Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial Rheumatology,
Keystone EC et al. – Certolizumab pegol (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. 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.
- 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.