Adverse events were similar for both arms of the study. The certolizumab pegol plus methotrexate group had a higher infection rate than the placebo plus methotrexate group (71.8 vs. 52.7/100 person-years), but results were similar for serious infections (3.3 vs. 3.7/100 person-years). Two deaths were reported with certolizumab pegol plus methotrexate. One stroke occurred, which was considered unrelated to the study drug. There was one case of systemic tuberculosis, which was considered related to the study drug. One patient had respiratory failure in a placebo plus methotrexate group, but it was considered unrelated to the study drug. No new safety signals for certolizumab pegol were reported.
Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- Mease PJ, van der Heijde D, Ritchlin CT, et al. A randomized, double-blind, active- and placebo-controlled phase 3 study of efficacy and safety of ixekizumab, adalimumab and placebo therapy in patients naïve to biologic disease-modifying anti-rheumatic drugs with active psoriatic arthritis. Arthritis Rheumatol. 2015;67(suppl 10).
- Weinblatt M, Bingham C, Burmester G, et al. Certolizumab pegol in combination with methotrexate in DMARD-naïve patients with active, severe, progressive rheumatoid arthritis: Results from a randomized, double-blind, controlled phase 3 study. Arthritis Rheumatol. 2015;67(suppl 10).
