Objective: To evaluate the safety and efficacy of 2-year administration of certolizumab pegol (CZP) + MTX in patients with active RA.
Methods: Patients completing 52 weeks in the Rheumatoid Arthritis Prevention of Structural Damage (RAPID) 1 trial (52-week completers), or withdrawing at week 16 due to lack of ACR20 response were eligible for open-label treatment (CZP 400 mg every other week + MTX). After 2 years' treatment, HAQ-Disability Index response, ACR20/50/70 responses, DAS-28 and radiographic progression were assessed in 52-week completers. ACR20/50/70 and DAS-28 were also calculated for the intent-to-treat (ITT) population. Adverse events were assessed in patients who received one or more CZP doses during the study.
Results: At week 100, 88.9% (n = 216) of 52-week completers who originally received CZP 200 mg + MTX and open-label treatment remained in the study. In this group, ACR20/50/70 at week 100 were 68.2, 55.2 and 35.6%, respectively. HAQ-DI and DAS-28 improvements were sustained throughout the open-label extension (mean change -0.79 and -3.5 at week 100, respectively). A total of 46.7% (n = 113) of CZP 200 mg + MTX 52-week completers achieved low disease activity by week 100. Inhibition of radiographic progression was maintained. Similar findings were observed in 52-week completers who originally received CZP 400 mg + MTX and in the ITT population. Rates of serious infection or malignancies did not increase over time and no new safety signals were observed.
Conclusion: CZP + MTX provided sustained, 2-year inhibition of radiographic progression and sustained improvements in RA clinical signs and symptoms, with no new safety signals observed in patients who completed 2 years of treatment.
Trial registration: clinicaltrials.gov, http://www.clinicaltrials.gov, NCT00175877.