Background/Purpose: Currently, five biologic disease-modifying antirheumatic drug (DMARD) therapies are used in MTX-naïve, early rheumatoid arthritis (RA). In the absence of head to head studies, indirect approaches are required in order to gain insight into the comparative efficacy and tolerability of these agents.
Objective: To determine the relative efficacy and tolerability of biologic agents approved for the treatment of MTX-naïve early RA patients using mixed treatment comparison (MTC) methodology.
Method: A systematic literature review was performed to identify RCTs published between January 1, 1990 and June 16, 2010 that measured efficacy and safety endpoints in an MTX-naïve, early RA population. Those RCTs that included any one of the approved biologics abatacept (ABA), adalimumab (ADA), etanercept (ETN), golimumab (GOL), and infliximab (INF), were included in the MTC that compared the following outcomes at 1 year: American College of Rheumatology (ACR) 20/50/70, Disease Activity Score 28 (DAS 28) remission, severe adverse events (AEs), serious infections and withdrawals due to an AE or due to any reason.
Result: No difference in the odds of achieving ACR 50 or ACR 70 scores was seen between the biologics, although both INF (odds ratio [OR]=0.48, 95% CI=0.27–0.82) and ADA (OR=0.53, 95% CI=0.29–0.94) had significantly lower odds of achieving ACR20 compared with ETN. The odds of achieving DAS28 remission was also found to be similar between all biologic therapies with the exception of INF which had significantly lower odds (OR=0.54, 95% CI=0.30–0.97) compared with ADA. Tolerability to the biologic agents was not significantly different with the exception of INF and GOL, as the former had significantly higher odds of experiencing serious infections compared with ETN (OR=5.12, 95% CI=1.20–24.80) and significantly higher odds of discontinuing treatment due to AEs compared with ABA (OR=4.80, 95% CI=1.45–17.08) and ETN (OR=4.28, 95% CI=1.75–11.35), while GOL had higher odds of discontinuing treatment due to AEs compared with those receiving ETN (OR=3.43, 95% CI=1.07–12.67).
Conclusion: In general, all biologic agents used in MTX-naïve early RA demonstrated similar efficacy and tolerability, except for INF which appeared to have less favorable efficacy and tolerability. For specific outcomes studied, ETN and ABA were not significantly different from each other and were the only biologics that did not demonstrate a significantly decreased likelihood of efficacy or tolerability compared with any of the other agents.
Disclosure: Y. Yazici, Centocor, Inc, Bristol-Myers Squibb, 2, Bristol-Myers Squibb, Celgene, Genentech, UCB, Roche, Pfizer, 5, Bristol-Myers Squibb, Genentech, 8 ; C. Swearingen, None; A. Nadkarni, Bristol-Myers Squibb, 1, Bristol-Myers Squibb, 3 ; L. Rosenblatt, Bristol-Myers Squibb, 1, Bristol-Myers Squibb, 3 .