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Researchers randomized 879 patients in a 3:1 ratio via a double-blind method to receive 400 mg certolizumab pegol at Weeks 0, 2 and 4 and then 200 mg certolizumab pegol every two weeks through Week 52 along with MTX (n=660), or placebo and MTX (n=219; either 15 mg to 25 mg weekly). The primary efficacy endpoint was the proportion of patients in sustained remission (DAS (ESR) <2.6) at both Weeks 40 and 52. The secondary endpoint was the proportion of patients with sustained low disease activity (DAS28 (ESR) ≤3.2) at both Weeks 40 and 52.
At Week 52, 29% vs. 15% (P<0.001) of certolizumab pegol plus MTX and MTX-only treated patients, respectively, achieved sustained remission. Additionally, 44% vs. 29% (P<0.001) of certolizumab pegol plus MTX and MTX-only treated patients, respectively, achieved sustained low disease activity. For certolizumab pegol plus MTX-treated patients, there was significantly greater inhibition of radiographic progression and physical functioning improvement vs. MTX plus placebo-treated patients. Of all randomized patients, 143 of placebo plus MTX-treated patients completed Week 52 and 500 certolizumab pegol plus MTX-treated patients completed Week 52.
Adverse events and serious adverse events were similar between both treatment groups. Infection occurred more frequently in the certolizumab pegol plus MTX-treated patients. Serious infection rates were similar between the two treatment groups. Two deaths occurred in the certolizumab pegol-treated group: one from a stroke not believed to be medication related, and one from a disseminated, mycobacterium infection thought to be medication related. One death also occurred in the MTX plus placebo-treated group that was not thought to be treatment related.
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.