1. Non-medical switch from the originator to biosimilar and between biosimilars of adalimumab in inflammatory bowel disease - a prospective, multicentre study.
- Author
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Lontai L, Gonczi L, Balogh F, Komlodi N, Resal T, Farkas K, Molnar T, Miheller P, Golovics PA, Schafer E, Szamosi T, Ilias A, and Lakatos PL
- Subjects
- Humans, Adalimumab therapeutic use, Infliximab therapeutic use, Gastrointestinal Agents therapeutic use, Prospective Studies, Treatment Outcome, Chronic Disease, Biosimilar Pharmaceuticals therapeutic use, Inflammatory Bowel Diseases drug therapy
- Abstract
Introduction: Clinical data on the efficacy and safety of non-medical switch between adalimumab(ADA) biosimilars are limited., Aims: The aim of this study was to evaluate medium-term clinical efficacy, drug sustainability and safety comparing non-medical switches from the originator to biosimilar ADA, and between ADA biosimilars., Methods: 276 consecutive patients on maintenance ADA therapy (n = 205 Crohn's disease, n = 71 ulcerative colitis) were included. Data on clinical efficacy, biomarkers and adverse events were collected at four time points: 8-12 weeks prior switch, at baseline/switch, 8-12 weeks and 20-24 weeks after switch. Drug survival was evaluated after a median 40(IQR:35-42) weeks follow-up., Results: A total 174 patients underwent a non-medical switch from the originator to a biosimilar, and 102 patients had a biosimilar-to-biosimilar switch. No significant difference was found in clinical remission rates at any time point in patients switching from originator to biosimilar(87.3%/88.5%/86.5%/85.7%) or biosimilar to biosimilar(74.5%/78.4%/85.3%/79.8%). Mean C-reactive protein levels remained unchanged in both cohorts(p = 0.856 and p = 0.525). Drug survival was similar between the two cohorts with a probability of 91.6%(SE: 2.2) and 87.0%(SE:3.4) to stay on drug after 40 weeks(log-rank:0.96; p = 0.327). Five cases of injection related adverse events were reported., Conclusion: Clinical benefit was sustained following non-medical switch from originator to biosimilar, or between biosimilars in adalimumab treated IBD patients., Competing Interests: Conflict of interest LL, LG, FB, NK, TS and ES declare no conflict of interest. KF has been a speaker and/or advisory board member: Abbvie and Ferring. TM, PM, TSZ have been a speaker and/or advisory board member: AbbVie, EGIS, Ferring, MSD and Takeda. AI has been a speaker and/or advisory board member: MSD. PAG. has been a speaker for AbbVie, Takeda, Fresenius, Ferring. PLL has been a speaker and/or advisory board member: AbbVie, Amgen, Arena Pharmaceuticals, Fresenius Kabi, Genetech, Gilead, Janssen, Merck, Mylan, Organon, Pharmacosmos, Pfizer, Roche, Takeda,Tillots and Viatris and has received unrestricted research grant: AbbVie, Gilead, Takeda and Pfizer., (Copyright © 2022. Published by Elsevier Ltd.)
- Published
- 2022
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