ACHIEVING LONG-TERM COMPREHENSIVE DISEASE CONTROL WITH ADALIMUMAB AND METHOTREXATE IN PATIENTS WITH EARLY RHEUMATOID ARTHRITIS IN THE OPTIMA STUDY

Background: The goals of the treat-to-target strategy for rheumatoid arthritis (RA) are to reduce inflammation, prevent structural damage, and to normalize function. Objectives: To compare the percentage of RA patients (pts) achieving comprehensive disease control (CDC) after obtaining stable DAS28<3.2 at wks 22 and 26 (target) with adalimumab (ADA)+methotrexate (MTX) or placebo (PBO)+MTX (responders, R) to the percentage of pts achieving CDC with open-label (OL) ADA+MTX in PBO+MTX pts not achieving target (inadequate responders, IR). CDC was defined as low disease activity (DAS28<3.2)+no radiographic progression (ΔmTSS≤0.5)+normal function (HAQ<0.5). Methods: MTX-naïve pts ≥18 yr with RA <1 yr, active disease [DAS28(CRP)>3.2, ESR≥28 mm/hr or CRP≥1.5 mg/dL], and either >1 erosion, RF+, or anti-CCP+ were randomized to ADA+MTX or PBO+MTX for 26 wks (Period 1, P1). ADA+MTX-R pts were randomized to withdraw ADA or continue ADA+MTX for an additional 52 wks (P2). PBO+MTX-R pts continued on MTX and pts with IR received OL ADA+MTX in P2. This post-hoc analysis examines the proportion of pts achieving CDC at wks 26, 52, and 78. For MTX IR pts the proportion of pts achieving CDC at wk 52 was compared with CDC response for ADA+MTX at wk 26 in P1. Baseline characteristics were compared for pts achieving CDC vs. non-achievers at wk 78. Results: At wk 26, 30% and 16% of pts achieved CDC with ADA+MTX and PBO+MTX, respectively (P <.001, table). At wk 78, high DAS28<3.2 response rates were seen in ADA+MTX(R)→ADA+MTX and PBO+MTX(R)→PBO+MTX pts (91%/81%); ΔmTSS≤0.5 response was 89%/78%; HAQ<0.5 was the most difficult to achieve, in 67%/64%. CDC at wk 78 was similar for ADA+MTX(R)→ADA+MTX and PBO+MTX(R)→PBO+MTX pts (P=.10). Using wk 26 as baseline for ΔmTSS, 24% (80/332) of PBO+MTX(IR)$→ $ADA+MTX pts achieved CDC after 26 wks of OL ADA+MTX, similar to pts on ADA+MTX in P1. Table 1. Number (%) pts achieving CDC Period 1 TreatmentADA+MTX (N=515)PBO+MTX (N=517) CDC Week 26153 (29.7)83 (16.1) Period 2 TreatmentADA+MTX (N=105)PBO+MTX (N=112)OL ADA+MTX (N=348) CDC Week 2662 (59.6)66 (58.9)16 (4.6) CDC Week 5263 (61.8)59 (54.1)61 (18.4) CDC Week 7861 (59.8)53 (48.6)82 (24.8) DAS28<3.2+ ΔmTSS≤0.5+HAQ<0.5. Intent-to-treat pts with at least one dose of study drug in period. % based on # pts with a non-missing value at visit (MI). ADA, adalimumab; MTX, methotrexate; OL, open-label; PBO, placebo. Although some baseline patient/disease characteristics differed between CDC achievers and non-achievers at wk 78, they were not consistent across treatment groups. Conclusions: Comprehensive disease control is an achievable goal for many early RA pts who respond initially to MTX or ADA+MTX. Introducing ADA in MTX-IR pts resulted in a similar proportion of pts achieving CDC as observed in all pts with initial ADA+MTX therapy. Disclosure of Interest: P. Emery Consultant for: Abbott, Pfizer, Merck, Roche, BMS, UCB, J. Smolen Grant/Research support from: Abbott, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, UCB, Consultant for: Abbott, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, UCB, R. Fleischmann Grant/Research support from: Abbott, Consultant for: Abbott, R. van Vollenhoven Grant/Research support from: Abbott, GSK, Merck, Pfizer, Roche, UCB, Consultant for: Abbott, GSK, Merck, Pfizer, Roche, UCB, S. Florentinus Shareholder of: Abbott, Employee of: Abbott, S. Santra Shareholder of: Abbott, Employee of: Abbott, H. Kupper Shareholder of: Abbott, Employee of: Abbott, L. Redden Shareholder of: Abbott, Employee of: Abbott, A. Kavanaugh Grant/Research support from: Abbott, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, UCB, Consultant for: Abbott, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, UCBCitation: Annals of the Rheumatic Diseases, volume 71, supplement 3, year 2012, page 369Session: Rheumatoid arthritis – anti-TNF therapy (Poster Presentations )