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Phase 3 study: Add-on certolizumab pegol has clinical benefit for patients with RA
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One year of certolizumab as an add-on to 2-year methotrexate therapy led to radiographic and clinical benefit through 2 years in methotrexate-naïve patients with early rheumatoid arthritis and poor prognosis, according to results of a recently published phase 3 trial.
Tatsuya Atsumi, MD, PhD, at Hokkaido University Graduate School of Medicine in Japan, and colleagues performed a randomized controlled study of patients with rheumatoid arthritis (RA). The study consisted of a 52-week double-blind (DB) period and a 52-week post-treatment (PT) period. For the DB period, patients received either optimized methotrexate (MTX) and certolizumab (CZB) (n = 159) or optimized MTX and placebo (n = 157). For the PT period, patients received MTX by itself (n = 108 from the first group; n = 71 from the second group). If patients flared, they could receive treatment with open-label CZB (n = 28). During PT, the discontinuation number was 34 for the first group and 14 for the second group.
In the PT period, researchers found significant inhibition of modified total Sharp score progression for the MTX and CZB group compared with the MTX group (84.2% vs. 67.5%). The CZB and MTX group maintained higher remission rates through week 104 in terms of SDAI (41.5% vs. 29.3%), Boolean (34.6% vs. 24.2%) and DAS28 (41.5% vs. 33.1%). Overall, remission rates declined after CZB discontinuation. In addition, patients who flared and received CZB re-treatment showed rapid clinical improvement and there was a similar adverse event rate between groups.
“Overall, these results suggest that patients with early RA would benefit from the addition of CZB to MTX therapy during the early stages of disease, particularly with respect to the prevention of joint destruction,” the researchers wrote. “Although this aggressive therapeutic strategy would not be recommended for all patients, it may be a potential option for those patients with a high risk of experiencing rapid joint destruction.” – by Will Offit
Disclosure: Atsumi reported taking part in speakers bureaus for Astellas, Bristol-Myers, Chugai and Mitsubishi-Tanabe.
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