Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring

Abstract

Objective The adalimumab biosimilars FKB327 and GP2017 were approved for the therapy of patients with inflammatory bowel disease (IBD). Relatively few prospective studies with biosimilar adalimumab in patients with IBD have been published. The aim of this prospective observational study was to evaluate the effectiveness and safety of the biosimilar adalimumab. Material and methods Adalimumab biosimilars FKB327 (Hulio®) and GP2017 (Hyrimoz®) were indicated to 50 naive patients in terms of biological therapy with Crohn’s disease (CD) or ulcerative colitis (UC). Effectiveness of therapy was evaluated via the Crohn’s Disease Activity Index [CDAI] or the Mayo Scoring System [MSS] in patients with CD or UC, respectively, before and after 12 weeks. Additional goals were to evaluate weight changes, laboratory tests and complications or adverse events of this therapy. Results In CD patients, remission (CDAI <150) was achieved in 73.5% of cases, partial response (≥70-point decrease in CDAI score from baseline) in 11.8%, no response in 11.8% and 2.9% patients discontinued therapy. In UC patients, remission (total score on partial Mayo index ≤2 points) was achieved only in 18.8% of cases, partial response (≥2-point decrease in partial Mayo score from baseline) in 43.8%, no response in 25.0% and 12.5% patients discontinued therapy. There were statistically significant improvements in CDAI, MSS, haemoglobin, fecal calprotectin, albumin and CRP serum levels after 12 weeks of therapy. Seven adverse events were identified, three of which resulted in therapy being discontinued. Conclusions This prospective observational study proved the effectiveness of the adalimumab biosimilars FKB327 and GP2017 in IBD.

Efficacy and Safety of Adalimumab Biosimilar GP2017 in Patients with Inflammatory Bowel Disease

“…Regarding the primary outcome, in the IBD patients starting GP2017 as their first adalimumab, the remission rate at 12 months was achieved in around 60% of the patients. This finding is coherent with previous data on the efficacy both for the adalimumab originator and other adalimumab biosimilars [34][35][36][37]. Among the patients who started GP2017 switching from the adalimumab originator or biosimilars, the primary outcome, which is maintenance of remission, was observed in around 80% of the patients.…”

A review of the therapeutic management of ulcerative colitis

“…74 Numerous ADA biosimilars have been approved in recent years, with real-life data limited to observational cohort studies. However, there has been no significant difference in clinical, biochemical and endoscopic outcomes noted in these studies, [75][76][77] thus providing patients with a much larger variety in therapeutic options moving forwards. Interestingly, patients that were intolerant on one biosimilar, were subsequently switched to another biosimilar successfully, 78 further cementing the role of biosimilars in the therapeutic armamentarium of IBD.…”

Biologics in Focus: A Comprehensive Review of the Current Biological Therapies for Ulcerative Colitis in the United Arab Emirates (UAE)

“…Shin et al [29] also compared the pharmacokinetic properties of Renflexis ® and Remicade ® , showing no significant differences between Renflexis ® and Remicade ® . Imraldi [29], Hyrimoz [30], and Hulio [45] are Humira ® biosimilars, with studies comparing biosimilars to Humira ® showing comparable efficacy and safety.…”