WASHINGTON, DC—Data from a head-to-head superiority trial comparing Cimzia (certolizumab pegol) and Humira (adalimumab)—two anti-tumor necrosis factor (TNF) agents—found no statistically significant difference in efficacy between the 2 agents in combination with methotrexate in both short-term and long-term evaluations in patients with moderate to severe rheumatoid arthritis (RA), researchers presented at the 2016 ACR/ARHP Annual Meeting.
The Phase 4, 104-week, randomized EXXELERATE study (n=915) compared Cimzia + methotrexate vs. Humira + methotrexate in adults with moderate to severe rheumatoid arthritis (RA) who were inadequate responders to methotrexate. Study authors reported that the trial did not meet its primary endpoints for superiority. “However, data from the study demonstrated that switching between these anti-TNFs without a wash-out period was beneficial to some patients,” reported Professor Dr. Josef S. Smolen, from the Medical University of Vienna, Austria.
Before this study, there was limited evidence supporting the use of anti-TNFs after initial anti-TNF treatment failure, as no studies evaluated the efficacy of an immediate switch from one anti-TNF agent to another.
The data showed the percentage of patients achieving ACR20 response at 3 months was 69.2% with Cimzia vs. 71.4% with Humira. The percentage of patients achieving low disease activity (LDA) at 2 years was 35.5% with Cimzia vs. 33.5% with Humira.
Initially, 14.7% of Cimzia patients and 12.9% of Humira patients did not respond to therapy at 3 months. Response was defined as being in LDA or DAS28 (ESR) reduction from Week 12 of ≥1.2. At 3 months, patients were switched to receive immediate treatment with the other agent without a wash-out period. Of the patients who switched, 57.9% who switched to Cimzia and 61.5% who switched to Humira responded 12 weeks later exhibiting a state of LDA or DAS28 (ESR) reduction from Week 12 of ≥1.2.
The safety profile was similar between the two agents among the study population in terms of incidence per 100 patient-years of treatment-emergent adverse events (TEAEs), serious TEAEs, and serious infections and infestations.
Findings from EXXELERATE highlight the importance of clinical decision-making 3 months after treatment initiation. By using a second anti-TNF agent at Week 12 in the event of inadequate response, clinicians can maximize the benefits of treatment and identify inadequate responders to anti-TNF within 6 months.
Full findings from the study have also been published in The Lancet.