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Journal articles on the topic 'Galcanezumab'

Author: Grafiati

Published: 4 June 2021

Last updated: 1 February 2022

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1

Oakes, Tina Marie Myers, Vladimir Skljarevski, Qi Zhang, William Kielbasa, Michael E. Hodsdon, Holland C. Detke, Angelo Camporeale, and Joel R. Saper. "Safety of galcanezumab in patients with episodic migraine: A randomized placebo-controlled dose-ranging Phase 2b study." Cephalalgia 38, no. 6 (January 8, 2018): 1015–25. http://dx.doi.org/10.1177/0333102417747230.

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Background Safety findings from a Phase 2b study of galcanezumab, a humanized monoclonal antibody against calcitonin gene-related peptide, for prevention of migraine (NCT02163993) are reported here. Methods Patients aged 18–65 years with episodic migraine were evaluated in this multicenter, double-blind, randomized study. After randomization, 410 patients were administered 5, 50, 120 or 300 mg of galcanezumab or placebo subcutaneously once every 4 weeks for 12 weeks, followed by a post-treatment off-drug period lasting 12 weeks. Results Treatment-emergent adverse events (TEAEs) were primarily rated as mild to moderate. Serious adverse events reported in galcanezumab dose groups were appendicitis, Crohn’s disease, suicidal ideation, and congenital ankyloglossia in an infant of a paternal pregnancy; each of these were reported by one patient. Adverse events leading to discontinuation with galcanezumab treatment were abdominal pain, visual impairment, and upper limb fracture, each reported by one patient. Treatment-emergent injection-site reactions were reported significantly more frequently ( p = 0.013) with galcanezumab (13.9%) than with placebo (5.8%). Injection-site pain was the most common injection-site reaction (galcanezumab 11.4%; placebo 2.9%, p = 0.004). Upper respiratory tract infection (galcanezumab 10.0%; placebo 8.8%) and nasopharyngitis (galcanezumab 7.0%; placebo 2.2%) also occurred more frequently with galcanezumab treatment. Potential hypersensitivity events were reported at similar frequencies in galcanezumab (3.3%) and placebo (5.1%) groups. Incidence of treatment-emergent anti-drug antibodies in galcanezumab dose groups (4.6% of patients during treatment period) did not appear to have any meaningful effects on safety, the pharmacokinetics of galcanezumab, or its ability to bind to the target ligand. Conclusion The results from this 3-month Phase 2b study support the initiation of larger Phase 3 trials of longer duration.

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Detke, Holland C., Peter J. Goadsby, Shufang Wang, Deborah I. Friedman, Katherine J. Selzler, and Sheena K. Aurora. "Galcanezumab in chronic migraine." Neurology 91, no. 24 (November 16, 2018): e2211-e2221. http://dx.doi.org/10.1212/wnl.0000000000006640.

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ObjectiveTo evaluate the efficacy and safety of galcanezumab, a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide, in the preventive treatment of chronic migraine.MethodsA phase 3, randomized, double-blind, placebo-controlled study of LY2951742 in patients with chronic migraine (Evaluation of Galcanezumab in the Prevention of Chronic Migraine [REGAIN]) was a phase 3 study with a 3-month double-blind, placebo-controlled treatment phase and a 9-month open-label extension. Eligible patients 18 to 65 years of age with chronic migraine were randomized 2:1:1 to monthly subcutaneous injections of placebo (n = 558), galcanezumab 120 mg (with a 240-mg loading dose, n = 278), or galcanezumab 240 mg (n = 277). The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days (MHDs) during the 3-month double-blind treatment phase.ResultsMean number of monthly MHDs at baseline was 19.4 for the total sample. Both galcanezumab dose groups demonstrated greater overall mean reduction in the number of monthly MHDs compared to placebo (placebo −2.7, galcanezumab 120 mg −4.8, galcanezumab 240 mg −4.6) (p < 0.001 for each dose compared to placebo). There were no clinically meaningful differences between galcanezumab doses and placebo on any safety or tolerability outcome except for a higher incidence of treatment-emergent injection-site reaction (p < 0.01), injection-site erythema (p < 0.001), injection-site pruritus (p < 0.01), and sinusitis (p < 0.05) in the galcanezumab 240-mg group relative to placebo.ConclusionsBoth doses of galcanezumab were superior to placebo in reducing the number of monthly MHDs. Galcanezumab appears efficacious, safe, and well tolerated for the preventive treatment of chronic migraine.ClinicalTrials.gov identifierNCT02614261.Classification of evidenceThis interventional study provides Class I evidence that galcanezumab is superior to placebo in the reduction of the number of monthly MHDs.

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Dodick, David W., Peter J. Goadsby, Christian Lucas, Rigmor Jensen, Jennifer N. Bardos, James M. Martinez, Chunmei Zhou, et al. "Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment." Cephalalgia 40, no. 9 (February 12, 2020): 935–48. http://dx.doi.org/10.1177/0333102420905321.

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Objective To report efficacy and safety of galcanezumab in adults with chronic cluster headache. Background Galcanezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide and inhibits its biological activity. Methods This study comprised a prospective baseline period, a 12-week double-blind, placebo-controlled treatment period, and a 52-week open-label period. Up to six protocol-specified concomitant preventive medications were allowed if patients were on a stable dose for 2 months prior to the prospective baseline period. Patients were randomized 1:1 to monthly subcutaneous galcanezumab (300 mg) or placebo. The primary endpoint was overall mean change from baseline in weekly attack frequency with galcanezumab compared to placebo. Key secondary endpoints were ≥50% response rate and percentage of patients meeting sustained response. Results from the double-blind treatment period are reported. Results A total of 237 patients were randomized and treated (120 placebo; 117 galcanezumab). At baseline, the mean age was 45 years and 63% were using ≥1 preventive drug. The primary endpoint was not met; mean change in weekly attack frequency was −4.6 placebo versus −5.4 galcanezumab ( p = 0.334). Key secondary endpoints also were not met. Injection site-related treatment-emergent adverse events were more common in the galcanezumab than the placebo group, with significantly more injection site erythema. Conclusion Treatment with galcanezumab 300 mg did not achieve its primary and key secondary endpoints. This study underscores the potential distinct biology of cCH as well as the significant unmet need for safe, effective, and well-tolerated preventive treatment. The safety profile of galcanezumab in cCH is consistent with that observed in trials of episodic CH and migraine. Trial registration NCT02438826; https://www.clinicaltrials.gov/ct2/show/NCT02438826 .

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Ruff, Dustin D., Janet H. Ford, Antje Tockhorn-Heidenreich, Matthew Sexson, Sriram Govindan, Eric M. Pearlman, Shuu-Jiun Wang, Arif Khan, and Sheena K. Aurora. "Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure." Cephalalgia 39, no. 8 (May 19, 2019): 931–44. http://dx.doi.org/10.1177/0333102419847957.

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Background Efficacy of galcanezumab in chronic migraine has been demonstrated in a pivotal Phase 3 study. Here, we assess efficacy in patients who have failed ≥2 and ≥1 prior migraine preventives for efficacy and/or safety reasons, and in those who never failed. Study design/methods REGAIN (NCT02614261) was a Phase 3, randomized, double-blind, placebo-controlled study in patients with chronic migraine. Patients were randomized 2:1:1 to receive placebo, galcanezumab 120 mg/240 mg once monthly during a double-blind treatment period lasting three months. Subgroup analyses were conducted among patients who failed ≥2 and ≥1 prior preventives and who never failed previously. Outcomes assessed were change from baseline in number of monthly migraine headache days, proportion of patients with ≥50% and ≥75% response (reduction in monthly migraine headache days), change in number of monthly migraine headache days with acute medication use and change in patient functioning per Migraine-Specific Quality of Life Questionnaire Role Function Restrictive (MSQ RF-R) domain score. Results Treatment with galcanezumab versus placebo resulted in significant improvements ( p < 0.01) in overall reduction (Months 1–3) from baseline in the number of monthly migraine headache days in patients with prior failures (LS mean change [SE]: ≥2 prior failures: galcanezumab 120 mg: −5.35 (0.71); galcanezumab 240 mg: −2.77 (0.66); placebo: −1.01 (0.54); ≥1 prior failures: galcanezumab 120 mg: −5.53 (0.60), galcanezumab 240 mg: −3.53 (0.59); placebo: −2.02 (0.49). Similarly, significant results were seen with galcanezumab versus placebo for ≥50% and ≥75% response rates, reductions in acute medication use and improvements in MSQ RF-R domain score. In the subgroup with no prior preventive failures, results were statistically significant for the 240 mg galcanezumab group versus placebo on all outcome measures, and for the 120 mg group on the reduction in migraine headache days with acute medication use. There was also a higher placebo response observed in the patients with no prior preventive failures. Conclusion Galcanezumab is consistently efficacious versus placebo in reducing monthly migraine headache days and several other key outcomes in patients with chronic migraine who have failed ≥2 or ≥1 preventives previously. In the subgroup with no prior failures, greater numerical differences were seen with galcanezumab, but statistical separation from placebo varied by dose and outcome. Clinicaltrials.gov identifier number NCT02614261.

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red. "Rabattverträge für Galcanezumab." NeuroTransmitter 30, no. 10 (October 2019): 59. http://dx.doi.org/10.1007/s15016-019-6873-7.

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red. "Zulassung für Galcanezumab." NeuroTransmitter 30, no. 3 (March 2019): 46. http://dx.doi.org/10.1007/s15016-019-6694-8.

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red. "Rabattverträge für Galcanezumab." Schmerzmedizin 35, no. 5 (September 2019): 57. http://dx.doi.org/10.1007/s00940-019-1168-4.

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red. "Zulassung für Galcanezumab." DNP - Der Neurologe & Psychiater 20, no. 2 (March 29, 2019): 69. http://dx.doi.org/10.1007/s15202-019-2177-9.

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red. "Rabattverträge für Galcanezumab." DNP - Der Neurologe & Psychiater 20, no. 6 (December 2019): 116. http://dx.doi.org/10.1007/s15202-019-2324-3.

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10

Goadsby, Peter J., David W. Dodick, James M. Martinez, Margaret B. Ferguson, Tina M. Oakes, Qi Zhang, Vladimir Skljarevski, and Sheena K. Aurora. "Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis." Journal of Neurology, Neurosurgery & Psychiatry 90, no. 8 (April 19, 2019): 939–44. http://dx.doi.org/10.1136/jnnp-2018-320242.

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Background and objectiveAs new migraine prevention treatments are developed, the onset of a preventive effect, how long it is maintained and whether patients initially non-responsive develop clinically meaningful responses with continued treatment can be assessed.MethodsAnalyses were conducted post-hoc of a double-blind, placebo-controlled, phase II-a study in patients with episodic migraine receiving galcanezumab 150 mg or placebo biweekly for 12 weeks (Lancet Neurol 13:885, 2014). The number of migraine headache days per week, and onset of efficacy measured as the first week galacanezumab separated from placebo were determined. Patients with ≥50%, ≥75% and 100% reduction in migraine headache days from baseline at months 1, 2 and 3 were calculated and defined as sustained responses. Non-responders (<50% response) at month 1 or 2 who then showed ≥50%, ≥75% and 100% response at later time-points were calculated.ResultsPatients were randomised to galcanezumab (n=107) or placebo (n=110). A significant (p=0.018) change of −0.89±0.11 (galcanezumab) vs −0.53±0.11 (placebo) migraine headache days indicated onset at week 1. Forty-seven per cent of galcanezumab and 25% of placebo patients responding at month 1 maintained response through months 2 and 3. Of non-responders at month 1, 27% on galcanezumab and 20% on placebo responded on months 2 and 3, and 50% of galcanezumab non-responders in months 1 and 2 responded on month 3, vs 24% on placebo.ConclusionsThe onset of efficacy of galcanezumab is within 1 week in a majority of patients, and patients receiving galcanezumab are twice more likely to maintain responses than placebo patients. Early non-responders may respond by month 2 or month 3.Trial registration numberNCT01625988.

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Sakai, Fumihiko, Akichika Ozeki, and Vladimir Skljarevski. "Efficacy and safety of galcanezumab for prevention of migraine headache in Japanese patients with episodic migraine: A phase 2 randomized controlled clinical trial." Cephalalgia Reports 3 (January 1, 2020): 251581632093257. http://dx.doi.org/10.1177/2515816320932573.

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Objective: This study was designed to assess the efficacy and safety of galcanezumab in comparison with placebo for the prevention of migraine in Japanese patients with episodic migraine. Methods: In this double-blind, placebo-controlled study, which was conducted over 6 months, randomized adult patients received subcutaneous injections of galcanezumab (120 mg n = 115, 240 mg n = 114) or placebo ( n = 230) once monthly. The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days. The key secondary outcome measures were response rates (≥50%, ≥75%, and 100%); the Migraine-Specific Quality-of-Life Questionnaire Role Function-Restrictive score; monthly migraine headache days requiring acute treatment; and Patient Global Impression of Severity (PGI-S). Results: The mean change from baseline in monthly migraine headache days over months 1–6 was significantly ( p < 0.001) greater for the 120-mg galcanezumab dose (−3.60 days) and the 240-mg galcanezumab dose (−3.36 days) compared with placebo (−0.59 days). Both the 120-mg and 240-mg doses of galcanezumab were superior compared with placebo for each of the key secondary endpoints except for PGI-S (only the 240-mg dose was superior). The most commonly reported treatment-emergent adverse events were local injection-site reactions; erythema, swelling, pruritus, and pain were more commonly reported by patients who were treated with galcanezumab than those treated with placebo. Conclusion: The number of monthly migraine headache days was reduced with both doses of galcanezumab, and both doses were safe and well tolerated in Japanese patients with episodic migraine.

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Gklinos, Panagiotis, and Dimos D. Mitsikostas. "Galcanezumab in migraine prevention: a systematic review and meta-analysis of randomized controlled trials." Therapeutic Advances in Neurological Disorders 13 (January 2020): 175628642091808. http://dx.doi.org/10.1177/1756286420918088.

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Background: Galcanezumab, along with three other monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway, represents the latest disease-specific and mechanism-based treatment for the prophylaxis of migraine. Galcanezumab shares data also for the prophylaxis of cluster headache. Objective: To provide a pooled safety and efficacy analysis of all phase III randomized controlled trials of galcanezumab in the preventive therapy of migraine. Methods: A computer-based literature search was conducted on MEDLINE and the US National Institutes of Health Clinical Trials Registry for phase III randomized controlled trials of galcanezumab in migraine prevention. The primary outcome was the mean change in monthly migraine days (MMDs). The proportions of patients who reported at least one adverse event (AE), at least one serious adverse event (SAE) or withdrew from the study were used as safety outcomes. Results: Two trials were included in the efficacy meta-analysis and three in the safety meta-analysis. Migraine preventive treatment with subcutaneous galcanezumab, at both 120 mg and 240 mg dosages, was associated with a significantly greater reduction in the mean number of MMDs versus placebo (120 mg, MD = –1.98, 95% CI = –2.33 to –1.63; p < 0.0001) or (240 mg, MD = –1.86, 95% CI = –2.20 to –1.53; p < 0.0001). Galcanezumab was found to be more efficacious in all key secondary outcomes as well. Regarding safety, most of the adverse events were mild to moderate, while drop-out rates and serious adverse events were low. Conclusions: Galcanezumab is an efficacious and well-tolerated preventive treatment for migraine. Larger clinical trials with longer follow-up periods need to be conducted in order to provide more safety data of the above-mentioned drug.

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Gklinos, Panagiotis, and Dimos Mitsikostas. "The Role of Galcanezumab in Migraine Prevention: Existing Data and Future Directions." Pharmaceuticals 14, no. 3 (March 9, 2021): 245. http://dx.doi.org/10.3390/ph14030245.

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Galcanezumab is a humanized monoclonal antibody blocking the calcitonin gene-related peptide (CGRP) pathway by targeting the CGRP. Data from four phase-3 randomized placebo-controlled clinical trials showed that galcanezumab is superior to placebo in reducing migraine headaches, migraine-specific quality of life, and headache-related disability. Most of the adverse events (AEs) were mild to moderate and did not affect trial completion rates significantly. Along with erenumab, fremanezumab, and eptinezumab, galcanezumab forms a novel class of anti-migraine preventative treatments that is disease-specific and mechanism-based, unlike the standard ones. In addition, galcanezumab has also been shown to be effective in cluster headache, though more clinical trials are required. Overall, galcanezumab is a promising emerging treatment in migraine prophylaxis. However, it needs to be tested in larger clinical trials focused on treatment-resistant migraine. Furthermore, its safety profile, especially its potential association with an increased cardiovascular risk, needs to be established through long-term, real-world data. This review aims to give an overview of its pharmacological properties as well as to report and discuss data from clinical trials and its potential place in headache therapeutics.

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Johnson, Kirk W., S. Michelle Morin, Victor J. Wroblewski, and Michael P. Johnson. "Peripheral and central nervous system distribution of the CGRP neutralizing antibody [125I] galcanezumab in male rats." Cephalalgia 39, no. 10 (April 19, 2019): 1241–48. http://dx.doi.org/10.1177/0333102419844711.

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Objective The objective of this investigation was to examine the distribution of galcanezumab and a control immunoglobulin 4 antibody containing the same constant regions as galcanezumab, into peripheral and central tissues. Methods Galcanezumab and a control immunoglobulin 4 antibody were radioiodinated with Iodine-125 to specific activities of 0.11 mCi/mg and 0.16 mCi/mg, respectively. At 24, 72, and 168 hours following subcutaneous injection of either antibody (4 mg/kg), cerebrospinal fluid and plasma were obtained followed by saline perfusion to remove residual blood and collection of selected tissues for determination of Iodine-125 content by gamma counting. Results The peak plasma levels of Iodine-125 galcanezumab and Iodine-125 control immunoglobulin 4 were observed at 72 hours and remained high at 168 hours post-dose. The rank order of tissue levels was dura mater = spleen > trigeminal ganglia ≫hypothalamus = spinal cord = prefrontal cortex = cerebellum. Iodine-125 galcanezumab levels in peripheral tissue (dura mater, spleen, and trigeminal ganglia) averaged 5% to 11% of plasma, whereas all of the central nervous system (CNS) tissue levels and the cerebrospinal fluid levels were < 0.4% of plasma. Distribution of the antibodies into the dura mater and the trigeminal ganglia was similar to that observed in the spleen and significantly greater than exposure in the brain or spinal cord. Conclusions The central levels of galcanezumab were relatively low, which would favor the dura mater and trigeminal ganglia as sites of action for its observed clinical efficacy. However, a central site of action cannot be excluded.

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Martinez, James M., Nada Hindiyeh, Greg Anglin, Kavita Kalidas, Michael E. Hodsdon, William Kielbasa, Brian A. Moser, Eric M. Pearlman, and Sandra Garces. "Assessment of immunogenicity from galcanezumab phase 3 trials in patients with episodic or chronic migraine." Cephalalgia 40, no. 9 (April 27, 2020): 978–89. http://dx.doi.org/10.1177/0333102420920642.

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Background This analysis characterizes the immunogenicity profile of galcanezumab, a humanized monoclonal antibody that selectively binds calcitonin gene-related peptide and inhibits its activity, in phase 3 migraine trials. Methods Immunogenicity data were analyzed from baseline and double-blind, placebo-controlled phases of the 3-month chronic migraine study REGAIN, the 6-month episodic migraine studies EVOLVE-1 and EVOLVE-2, and from baseline and open-label phases of the 12-month chronic and episodic migraine Study CGAJ. The incidence of baseline antidrug antibodies, treatment-emergent antidrug antibodies, neutralizing antidrug antibodies, and the effect of antidrug antibody titer on pharmacokinetics and pharmacodynamics were assessed. The relationship between antidrug antibody status and efficacy was explored using average change in monthly migraine headache days. Safety analyses assessed the potential relationship between treatment-emergent antidrug antibodies and hypersensitivity events or adverse events related to injection sites. Findings Across studies, 5.9–11.2% of patients had baseline antidrug antibodies. The incidence of treatment-emergent antidrug antibodies was 2.6–12.4% in the galcanezumab group and 0.5–1.7% in the placebo group. The majority of treatment-emergent antidrug antibodies were detected approximately 3–6 months after first study drug dose. Overall, the observed antidrug antibody titer did not impact galcanezumab concentrations, calcitonin gene-related peptide concentrations, or galcanezumab efficacy. There was no evidence that hypersensitivity events or adverse events related to injection sites were mediated by treatment-emergent antidrug antibodies. Interpretation These data showed that immunogenicity did not impact galcanezumab concentrations, calcitonin gene-related peptide concentrations, or the efficacy and hypersensitivity profile of galcanezumab in patients with migraine.

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Reuter, Uwe. "Galcanezumab CONQUERs migraine prevention." Lancet Neurology 19, no. 10 (October 2020): 798–99. http://dx.doi.org/10.1016/s1474-4422(20)30324-0.

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Schuhmacher, Beate. "Keine Tachyphylaxie unter Galcanezumab." Schmerzmedizin 35, no. 2 (February 26, 2019): 12. http://dx.doi.org/10.1007/s00940-019-1019-3.

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Lamb, Yvette N. "Galcanezumab: First Global Approval." Drugs 78, no. 16 (October 30, 2018): 1769–75. http://dx.doi.org/10.1007/s40265-018-1002-7.

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Siegmund-Schultze, Nicola. "Galcanezumab bei therapierefraktärer Migräne." DNP - Der Neurologe & Psychiater 22, no. 4 (August 2021): 54. http://dx.doi.org/10.1007/s15202-021-4718-2.

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Kopka, Marcin. "Galcanezumab in the prophylaxis of migraine." Pharmacotherapy in Psychiatry and Neurology 36, no. 1 (2020): 59–66. http://dx.doi.org/10.33450/fpn.2020.03.001.

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The aim of preventive treatment of episodic and chronic migraine is to reduce the frequency and severity of seizures and thereby improve the quality of patients' lives. It is estimated that 38% of patients with migraine would benefit from preventive treatment. However, in clinical practice only approximately 13% of patients with migraine receive it. Intolerable side effects and lack of efficacy of pharmacological treatment are the main reasons of treatment discontinuation. It is suggested that calcitonin-gene-related-peptide (CGRP) plays a critical role in migraine pathophysiology. One of them is galcanezumab – a humanised monoclonal antibody that selectively binds to the CGRP peptide. Galcanezumab has demonstrated efficacy in EVOLVE-1, EVOLVE-2 and REGAIN trials. It significantly reduces migraine days per month versus placebo. Moreover, the quality of patients' lives treated with galcanezumab also improved. It has a favourable safety profile, similar to placebo groups. The most frequent adverse event in patients treated with galcanezumab was injection site pain. No toxic effects on the liver or negative influences on hemodynamic or laboratory parameters were reported. The discontinuation rates due to adverse events in patients treated with galcanezumab were low. In October 2019, lasmiditan was approved by FDA and EMA in prophylaxis treatment of migraine in adult patients. Currently, this medicine is not accessible in Poland.

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Ford, Janet H., David W. Ayer, Qi Zhang, Jeffrey N. Carter, Elizabeth Leroux, Vladimir Skljarevski, Sheena K. Aurora, Antje Tockhorn-Heidenreich, and Richard B. Lipton. "Two randomized migraine studies of galcanezumab." Neurology 93, no. 5 (July 3, 2019): e508-e517. http://dx.doi.org/10.1212/wnl.0000000000007856.

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ObjectiveTo evaluate changes from baseline in patient-reported outcomes for measures of functioning and disability among patients with migraine treated with galcanezumab or placebo.MethodsPatients with episodic migraine (4–14 monthly migraine headache days) were treated with either galcanezumab (Evaluation of LY2951742 in the Prevention of Episodic Migraine [EVOLVE]–1: 120 mg n = 210, 240 mg n = 208; EVOLVE-2: 120 mg n = 226, 240 mg n = 220) or placebo (EVOLVE-1 n = 425; EVOLVE-2 n = 450) during 6 months of treatment. Migraine-Specific Quality of Life Questionnaire v2.1 (MSQv2.1) measured the effect of migraine on patient functioning (physical and emotional) in 3 domains, and the Migraine Disability Assessment (MIDAS) quantified headache-related disability associated with missed or reduced productivity at work or home and social events. Both were collected at baseline and during the treatment period (MSQv2.1 = monthly; MIDAS = months 3 and 6 only).ResultsDifferences in MSQv2.1 total score least squares (LS) mean change from baseline (month 4–6) for galcanezumab (120 and 240 mg, respectively) were superior to placebo (EVOLVE-1 = 7.3 and 6.7 [both p < 0.001]; EVOLVE-2 = 8.5 and 7.3 [both p < 0.001]). Differences were similar for all domain scores (p < 0.001 for both galcanezumab doses compared with placebo), were observed as early as month 1, and were sustained for 6 months for most domains. Differences of MIDAS LS mean change from baseline (month 6) for galcanezumab (120 and 240 mg, respectively) compared with placebo were: EVOLVE-1 = −6.3 (p < 0.001) and −5.2 (p = 0.002); EVOLVE-2 = −9.2 and −8.2 (both p < 0.001).ConclusionsPatients with episodic migraine treated with galcanezumab reported significant and clinically meaningful improvements in daily functioning and decreased disability compared with patients who received placebo.Classification of evidenceThis study provides Class II evidence that for patients with migraine, galcanezumab (120 mg or 240 mg) given once monthly improved functioning and reduced disability.

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Plato, Brian, J. Scott Andrews, Mallikarjuna Rettiganti, Antje Tockhorn-Heidenreich, Jennifer Bardos, Richard Wenzel, Dulanji Kuruppu, and Anna Ambrosini. "Efficacy of galcanezumab in patients with episodic cluster headaches and a history of preventive treatment failure." Cephalalgia Reports 4 (January 1, 2021): 251581632110156. http://dx.doi.org/10.1177/25158163211015654.

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Objective: The efficacy of galcanezumab was evaluated in patients with episodic cluster headache and history of preventive treatment failure. Methods: In the randomized, 8-week, double-blind study (CGAL), patients with episodic cluster headache received once-monthly subcutaneous injections of galcanezumab 300 mg or placebo. Patients who completed CGAL and enrolled in an open-label study were queried for preventive treatment history. In a subset of patients with a known history of failure of verapamil or any other prior preventive treatment, a post hoc analysis of least square mean change from baseline in weekly cluster headache attack frequency across Weeks 1 to 3 was assessed. Results: Fifteen patients provided data for known history of prior preventive treatment failure (6 placebo, 9 galcanezumab), of whom 11 failed verapamil. The mean reduction in the weekly frequency of cluster headache attacks was greater with galcanezumab compared to placebo among patients with prior preventive treatment failure (8.2 versus 2.4); mean difference 5.8 (95% confidence interval [CI] 2.0, 13.6) and among patients with verapamil failure (10.1 versus 1.6); mean difference 8.5 (95% CI 0.4, 16.7). Conclusion: In this exploratory analysis of patients with a known history of prior preventive treatment failures, treatment with galcanezumab resulted in greater mean reductions in weekly cluster headache attacks compared with placebo. ClinicalTrials.gov: NCT02397473 (I5Q-MC-CGAL) NCT02797951 (I5Q-MC-CGAR)

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Skljarevski, Vladimir, Manjit Matharu, Brian A. Millen, Michael H. Ossipov, Byung-Kun Kim, and Jyun Yan Yang. "Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial." Cephalalgia 38, no. 8 (May 31, 2018): 1442–54. http://dx.doi.org/10.1177/0333102418779543.

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Introduction Galcanezumab is a humanized monoclonal antibody binding calcitonin gene-related peptide, used for migraine prevention. Methods A global, double-blind, 6-month study of patients with episodic migraine was undertaken with 915 intent-to-treat patients randomized to monthly galcanezumab 120 mg (n = 231) or 240 mg (n = 223) or placebo (n = 461) subcutaneous injections. Primary endpoint was overall mean change from baseline in monthly migraine headache days. Key secondary endpoints were ≥50%, ≥ 75%, and 100% response rates; monthly migraine headache days with acute migraine medication use; Patient Global Impression of Severity rating; the Role Function-Restrictive score of the Migraine-Specific Quality of Life Questionnaire. Results Mean monthly migraine headache days were reduced by 4.3 and 4.2 days by galcanezumab 120 and 240 mg, respectively, and 2.3 days by placebo. The group differences (95% CIs) versus placebo were 2.0 (−2.6, −1.5) and 1.9 (−2.4, −1.4), respectively. Both doses were superior to placebo for all key secondary endpoints. Injection site pain was the most common treatment-emergent adverse event, reported at similar rates in all treatment groups. Both galcanezumab doses had significantly more injection site reactions and injection site pruritus, and the 240 mg group had significantly more injection site erythema versus placebo. Conclusions Galcanezumab 120 or 240 mg given once monthly was efficacious, safe, and well tolerated. Study identification EVOLVE-2; NCT02614196; https://clinicaltrials.gov/ct2/show/NCT02614196 . Trial Registration NCT02614196.

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Özgör, Lamia. "CGRP-Antikörper Galcanezumab zur Migräneprophylaxe." NeuroTransmitter 30, no. 4 (April 2019): 44. http://dx.doi.org/10.1007/s15016-019-6716-6.

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Schmidt, Joana. "Galcanezumab verringert Migräne und Clusterkopfschmerz." Schmerzmedizin 36, no. 3 (May 2020): 12. http://dx.doi.org/10.1007/s00940-020-1735-8.

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Klager, Skylar, Marina Khalil, Kenneth Shulman, and Naveed Sami. "Galcanezumab-induced fixed drug eruption." JAAD Case Reports 9 (March 2021): 90–92. http://dx.doi.org/10.1016/j.jdcr.2021.01.015.

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Xu, Da, Deng Chen, Li-na Zhu, Ge Tan, Hai-jiao Wang, Yu Zhang, and Ling Liu. "Safety and tolerability of calcitonin-gene-related peptide binding monoclonal antibodies for the prevention of episodic migraine – a meta-analysis of randomized controlled trials." Cephalalgia 39, no. 9 (February 21, 2019): 1164–79. http://dx.doi.org/10.1177/0333102419829007.

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Aim To systematically evaluate the safety and tolerability of calcitonin-gene-related peptide binding monoclonal antibodies from the results of randomized controlled trials. Methods Online databases were searched on calcitonin-gene-related peptide binding monoclonal antibodies for the prevention of episodic migraine. Overall withdrawal, withdrawal due to adverse events, adverse events, serious adverse events and specific adverse events were extracted from the included studies. A meta-analysis was performed with Revman 5.3.0 software. Results Ten studies that investigated four drugs (galcanezumab, erenumab, fremanezumab and eptinezumab) with 5817 participants were included in this study. Serious adverse events, overall withdrawals, withdrawal due to adverse events and any adverse events were not significantly associated with monoclonal antibody treatment. Injection site pain and erythema were significantly higher in the calcitonin-gene-related peptide binding monoclonal antibodies treatment group than in the placebo group. The rates of serious adverse events were significantly higher in the galcanezumab 120 mg group. Injection site erythema was associated with galcanezumab 120 mg and 240 mg. Injection site pain and nasopharyngitis were associated with galcanezumab 150 mg and 5 mg, respectively. Overall adverse events were significantly higher with erenumab 70 mg and 140 mg. Treatment-related adverse events were significantly higher with fremanezumab 225 mg/month and 675 mg/quarter. Conclusions This study provides data on the safety and tolerability profiles of calcitonin-gene-related peptide binding monoclonal antibodies and confirms their potential use as preventive treatments for episodic migraine. In addition to the acceptable withdrawal rates, serious adverse events were rare, and the severity of most adverse events was mild to moderate. Injection site reaction may be the major adverse event associated with galcanezumab.

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Kielbasa, William, and Danielle L. Helton. "A new era for migraine: Pharmacokinetic and pharmacodynamic insights into monoclonal antibodies with a focus on galcanezumab, an anti-CGRP antibody." Cephalalgia 39, no. 10 (March 27, 2019): 1284–97. http://dx.doi.org/10.1177/0333102419840780.

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Purpose To review pharmacokinetic and pharmacodynamic characteristics of antibodies that bind to soluble ligands within the framework of calcitonin gene-related peptide antibodies. Overview Calcitonin gene-related peptide has been implicated in the pathophysiology of migraine. Galcanezumab is an antibody that binds to the ligand calcitonin gene-related peptide. Other antibodies that target calcitonin gene-related peptide include eptinezumab and fremanezumab. To understand how antibodies can affect the extent and duration of free ligand concentrations, it is important to consider the dose and pharmacokinetics of an antibody, and the kinetics of the ligand and antibody–ligand complex. Insights regarding the pharmacokinetic/pharmacodynamic properties of galcanezumab as a probe antibody drug and calcitonin gene-related peptide as its binding ligand regarding its clinical outcomes are provided. Discussion Antibodies are administered parenterally because oral absorption is limited by gastrointestinal degradation and inefficient diffusion through the epithelium. The systemic absorption of antibodies following intramuscular or subcutaneous administration most likely occurs via convective transport through lymphatic vessels into blood. The majority of antibody elimination occurs via intracellular catabolism into peptides and amino acids following endocytosis. Binding of ligand to an antibody reduces the free ligand that is available to interact with the receptor and efficacy is driven by the magnitude and duration of the reduction in free ligand concentration. A galcanezumab pharmacokinetic/pharmacodynamic model shows that galcanezumab decreases free calcitonin gene-related peptide concentrations in a dose- and time-dependent manner and continues to suppress free calcitonin gene-related peptide with repeated dosing. The model provides evidence for a mechanistic linkage to galcanezumab therapeutic effects for the preventive treatment of migraine.

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red. "Europäische Kommission erteilt Zulassung für Galcanezumab." Schmerzmedizin 35, no. 2 (February 26, 2019): 62. http://dx.doi.org/10.1007/s00940-019-1037-1.

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Pellesi, Lanfranco, Roberto De Icco, Mohammad Al-Mahdi Al-Karagholi, and Messoud Ashina. "Reducing Episodic Cluster Headaches: Focus on Galcanezumab." Journal of Pain Research Volume 13 (July 2020): 1591–99. http://dx.doi.org/10.2147/jpr.s222604.

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Kreimer, Susan. "Galcanezumab Prevents Episodic Cluster Headache, Study Finds." Neurology Today 19, no. 17 (September 2019): 1. http://dx.doi.org/10.1097/01.nt.0000581832.64132.a5.

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Chaplin, Steve. "Galcanezumab: a monoclonal antibody for migraine prophylaxis." Prescriber 31, no. 2 (February 2020): 33–34. http://dx.doi.org/10.1002/psb.1826.

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Giani, Luca, Alberto Proietti Cecchini, and Massimo Leone. "Galcanezumab for the prevention of cluster headache." Expert Opinion on Biological Therapy 20, no. 10 (August 4, 2020): 1133–42. http://dx.doi.org/10.1080/14712598.2020.1800635.

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Sifontes, Erick Perez, Sonja Knittel-Hliddal, Zhao Han, Rahimullah Asad, Aya Marachi, and Uma Iyer. "1125: GALCANEZUMAB-INDUCED ANAPHYLAXIS: A CASE REPORT." Critical Care Medicine 48, no. 1 (January 2020): 542. http://dx.doi.org/10.1097/01.ccm.0000643436.98157.e4.

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Diener, Hans-Christoph. "Galcanezumab wirkt auch bei mehreren gescheiterten Vortherapien." InFo Neurologie + Psychiatrie 23, no. 1 (January 2021): 24. http://dx.doi.org/10.1007/s15005-020-1788-1.

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Kreutzkamp, Barbara. "Galcanezumab zur Migräneprophylaxe: Phase-II-Studie erfolgreich abgeschlossen." Schmerzmedizin 34, no. 2 (March 2018): 10. http://dx.doi.org/10.1007/s00940-018-0756-z.

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Diener, Hans-Christoph. "Galcanezumab ist auch bei Migränepatienten mit Schmerzmittelübergebrauch wirksam." InFo Neurologie + Psychiatrie 23, no. 4 (April 2021): 27. http://dx.doi.org/10.1007/s15005-021-1846-3.

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Siegmund-Schultze, Nicola. "Galcanezumab bei therapierefraktären Migränepatienten rasch und anhaltend wirksam." Schmerzmedizin 37, no. 4 (July 2021): 66–67. http://dx.doi.org/10.1007/s00940-021-3182-6.

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Noseda, Roberta, Francesca Bedussi, Claudio Gobbi, Chiara Zecca, and Alessandro Ceschi. "Safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation: Analysis of the WHO pharmacovigilance database." Cephalalgia 41, no. 7 (January 12, 2021): 789–98. http://dx.doi.org/10.1177/0333102420983292.

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Objective To assess the safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation. Methods Safety reports of suspected adverse drug reactions were retrieved from VigiBase as of 31 December 2019, for a case-by-case assessment and disproportionality analysis using the reporting odds ratio (ROR). Results There were 94 safety reports: 50 (53.2%) on erenumab, 31 (33.0%) on galcanezumab, and 13 (13.8%) on fremanezumab. In five (5.3%) safety reports, drug exposure occurred prior to pregnancy, in 85 (90.4%) during pregnancy, in one (1.1%) during lactation, in one (1.1%) via paternal exposure, and in two (2.1%) the exposure time was unknown. Out of 94 safety reports, 51 (54.3%) consisted only of drug exposure, while 43 (45.7%) additionally reported 47 adverse drug reactions including maternal toxicities (n = 18), poor breastfeeding (n = 1), spontaneous abortion (n = 23), preterm birth/prematurity (n = 3), and birth defects (n = 2). There was no signal of disproportionate reporting for spontaneous abortion compared to the full database (reporting odds ratio 1.46, 95% confidence interval 0.97–2.20). When triptans were used as a comparator group, a signal of disproportionate reporting for spontaneous abortion was detected in association with erenumab, galcanezumab, and fremanezumab (reporting odds ratio 1.86, 95% confidence interval 1.12–3.13), which was not statistically significant after excluding confounded safety reports (reporting odds ratio 1.21, 95% confidence interval 0.67–2.21). Conclusions No specific maternal toxicities, patterns of major birth defects, or increased reporting of spontaneous abortion were found. However, because of the relatively limited number of adverse drug reactions reported and the lack of long-term safety data, continuous surveillance is required in pregnant and lactating women exposed to these drugs.

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Goadsby, Peter J., David W. Dodick, Massimo Leone, Jennifer N. Bardos, Tina M. Oakes, Brian A. Millen, Chunmei Zhou, et al. "Trial of Galcanezumab in Prevention of Episodic Cluster Headache." New England Journal of Medicine 381, no. 2 (July 11, 2019): 132–41. http://dx.doi.org/10.1056/nejmoa1813440.

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Stauffer, Virginia L., David W. Dodick, Qi Zhang, Jeffrey N. Carter, Jessica Ailani, and Robert R. Conley. "Evaluation of Galcanezumab for the Prevention of Episodic Migraine." JAMA Neurology 75, no. 9 (September 1, 2018): 1080. http://dx.doi.org/10.1001/jamaneurol.2018.1212.

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Hussar, Daniel A., and Matthew R. Moyer. "Baloxavir marboxil, Fremanezumab-vfrm, Galcanezumab-gnlm, and Lofexidine hydrochloride." Journal of the American Pharmacists Association 59, no. 1 (January 2019): 141–44. http://dx.doi.org/10.1016/j.japh.2018.12.002.

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Diener, Hans-Christoph. "Beim chronischen Clusterkopfschmerz ist Galcanezumab nicht wirksamer als Placebo." InFo Neurologie + Psychiatrie 22, no. 5 (May 2020): 34. http://dx.doi.org/10.1007/s15005-020-1351-0.

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Mo, Heejung, Min Jun Song, and Soo-Jin Cho. "Prevention with 240 mg Galcanezumab of Episodic Cluster Headache." Journal of the Korean Neurological Association 39, no. 3 (August 1, 2021): 228–29. http://dx.doi.org/10.17340/jkna.2021.3.23.

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Park, Hong-Kyun, and Byung-Kun Kim. "Calcitonin Gene-Related Peptide Targeting Therapies for Migraine: A New Era for Migraine Treatment." Journal of the Korean Neurological Association 38, no. 2 (May 1, 2020): 88–99. http://dx.doi.org/10.17340/jkna.2020.2.2.

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Development of medications targeting the trigeminal sensory neuropeptide calcitonin gene-related peptide (CGRP) or its receptor has ushered in the new era for the treatment of migraine. Some of these drugs are approved by the USA Food and Drug Administration and European Medicines Agency since 2018, and others are in the process of approval. Since the CGRP-related therapies act directly on the migraine pathophysiology, they have advantages over conventional treatments not only in effect but also in terms of adverse effects. CGRP receptor antagonist have an effect on both acute and preventive treatment of migraine, while monoclonal antibodies for CGRP ligand (fremanezumab, galcanezumab, and eptinezumab) or receptor (erenumab) reduce migraine frequency and related disability. Galcanezumab was approved by the Ministry of Food and Drug Safety in Korea in September 2019. As of December 2019, it is available for use in adult patients with migraine. We describe the pathophysiology of CGRP in migraine, summarize the results of recent CGRP antagonism related clinical trials, and provide opinions about the use of CGRP-related therapies in clinical practice.

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Bhola, Ria, and Juel Tuazon. "Migraine and calcitonin gene-related peptide pathway antibodies: a treatment route in tertiary care." British Journal of Neuroscience Nursing 15, no. 5 (October 2, 2019): 212–15. http://dx.doi.org/10.12968/bjnn.2019.15.5.212.

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Inhibiting the calcitonin gene-related peptide (CGRP) pathway is a new treatment to prevent migraines. CGRP is a potent vasodilator and is a key neuropeptide which plays a crucial role in migraine pathophysiology. Following the European Medicines Agency's approval of three CGRP pathway monoclonal antibodies (mAbs), erenumab, fremanezumab and galcanezumab, the authors proceeded with early adoption in practice. Here they summarise and share their patient treatment pathway using erenumab, the first mAb to become clinically available.

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Kearney, Elizabeth, Timothy Collins, and Sweta Sengupta. "De Novo Visual Aura Onset in a Migraineur on Galcanezumab‐Gnlm." Headache: The Journal of Head and Face Pain 60, no. 7 (June 2020): 1435–37. http://dx.doi.org/10.1111/head.13855.

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Urits, Ivan, Melis Yilmaz, Karina Charipova, Kyle Gress, Ehab Bahrum, Michael Swett, Amnon A. Berger, et al. "An Evidence-Based Review of Galcanezumab for the Treatment of Migraine." Neurology and Therapy 9, no. 2 (October 3, 2020): 403–17. http://dx.doi.org/10.1007/s40120-020-00214-3.

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Skljarevski, Vladimir, Tina M. Oakes, Qi Zhang, Margaret B. Ferguson, James Martinez, Angelo Camporeale, Kirk W. Johnson, et al. "Effect of Different Doses of Galcanezumab vs Placebo for Episodic Migraine Prevention." JAMA Neurology 75, no. 2 (February 1, 2018): 187. http://dx.doi.org/10.1001/jamaneurol.2017.3859.

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Goadsby, Peter J. "Primary headache disorders." Neurology: Clinical Practice 9, no. 3 (May 17, 2019): 233–40. http://dx.doi.org/10.1212/cpj.0000000000000654.

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Purpose of reviewTo review 5 new areas in primary headache disorders, especially migraine and cluster headache.Recent findingsCalcitonin gene-related peptide (CGRP) receptor antagonists (gepants—rimegepant and ubrogepant) and serotonin 5-HT1F receptor agonists (ditans—lasmiditan) have completed phase 3 clinical trials and will soon offer novel, effective, well-tolerated nonvasoconstrictor options to treat acute migraine. CGRP preventive treatment is being revolutionized after the licensing of 3 monoclonal antibodies (MABs), erenumab, fremanezumab, and galcanezumab, with eptinezumab to follow, especially designed for migraine; they are effective and well tolerated. For patients seeking a nondrug therapy, neuromodulation approaches, single-pulse transcranial magnetic stimulation, noninvasive vagus nerve stimulation (nVNS), and external trigeminal nerve stimulation, represent licensed, well-tolerated approaches to migraine treatment. For the acute treatment of episodic cluster headache, nVNS is effective, well tolerated, and licensed; nVNS is effective and well tolerated in preventive treatment of cluster headache. The CGRP MAB galcanezumab was effective and well tolerated in a placebo-controlled trial in the preventive treatment of episodic cluster headache. Sphenopalatine ganglion stimulation has been shown to be effective and well tolerated in 2 randomized sham-controlled studies on chronic cluster headache. Understanding the premonitory (prodromal) phase of migraine during which patients experience symptoms such as yawning, tiredness, cognitive dysfunction, and food cravings may help explain apparent migraine triggers in some patients, thus offering better self-management.SummaryHeadache medicine has made remarkable strides, particularly in understanding migraine and cluster headache in the past 5 years. For the most common reason to visit a neurologist, therapeutic advances offer patients reduced disability and neurologists a rewarding, key role in improving the lives of those with migraine and cluster headache.

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