Adalimumab Induction in Early RA Yields Erosive Benefits in the OPERA Study Save

A number of studies have shown that the treat-to-target approach is effective in achieving clinical remission - the ultimate therapeutic goal in patients with early RA.

The OPERA study was a 2-year investigator-initiated, double-blinded, randomized, controlled trial to evaluate the clinical and radiographic outcomes in DMARD naïve, early RA patients who are begun on methotrexate, with or without adalimumab induction therapy.

A 180 of early RA patient were randomized to receive placebo adalimumab (DMARD group, n=91) or adalimumab (40 mg/every other week) (DMARD+adalimumab group, n=89) during the first year. Sulfasalazine and hydroxychloroquine could be added if disease activity persisted after 3 months. During year 2, synthetic DMARDs were continued and ADA (or placebo) were stopped.

One year after adalimumab withdrawal, treatment profiles and clinical responses did not differ between groups, with both groups taking equal doses of methotrexate, equal percentages on triple DMARD therapy and equally low numbers requiring intraarticular triamcinolone or ADA reintroduction. Moreover, over 85% of patients were able to meet T2T goals at the end of the study. 

Although radiographic progression was similar, better Xray outcomes were observed with adalimumab induction therapy who had less erosive changes at year 1 and year 2.  The adalimumab induction group had no erosive progression in79% (ΔES≤0) at 2 years (vs 64% in those on DMARD. 

This aggressive treat-to-target strategy in eRA provided excellent 2-year clinical outcomes. However, ADA induction afforded an addition degree of erosive benefit that continues a year after ADA was withdrawn.