Adalimumab Biosimilar on Par With Original in Crohn's Disease

By Reuters Staff

August 20, 2021

NEW YORK (Reuters Health) - For patients with moderate to severe active Crohn's disease, the adalimumab biosimilar BI 695501 from Boehringer Ingelheim proved as safe and effective as the original, AbbVie's Humira, in the phase-3 VOLTAIRE-CD study.

The treatment benefits of the biosimilar were maintained in patients taking the reference product first who then switched to BI 695501.

"These results further support the existing licensure of BI 695501 as an alternative to adalimumab reference product for patients with Crohn's disease, as well as the other indications for which BI 695501 is approved," write Dr. Stephen Hanaeur of Northwestern University Feinberg School of Medicine and colleagues in The Lancet Gastroenterology and Hepatology.

VOLTAIRE-CD was a randomized, double-blind, multicenter trial comparing BI 695501 with the adalimumab reference in 147 adults with moderately to severely active Crohn's disease.

By random assignment, 72 patients received BI 695501 and 75 received the reference product via subcutaneous injection every two weeks. Patients were assessed using the Crohn's Disease Activity Index (CDAI) at four, 12, 24 and 48 weeks.

Those achieving a decrease from baseline on the CDAI of at least 70 points at week four were classified as responders and could continue receiving study treatment until 46 weeks. At week 24, those who had been taking the reference product switched to the biosimilar.

The primary endpoint - the proportion of patients with a clinical response (CDAI decrease of at least 70 points) at week 4 - was not significantly different in the BI 695501 group and the adalimumab group (90% and 94%, respectively).

Overall safety results were similar between the biosimilar and reference adalimumab.

Patients switching from the reference product to BI 695501 showed no reduction in efficacy and no increase in the incidence of adverse events.

"Numerically higher proportions of patients who received BI 695501 throughout the study tested positive for antidrug antibodies and neutralizing antibodies compared with patients who received adalimumab reference product followed by BI 695501; however, post-hoc analyses indicated that a similar proportion of patients in both groups had clinically relevant anti-drug antibodies (titre >=256) or neutralizing antibody positivity," the researchers report.

The similar efficacy of BI 695501 and adalimumab reference product are in line with comparisons of the two drugs in patients with rheumatoid arthritis and chronic plaque psoriasis, as well as in healthy volunteers, they note.

The VOLTAIRE-CD study was funded by Boehringer Ingelheim. Several authors disclosed financial relationships with the company.

SOURCE: The Lancet Gastroenterology and Hepatology, online August 10, 2021.