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 or 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.
Study authors caution: Patients on infliximab who have developed antibodies to infliximab should not be switched to an infliximab biosimilar.
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.
References
- Ruiz-Argüello B, Maguregu A, Ruiz del Agua A, et al. Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilar CT-P13. Ann Rheum Dis. 2016 Mar 10. pii: annrheumdis-2015-208684. doi: 10.1136/annrheumdis-2015-208684. [Epub ahead of print]
- Lampropoulos CE, Orfanos P, Manoussakis M, et al. Efficacy of treat-to-target biologic therapy in patients with rheumatoid arthritis compared to delayed initiation of biologics: A real world study. Ann Rheum Dis. 2016;75(Suppl2):193. doi: 10.1136/annrheumdis-2016-eular.1187
- Emery P, Bingham III CO, Burmester GR, et al. Certolizumab pegol in combination with dose-optimised methotrexate in DMARD-naive patients with early, active rheumatoid arthritis with poor prognostic factors: 1-year results from C-EARLY, a randomised, double-blind, placebo-controlled Phase III study. Ann Rheum Dis. 2016 May 10. pii: annrheumdis-2015-209057. doi: 10.1136/annrheumdis-2015-209057. [Epub ahead of print].
