Adalimumab Clinical Trial Updates

The Big Molecule Watch is monitoring clinical trial activities involving adalimumab. Here we report on three recent studies with adalimumab biosimilars for treating psoriasis, inflammatory bowel disease, Crohn’s disease and ulcerative colitis.

In July 2022, clinical trial data was published from a real-life retrospective observational study of pediatric (<18 years) and geriatric (≥65 years) patients with psoriasis in Italy. A total of 11 children and 23 elderly psoriasis patients were enrolled. Patients received either adalimumab or etanercept biosimilars. The study found that both biosimilars were found to be effective and safe in treating moderate-to-severe psoriasis in children and the elderly, with no statistically significant difference in safety and efficacy.

Another study was published earlier this month of clinical data on the efficacy and safety of non-medical switches between the originator to a biosimilar adalimumab and between adalimumab biosimilars. A total of 276 patients with Crohn’s disease (n=205) and ulcerative colitis (n=71) who were on maintenance adalimumab therapy were enrolled. The study found that there were no significant difference in clinical remission rates at any time point of patients switching from originator to biosimilar or biosimilar to biosimilar. The clinical benefit was found to be sustained in these non-medical switches.

The most recent study was published last week from a multi-center observational study of the efficacy of adalimumab biosimilars Mylan’s HULIO (also called FKB327) and Sandoz’s HYRIMOZ (also called GP2017) in patients with Crohn’s disease (CD) or ulcerative colitis (UC) in the Czech Republic. A total of 34 CD and 16 UC patients were enrolled. The study found that 73.5% of the CD patients and 18.8% of the UC patients achieved remission. The authors concluded that “this prospective observational study proved the effectiveness of the adalimumab biosimilars FKB327 and GP2017 in IBD.”