Adding a Biologic to Methotrexate May Benefit Patients With Early RA

In a recent study, funded by Astellas and UCB and published in Annals of the Rheumatic Diseases, researchers sought to investigate the clinical impact of 1-year certolizumab pegol (CZP) therapy added to the first year of a 2-year treatment with methotrexate (MTX) in patients with early rheumatoid arthritis (RA), and to compare that outcome with the clinical impact of a 2-year treatment with MTX alone.

The multicenter, randomized, controlled study investigated patients who had early RA with a poor prognosis and were naïve to MTX treatment. During the first 52 weeks, patients were randomized into 2 arms: the first arm received MTX and CZP (n = 159) and the second arm received MTX and placebo (n = 157). Following this double-blind period, both groups entered a 52-week period of treatment with MTX alone, though patients in need of rescue treatment received open-label CZP.

The researchers observed that remission rates decreased after CZP was discontinued; however, higher rates of remission were maintained through week 104 in the group receiving MTX and CZP (41.5%) versus the group that received MTX and the placebo (29.3%). Patients who were treated with CZP as a rescue therapy showed rapid clinical improvement. The incidence of adverse effects was similar between the 2 treatment arms.

Based on the trial results, the researchers concluded that, in patients with early RA who were naïve to MTX treatment and who had poor prognostic factors, an initial 1 year of CZP added to a 2-year MTX therapy rendered a clinical benefit over 2 years, even after CZP was discontinued.

The study’s authors state that aggressive initial treatment with a biological disease-modifying anti-rheumatic drug such as CZP is a potential treatment option at the early stage of RA, especially for patients who have poor prognoses. After patients achieve treatment goals, such biologics may be withdrawn. While such an aggressive approach may not be appropriate for all patients, the authors caution, those at high risk for rapid joint destruction may benefit from such a protocol. The approach, the authors say, has the potential to prevent irreversible joint damage, reduce the risk of adverse events, and provide a more cost-effective treatment for RA in the long term.