ArticleFrontiers in gastroenterology (Lausanne, Switzerland)2023
Adalimumab biosimilar ABP 501 is equally effective and safe in long-term management of inflammatory bowel diseases patients when used as first biologic treatment or as replace of the ADA originator for a non-medical reason.
Article in Frontiers in gastroenterology (Lausanne, Switzerland), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
2 citing papers in PubMed.
- Comparative Study Assessing Multiple Switches Between Biosimilar ABP 501 (adalimumab-atto) and Adalimumab Reference Product in Patients with Plaque Psoriasis.Advances in therapy · 2026Trial
- Effectiveness and safety of adalimumab biosimilar in bio-naive patients with inflammatory bowel disease: a real-life multicenter observational study comparing ABP501, SB5, MSB11022, GP2017, and FKB327.Crohn's & colitis 360 · 2026Article
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16 authors.
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No grant is acknowledged in the PubMed record.
Abstract
Objective: Biosimilars represent a new opportunity for inflammatory bowel disease (IBD) treatment and economic sustainability of therapies. This study aimed to evaluate the efficacy and long-term safety of the adalimumab biosimilar ABP 501 in biologic-naïve vs. biologic-switched IBD patients. Methods: A retrospective observational study was conducted using a database of patients with IBD treated with ABP 501, biologic-naïve or switched from the original, at eight IBD centers. We included adult patients with at least one year of follow-up. The primary objective of this study was to assess the efficacy (persistence) and safety (adverse event rate) of ABP 501 therapy. Results: A total of 118 patients with IBD were included in the analysis: 84 patients with Crohn's disease (CD) (39 women, 45 men, mean age 40.4 ± 14.3 years; 33% biologic-naïve) and 34 patients with ulcerative Colitis (UC) (16 women, 18 men, mean age 38.9 ± 14.9 years; 61.8% biologic-naïve). Regarding the primary endpoint, no difference was observed in the efficacy between biologic-naïve patients and patients with Adalimumab (ADA) originator replacement for non-medical reasons in terms of long-term persistence. However, ABP 501 showed a higher percentage of sustained clinical remission at 2 years in patients with CD (64 patients, 77%) than in those with UC (15 patients, 45.5%; p=0.00091). Nine patients (six with CD and three with UC) experienced adverse events that led to drug discontinuation in three. Conclusions: APB 501 showed a good safety and efficacy profile in maintaining clinical response at 2 years in patients with IBD, both as a treatment-naïve and as a replacement for ADA originator for non-medical reasons.
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