Biológica de control libre de la enfermedad (CDPB) en la AR temprana: predictores de la retirada exitosa de adalimumab (ADA) después de la consecución de la actividad de la enfermedad estable bajo con ada más metotrexato (MTX) - Los datos del estudio optima

Background It is unknown which pts may be able to achieve BFDC after initially responding to combination therapy with ADA plus MTX. Objectives To identify variables predictive of 1) stable DAS28(CRP)<3.2 (low disease activity, LDA) following 26 wks of treatment with either MTX monotherapy or ADA+MTX, and 2) BFDC following ADA withdrawal. Methods MTX-naïve pts ≥18 yrs with RA <1 yr, active disease [DAS28>3.2, and ESR≥28 mm/hr or CRP≥1.5 mg/dL], and either >1 erosion, RF+, or anti-CCP+ were randomized to ADA+MTX or placebo (PBO)+MTX for 26 wks. Pts who achieved stable DAS28<3.2 at wks 22 & 26 with ADA+MTX were re-randomized to blindly withdraw or continue ADA for an additional 52 wks. This post hoc analysis examined variables associated with DAS28<3.2 at wks 22 & 26 and with BFDC (DAS28<3.2 at wks 52, 66, & 78). Continuous variables included CRP, SJC66, and Pt and MD global assessments (GA) of disease activity at baseline (BL) and wks 12 or 26. Categorical variables included sex, smoker, BL concomitant steroid use, joint erosions, MTP erosions, HLA-DRB1 shared epitope, IL4R, and FcγRIIb, and wk 12 or 26 clinical responders. Step-wise multivariate selection was done on variables with P<.10 in univariate analysis. Results At wks 22 & 26, 44% (207/466) ADA+MTX and 24% (112/460) MTX pts achieved stable DAS28<3.2 (P<.001). Lower disease activity levels at wk 12 were modestly associated with reaching the stable LDA target (table). Significantly more pts who achieved this target and continued ADA+MTX maintained stable DAS28<3.2 from wk 52-78 (71/82, 87%) compared with pts who withdrew ADA (49/75, 65%; P=.002). Significant predictors of successful BFDC in pts who withdrew ADA included MD GA at BL and CRP levels at wk 26 Conclusions Lower disease activity levels early during treatment were predictive of achieving an initial stable DAS28<3.2 target. Significantly more pts who continued ADA+MTX maintained this target compared with pts who had ADA withdrawn. The physician's assessment of disease activity may identify pts as candidates for BFDC, and low CRP levels after achieving the initial target are indicative of increased likelihood of success upon ADA withdrawal. (Table Presented).