BI695501 is a biosimilar product for adalimumab. A phase IIIb study compared BI695501 to the reference product adalimumab in patients with moderate-to-severe chronic plaque psoriasis over a 24-week treatment period and observed that the two were equivalent in efficacy, safety, and immunogenicity. The results of the study were published as part of the American Academy of Dermatology Virtual Meeting Experience 2020.
The randomized, double-blind, parallel-arm, multiple-dose, active comparator trial included 318 adult patients who had active moderate-to-severe chronic plaque psoriasis for six or more months. Patients had received no more than one previous biologic agent and had not previously received adalimumab.
Patients were randomized 1:1 to receive BI695501 40 mg subcutaneously (SC) every other week or adalimumab 40 mg SC every other week. A total of 286 patients with Psoriasis Area and Severity Index (PASI) 50 at week 16 continued on the trial for the current analysis; 141 patients in the BI695501 cohort and 134 in the adalimumab cohort completed the 24-week trial.
PASI 75 response rates at week 24 showed significant similarity between the BI695501 and adalimumab treatment groups, with the difference of 2.9% between the groups well within the predefined equivalence margins, according to the researchers. PASI 50, 90, and 100 response rates were also similar between the groups at week 24. Mean improvement in PASI at week 24 was 84.6% (95% confidence interval [CI], 80.7-88.6) for BI695501 and 85.4% (95% CI, 81.5-89.4) for adalimumab.
The proportion of adverse events (AEs) was similar between the two groups: 66 patients (41.5%) in the BI695501 group and 71 (44.9%) in the adalimumab group experienced one or more AEs. Serious AEs reported in the BI695501 group were abdominal abscess, oral herpes, upper respiratory tract infection, congestive cardiomyopathy, and psoriasis, while serious AEs reported in the adalimumab group were furuncle, kidney infection, orchitis, transient ischemic attack, pericarditis, pancreatitis chronic, hepatitis toxic, exostosis, foot deformity, and renal colic.
A similar proportion of patients in each treatment group were positive for anti-drug antibodies (ADAs) and neutralizing antibodies at week 24, suggesting immunogenicity of the two agents, according to the authors. PASI 75 response at week 24 was higher in ADA-negative patients than ADA-positive patients.
Menter A, Arenberger P, Balser S, et al. Biosimilar BI 695501 demonstrates equivalence to adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis through 24 weeks.Presented during the AAD Virtual Meeting Experience 2020, June 12-14, 2020.