The Lancet has published results from the first head-to-head superiority study of two treatments in the anti-tumor necrosis factor (TNF) class. The study compared certolizumab pegol (Cimzia, UCB) plus methotrexate (MTX) with adalimumab (Humira, AbbVie) plus MTX in adults with moderate-to-severe rheumatoid arthritis (RA) who were inadequate responders to MTX.
The study did not meet its primary endpoints for superiority, demonstrating no statistically significant difference in efficacy between certolizumab and adalimumab in combination with MTX in both short-term (12-week) and long-term (two-year) evaluations. However, the data indicated that switching between these anti-TNFs without a wash-out period was beneficial in some patients.
The proportions of patients achieving at least 20% improvement on American College of Rheumatology response criteria (ACR20) at three months were 69.2% for certolizumab and 71.4% for adalimumab, and the proportions of patients achieving a state of low disease activity (LDA) at two years were 35.5% and 33.5%, respectively.
In the study, 14.7% of patients receiving certolizumab (n = 67) and 12.9% of those receiving adalimumab (n = 59) did not respond to their initial therapy at three months. At that time point, 65 patients in the certolizumab group and 57 patients in the adalimumab group were switched to receive immediate treatment with the other agent without a wash-out period between treatments. Of those patients, 57.9% (33/57) switching to certolizumab and 61.5% (40/65) of those switching to adalimumab responded 12 weeks later.
The proportions of patients treated with certolizumab or adalimumab achieving the secondary efficacy endpoint of LDA were 20.5% vs. 18.1%, respectively, at week 6; 30.4% vs. 29.7% at week 12; and 41.6% vs. 38.3% at week 52.
Certolizumab is the only Fc-free, PEGylated anti-TNF agent. It is indicated for the treatment of adults with moderately to severely active RA; adults with active psoriatic arthritis; and adults with active ankylosing spondylitis. Certolizumab is also indicated for reducing the signs and symptoms of Crohn’s disease and for maintaining a clinical response in adult patients with moderately to severely active disease who have shown an inadequate response to conventional therapy.
Source: UCB; November 15, 2016.