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Journal articles on the topic 'Biologics'

Author: Grafiati

Published: 4 June 2021

Last updated: 25 July 2025

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1

Agrahari, Aman, Vipin Kesharwani, Shashi Singh, and Nandini Nath. "Bridging the Gap: Investigating the State-of-the-Art Approaches in Oral Biologic Delivery and Their Role in Redefining Therapeutic Possibilities." International Journal of Medical Sciences and Pharma Research 10, no. 4 (2024): 1–8. https://doi.org/10.22270/ijmspr.v10i4.100.

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Biopharmaceutical medications that originate from biological sources and processes are known as biologics. Biologics are now the most promising medications for oral use in treating a variety of illnesses. These illnesses may involve problems with inflammation and metabolism. It has been established that the most practical way to provide medication is by oral delivery of biologics. Due to the simplicity of taking doses, patients are observed to be directed towards the oral drug, demonstrating its great effectiveness. Even though biologicals are the most promising medicine, oral delivery of thes

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Vuckovic, C., A. Cremer, C. Minsart, et al. "P0367 A Clustering approach to discriminate slow and rapid biologics switchers in difficult-to-treat Crohn’s Disease patients." Journal of Crohn's and Colitis 19, Supplement_1 (2025): i842—i844. https://doi.org/10.1093/ecco-jcc/jjae190.0541.

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Abstract Background CD patients exhibit highly variable responses to biologics. While some patients achieve sustained remission with only one biologic over the course of their disease, other will require the sequencing of multiple biologics (“difficult-to-treat” patients) for optimal disease control. The aim of this study was to delineate the profile of treatment regimen of the biological exposed CD patients with luminal disease. Methods Among CD patients diagnosed between 1999 and 2019 with B1 phenotype at diagnosis, 203 patients who maintained this phenotype at maximum follow-up (FU, median

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Adami, Giovanni, Kenneth G. Saag, Roland D. Chapurlat, et al. "Balancing benefits and risks in the era of biologics." Therapeutic Advances in Musculoskeletal Disease 11 (January 2019): 1759720X1988397. http://dx.doi.org/10.1177/1759720x19883973.

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Biologics are substances synthetized from biological sources used in the prevention and treatment of several diseases. Rheumatologists have many years of experience with biologics for the treatment of immune-mediated diseases and osteoporosis. Randomized clinical trials and postmarketing studies have demonstrated that treatment with biologics can result, albeit infrequently, in serious adverse events. To date, several risk mitigation strategies have been identified and implemented. The objective of the present perspective review is to examine the risk mitigation strategies of biologic treatmen

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Farih, S., H. Rkain, S. Fellous, et al. "POS1417 DO SOCIAL FACTORS IMPACT ON BIOLOGICS COSTS IN RHEUMATOID ARTHRITIS? RESULTS FROM THE MOROCCAN RBSMR REGISTRY." Annals of the Rheumatic Diseases 80, Suppl 1 (2021): 992.2–992. http://dx.doi.org/10.1136/annrheumdis-2021-eular.4225.

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Background:Objectives:The aim of this study was to estimate the annual direct cost of biologics in rheumatoid arthritis and to evaluate the impact of social factors on biological use and costs.Methods:Patients in the Moroccan register of biologicals (RBSMR) with available 1-year data were included. Variables related to socio-economic status, disease and biological were collected. Direct costs included prices of biologics, costs of infusions, and subcutaneous injections. Biological use and costs were compared based on social factors.Results:Our study included 197 patients (female sex of 86.8%,

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Jagruti, Pansare* Shraddha Bhalake Sayali Erande Ragini Patil. "Biosimilar Drug: Current Situation." International Journal of Pharmaceutical Sciences 2, no. 11 (2024): 1674–79. https://doi.org/10.5281/zenodo.14246072.

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Biopharmaceuticals, derived from living cells through biological processes, replicate natural substances like hormones, offering targeted treatments for various diseases. As patents for original biologic drugs expire, biosimilars—subsequent versions of these drugs with similar but not identical characteristics—have emerged as cost-effective alternatives. In India, these are termed "similar biologics," with regulatory guidelines ensuring their safety, efficacy, and quality. Biosimilars are categorized based on their production processes, regulatory pathways, and branding strategies.

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Vadstrup, K., S. Alulis, A. Borsi, et al. "DOP78 Intestinal surgery rates in ulcerative colitis and Crohn’s disease in the era of biologics: A Danish Nationwide Register Study from 2003 to 2016." Journal of Crohn's and Colitis 14, Supplement_1 (2020): S116—S117. http://dx.doi.org/10.1093/ecco-jcc/jjz203.117.

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Abstract Background Biologic response modifiers (biologics) has been introduced as potent drugs for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC). Whether this has resulted in a reduction in the need for surgical treatment is controversial. This study aims to explore the surgery rates of patients diagnosed with CD and UC between 2003 and 2015 and correlate to those treated with biologics or not in Denmark with a follow-up until 2016. Methods This national register study included patients diagnosed between 2003 and 2015 and followed up until 2016, identified in the Danish Na

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Lin, R. J. "The Biological Response to Biologics." Science Translational Medicine 3, no. 80 (2011): 80ec61. http://dx.doi.org/10.1126/scitranslmed.3002541.

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S, Patil Prasad. "Biosimilars: The Future of Biologic Therapy." International Journal for Research in Applied Science and Engineering Technology 13, no. 4 (2025): 1449–65. https://doi.org/10.22214/ijraset.2025.68559.

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Chronic diseases are continuing to rise globally, emphasizing the need for patients to have access to safe and effective treatments. Biologics represent a unique and powerful class of medications that have significantly changed how doctors manage conditions like cancer, diabetes, and autoimmune diseases. These treatments have led to outstanding patient outcomes—for example, biologics have halved the mortality rate for non-Hodgkin’s lymphoma. Presently, there are over 200 biologics and vaccines available worldwide, most of which are therapeutic proteins—lab-engineered proteins used in medicine,

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Furer, Victoria, and Ori Elkayam. "Dual Biologic Therapy in Patients with Rheumatoid Arthritis and Psoriatic Arthritis." Rambam Maimonides Medical Journal 14, no. 2 (2023): e0007. http://dx.doi.org/10.5041/rmmj.10494.

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Treatment with biological agents has become standard of care in treatment of immune-mediated diseases (IMD), including rheumatoid arthritis and psoriatic arthritis. Yet, a significant proportion of patients experience loss of response to biologics, need treatment escalation, or develop side effects. During the past decade, new biologic agents with different targeted molecular pathways have been approved for treatment of IMD, introducing the possibility of concomitant dual biologic therapy. The role of dual biologic therapy targeting different inflammatory pathways has become an area of great i

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Vender MD FRCPC, Ronald. "Transitioning Between Biologics." SKIN The Journal of Cutaneous Medicine 3, no. 6 (2019): 374–80. http://dx.doi.org/10.25251/skin.3.6.2.

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Background: Transitioning between biologics has become an important part of practice.Objective: Patients with moderate to severe plaque psoriasis who are on biologics can have efficacy failures, as well as safety concerns. This would often necessitate a change of biologic, which may be within the same class or to a different class. A change due to an adverse event from the presently used biologic may resolve or require treatment until a new biologic is introduced, which may pose some delay in the initiation of the subsequent biologic. Methods: A review of the literature and guidelines publishe

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Ochsenkuehn, T., C. Tillack-Schreiber, F. Bader, et al. "P501 Safety of peri-operative biologics in patients with IBD undergoing resective bowel surgery: experiences of a single center cohort." Journal of Crohn's and Colitis 17, Supplement_1 (2023): i630—i631. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0631.

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Abstract Background Despite good safety data, the risk of peri-operative treatment with biologics in IBD is still discussed controversially. Recently, the prospective PUCCINI trial demonstrated that direct exposure to TNF-blockers within 12 wks. of abdominal surgery was not associated with more infectious complications. However, in daily clinical practice experiences on biological treatment peri-operatively are limited. In our current retrospective trial, we addressed the safety of different biologicals in a peri-operative setting. Methods Eligible pat. in this single center study were recruit

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Levitskaya, A. V., E. A. Belousova, E. Yu Lomakina, and M. V. Teberdieva. "Comparative efficacy and survival of biologics in inflammatory bowel disease in different lines of therapy: the clinician’s view of the problem." Koloproktologia 24, no. 1 (2025): 103–14. https://doi.org/10.33878/2073-7556-2025-24-1-103-114.

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AIM: to analyze publications and assess the current state of the issue on the comparative efficacy and survival of different classes and different lines of biological therapy for inflammatory bowel diseases (IBD)MATERIALS AND METHODS: the search for publications was done in the PUBMED, MEDLINE, EMBASE databases and Cochrane Library from 2013 to 2024 using key words and phrases “Inflammatory bowel disease”, “ulcerative colitis”, “Crohn’s disease”, “biologics survival/persistence”, “comparative efficacy of biologics in different therapy lines”, “biologics”, “immunogenicity”. RESULTS: loss of res

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Gamerman, Gary E., Bruce F. Mackler, and Michael M. Landa. ""1996“Starting the modern era of biologics regulation: FDA's elimination ofestablishment licensure and other changes“." Biotechnology and Applied Biochemistry 25, no. 3 (1997): 189–95. http://dx.doi.org/10.1111/j.1470-8744.1997.tb00432.x.

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On May 14, 1996, the U.S. Food and Drug Administration (FDA) issued a new regulation eliminating the establishment licensure requirement for certain “specified” biologics and expanded the definition of “manufacturer” for biologic products in general. These regulatory changes are a significant change in the history of biologics regulation and are the logical culmination to the FDA's recent efforts to make modern biologics regulation conform to modern biologics technology. This regulation essentially placed modern biologics on an equal regulatory and commercial footing with traditional chemical

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Hisamatsu, T., and A. Yoon. "P179 Treatment decisions and biologic adoption rates in newly diagnosed Crohn’s disease in Japan." Journal of Crohn's and Colitis 15, Supplement_1 (2021): S251. http://dx.doi.org/10.1093/ecco-jcc/jjab076.306.

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Abstract Background Biologic therapy in Crohn’s disease (CD) has significantly improved treatment outcomes. Still, providing an optimal care for individual patient in real-world is complex. We report the real-world treatment decisions between biologics and systemic corticosteroids (SCS) and associated factors in newly diagnosed CD in Japan. Methods Patients with CD diagnosis (Index) and at least one CD therapeutic agent prescribed between 2006 and 2019 were screened from the JMDC database. JMDC is a health claims database where various sized (small to very large) companies’ employees and their

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Ochsenkühn, Thomas, Constanze Waggershauser, Cornelia Tillack-Schreiber, et al. "SAFETY OF PERIOPERATIVE BIOLOGICS IN PATIENTS WITH IBD UNDERGOING RESECTIVE BOWEL SURGERY: THE MUNICH IBD CENTER EXPERIENCE." Inflammatory Bowel Diseases 29, Supplement_1 (2023): S2. http://dx.doi.org/10.1093/ibd/izac247.003.

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Abstract BACKGROUND AND AIMS The risk of biologics in the peri-operative setting in IBD is still discussed controversially. Recently, the large prospective PUCCINI trial could demonstrate that direct exposure to TNF-blockers within 12 weeks before abdominal surgery was not associated with a higher risk of infectious complications. However, in daily clinical practice experiences on biological treatment perioperatively are limited. In our current retrospective trial, we addressed the safety of different biologicals in a peri-operative setting. METHODS Eligible IBD patients in this single center

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Overbeck, N., G. M. Nagvajara, S. Ferzoco, B. C. H. May, A. Beierschmitt, and S. Qi. "In-vivo evaluation of a reinforced ovine biologic: a comparative study to available hernia mesh repair materials." Hernia 24, no. 6 (2020): 1293–306. http://dx.doi.org/10.1007/s10029-019-02119-z.

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Abstract Purpose Two innovative reinforced biologic materials were studied in a non-human primate hernia repair model. The test articles, which combine layers of ovine decellularized extracellular matrix with minimal amounts of synthetic polymer, were evaluated for their biologic performance as measured by inflammatory response, healing kinetics, integration, and remodeling into functional host tissue. For comparison, seven clinically used biologic and synthetic meshes were also studied. Methods Animals were implanted with test articles in surgically created full-thickness midline abdominal wa

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Montas, Alana. "Cheaper Clinical Trials: The Real Solution to the Biologic Industry's Gordian Knot." American Journal of Law & Medicine 37, no. 1 (2011): 172–93. http://dx.doi.org/10.1177/009885881103700105.

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Biologics include a wide range of products, such as vaccines, allergenics, gene therapies, and tissues, among others. Biologics are complex combinations of sugars, proteins, or nucleic acids that are produced by biotechnology methods or other advanced technology. Biologics often represent the only medical treatment for complex medical conditions such as: Hepatitis B; Measles, Mumps, Rubella and Varicella; and Tetravalent meningococcal conjugate among others. As a result, biologic sales are growing at twice the rate of chemical pharmaceuticals and are expected to exceed $158 billion by 2015. Va

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Yu, J., H. K. Hyun, J. Park, et al. "P429 Continued postoperative use of biologics for the prevention of recurrence of Crohn’s disease." Journal of Crohn's and Colitis 15, Supplement_1 (2021): S432—S433. http://dx.doi.org/10.1093/ecco-jcc/jjab076.553.

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Abstract Background Many patients with Crohn’s disease undergo major abdominal surgery during the disease course. Despite surgery, postoperative recurrence (POR) commonly occurs. Although postoperative use of biologic agents is known to be effective in preventing POR, few studies have evaluated the effectiveness of continuing the same biologic agents postoperatively in patients who received biologic agents preoperatively. Methods This retrospective observational study was performed in a single tertiary medical center. We retrospectively reviewed patients who underwent the first major abdominal

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Garvey, Mary. "Non-Mammalian Eukaryotic Expression Systems Yeast and Fungi in the Production of Biologics." Journal of Fungi 8, no. 11 (2022): 1179. http://dx.doi.org/10.3390/jof8111179.

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Biologics have become an important area of medical research generating therapeutics essential for the treatment of many disease states. Biologics are defined as biologically active compounds manufactured by living cells or through biological processes termed bioprocessing. Compared to small molecules which are chemically synthesised they are relatively complex and therapeutically specific molecules. Biologics include hormones, vaccines, blood products, monoclonal antibodies, recombinant therapeutic proteins, enzymes, gene and cellular therapies amongst others. For biologic production prokaryot

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Bowers, Robert L., Wesley D. Troyer, Rudolph A. Mason, and Kenneth R. Mautner. "Biologics." Techniques in Vascular and Interventional Radiology 23, no. 4 (2020): 100704. http://dx.doi.org/10.1016/j.tvir.2020.100704.

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Prinz, J. C. "Biologics." Der Hautarzt 61, no. 8 (2010): 668–75. http://dx.doi.org/10.1007/s00105-010-1941-8.

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Dinakar, Chitra, David A. Khan, Stanley M. Fineman, David Michael Lang, and Stephen A. Tilles. "Biologics." Annals of Allergy, Asthma & Immunology 120, no. 4 (2018): 354–56. http://dx.doi.org/10.1016/j.anai.2018.02.030.

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Nishida, D., T. Ishige, K. Arai, et al. "P723 Comparison of the Persistence Rates of Biologic Agents in Paediatric Crohn's Disease Patients (Japanese Paediatric IBD Registry Study)." Journal of Crohn's and Colitis 17, Supplement_1 (2023): i854. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0853.

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Abstract Background Biologics are widely used for paediatric Crohn's disease (CD) and are highly effective; however, primary inefficacy and the emergence of secondary inefficacy during long-term use remain challenges. Although it is desirable for biologics used in paediatric patients to be safe and usable long-term, there are few detailed reports on the comparison of persistence rates of biologics in paediatric patients. Methods This was a multicentre prospective cohort study using a web-based registry system in Japan that was performed between October 2012 and March 2020. New paediatric infla

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Shinzaki, S., K. Matsuoka, T. Fujii, et al. "P775 Disease activity and treatment patterns of newly diagnosed adult patients with Crohn's disease in Japan: Interim analysis of inception cohort registry study of patients with Crohn's disease (iCREST-CD)." Journal of Crohn's and Colitis 17, Supplement_1 (2023): i905—i908. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0905.

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Abstract Background Biologics are commonly used for the treatment of Crohn’s disase (CD); however, the proportion of biologics used and their initiation time from diagnosis differs widely between different regions. There is limited information about the patient characteristics and the treatment persistence of each initial biologics, and the treatment persistence of top-down and step-up therapy. iCREST-CD is a prospective, non-interventional, longitudinal, observational registry study conducted at 19 tertiary centres to understand the characteristics of CD treatments in actual clinical settings

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Tai, W. C., C. C. Yao, and Y. C. Tsai. "P1219 Changes in gut microbiota of patients with inflammatory bowel disease receiving biologic therapy." Journal of Crohn's and Colitis 18, Supplement_1 (2024): i2166. http://dx.doi.org/10.1093/ecco-jcc/jjad212.1349.

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Abstract Background Inflammatory bowel disease (IBD), comprising the predominant forms Crohn’s disease (CD) and ulcerative colitis (UC), is associated with compositional and metabolic changes in the intestinal dysbiosis. The aim of this study is to evaluate the composition in the microbiota of IBD patients who received biologic therapy Methods This is a prospective study recruited 14 patients with IBD received biologic therapy and 13 IBD controls who received conventional treatment . The taxonomic composition of the gut microbiota was determined by 16S ribosomal RNA gene sequencing of stool sa

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Chin, Y. F., O. PUJJI, B. Wilkinson, S. Mohan, M. Nnaji, and N. Yassin. "P275 Biological therapies for patients with Crohn’s disease: More options mean less surgical interventions." Journal of Crohn's and Colitis 14, Supplement_1 (2020): S288—S289. http://dx.doi.org/10.1093/ecco-jcc/jjz203.404.

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Abstract Background The advent of biologic therapy and their acceptance into mainstream use for the medical management of patients with inflammatory bowel disease (IBD) has transformed the landscape of treatment for this condition. It has particularly become a mainstay in the treatment of fistulating or perianal Crohn’s Disease (CD). Data have shown that overall, 70% of patients will require surgical resections for CD. Consequently, questions have endured regarding the effect of biologic medications on the overall treatment course of CD patients. Our aim is to identify the efficacy of biologic

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Riccardi, Elisa, Giuseppe Guida, Sonia Garino, et al. "Biologics in T2 Severe Asthma: Unveiling Different Effectiveness by Real-World Indirect Comparison." Journal of Clinical Medicine 13, no. 16 (2024): 4750. http://dx.doi.org/10.3390/jcm13164750.

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Background: Indirect comparison among biologics in severe asthma (SA) is a challenging but desirable goal for clinicians in real life. The aim of the study is to define characteristics of a biologic-treated T2-driven-SA population and to evaluate the effectiveness of biologic treatments in a real-world setting by variation in intra/inter-biologic parameters in an up to 4-year follow-up. Methods: Demographic, clinical, functional, and biological characteristics were evaluated retrospectively in 104 patients recruited until July 2022 at baseline (T0) and over a maximum of 4 years (T4) of biologi

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Alulis, S., K. Vadstrup, A. Borsi, et al. "P800 Treatment patterns for biologics in ulcerative colitis and Crohn’s disease: A Danish Nationwide Register Study from 2003 to 2015." Journal of Crohn's and Colitis 14, Supplement_1 (2020): S628. http://dx.doi.org/10.1093/ecco-jcc/jjz203.928.

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Abstract Background The choice of biological treatment for Crohn’s disease (CD) and Ulcerative Colitis (UC) depends on disease severity and possible other factors. Patients with moderate to severe disease should be prescribed biologic response modifiers (biologics), according to guidelines. This study aims to explore the treatment patterns of patients diagnosed with CD and UC. Methods This national register study included patients diagnosed between 2003 and 2015, identified in the Danish National Patient Registry (NPR). Biologic therapies available during the study period were infliximab, adal

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Presto, J. K., E. Z. Hejazi, and V. P. Werth. "Biological therapies in the treatment of cutaneous lupus erythematosus." Lupus 26, no. 2 (2016): 115–18. http://dx.doi.org/10.1177/0961203316670731.

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Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease occurring in association with or without systemic lupus erythematosus (SLE). Although antimalarials are widely used as the first-line systemic agent, refractory cases may benefit from additional immunomodulators, immunosuppressives, and biologics. An interest in biological therapies for CLE has emerged in recent years due to novel insight into the pathogenesis of CLE. These targets include B cells, T cells, and cytokines that are involved in immune system pathways. Currently belimumab is the only biological therapy approved for

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Zhang, Ze, Bing-He Zhou, Liang Hu, Ming-Chao Li, Dong Chang, and Xin Dou. "Relationship between biologic therapy and cytokine levels in patients with inflammatory arthritis." Medicine 104, no. 25 (2025): e42953. https://doi.org/10.1097/md.0000000000042953.

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Biological agents are frontline treatments for ankylosing spondylitis (AS) and rheumatoid arthritis (RA); however, their efficacy varies owing to differences in patient autoimmune status. This study aimed to evaluate peripheral blood cytokine profiles in patients with AS and RA and assess the impact of different treatment modalities. Data from 145 patients with AS, 491 patients with RA, and 125 healthy controls were collected. Cytokine levels (tumor necrosis factor [TNF]-α, interleukin [IL]-6, IL-8, IL-17, IL-5, etc) were analyzed in healthy controls and patients with AS and RA, with a focus o

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Nardone, O. M., G. Calabrese, L. Alfonsi, et al. "P589 Effectiveness of partial enteral nutrition to treat adults with Crohn's Disease who lost response to biological therapy." Journal of Crohn's and Colitis 17, Supplement_1 (2023): i717—i718. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0719.

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Abstract Background Partial enteral nutrition (PEN) is a consolidated treatment in children with active Crohn’s disease (CD). However, the benefit of PEN is not well-established for adults with CD. Based on the assumption that diet could aid in treating active disease, we aimed to assess the effectiveness of PEN in combination with biological therapy on transmural response/remission and selected clinical outcomes in adults with CD who lost response to biologics Methods We performed a single-centre retrospective observational study by including patients who received PEN due to loss of response

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Poddighe, Dimitri, Micol Romano, Maurizio Gattinara, and Valeria Gerloni. "Biologics for the Treatment of Juvenile Idiopathic Arthritis." Current Medicinal Chemistry 25, no. 42 (2019): 5860–93. http://dx.doi.org/10.2174/0929867325666180522085716.

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Juvenile Idiopathic Arthritis (JIA) is one of the most common chronic diseases in children. Recently, the management of JIA has substantially changed, thanks to the availability of new treatment options, represented by biological drugs or biologics. These drugs modulate the specific mechanisms of the immune systems, such as TNF-α, IL-1 and IL-6 signaling, or lymphocyte activation and/or functioning. In this review, we provide a comprehensive discussion on the current recommendations and clinical evidence regarding the use of the available biologics in the treatment of JIA; moreover, the main p

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Woo, Emily Jane. "Postmarketing safety of biologics and biological devices." Spine Journal 14, no. 3 (2014): 560–65. http://dx.doi.org/10.1016/j.spinee.2013.09.056.

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Muhammad Shaheer. "Biosimilars in Ophthalmology: Trends and Potential." Ophthalmology Pakistan 14, no. 4 (2024): 89–90. https://doi.org/10.62276/ophthalmolpak.14.04.170.

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Biosimilarsarebiotechnology-derivedproteinproducts which are almost identical to certain drugs which may be called spearhead or reference biologics. Biological and therapeutic effects of biosimilars are achieved in the same manner as the respective spearhead drug but in a speedy manner and at a low cost without diminishing comparative 1safety and efficacy.These specks are highly and vigorously researched, so they may be 100-1000 times larger in size than the generic or spearhead drug. The road to approval for biosimilars is different from that of generic biologics. Since the generic biologics

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Genovese, Dario, Daniele Brinch, Stefano Muscarella, et al. "Neutralizing Antibody Response to SARS-CoV-2 Variants After Two mRNA COVID-19 Vaccine Doses in a Cohort of Patients with Inflammatory Bowel Disease from a Southern Italy Tertiary Hospital." Healthcare 13, no. 5 (2025): 508. https://doi.org/10.3390/healthcare13050508.

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Introduction: Inflammatory bowel diseases (IBDs) require immunosuppressive drugs like biologics. All IBD patients, including those on biological therapy, should be vaccinated against COVID-19, according to the ECCO recommendations. IBD patients on anti-TNF treatment exhibited lower COVID-19 vaccine responses; however, SARS-CoV-2 variant neutralizing antibody titers have been seldom studied. Methods: IBD patients and healthcare professionals (control group) were tested for COVID-19 vaccine immunogenicity by neutralizing antibody titers against Wild-Type SARS-CoV-2 and its variants. IBD patients

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Mullins, C. Daniel, Fenghao Wang, Kaloyan A. Bikov, Brian S. Seal, and Nader Hanna. "Use of biologics in addition to chemotherapy in the treatment of elderly Medicare patients with stage IV metastatic colon cancer." Journal of Clinical Oncology 31, no. 15_suppl (2013): e14602-e14602. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.e14602.

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e14602 Background: On February 12 and 26, 2004, the FDA approved bevacizumab and cetuximab, respectively, two biologic drugs for the first–line treatment of metastatic colorectal cancer (mCC), followed by panitumumab, another biologic approved on September 27, 2006. NCCN guidelines suggest that biologics may be added to fluorouracil and leucovorin (5-FU/LV), irinotecan (IRI), or oxaliplatin (OX), yet a number of recent articles raise questions regarding the added benefit of biologics on top of a backbone chemotherapy regimen, which might affect the utilization pattern of biologics. To examine

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Arieira, C., F. Dias de Castro, T. Cúrdia Gonçalves, M. J. Moreira, and J. Cotter. "P562 5-ASA in ulcerative colitis: Are they really needed in the biological therapy era?" Journal of Crohn's and Colitis 14, Supplement_1 (2020): S474. http://dx.doi.org/10.1093/ecco-jcc/jjz203.690.

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Abstract Background Biologic therapy has demonstrated efficacy for induction and maintenance of remission in ulcerative colitis (UC). However, it remains unclear whether oral aminosalicylates (5-ASA) should be continued or stopped after treatment escalation to biologics. The aim of the study was to evaluate differences in inflammatory biomarkers or the occurrence of complications in UC patients being treated with a combination of 5-ASA and biologics vs. biologics alone. Methods Retrospective study, including patients with UC and on biologic therapy with a minimum follow-up of 6 months. Collect

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Sweis, Auddie M., Tran B. Locke, Kevin I. Ig-Izevbekhai, et al. "Effectiveness of endoscopic sinus surgery and aspirin therapy in the management of aspirin-exacerbated respiratory disease." Allergy and Asthma Proceedings 42, no. 2 (2021): 136–41. http://dx.doi.org/10.2500/aap.2021.42.210002.

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Background: Aspirin therapy and/or type 2 (T2) biologics are used in the management of aspirin-exacerbated respiratory disease (AERD). Objective: To identify the number of patients with AERD who tolerated aspirin therapy, yet due to persistent symptoms, incorporated T2 biologic management. Methods: A retrospective review was performed between July 2016 and June 2019. Patients with AERD and who underwent endoscopic sinus surgery (ESS), aspirin desensitization (AD), and at least 6 months of aspirin therapy (ATAD) after AD, and who remained biologic-naive up through this timepoint were included i

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Choy, Alexa Haley, Jonathan Vebman, and Christopher Yao. "Biologic Prescribing Patterns Among Mount Sinai Psoriasis Patients: Results of a Retrospective Chart Review." SKIN The Journal of Cutaneous Medicine 4, no. 2 (2020): 106. http://dx.doi.org/10.25251/skin.4.2.2.

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Objectives: Psoriasis is a painful and chronic inflammatory skin condition that not only impacts the quality of life of patients but is also a socioeconomic burden due to the cost of treatment, particularly with biologic treatments. The purpose of the study is to understand biologic prescribing patterns among Mount Sinai psoriasis patients and assess its relationship to insurance policy, which may limit treatment access.Methods: This study reviewed randomized, de-identified charts of psoriasis patients in a nine physician academic practice at Mount Sinai (New York, United States) with the foll

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Scott, G. "N39 Exploring the impact of an Inflammatory Bowel Disease Biologics Nurse on the management of a biologics service." Journal of Crohn's and Colitis 18, Supplement_1 (2024): i2247. http://dx.doi.org/10.1093/ecco-jcc/jjad212.1411.

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Abstract Background Biologics nurses play a critical role in the management of patients receiving treatment for Inflammatory Bowel Disease (IBD).Their impact spans various facets of patient care and service management. Prior to December 2021 all patients who required biological therapy were reviewed by any member of the IBD nursing team. This review would entail a comprehensive history taken, screening bloods ordered and explained and a thorough ex[planation of the risks and benefits of the medication including a detailed explanation of the use of the drug. The nurses were also responsible for

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Tenhoeve, Samuel A., Monica-Rae Owens, Rogina Rezk, Abanob G. Hanna, and Brandon Lucke-Wold. "Emerging and Current Biologics for the Treatment of Intracranial Aneurysms." Biologics 4, no. 4 (2024): 364–75. http://dx.doi.org/10.3390/biologics4040022.

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The integration of biologics in endovascularly treated intracranial aneurysms is a significant area of focus in an evolving field. By presenting the clinical relevance, pathogenesis, management (historical and current), and emerging biologics themselves, this work provides a broad overview of the current landscape of the biologics under current investigation. Growth factors, cytokines, and biologic-coated coils are compared and described as modalities to increase healing, aneurysm occlusion, and long-term recovery. These emerging biologics may increase the efficacy and durability of less invas

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Singhania, Smita Suneel, and Krishan Kumar Tripathi. "India: Similar biologics guidelines and implementation." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 9, no. 4 (2012): 181–86. http://dx.doi.org/10.1177/1741134312466560.

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Indian regulatory authorities for biologics, jointly at Department of Biotechnology and Central Drug Standard Control organization in association with the task force comprising Indian biologics manufacturers laid down the regulatory pathway for manufacturing and marketing authorization of similar biologics, claiming to be similar to an already authorized reference biologic. This guidance has come in force from 15 September 2012 in India. This guidance document is a simple abridged process for evaluation of ‘Similar Biologics’ that are approved and marketed either in India, Europe or USA or any

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Tsai, Chia-Jung, Yu-Chih Lin, Chung-Yu Chen, Chih-Hsing Hung, and Yi-Ching Lin. "The Effects of Biologics on Hematologic Malignancy Development in Patients with Ankylosing Spondylitis, Psoriasis, or Psoriatic Arthritis: A National Cohort Study." Biomedicines 11, no. 9 (2023): 2510. http://dx.doi.org/10.3390/biomedicines11092510.

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Biologics are used for ankylosing spondylitis (AS), psoriasis, and psoriatic arthritis (PsA) treatment. The association between biologics and the development of hematologic malignancies is controversial, and data on patients with AS, psoriasis, and PsA are scarce. This retrospective cohort study used data from 2010 to 2020 from Taiwan’s National Health Insurance Research Database (NHIRD). Patients with AS, psoriasis, and PsA were divided into a biologics and non biologics group after 1:10 propensity score matching. The hematologic malignancy incidences and the time-/dose-dependent effects on b

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Bornheimer, R., S. Hass, A. NAG, and G. Oster. "P522 Prior pharmacotherapy patterns among patients with IBD in the USA initiating biologic therapy." Journal of Crohn's and Colitis 14, Supplement_1 (2020): S450—S451. http://dx.doi.org/10.1093/ecco-jcc/jjz203.650.

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Abstract Background Treatment for inflammatory bowel disease (IBD: Crohn’s disease [CD] and ulcerative colitis [UC]) has shifted from symptom management using corticosteroids to targeted therapies such as tumour necrosis factor (TNF) inhibitors. An increase in therapeutic options warrants a better understanding of current treatment pathways. This study reports on the pharmacotherapy history of patients with CD and UC prior to initiation of an IBD-targeted biologic. Methods Using the US IQVIA™ Real-World Data Adjudicated Claims Database, we identified adults (≥18 years) with CD or UC who initia

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Fang, Emily, Campbell Bunce, Philip Payne, et al. "Abstract 1537: DRIVE-Biologics: All the steps from discovery to development of novel biological entities." Cancer Research 83, no. 7_Supplement (2023): 1537. http://dx.doi.org/10.1158/1538-7445.am2023-1537.

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Abstract Biologics first revolutionized cancer treatment in the late 1900s with the approval of rituximab and trastuzumab, two monoclonal antibodies targeting antigens expressed on tumor cells. Another milestone was achieved in the early 2010s with the approval of antibodies targeting immune checkpoints. Nowadays, the discovery and development of new biological entities and biological therapeutic products represent a rapidly growing market in various therapeutic areas, with about 10 to 15 biologics being approved each year. We have built a premium expert ecosystem services - DRIVE-Biologics -

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Mease, Philip J., Soumya Reddy, Sarah Ross, et al. "Evaluating the efficacy of biologics with and without methotrexate in the treatment of psoriatic arthritis: a network meta-analysis." RMD Open 10, no. 1 (2024): e003423. http://dx.doi.org/10.1136/rmdopen-2023-003423.

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IntroductionAn important consideration in the treatment of patients with psoriatic arthritis (PsA) is whether the addition of methotrexate (MTX) to biologics has greater efficacy than biologic monotherapy with respect to efficacy outcomes in these patients.ObjectivesTo conduct a network meta-analysis (NMA) comparing biologics by treatment class with and without MTX for treatment of adults with active PsA.MethodsA systematic literature review (SLR) identified randomised, double-blinded, controlled trials, and a Bayesian NMA compared biologics with and without MTX by treatment class (tumour necr

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Nopriyati and Reza Mayasari. "Agen Biologik Psoriasis Terkini." Conferences of Medical Sciences Dies Natalis Faculty of Medicine Universitas Sriwijaya 1, no. 1 (2019): 62–75. http://dx.doi.org/10.32539/confmednatalisunsri.v1i1.12.

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Psoriasis is a chronic inflammatory skin disease with genetic basis, characterized by complex alterations in epidermal growth and differentiation and multiple biochemical, immunologic, and vascular abnormalities. Standard systemic therapies, such as methotrexate, cyclosporine, and acitretin very effective for psoriasis, but associated with significant toxicities. Survey of psoriasis patients in United States shows they have expressed a high level of dissatisfaction with them. Over the past decade, biologic therapies developed as optional therapy of psoriasis. No definition on biologics for pso

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Sceats, Lindsay Anne, Cindy Kin, Amber Trickey, Maria Polyakova, and M. Kate Bundorf. "3334 Insurance Generosity and Inflammatory Bowel Disease: Does Higher Patient Cost-Sharing Result in Suboptimal Medication Habits and Inferior Clinical Outcomes?" Journal of Clinical and Translational Science 3, s1 (2019): 148. http://dx.doi.org/10.1017/cts.2019.336.

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OBJECTIVES/SPECIFIC AIMS: Our primary objectives were to examine the impact of biologic cost sharing on 1) adherence to biologics and 2) persistence on biologics in inflammatory bowel disease (IBD) patients. Our secondary objective was to assess the effect of biologic cost sharing on clinical IBD outcomes, including rates of hospitalization, abdominal surgery, and corticosteroid treatment. METHODS/STUDY POPULATION: This retrospective cohort analysis used a national insurance claims database (Optum Clinformatics DataMart) to assess adult IBD patients enrolled in medium or large private insuranc

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Rao, A., A. Bazarova, P. Mitra, et al. "P209 Delayed IBD diagnosis increases risk of requiring biologics in first 4-years - an Inception cohort study." Journal of Crohn's and Colitis 17, Supplement_1 (2023): i360—i361. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0339.

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Abstract Background Delays in diagnosis can be due to patient and health-system related factors. The impact of such delays in Inflammatory Bowel Diseases (IBD), particularly on biological therapies, continues to be of interest. The aim of the study was to investigate if delays could predict need for biologics and report on related adverse outcomes (AOs). Methods New patients referred for suspected IBD to a single tertiary care centre between Jan 2013 to Dec 2017 were identified using EMR. For this study, delay-types and cut-off times for each type were set based on best average hospital waitin

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Onalan, Tugba, Fatih Colkesen, Fatma Arzu Akkus, Mehmet Emin Gerek, Filiz Sadi Aykan, and Sevket Arslan. "Biologic treatment discontinuation in severe asthma: A real-life study on factors influencing clinical remission and physician decision-making." Allergy and Asthma Proceedings 46, no. 4 (2025): 287–95. https://doi.org/10.2500/aap.2025.46.250023.

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Background: Real-life studies have shown the effects of biologic therapies on severe asthma. However, evidence for discontinuing treatment after targeted improvement remains limited. Objective: This study investigated the factors associated with clinical remission in patients with severe asthma treated with biologics and explores physician decision-making with regard to the continuation or discontinuation of treatment after remission. Method: A retrospective analysis was conducted on 65 patients with severe asthma who received biologics for at least 12 months between 2012 and 2024. Demographic

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