ABATACEPT IN INDIVIDUALS AT RISK OF DEVELOPING RHEUMATOID ARTHRITIS: RESULTS FROM THE ARTHRITIS PREVENTION IN THE PRE-CLINICAL PHASE OF RA WITH ABATACEPT (APIPPRA) TRIAL
Authors: Andrew Cope et al.
In the recent years we have seen several studies aimed at delaying or preventing the development of RA in probands at high risk of the disease based on biomarkers or imagery procedures. The “Arthritis Prevention In the Pre-clinical Phase of RA with Abatacept” (APIPPRA) study is a randomised, double blind, placebo-controlled trial that enrolled ACPA+RF+ or high titers of ACPA+RF– individuals with arthralgias. Participants were randomised to receive 52 weekly sc injections of placebo (PBO) or 125 mg abatacept (ABA). 103 participants were randomized to PBO and 110 to ABA. At 1 year, significantly more participants had developed RA or arthritis in the PBO arm (29%) than in the ABA arm (6%). After one additional year of follow-up without therapy, 37% and 25% respectively had developed the outcome (difference in survival p=0.044). Four serious adverse events in the ABA group and 10 in the PBO group.
Therapeutic intervention during the RA at risk phase is feasible and ABA seems an attractive option because of its good safety profile and mode of action. One year of treatment with ABA reduced the development of the disease, but mainly during the first year. After treatment discontinuation, the survival curves appear to converge slowly, which suggests a delay in disease development, rather than a true disease prevention. Health authorities are unlikely to grant an extension of the market authorization for ABA based on these results, so that these results are unlikely to reach clinical practice.