Clinical Edge

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Certolizumab Pegol in RA

Assessing efficacy and safety over time

Certolizumab pegol (CZP) provided sustained improvements in clinical outcomes for almost 5 years, according to a study of 492 patients with active rheumatoid arthritis (RA) randomized to CZP plus methotrexate (MTX) and 127 patients with active RA randomized to placebo plus MTX. Researchers found:

• Of all randomized patients, 57.8% were ongoing at Week 232.

• Annual dropout rates during the first 4 years ranged from 8.4% to 15.0%.

• Event rates per 100 patient-years were 163.0 for adverse events (AEs) and 15.7 for serious adverse events (SAEs).

• 19 patients had fatal AEs.

• Clinical improvements were maintained to Week 232 in the CZP Completers.

• Similar improvements seen in the intention-to-treat group were maintained following dose reduction.

• 73.2% of CZP Completers had no radiographic progression at Week 128.

Citation: Smolem JS, van Vollenhoven R, Kavanaugh A, et al. Certolizumab pegol plus methotrexate 5-year results from the rheumatoid arthritis prevention of structural damage (RAPID) 2 randomized controlled trial and long-term extension in rheumatoid arthritis patients. Arthritis Res Ther. 2015 Sep 10;17(1):245. doi: 10.1186/s13075-015-0767-2.