Branko, Anna Chaimani, Iztok Hozo, and Benjamin Djulbegovic. "Indirect Treatment Comparison." Stata Journal: Promoting communications on statistics and Stata 14, no. 1 (March 2014): 76–86. http://dx.doi.org/10.1177/1536867x1401400106.

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Marquez, M., J. P. Diaz, A. Ibarra, M. Pizarro, A. Cervantes, M. Rodríguez, and H. Soto. "Bayesian mixed treatment comparison of early treatment for Parkinson disease: an indirect comparison." Value in Health 18, no. 3 (May 2015): A280. http://dx.doi.org/10.1016/j.jval.2015.03.1635.

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Guyot, Patricia, Wei Cheng, Gabriel Tremblay, Ronda Copher, Heather Burnett, Xuan Li, and Charles Makin. "Number needed to treat in indirect treatment comparison." Journal of Comparative Effectiveness Research 7, no. 3 (March 2018): 259–69. http://dx.doi.org/10.2217/cer-2017-0023.

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Gala, S., and M. Mwamburi. "Indirect Treatment Comparison Of Newer Treatments In Relapsed / Refractory Multiple Myeloma." Value in Health 19, no. 3 (May 2016): A138. http://dx.doi.org/10.1016/j.jval.2016.03.1647.

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Parks, D., and S. A. Ferrante. "PNS211 ASSESSING POPULATION-ADJUSTED INDIRECT COMPARISON METHODS (MATCHING-ADJUSTED INDIRECT COMPARISON AND SIMULATED TREATMENT COMPARISON) USING MONTE-CARLO SIMULATIONS." Value in Health 22 (May 2019): S321. http://dx.doi.org/10.1016/j.jval.2019.04.1568.

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Swallow, Elyse, Oscar Patterson-Lomba, Rajeev Ayyagari, Corey Pelletier, Rina Mehta, and James Signorovitch. "Causal inference and adjustment for reference-arm risk in indirect treatment comparison meta-analysis." Journal of Comparative Effectiveness Research 9, no. 10 (July 2020): 737–50. http://dx.doi.org/10.2217/cer-2020-0042.

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Aim: To illustrate that bias associated with indirect treatment comparison and network meta-analyses can be reduced by adjusting for outcomes on common reference arms. Materials & methods: Approaches to adjusting for reference-arm effects are presented within a causal inference framework. Bayesian and Frequentist approaches are applied to three real data examples. Results: Reference-arm adjustment can significantly impact estimated treatment differences, improve model fit and align indirectly estimated treatment effects with those observed in randomized trials. Reference-arm adjustment can possibly reverse the direction of estimated treatment effects. Conclusion: Accumulating theoretical and empirical evidence underscores the importance of adjusting for reference-arm outcomes in indirect treatment comparison and network meta-analyses to make full use of data and reduce the risk of bias in estimated treatments effects.

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Rugo, Hope S., Anja Haltner, Lin Zhan, Anh Tran, Eustratios Bananis, Becky Hooper, Debanjali Mitra, and Chris Cameron. "Matching-adjusted indirect comparison of palbociclib versus ribociclib and abemaciclib in hormone receptor-positive/HER2-negative advanced breast cancer." Journal of Comparative Effectiveness Research 10, no. 6 (April 2021): 457–67. http://dx.doi.org/10.2217/cer-2020-0272.

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Aim: Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM), in combination with fulvestrant (FUL), are approved for the treatment of hormone receptor-positive, HER2-negative advanced breast cancer. This study aims to determine relative efficacy of PAL+FUL versus RIB+FUL and ABM+FUL using matching-adjusted indirect treatment comparisons. Patients & methods: Anchored matching-adjusted indirect treatment comparisons were conducted using individual patient data from PALOMA-3 and published summary-level data from MONARCH 2 and MONALEESA-3. The primary outcome was overall survival (OS). Results: OS was similar for PAL+FUL versus ABM+FUL (hazard ratio: 0.87; 95% CI: 0.54–1.40) and RIB+FUL (hazard ratio: 0.89; 95% CI: 0.48–1.63). Conclusion: Adjusting for cross-trial differences suggests similar OS between treatments, underscoring the importance of accounting for these differences when indirectly comparing treatments.

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Bourdin, Arnaud, and Nicolas Molinari. "Indirect treatment comparison of asthma biologics fraught with methodology issues." Journal of Allergy and Clinical Immunology 143, no. 3 (March 2019): 1266–67. http://dx.doi.org/10.1016/j.jaci.2018.11.024.

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Weber, Jeffrey, Paolo Ascierto, Mark Middleton, Delphine Hennicken, Roberto Zoffoli, Anne Pieters, Adenike Amadi, et al. "308 Indirect treatment comparison of nivolumab versus placebo as adjuvant treatment for melanoma." Journal for ImmunoTherapy of Cancer 8, Suppl 3 (November 2020): A335. http://dx.doi.org/10.1136/jitc-2020-sitc2020.0308.

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BackgroundWe have previously performed indirect treatment comparisons (ITCs) to demonstrate improvements in recurrence-free survival (RFS) and distant metastasis-free survival with nivolumab versus placebo as adjuvant treatment for resected melanoma; however, overall survival (OS) data were not available at the time. Recently, results of the phase 3 CheckMate 238 trial in patients with resected stage IIIB–IIIC/IV melanoma (American Joint Committee on Cancer [AJCC], 7th edition) showed no statistically significant difference in OS between nivolumab and ipilimumab; however, OS events were fewer than expected. In the phase 3 EORTC 18071 trial in patients with resected stage IIIA–IIIC melanoma (AJCC, 6th edition), OS was improved with ipilimumab versus placebo. Here, we provide an update on RFS and an analysis of OS in ITCs of nivolumab and placebo using data from these 2 trials with a common comparator arm: ipilimumab 10 mg/kg.MethodsITCs of nivolumab versus placebo were conducted using 4-year minimum follow-up data from CheckMate 238 (NCT02388906) and 5.3-year median follow-up data from EORTC 18071 (NCT00636168). Bucher ITCs were performed to estimate RFS and OS in the intention-to-treat populations. A sensitivity analysis of OS adjusting for subsequent therapy options was conducted in 2 steps: (1) after controlling for possible confounders and assuming that the only difference was the effect of different subsequent therapies, postrecurrence survival was compared between the 2 ipilimumab arms in each study, and (2) after adjusting for differences in postrecurrence survival, ITCs of nivolumab versus adjusted placebo were performed.ResultsIn these ITC analyses, RFS and OS results with nivolumab suggested an improvement compared with placebo. In the intention-to-treat population, nivolumab was associated with a lower risk of recurrence or death (RFS HR, 0.55; 95% CI, 0.43–0.70) and a lower risk of death (OS HR, 0.62; 95% CI, 0.44–0.88) than placebo. In the sensitivity analysis, a 63% average increase in postrecurrence survival benefit was estimated with ipilimumab in CheckMate 238 compared with ipilimumab in EORTC 18071. After adjusting for this increase in both the ipilimumab and placebo arms in EORTC 18071, nivolumab was associated with a lower risk of death than placebo (OS HR, 0.65; 95% CI, 0.45–0.91), similar to the unadjusted analysis.ConclusionsDespite the changing treatment landscape and the increased number of therapeutic options for metastatic melanoma, these ITCs suggested clinically meaningful improvement in RFS and OS with adjuvant nivolumab compared with a wait-and-watch strategy in high-risk patients with resected melanoma.AcknowledgementsWriting and editorial assistance were provided by Kakoli Parai, PhD, and Andrea Lockett of Ashfield Healthcare Communications, funded by Bristol-Myers Squibb Company.Trial RegistrationNCT02388906 (CheckMate 238), NCT00636168 (EORTC 18071)

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Hemstock, Matthew, Adenike Amadi, Katrin Kupas, Neil Roskell, Srividya Kotapati, Kyna Gooden, Mark R. Middleton, and Dirk Schadendorf. "Indirect treatment comparison of nivolumab versus placebo for the adjuvant treatment of melanoma." European Journal of Cancer 132 (June 2020): 176–86. http://dx.doi.org/10.1016/j.ejca.2020.03.011.

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Hoaglin, David C., Neil Hawkins, Jeroen P. Jansen, David A. Scott, Robbin Itzler, Joseph C. Cappelleri, Cornelis Boersma, et al. "Conducting Indirect-Treatment-Comparison and Network-Meta-Analysis Studies: Report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: Part 2." Value in Health 14, no. 4 (June 2011): 429–37. http://dx.doi.org/10.1016/j.jval.2011.01.011.

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12

Rael, Michael, Agnes Benedict, Jack Ishak, Sarah Cadarette, Marco Campioni, and Sumeet Panjabi. "Indirect Comparison to Assess the Relative Efficacy of Carfilzomib + Lenalidomide + Dexamethasone Versus Bortezomib + Thalidomide + Dexamethasone: A Matching Adjusted Indirect Comparison." Blood 126, no. 23 (December 3, 2015): 5624. http://dx.doi.org/10.1182/blood.v126.23.5624.5624.

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Abstract Background: Several novel treatments have recently been approved for the treatment of relapsed multiple myeloma (RMM). In the absence of head-to-head comparisons between these novel treatments, clinicians and payers must rely on statistical indirect comparisons. The objective of this analysis is to derive measures of relative effectiveness for carfilzomib + lenalidomide + dexamethasone (KRd) against bortezomib + thalomide + dexamethasone (VTd) in patients with RMM who have been treated with at least one prior therapy and who had an autologous stem cell transplant (ASCT). Methods: A matching-adjusted indirect comparison (MAIC) (Signorovitch, 2010) for progression-free survival (PFS) and overall survival (OS) was conducted between KRd with results from the Phase III study ASPIRE study (Stewart et al., 2015) and VTd with results from the MMVAR trial (Garderet et al., 2012). The MAIC utilized patient level data from ASPIRE, and adjusted for observed patient population differences. An MAIC uses a propensity score type equation to assign case weights to the KRd patients so that their weighted baseline characteristics match the baseline of the VTd population. This re-weighting process attempts to answer the question: What would the outcomes be if KRd had been administered to the VTd population? Adjustments were made for age, gender, history of ASCT, disease duration, ISS stage, beta-2-microglobulin, and creatinine clearance rate. Cox PH models were fitted to estimate hazard ratios (HRs) for PFS and OS. Weibull survival curves best fit the adjusted survival data and were used to estimate median survival times. A simulated treatment comparison (STC) (Ishak et al., 2015), which adjusts for reported patient population differences using regression equations, was conducted as a cross validation. Results: The KRd arm in ASPIRE included 396 patients and VTD arm in MMVAR included 135 patients. After successfully matching, the effective sample size (ESS) of the KRd population was 56. See Figure 1 for the MAIC adjusted PFS Kaplan-Meier curves. HRs (95% CIs) from the Cox models for PFS and OS outcome were 0.535 (0.346, 0.828) and 0.694 (0.38, 1.27), respectively. Corresponding HRs from the STC were similar and validate the MAIC results. Estimates of median PFS and OS in months were 28.6 and 57.9 for KRd compared to 18.0 and 43.2 for VTd, respectively. Conclusion: This MAIC analysis suggests that KRd provides a consistent benefit relative to VTd in RMM patients who have been treated with at least one prior therapy and an ASCT. Beyond the patient characteristics available from MMVAR, other variables that may potentially influence outcomes were not adjusted for in the analysis. The small ESS is a potential limitation of this analysis. Figure 1. Figure 1. Disclosures Rael: Onyx: Consultancy; Evidera: Employment. Benedict:Evidera: Employment; Onyx: Consultancy. Ishak:Evidera: Employment; Onyx: Consultancy. Cadarette:Evidera: Employment; Onyx: Consultancy. Campioni:Amgen: Employment, Equity Ownership. Panjabi:Onyx Pharmaceuticals Inc., An Amgen Subsidiary: Employment, Equity Ownership.

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Chu, Paula, Miranta Antoniou, Mohit K. Bhutani, Amine Aziez, and Monica Daigl. "Matching-adjusted indirect comparison: entrectinib versus crizotinib in ROS1 fusion-positive non-small cell lung cancer." Journal of Comparative Effectiveness Research 9, no. 12 (August 2020): 861–76. http://dx.doi.org/10.2217/cer-2020-0063.

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Aim: To perform indirect treatment comparisons of entrectinib versus alternative ROS1 fusion-positive non-small cell lung cancer treatments. Methods: Relevant studies with crizotinib and chemotherapy as comparators of interest identified by systematic literature review were selected for matching-adjusted indirect comparison by feasibility assessment. Matching was based on known prognostic/predictive factors and scenario analyses were used for unreported confounders in comparator trials. Results: Entrectinib yielded significantly better responses versus crizotinib in all scenarios (odds ratio [OR]: 2.43–2.74). Overall survival (hazard ratio: 0.47–0.61) and adverse event-related discontinuation (OR: 0.79–0.90) favored entrectinib. Progression-free survival was similar across treatments, except in one scenario. Conclusion: These results suggested improved outcomes with entrectinib versus crizotinib/chemotherapy and may help to make better informed treatment decisions.

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Aleman, Alicia, Daniel Pedrosa, Magdalena Irisarri, Rafael Alonso, Ana Perez Galán, and Regina Guzman. "PD66 Indirect Comparison Of Treatments For Metastatic Melanoma." International Journal of Technology Assessment in Health Care 34, S1 (2018): 154. http://dx.doi.org/10.1017/s0266462318003276.

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Introduction:Vemurafenib plus cobimetinib (VC) for the treatment of metastatic melanoma was requested to be included in the National Formulary in Uruguay. The standard of care for metastatic melanoma in Uruguay is dacarbazine. There is no published head-to-head trial assessing the effects of VC versus dacarbazine. The objective of this study was to perform an indirect comparison of the effects of dacarbazine, compared with VC, based on the results of trials that included both treatments versus the same comparator (vemurafenib alone).Methods:We searched Pubmed and The Cochrane Library for trials comparing either VC or dacarbazine with vemurafenib. Trials were assessed in terms of risk of bias, similarity of interventions and inclusion and exclusion criteria, and comparability of characteristics of patients in the vemurafenib arm. We performed an indirect comparison using the Bucher method.Results:From the literature search we retrieved two studies that met the inclusion criteria: a randomized clinical trial that assessed VC versus vemurafenib or placebo and another assessing dacarbazine versus vemurafenib. Both studies were similar in terms of methodological quality, inclusion and exclusion criteria, and comparability of the vemurafenib arms. However, the comparison of overall survival and progression-free survival curves for the vemurafenib arms were quite different between the two trials. At 9 months, overall survival was eighty-one percent and fifty-five percent and progression-free survival was thirty percent and fifteen percent, respectively. The indirect comparison provided the following hazard ratios: 0.24 (95% confidence interval [CI]: 0.14–0.48) for overall survival; 0.13 (95% CI: 0.09–0.19) for progression-free survival; and 0.15 (95% CI: 0.02–1.29) for grade 4 adverse events.Conclusions:Treatment with VC increased overall survival and progression-free survival, compared with dacarbazine. Severe adverse events were less frequent with the combined therapy. However, the differences in the vemurafenib survival curves increases doubts about the accuracy of the indirect estimators of overall survival and progression-free survival.

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Ivanescu, C., K. Skaltsa, and P. Kráľ. "Acceptance of Population-Adjusted Indirect Treatment Comparison Methods In Nice Assessments." Value in Health 20, no. 9 (October 2017): A695. http://dx.doi.org/10.1016/j.jval.2017.08.1785.

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Obloza, Aneta, Joshua Kirby, Derrick Yates, and Philip Toozs-Hobson. "Indirect treatment comparison (ITC) of medical therapies for an overactive bladder." Neurourology and Urodynamics 36, no. 7 (February 21, 2017): 1824–31. http://dx.doi.org/10.1002/nau.23189.

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Peters, Anju T., Joseph K. Han, Peter Hellings, Enrico Heffler, Philippe Gevaert, Claus Bachert, Yingxin Xu, et al. "Indirect Treatment Comparison of Biologics in Chronic Rhinosinusitis with Nasal Polyps." Journal of Allergy and Clinical Immunology: In Practice 9, no. 6 (June 2021): 2461–71. http://dx.doi.org/10.1016/j.jaip.2021.01.031.

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Kang, Nayon, and Diana M. Sobieraj. "Indirect treatment comparison of new oral anticoagulants for the treatment of acute venous thromboembolism." Thrombosis Research 133, no. 6 (June 2014): 1145–51. http://dx.doi.org/10.1016/j.thromres.2014.03.035.

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Zhu, Xiaoying. "Comparison of Nusinersen and Evrysdi in the Treatment of Spinal Muscular Atrophy." E3S Web of Conferences 271 (2021): 03035. http://dx.doi.org/10.1051/e3sconf/202127103035.

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Spinal Muscular Atrophy (SMA) is a genetic neuromuscular disease that commonly affects children, and usually worsens with age that often leads to permanent disability and death for many of the SMA patients. Recently, two drugs are developed to improving the quality of life of SMA sufferers: Evrysdi and Nusinersen. This study is identified by a systematic literature review to compare two treatments. The comparison attempts to focus on mechanism, administration and clinical trials. The trials include the ENDEAR study for Nusinersen, and the FIREFISH study for Evrysdi. Due to the different baselines of two trials, matching-adjusted indirect comparison (MAIC) is used to “weighted” baseline characteristics to match each other across all the studies. Each of the trials highlighted the effectiveness for comparison. Both Nusinersen and Evrysdi have had a major and positive impact on improving the quality of life of SMA, and both therapies have been shown to be highly effective. Moreover, the indirect comparison with Matching Adjustment Indirect Comparison shows that Risdiplam is more effective as compared to Nusinersen. Nonetheless, the comparison is still inaccurate due to lack of real-world evidence from patients.

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Weber, Dorothea, Katrin Jensen, and Meinhard Kieser. "Comparison of Methods for Estimating Therapy Effects by Indirect Comparisons: A Simulation Study." Medical Decision Making 40, no. 5 (July 2020): 644–54. http://dx.doi.org/10.1177/0272989x20929309.

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Objective. In evidence synthesis, therapeutic options have to be compared despite the lack of head-to-head trials. Indirect comparisons are then widely used, although little is known about their performance in situations where cross-trial differences or effect modification are present. Methods. We contrast the matching adjusted indirect comparison (MAIC), simulated treatment comparison (STC), and the method of Bucher using a simulation study. The different methods are evaluated according to their power and type I error rate as well as with respect to the coverage, bias, and the root mean squared error (RMSE) of the effect estimate for practically relevant scenarios using binary and time-to-event endpoints. In addition, we investigate how the power planned for the head-to-head trials influences the actual power of the indirect comparison. Results. Indirect comparisons are considerably underpowered. None of the methods had substantially superior performance. In situations without cross-trial differences and effect modification, MAIC and Bucher led to similar results, while Bucher has the advantage of preserving the within-study randomization. MAIC and STC could enhance power in some scenarios but at the cost of a potential type I error inflation. Adjusting MAIC and STC for confounders that did not modify the effect led to higher bias and RMSE. Conclusion. The choice of effect modifiers in MAIC and STC influences the precision of the indirect comparison. Therefore, a careful selection of effect modifiers is warranted. In addition, missed differences between trials may lead to low power and partly high bias for all considered methods, and thus, results of indirect comparisons should be interpreted with caution.

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Rasouliyan, L. "Comparison of Methods for Indirect Treatment Comparison Combining Individual and Aggregate Patient Data: A Simulation." Value in Health 19, no. 7 (November 2016): A392—A393. http://dx.doi.org/10.1016/j.jval.2016.09.262.

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Schiffner-Rohe, Julia, Jörg Rahnenführer, Friedhelm Leverkus, and Sarah Kühnast. "Evaluation of Adjusted and Unadjusted Indirect Comparison Methods in Benefit Assessment." Methods of Information in Medicine 56, no. 03 (2017): 261–67. http://dx.doi.org/10.3414/me15-02-0016.

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SummaryBackground: With the Act on the Reform of the Market for Medicinal Products (AMNOG) in Germany, pharmaceutical manufacturers are obliged to submit a dossier demonstrating added benefit of a new drug compared to an appropriate comparator. Underlying evidence was planned for registration purposes and therefore often does not meet the appropriate comparator as defined by the Federal Joint Committee (G-BA). For this reason AMNOG allows indirect comparisons to assess the extent of added benefit.Objectives: The aim of this study is to evaluate the characteristics and applicability of adjusted indirect comparison described by Bucher and Matching-Adjusted Indirect Comparison (MAIC) in various situations within the early benefit assessment according to §35a Social Code Book 5. In particular, we consider time-to-event endpoints.Methods: We conduct a simulation study where we consider three different scenarios: I) similar study populations, II) dissimilar study populations without interactions and III) dissimilar study populations with interactions between treatment effect and effect modifiers. We simulate data from a Cox model with Wei- bull distributed survival times. Desired are unbiased effect estimates. We compare the power and the proportion of type 1 errors of the methods.Results: I) Bucher and MAIC perform equiva- lently well and yield unbiased effect estimates as well as proportions of type 1 errors below the significance level of 5%. II) Both Bucher and MAIC yield unbiased effect estimates, but Bucher shows a higher power for detection of true added benefit than MAIC. III) Only MAIC, but not Bucher yields unbiased effect estimates. When using robust variance estimation MAIC yields a proportion of type 1 error close to 5%.In general, power of all methods for indirect comparisons is low. An increasing loss of power for the indirect comparisons can be observed as the true treatment effects decrease.Conclusion: Due to the great loss of power and the potential bias for indirect comparisons, head-to-head trials using the appropriate comparator as defined by the Federal Joint Committee should be conducted whenever possible. However, indirect comparisons are needed if no such direct evidence is available. To conduct indirect comparisons in case of a present common comparator and similar study populations in the trials to be compared, both Bucher and MAIC can be recommended. In case of using adjusted effect measures (such as Hazard Ratio), the violation of the similarity assumption has no relevant effect on the Bucher approach as long as interactions between treatment effect and effect modifiers are absent. Therefore Bucher can still be considered appropriate in this specific situation. In the authors’ opinion, MAIC can be considered as an option (at least as sensitivity analysis to Bucher) if such interactions are present or cannot be ruled out. Nevertheless, in practice MAIC is potentially biased and should always be considered with utmost care.

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Dyakov, I. N., and S. K. Zyryanov. "Pharmacoeconomic comparison of insulin glargine and insulin detemir in diabetes mellitus type 2." Kachestvennaya klinicheskaya praktika, no. 3 (September 27, 2020): 4–14. http://dx.doi.org/10.37489/2588-0519-2020-3-4-14.

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Second generation insulin analogue — insulin glargine 300 UI/ml (GLA-300) — can provide an effective control of Diabetes Mellitus (DM) with minimal risk of hypoglycemic events and prevent of cardiovascular complications or events (CVS). Pharmacoeconomic comparison of most used insulins — GLA-300 and detemir (IDet) has been based on indirect treatment comparison in DM Type 2. Materials and methods. Indirect treatment comparison was created according to published data of a real world evidence data for the treatment of DM Type 2 with GLA-300 and IDet, and common comparator — GLA-100 — has been used. Patients (%) who reached HbA1c target were indicated as an efficacy criteria. Odds ratios (OR) were calculated for clinical efficacy and severe hypoglycemia’s rate comparisons for GLA-300 and IDet. Direct (cost of annual treatment, hypoglycemia correction, CVS treatment), indirect medical costs as well as indirect costs (GDP loses) were calculated for GLA-300 and IDet strategies. Sensitivity analysis has been performed for confirmation of the base scenario results. Results. GLA-300 has advantages vs IDet by efficacy and less risks of severe hypoglycemia (OR 1.27 CI 95 % 1.02; 1.58 and OR 0.72 CI 95 % 0.56; 0.88 accordingly). Probability of good control of DM Type 2 (based on target of HbA1c<7.0 %) was higher on 27 % in GLA-300. Costs of insulins, expenditures for CVS treatment and payment for temporary disability were similar for GLA-300 and IDet groups (for the one-year treatment period), in the same time in GLA-300 group the less expenditures for hypoglycemia were observed. Total expenditures were slightly less for GLA-300 on 3.7 % vs IDet.Conclusion. GLA-300 and IDet have no economic advantages between groups in total costs, but GLA-300 has tended for economic benefi ts in compare with IDet in DM Type 2.

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Andreozzi, Valeska, Björn Vandewalle, and Jorge Parreira. "Comparing Randomized Controlled Data with Grouped Data from the Literature to Inform Decision Making When Standard of Care Has Low Level of Evidence Available." Blood 132, Supplement 1 (November 29, 2018): 5920. http://dx.doi.org/10.1182/blood-2018-99-118601.

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Abstract Objectives: To apply indirect comparison methods to inform decision-making when standard of care has low level of evidence available. Methods: Simulated treatment comparison is one of the methods available to generate indirect comparison of data in different formats and levels of evidence. It is particularly helpful when patient level data exists for one set of data and there is the need to compare it with single-arm studies. In theses cases evidence is deemed ''unanchored'' due to a lack of a common comparator. We use the case of second line treatment of chronic immune thrombocytopenic purpura (ITP). Splenectomy has been historically recommended in guidelines mainly due to the lack of evidence for other second-line therapies for ITP. We use individual patient data from eltrombopag clinical trials and one of the only studies published in the literature reporting long term outcomes for splenectomy to generate an indirect comparison of eltrombopag and splenectomy in second line treatment of ITP. Results: A subset of patients (n=84) treated with eltrombopag but not subject to splenectomy in the randomised, phase 3 study RAISE (PMID:20739054) were indirectly compared with a large retrospective cohort of patients (n=233) who underwent splenectomy for ITP in the study by Vianelli et al (PMID:23144195). After controlling for gender, age, baseline platelet count and number of previous therapies, we estimate that the proportion of patients with ITP responding to second line therapy is higher with eltrombopag in comparison to splenectomy: complete response (platelet count >100x109/L) 68.6% vs 54.0%; partial response 18.6% vs 24.6%; no response (platelet count <30x109/L)) 12.8% vs 21.4%. Conclusions: Indirect comparison with simulated treatment comparison is useful for decision making when no head to head data exists between new treatment options and standard of care and also when standard of care has low level of evidence available. Disclosures No relevant conflicts of interest to declare.

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Richardson, Paul G., Jae Hoon Lee, Istvan Majer, Arun Krishna, and Richard C. Woodman. "Efficacy of Treatments in Relapsed or Relapsed and Refractory Multiple Myeloma: An Indirect Treatment Comparison." Blood 124, no. 21 (December 6, 2014): 2638. http://dx.doi.org/10.1182/blood.v124.21.2638.2638.

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Abstract Background: In the phase 3, randomized, international, double-blind PANORAMA 1 trial, panobinostat in combination with bortezomib and dexamethasone (PAN/BTZ/DEX, n=387) demonstrated superior progression-free survival (PFS), time to progression (TTP) and near complete response plus complete response rate (nCR+CR) over placebo/BTZ/DEX (n=381) in patients with relapsed or relapsed and refractory multiple myeloma (RR MM). These results support the addition of panobinostat to BTZ/DEX and demonstrate that this regimen is a valuable addition to the current treatment options for RR MM. However, evidence on the efficacy of PAN/BTZ/DEX relative to other relevant treatments is lacking. The aim of this study was to perform an indirect treatment comparison (ITC) to estimate the relative efficacy of PAN/BTZ/DEX compared to commonly used treatment regimens. Methods: A systematic literature review was conducted. MEDLINE, MEDLINE In-Process, EMBASE, the Cochrane Library, and conference proceedings were searched covering clinical studies dating from January 2003 to April 2014. Studies included phase 2-4 clinical trials specifically focusing on RR MM, reporting results in English for the most commonly used agents: intravenous BTZ, lenalidomide (LEN), thalidomide (THAL), and doxorubicin (DOX). Data were extracted on study details, study duration, and efficacy outcomes including the hazard ratio (HR) of PFS, the HR of TTP, and the number of patients who achieved nCR+CR. Multi-arm randomized controlled trials were selected for inclusion in the evidence base of the ITC. Included studies were similar in terms of trial design (e.g. patient selection criteria), patient characteristics (e.g. age, time since diagnosis, number of prior lines of therapy), and included treatments that could be linked via common comparators. Data were analysed by applying fixed effects models to estimate HRs of PFS, HRs of TTP, and odds ratios (OR) of nCR+CR. PAN/BTZ/DEX was chosen as the reference treatment for ease of comparability and interpretability of the results. The models were conducted using Markov Chain Monte Carlo simulation methods implemented in WinBUGS 1.4. The mean of the posterior distribution was taken as the point estimate and 95% credible intervals (CI), i.e. range of values containing the true mean with a probability of 95%, were calculated. Results: The analysis screened 637 studies of which 83 were assessed by full text. Five relevant trials were identified (PANORAMA 1, MM-009, MM-010, APEX, and DOXIL-MMY-3001) that included PAN/BTZ/DEX, BTZ/DEX, BTZ, DEX, LEN/DEX, and BTZ/DOX. Since no trial was conducted to assess the efficacy of BTZ/DEX versus DEX, results of a matched-pairs comparison analysis (using propensity score matching) were utilized in the evidence network. The patient populations across the studies were similar in terms of median age (61-64 years), disease duration (24-48 months at baseline), and proportions of patients with one prior line of therapy (32-46%), except the matched pairs analysis, where only patients with one prior line of therapy were considered. The number of patients included in the studies totaled 4,109. Results of the comparison between PAN/BTZ/DEX and other treatments in terms of PFS indicated that PAN/BTZ/DEX was associated with the lowest risk of progression or death. Similarly, the HR of time to progression was estimated to be higher for other drugs than for PAN/BTZ/DEX. The odds ratio of nCR+CR indicated higher response rates for PAN/BTZ/DEX than for other treatments. Coefficients and CIs are reported in Table 1. Discussion: The analyses implicitly assume that covariates acting as potential relative treatment effect modifiers (e.g. patients with relapsed and refractory MM, ß2-microglobulin level) are similar across trials. The numerical trends of the analyses suggest that PAN/BTZ/DEX is at least as efficacious as other treatments in RR MM with significant advantage against most comparators. Table 1. Results of the indirect treatment comparisons PAN/BTZ/DEX BTZ/DEX BTZ DEX LEN/DEX DOX/BTZ PFS (HR,+/-1 CI) 1.00 1.60 (1.32-1.92) 2.77 (1.53-4.62) 5.11 (2.51-9.20) 1.87 (0.87-3.49) 1.66 (0.87-2.90) TTP (HR,+/-1 CI) 1.00 1.67 (1.37-2.02) 2.90 (1.60-4.83) 5.35 (2.59-9.65) 1.90 (0.89-3.50) 1.61 (0.83-2.82) CR+nCR (OR,+/-1 CI) 1.00 0.50 (0.34-0.69) 0.44 (0.14-1.04) 0.05 (0.01-0.15) 0.49 (0.08-1.63) 0.60 (0.17-1.51) Disclosures Richardson: Takeda: Research Funding; Millennium: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees. Majer:Novartis: Consultancy. Krishna:Novartis: Employment. Woodman:Novartis: Employment, Equity Ownership.

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Tan, Pui S., Benjamin Haaland, Alberto J. Montero, Christos E. Kyriakopoulos, and Gilberto Lopes. "Hormonal Therapeutics Enzalutamide and Abiraterone Acetate in the Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC) Post-docetaxel—an Indirect Comparison." Clinical Medicine Insights: Oncology 8 (January 2014): CMO.S13671. http://dx.doi.org/10.4137/cmo.s13671.

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Introduction This study aims to make an indirect comparison between enzalutamide and abiraterone acetate for mCRPC post-docetaxel. Methods A search for published phase 3 trials was performed with PubMed. Indirect comparisons of enzalutamide (AFFIRM) to abiraterone acetate (COU-AA-301) on outcomes overall survival (OS), time to prostate-specific-antigen (PSA) progression, radiographic progression-free survival (PFS), and PSA response were constructed in the context of log-linear regression models. Results There was no statistically significant difference in OS (hazard ratio (HR) 0.85, 95% CI 0.68–1.07). However, there was some evidence that enzalutamide may outperform abiraterone acetate with respect to secondary outcomes: time to PSA progression (HR 0.40, 95% CI 0.30–0.53), radiographic PFS (HR 0.61, 95% CI 0.50–0.74), and PSA response rates (RRs) (OR 10.69, 95% CI 3.92–29.20). Conclusion While there was no statistically significant difference in OS, enzalutamide may be advantageous for secondary endpoints. Findings of this indirect comparison serve to be hypothesis-generating for future head-to-head trials.

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Kim, H., L. Gurrin, and D. Liew. "DB3 Indirect Treatment Comparison (ITC) or Cost-Effectiveness Analysis (CEA): a Study." Value in Health 15, no. 7 (November 2012): A604. http://dx.doi.org/10.1016/j.jval.2012.08.015.

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Leleu, H., I. Rodriguez, M. Blachier, and J. Pentel. "Indirect Comparison for E/C/F/Taf In Treatment Naïve Hiv Patients." Value in Health 18, no. 7 (November 2015): A578. http://dx.doi.org/10.1016/j.jval.2015.09.1926.

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Chen, Yao-Yao, Juan Li, Min Chen, Ling Yue, Tian-Wei She, and Hui Zheng. "Acupuncture versus propranolol in migraine prophylaxis: an indirect treatment comparison meta-analysis." Journal of Neurology 267, no. 1 (August 21, 2019): 14–25. http://dx.doi.org/10.1007/s00415-019-09510-x.

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Alsop, Jonathan, Lawrence Pont, and Martin Scott. "VP90 Which Matching Adjusted Indirect Comparison Method Is Best?" International Journal of Technology Assessment in Health Care 35, S1 (2019): 94–95. http://dx.doi.org/10.1017/s0266462319003350.

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IntroductionMatching adjusted indirect comparison (MAIC) methods are extremely useful when conducting ITCs, as they reduce baseline imbalances between studies, particularly upon patient characteristics that are confounded with treatment. The standard approach when conducting MAIC is that proposed by Signorovitch et al. (2010). However, there are newer, and potentially better, methods available.MethodsThree different MAIC methods (Signorovitch, Entropy Balancing, Polynomial Weighting) were compared using multiple phase 3 RCTs conducted in Diabetic Retinal Edema. The matching ability of each method was assessed, alongside its ability to avoid large weights (i.e. avoiding high leverage), and maximise effective same size (ESS). Each method's overall ease of use and impact upon estimates of treatment effectiveness were also evaluated.ResultsAll methods were able to precisely match the aggregate level data. However, the Entropy Balancing and Polynomial Weighting both outperformed the Signorovitch method in terms of having the lowest maximum weights. The Polynomial Weighting provided the highest ESS. The Entropy Balancing method was arguably the most challenging to implement, whilst the Signorovitch method the least. The Polynomial Weighting method appears to provide the greatest flexibility to the user.ConclusionsWhilst the Signorovitch method has become almost synonymous with MAIC, the Entropy Balancing and Polynomial Weighting methods offer potentially superior performance. In the absence of head-to-head trial data, these new MAIC approaches should provide less biased and more precise estimates of comparative effectiveness – ultimately leading to better decision making by regulators and payers.

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Bonthapally, V., S. Ghosh, and H. Rappaport. "PCN11 INDIRECT COMPARISON TO ESTIMATE THE EFFICACY OF INTERVENTIONS IN TREATMENT OF METASTATIC RENAL CELL CARCINOMA: A MIXED TREATMENT COMPARISON." Value in Health 12, no. 7 (October 2009): A258. http://dx.doi.org/10.1016/s1098-3015(10)74263-7.

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Bagust, A., A. Boland, J. Hockenhull, N. Fleeman, J. Greenhalgh, Y. Dundar, C. Proudlove, et al. "Rituximab for the treatment of rheumatoid arthritis." Health Technology Assessment 13, Suppl 2 (September 2009): 23–29. http://dx.doi.org/10.3310/hta13suppl2-04.

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This paper presents a summary of the evidence review group’s critical review of the evidence for the clinical effectiveness and cost-effectiveness of rituximab for the treatment of severe rheumatoid arthritis (RA) following failure of previous therapy, including one or more tumour necrosis factor-α inhibitors (TNFi), compared with current standards of care, based upon the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The submission’s clinical evidence came from one randomised, placebo-controlled, double-blind trial (REFLEX – Random Evaluation of Long-term Efficacy of Rituximab in Rheumatoid Arthritis) comparing rituximab plus methotrexate (MTX) with placebo plus MTX in 517 patients with long-standing refractory RA. Rituximab plus MTX was more effective than placebo plus MTX across a range of primary and secondary outcome measures, e.g. American College of Rheumatology (ACR) responses, Health Assessment Questionnaire (HAQ). However, this evidence cannot be used directly to address the manufacturer’s analysis of the decision problem because, in the REFLEX trial, rituximab was not compared with a relevant comparator (e.g. leflunomide or second or third TNFi). Long-term efficacy data for retreatment with rituximab are favourable, with an estimated mean time to retreatment of 307 days (n = 164). Evidence from a further five trials is presented as the basis for indirect comparisons with other disease-modifying antirheumatic drugs (DMARDs); however, it is not clear that all relevant clinical studies have been included in the indirect comparison exercise, the rationale for the choice of indirect comparison method adopted is unclear and the indirect comparison method used to adjust the ACR responses only uses a single value for the reference placebo. The submitted microsimulation Markov model was based upon the REFLEX trial. For the ‘NICE-recommended’ scenario and the ‘sequential TNFi’ scenario, the original submission reports incremental cost-effectiveness ratios (ICERs) of £14,690 and £11,601 per quality-adjusted life-year (QALY) gained respectively. After model assumptions were adjusted to more realistic estimates by the ERG, the ICERs for the NICE-recommended scenario and the sequential use of TNFi range from £37,002 to £80,198 per QALY gained and from £28,553 to £65,558 per QALY gained respectively. The guidance issued by NICE in August 2007 states that rituximab in combination with methotrexate is recommended as an option for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response to or intolerance of other DMARDs including treatment with at least one TNFi therapy.

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Busse, William, Geoffrey Chupp, Hiroyuki Nagase, Frank C. Albers, Scott Doyle, Qin Shen, Daniel J. Bratton, and Necdet B. Gunsoy. "Anti–IL-5 treatments in patients with severe asthma by blood eosinophil thresholds: Indirect treatment comparison." Journal of Allergy and Clinical Immunology 143, no. 1 (January 2019): 190–200. http://dx.doi.org/10.1016/j.jaci.2018.08.031.

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Freemantle, N., C. Cooper, A. Diez-Perez, M. Gitlin, H. Radcliffe, S. Shepherd, and C. Roux. "Results of indirect and mixed treatment comparison of fracture efficacy for osteoporosis treatments: a meta-analysis." Osteoporosis International 24, no. 1 (July 26, 2012): 209–17. http://dx.doi.org/10.1007/s00198-012-2068-9.

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Danchenko, N., D. Delgado, K. Haeussler, M. Malmenas, C. Rios, and J. Lundkvist. "PND10 INDIRECT TREATMENT COMPARISON OF BOTULINUM TOXINS A FOR THE TREATMENT OF PEDIATRIC UPPER LIMB SPASTICITY." Value in Health 23 (May 2020): S260. http://dx.doi.org/10.1016/j.jval.2020.04.903.

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Patel, V., I. Kontoudis, and G. Tremblay. "An Indirect Treatment Comparison Of Eribulin Versus Trabectedin For The Treatment Of Advanced Soft Tissue Sarcoma." Value in Health 19, no. 3 (May 2016): A140. http://dx.doi.org/10.1016/j.jval.2016.03.1657.

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Peters, A., J. Han, P. Hellings, E. Heffler, P. Gevaert, C. Bachert, Y. Xu, et al. "P506 INDIRECT TREATMENT COMPARISON OF BIOLOGICS USED FOR THE TREATMENT OF CHRONIC RHINOSINUSITIS WITH NASAL POLYPS." Annals of Allergy, Asthma & Immunology 125, no. 5 (November 2020): S48—S49. http://dx.doi.org/10.1016/j.anai.2020.08.164.

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Bourdin, Arnaud, Don Husereau, Nicolas Molinari, Sarowar Golam, Mohd Kashif Siddiqui, Leandro Lindner, and Xiao Xu. "Matching-adjusted indirect comparison of benralizumab versus interleukin-5 inhibitors for the treatment of severe asthma: a systematic review." European Respiratory Journal 52, no. 5 (October 11, 2018): 1801393. http://dx.doi.org/10.1183/13993003.01393-2018.

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Benralizumab is an interleukin-5 receptor α-directed cytolytic monoclonal antibody that directly depletes eosinophils. Its relative efficacy versus other IL-5-targeted treatments for patients with severe, uncontrolled asthma is not yet fully characterised.We performed a matching-adjusted indirect comparison (MAIC) of benralizumab versus mepolizumab and reslizumab. Trials were selected through systematic review and evaluation of trial methods. Benralizumab patient-level data were weighted to match treatment-effect-modifying patient characteristics of comparator trials before indirect efficacy comparisons.After matching adjustment, benralizumab and mepolizumab reduced exacerbations versus placebo by 52% and 49%, respectively (rate ratio [RR] 0.94, 95% CI 0.78–1.13; n=1524) and reduced the rate of exacerbations requiring hospitalisation/emergency department visit by 52% and 52%, respectively (RR 1.00, 95% CI 0.57–1.75; n=1524). Benralizumab and mepolizumab similarly improved pre-bronchodilator forced expiratory volume in 1 s at 32 weeks (difference 0.03 L, 95% CI −0.06–0.12; n=1443). Benralizumab and reslizumab patient populations were too dissimilar to generate a sufficient effective sample size to produce a reliable estimate for MAIC.MAIC is a robust way to indirectly compare treatment efficacies from trials with heterogeneous patient populations. When baseline patient characteristics were matched across asthma trials, benralizumab and mepolizumab yielded similar efficacy.

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Finkel, RS, O. Dabbous, R. Arjunji, M. Droege, DE Feltner, A. Novack, M. Menier, and DM Sproule. "P.060 Time to treatment effect in Spinal Muscular Atrophy Type 1 (SMA1): an indirect comparison of treatments." Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques 46, s1 (June 2019): S30. http://dx.doi.org/10.1017/cjn.2019.160.

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Background: SMA1 is a rapidly progressing disease resulting in death/permanent ventilation by 2 years. This study compared clinical trial data evaluating the relationship between treatment timing, time to treatment effect, and clinical outcomes in SMA1 patients Methods: A post-hoc indirect treatment comparison was conducted to measure time-to-effect differences in AVXS-101 (CL-101, NCT02122952, cohort 2) vs nusinersen (ENDEAR, NCT02193074) or risdiplam (FIREFISH, NCT02913482) using CHOP-INTEND scores. Results: Compared with nusinersen, AVXS-101 more rapidly increased mean CHOP-INTEND score from baseline (9.8- and 14.9-point increase at 1- and 2-months post-AVXS-101 vs ≤5-point increase at 2-months post-nusinersen). Greater survival benefits and lower rates of permanent ventilatory support were also observed in AVXS-101- vs nusinersen-treated patients. Compared with risdiplam treatment, AVXS-101 improved median CHOP-INTEND scores (14.0-point increase at 2-months post-AVXS-101 vs 5.5-point increase at ~2-months post-risdiplam). Treatment differences were maintained through 8-months with additional improvements at all time-points. Conclusions: Although patients in these 3 cohorts are not entirely matched (e.g. age, disease severity), useful comparisons can still be made. Based on CHOP-INTEND scores, the treatment effect of AVXS-101 appears to be more rapid vs nusinersen or risdiplam. These findings suggest that timely restoration of SMN protein may be essential for maximizing outcomes in SMA1 patients.

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Skedgel, C., D. Rayson, and T. Younis. "Direct and indirect economic evaluation of upfront and sequential adjuvant treatment in postmenopausal women with breast cancer based on the BIG 1–98 trial." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): 6594. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.6594.

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6594 Background: The monotherapy arms of the BIG 1–98 trial established the clinical superiority of upfront letrozole (LET) relative to tamoxifen alone (TAM) but direct comparison of sequential TAM-LET, LET-TAM and upfront LET did not establish a clinically superior strategy. We undertook an economic evaluation to identify an economically preferred strategy based on the relative cost-effectiveness (CE) of TAM, LET, TAM-LET, and LET-TAM in terms of cost per quality-adjusted life year gained (QALYG). Methods: A state-transition model was developed to calculate cumulative costs and QALYs over a 25yr horizon for hypothetical cohorts of postmenopausal women with HR+ breast cancer undergoing adjuvant hormonal treatment. As the sequential arms were not directly compared to TAM alone, it was not possible to directly compare all strategies. As such, the analysis conducted direct within-arm comparisons and an indirect between-arm comparison. DFS endpoints and relative DFS benefit were derived from the monotherapy and sequential arms of BIG 1–98. Adverse events were not included as these have not yet been reported. Sensitivity analyses were conducted for the key parameters and assumptions, including the baseline recurrence risk and the duration of carry-over benefit. Costs and utility weights were derived from the literature. The analysis took a Canadian direct payer perspective and drug costs were based on 2008 Canadian average wholesale prices. Costs and outcomes were discounted at 3%. Results: In the monotherapy arms LET had a CE of $16,650 relative to TAM. In the sequential arms LET-TAM had superior QALYGs and cost savings relative to LET and TAM-LET. In economic terms, LET-TAM dominated LET and TAM-LET. In the indirect comparison, LET-TAM dominated LET and TAM-LET and had superior QALYGs at increased cost relative to TAM for a CE of $178. Conclusions: Direct comparisons confirm the economic favourability of LET relative to TAM and establish the dominance of LET-TAM over LET and TAM-LET. These indirect comparisons support the strong economic favourability of LET-TAM relative to TAM in the indirect comparison. In the absence of superior clinical outcomes, economic evaluation is a useful in suggesting a preferred strategy. No significant financial relationships to disclose.

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Aggarwal, Saurabh, Michael Serbin, and Chuck Yonan. "Indirect treatment comparison of valbenazine and deutetrabenazine efficacy and safety in tardive dyskinesia." Journal of Comparative Effectiveness Research 8, no. 13 (October 2019): 1077–88. http://dx.doi.org/10.2217/cer-2019-0059.

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Aim: Utilize the Bucher indirect treatment comparison (ITC) method to compare valbenazine and deutetrabenazine efficacy using clinical trial data. Methods: Outcomes included mean change from baseline in Abnormal Involuntary Movement Scale (AIMS) total score, AIMS response (≥50% improvement), clinical global impression of change response (score ≤2) and safety outcomes. Data were pooled by trial and dose; outcomes were analyzed at multiple time points. Results: ITC of AIMS score improvement significantly favored valbenazine 80 mg/day at 6 weeks versus deutetrabenazine 36 mg/day at 8 weeks, while valbenazine 40 mg/day was statistically similar to all doses of deutetrabenazine at all time points. No significant differences between drugs were found in AIMS and clinical global impression of change responses and safety outcomes. Conclusion: In this ITC of pooled trial data, valbenazine was generally favorable over deutetrabenazine, although dose titration and equivalency should be considered when interpreting results.

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Cockle, Sarah M., Gillian Stynes, Necdet B. Gunsoy, Daniel Parks, Rafael Alfonso-Cristancho, Jaro Wex, Eric S. Bradford, Frank C. Albers, and Jenny Willson. "Comparative effectiveness of mepolizumab and omalizumab in severe asthma: An indirect treatment comparison." Respiratory Medicine 123 (February 2017): 140–48. http://dx.doi.org/10.1016/j.rmed.2016.12.009.

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Freemantle, Nick, David A. Ginsberg, Rachael McCool, Kelly Fleetwood, Mick Arber, Kristin Khalaf, Clara Loveman, Quanhong Ni, and Julie Glanville. "Comparative assessment of onabotulinumtoxinA and mirabegron for overactive bladder: an indirect treatment comparison." BMJ Open 6, no. 2 (February 2016): e009122. http://dx.doi.org/10.1136/bmjopen-2015-009122.

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Kirson, N., S. Rao, H. G. Birnbaum, E. Kantor, R. Wei, and M. Cifaldi. "PMS37 INDIRECT COMPARISON OF ADALIMUMAB VERSUS ETANERCEPT FOR THE TREATMENT OF PSORIATIC ARTHRITIS." Value in Health 14, no. 3 (May 2011): A129—A130. http://dx.doi.org/10.1016/j.jval.2011.02.722.

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Cohan, Stanley, Tom Tencer, Stella Arndorfer, Xuelian Zhu, Marko Zivkovic, and Jinender Kumar. "Matching-adjusted indirect treatment comparison of ozanimod versus teriflunomide for relapsing multiple sclerosis." Multiple Sclerosis and Related Disorders 52 (July 2021): 102972. http://dx.doi.org/10.1016/j.msard.2021.102972.

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Rael, Michael, Agnes Benedict, Jack Ishak, Sarah Cadarette, Marco Campioni, and Sumeet Panjabi. "Indirect Comparisons to Assess the Relative Efficacy of Carfilzomib + Lenalidomide + Dexamethasone Versus Panobinostat + Bortezomib + Dexamethasone and Bortezomib + Dexamethasone: A Matching Adjusted Indirect Comparison." Blood 126, no. 23 (December 3, 2015): 5622. http://dx.doi.org/10.1182/blood.v126.23.5622.5622.

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Abstract Background: Several novel treatments have recently been approved for the treatment of relapsed multiple myeloma (RMM). In the absence of head-to-head comparisons between these novel treatments, clinicians and payers must rely on statistical indirect comparisons. The objective of this analysis is to derive measures of relative effectiveness for carfilzomib + lenalidomide + dexamethasone (KRd) against bortezomib + dexamethasone (Vd), and the recently approved combination of panobinostat + bortezomib + dexamethasone (PVd) in patients with RMM who have been treated with at least one prior therapy. Methods: A matching-adjusted indirect comparison (MAIC) (Signorovitch, 2010) for progression-free survival (PFS) and overall survival (OS) was conducted between the KRd arm of the phase III study ASPIRE (Stewart et al., 2015) versus the PVd and Vd arms of the phase III study PANORAMA 1 (San-Miguel et al., 2014). The MAIC utilized patient level data from ASPIRE, and adjusted for reported patient population differences. An MAIC uses a propensity score type equation to assign case weights to the KRd patients so that their weighted baseline characteristics match the baseline of the PVd or Vd population. This re-weighting process attempts to answer the question: What would the outcomes be if KRd had been administered to a population matching the characteristics of the PVd or Vd arms? Adjustments were made for age, gender, ECOG status, history of autologous stem cell transplant, disease duration, number of prior regimens, ISS stage, prior bortezomib use, and creatinine clearance rate. Cox PH models were fitted to estimate hazard ratios (HRs) for PFS and OS. Weibull survival curves best fit the adjusted survival data and were used to estimate median survival times. A simulated treatment comparison (STC) (Ishak et al., 2015), which adjusts for reported patient population differences using regression equations, was conducted as a cross validation. Results: The KRd arm in ASPIRE included 396 patients and the PVd and Vd arms in PANORAMA 1 included 387 and 381 patients, respectively. After successfully matching, the effective sample size of the KRd population was 131 for the PVd comparison and 138 for the Vd comparison. See Figure 1 for the MAIC adjusted PFS and OS Kaplan-Meier curves. Hazard ratios (95% CIs) from the Cox models for PFS and OS outcomes were 0.317 (0.228, 0.44) and 0.582 (0.394, 0.86) for KRd vs PVd, respectively and 0.208 (0.153, 0.283) and 0.472 (0.324, 0.688) for KRd vs Vd, respectively. Corresponding hazard ratios from the STC were similar and validate the MAIC results. Estimates of median PFS and OS in months were 29.5 and 65.2 for KRd compared to 12.0 and 40.9 for PVd, respectively. Corresponding estimates were 29.7 and 57.3 for KRd compared to 8.2 and 33.0 for Vd. Figure 1. Conclusion: This MAIC analysis suggests that KRd provides a consistent and statistically significant PFS and OS benefit relative to PVd and Vd in RMM patients who have been treated with at least one prior therapy. Beyond the patient characteristics available from PANORAMA 1, other variables that may potentially influence outcomes were not adjusted for in the analysis. This analysis did not compare KRd to PVd in patients who have received at least 2 prior regimens including bortezmib and an IMiD (panobinostat's FDA-approved indication) due to lack of published data on the baseline characteristics of this patient subset studied in PANORAMA 1. Disclosures Rael: Onyx: Consultancy; Evidera: Employment. Benedict:Onyx: Consultancy; Evidera: Employment. Ishak:Onyx: Consultancy; Evidera: Employment. Cadarette:Evidera: Employment; Onyx: Consultancy. Campioni:Amgen: Employment, Equity Ownership. Panjabi:Onyx Pharmaceuticals Inc., An Amgen Subsidiary: Employment, Equity Ownership.

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Ishak, K. J., I. Proskorovsky, A. Benedict, and C. Chen. "Simulated Treatment Comparisons – An Alternative Approach to Indirect Comparison When Standard Methods Are Not Feasible or Appropriate." Value in Health 16, no. 7 (November 2013): A615. http://dx.doi.org/10.1016/j.jval.2013.08.1782.

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Diaz, F. A., D. L. Paccamonti, K. R. Bondioli, and G. T. Gentry. "52 VITRIFICATION OF DAY-8 EQUINE EXPANDED BLASTOCYST: AN IN VITRO COMPARISON OF DIRECT VERSUS INDIRECT MECHANICAL INTRODUCTION OF CRYOPROTECTANT." Reproduction, Fertility and Development 26, no. 1 (2014): 140. http://dx.doi.org/10.1071/rdv26n1ab52.

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The cryopreservation of equine expanded blastocysts (>300 μm) has been largely unsuccessful primarily due to the low permeability of the embryo to cryoprotectants. This low permeability has been attributed to the acellular glycoprotein capsule that develops when an embryo approaches approximately 300 μm in diameter. Mechanical alternatives may provide a means to overcome the capsule barrier and the relative large embryo size to successfully cryopreserve equine embryos. The objective of this experiment was to compare re-expansion rates of vitrified equine expanded blastocysts following either direct or indirect mechanical introduction of cryoprotectants using a coaxial microinjection system (Dracula pipette). Twenty-six Day-8 expanded blastocysts were subjected to capsule puncture, cryoprotectant injection, and blastocoele fluid extraction (direct treatment) or capsule puncture and blastocoele fluid extraction (indirect treatment) before cryopreservation. The Dracula pipette incorporates the injection pipette within the holding pipette, facilitating aspiration of blastocoele fluid or injection of cryoprotectant in a single unit. A standard vitrification protocol using a final concentration of 3.4 M glycerol and 4.6 M ethylene glycol at cryopreservation was used. Vitrified embryo re-expansion was assessed following in vitro culture at 24, 48, and 72 h post-warming. Differences across treatments were analysed using the Student's t-test for re-expansion and the chi-squared test of independence for capsule loss. Pre-vitrification embryo mean diameter (mean ± standard error) for direct and indirect treatment groups were not different, 979 ± 85.6 μm and 912 ± 101.4 μm, respectively (P = 0.62). Post-vitrification embryo mean diameters were not different for the direct and indirect treatments (688 ± 63 and 662 ± 75 μm, respectively; P = 0.79). Following 72 h of in vitro culture, there was no difference in mean embryo diameter (1813.16 ± 209 μm v. 1383.88 ± 198 μm; P = 0.21), or re-expansion rates (69 v. 69%) for direct and indirect treatment groups, respectively. However, partial or total capsule loss was 69% (9/13) for direct treatment embryos compared with 30% (4/13) for indirect treatment embryos (P = 0.049). Results from this experiment demonstrate that capsule puncture and blastocoele fluid extraction before vitrification resulted in high re-expansion rates of Day-8 equine expanded blastocysts after warming. More importantly, the relatively large percentage of capsule failure when directly introducing cryoprotectant into the embryo may interfere with maternal recognition of pregnancy following embryo transfer. Nonetheless, based on the embryonic re-expansion rate of vitrified equine embryos following the indirect technique, we anticipate that a relatively high pregnancy rate can be obtained if this technique is used.

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Galvano, Antonio, Marta Castiglia, Sergio Rizzo, Nicola Silvestris, Oronzo Brunetti, Giovanni Vaccaro, Valerio Gristina, et al. "Moving the Target on the Optimal Adjuvant Strategy for Resected Pancreatic Cancers: A Systematic Review with Meta-Analysis." Cancers 12, no. 3 (February 26, 2020): 534. http://dx.doi.org/10.3390/cancers12030534.

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Combination regimens have shown superiority over single agents in the adjuvant treatment of resected pancreatic cancer (PC), but there are no data supporting definition of the best regimen. This work aimed to compare the efficacy and safety of mFOLFIRINOX, gemcitabine+capecitabine, and gemcitabine+nab/paclitaxel in PC patients. A meta-analysis was performed for direct comparison between trials comparing combination regimens and gemcitabine monotherapy. Subsequently, an indirect comparison was made between trials investigating the efficacy and safety of mFOLFIRINOX, gemcitabine+capecitabine, and gemcitabine+nab/paclitaxel because of the same control arm (gemcitabine). A total of three studies met the selection criteria and were included in our indirect comparison. Indirect comparisons for efficacy outcomes showed a benefit in terms of DFS (disease-free survival)/EFS (event-free survival)/RFS (relapse-free survival) for both mFOLFIRINOX versus gemcitabine+capecitabine (HR 0.69, 95% CI 0.52–0.91) and versus gemcitabine+nab/paclitaxel (HR 0.67, 95% CI 0.50–0.90). No significant advantage was registered for OS (overall survival). Indirect comparisons for safety showed an increase in terms of G3-5 AEs (with the exception of neutropenia) for mFOLFIRINOX versus gemcitabine+capecitabine (RR 1.24, 95% CI 1.03–1.50), while no significant differences were observed versus gemcitabine+nab/paclitaxel. According to our results, mFOLFIRINOX is feasible and manageable and could represent a first option for fit PC resected patients.

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Mantha, Simon, and Jack Ansell. "Indirect Comparison Of Dabigatran, Rivaroxaban and Apixaban For Venous Thromboembolic Disease." Blood 122, no. 21 (November 15, 2013): 3640. http://dx.doi.org/10.1182/blood.v122.21.3640.3640.

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Abstract Background Three target-specific oral anticoagulants (TSOA's) have been recently compared to standard therapy with a vitamin K antagonist (VKA) for the treatment of acute venous thromboembolism (VTE). Dabigatran (D) is a direct thrombin inhibitor, while rivaroxaban (R) and apixaban (A) block activated coagulation factor X. Those agents have not been compared head-to-head and minimal data exist to guide the choice of drug for any given patient. Materials and Methods We performed an indirect comparison between TSOA's using all phase III trials comparing D, R or A to a VKA for the acute treatment of VTE. Studies including patients with deep vein thrombosis (DVT), pulmonary embolism (PE) or both were considered. The method used to compute the measure of effect has been described elsewhere (Altman DG et al); briefly, the relative risk (RR) of an event for patients receiving treatment X versus Y (RRXY) is estimated by dividing the RR for treatment X versus Z by the RR for treatment Y versus Z. The standard error (SE) on the logarithmic scale for the indirect comparison XY can be easily computed (SEXY=√[SEXZ2+SEYZ2]). This approach has been previously applied to compare the results of atrial fibrillation trials for D, R and A (Mantha S et al). We employed the SAS 3.0.1 statistical platform, along with the “meta” package. The hazard ratio (HR) of an event during the study period was used for computations when provided in the original journal article since it reflected adjustment for pertinent factors and because for infrequent events the HR and RR have similar values. Results Four phase III trials were identified, consisting of RE-COVER (Schulman S et al), EINSTEIN-DVT (EINSTEIN Investigators), EINSTEIN-PE (EINSTEIN-PE Investigators) and AMPLIFY (Agnelli G et al). The distribution of patient characteristics was similar between studies (see Table). VTE outcomes were reported for the intention-to-treat population and results for major bleeding were given for the safety (ie “on-treatment”) groups. The measures of effect for EINSTEIN-DVT and EINSTEIN-PE where combined using inverse variance weights and the fixed effect meta-analysis model. The estimated RR of recurrent VTE was 0.76 (95% CI=0.41-1.42, p=0.39) for A vs D, 0.95 (95% CI=0.61-1.48, p=0.81) for A vs R and 0.81 for R vs D (95% CI=0.44-1.47, p=0.48). For major bleeding, the RR of an event was 0.38 for A vs D (95% CI=0.16-0.87, p=0.02), compared with 0.58 for A vs R (95% CI=0.29-1.17, p=0.13) and 0.65 for R vs D (95% CI=0.32-1.33, p=0.24). Finally, the RR of all-cause mortality was 0.81 for A vs D (95% CI=0.39-1.67, p=0.56), 0.88 for A vs R (95% CI=0.54-1.45, p=0.63) and 0.91 for R vs D (95% CI=0.47-1.78, p=0.79). See Figure for corresponding plots. Conclusions Except for major bleeding, there was no significant difference in evaluated outcomes between dabigatran, rivaroxaban and apixaban. A dedicated randomized trial directly comparing the new agents would be required to confirm those results. Disclosures: Ansell: Bristol-Myers Squibb: Consultancy; Pfizer: Consultancy; Janssen: Consultancy; Boehringer Ingelheim: Consultancy; Daiichi: Consultancy; Alere: Consultancy; Perosphere: Equity Ownership, Membership on an entity’s Board of Directors or advisory committees; Instrumentation Laboratories: Membership on an entity’s Board of Directors or advisory committees.

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