Non-medical switch from the originator to biosimilar and between biosimilars of adalimumab in inflammatory bowel disease - a prospective, multicentre study

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 ul-cerative 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 remis-sion 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.(c) 2022 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Automated summary

This study evaluated the medium-term clinical efficacy, drug sustainability, and safety of non-medical switches between adalimumab biosimilars. The results showed no significant difference in clinical remission rates or drug survival between non-medical switches from the originator to biosimilar ADA or between ADA biosimilars. The study concludes that clinical benefit can be sustained following non-medical switches in adalimumab-treated patients with inflammatory bowel disease.