AB0835 THE IMPACT OF ADALIMUMAB VS PLACEBO ON PATIENT-REPORTED OUTCOMES AND UTILITY MEASURES AMONG PATIENTS WITH MODERATELY TO SEVERELY ACTIVE PSORIATIC ARTHRITIS

Abstract

Background:Physical function and health-related quality of life(HRQoL) are negatively impacted in patients(pts) with PsA. Treatment with conventional and biological (b) DMARDs improved patient-reported outcomes(PROs).Objectives:To assess impact of adalimumab(ADA) vs placebo(PBO) on PROs following 12-week (wk) treatment.Methods:Pts(n=315) with moderately to severely active PsA and bDMARD naive were randomized to ADA 40mg or PBO every other wk. We assessed PROs at baseline(BL) and wk 12 using the 36-item Short-Form(SF-36) Health Survey physical(PCS) and mental component summary(MCS) scores, 8 domain scores ranging from 0(worst) to 100(best), and SF-6D utility measure derived from all 8 SF-36 domains with scores ranging from 0.296(worst) to 1.00(full health) and minimally important difference(MID) of 0.041. Patient Global Assessment of disease activity(PtGA) and pain(both utilizing 100 mm visual analog scale[VAS]) and HAQ disability index(DI) were assessed. Mean changes from BL, percentages of pts with improvements ≥minimum clinically important differences(MCID), and scores ≥US age-and gender-matched normative values(A/G norms) were analyzed, based on as observed data.Pvalues were assessed by analysis of variance model for continuous variables andCochran–Mantel–Haenszeltest for binary outcomes, adjusting by baseline MTX use and extent of psoriasis. Numbers needed to treat(NNTs) are reported using proportions of pts reporting improvements ≥MCID in SF-36, PtGA, pain, and HAQ-DI.Results:BL PRO scores were similar between ADA(n=151) and PBO(n=162;Table 1). Improvements from BL at wk 12 with ADA vs PBO were significant in PtGA, pain, HAQ-DI, and SF-36 PCS(change: 9.3 vs 1.4;P<0.001) but not in SF-36 MCS(1.6 vs 1.2;Table 1). Six of 8 SF-36 domains significantly improved from BL to wk 12 with ADA vs PBO(allP≤0.05;Table 1andFigure 1). SF-6D improvements exceeded MID with ADA(change: 0.071) vs PBO(0.018). Proportions of pts reporting improvements ≥MCID at wk 12 were significantly greater with ADA vs PBO in all PROs, except SF-36 role emotional and mental health domains, with corresponding NNTs ≤6.4(Figure 2). Proportions of pts who reported scores ≥A/G norms in HAQ-DI, SF-36 PCS, and 6 of 8 SF-36 domains were significantly greater with ADA vs PBO(Figure 2).Table 1.Mean Disease Characteristics and SF-36 Domain Scores by Treatment Group at Baseline and Wk 12 Compared With Age-and Gender-Matched Normative ValuesADA 40 mg eowPBOA/G normsBaselineWeek 12[change from baseline to week 12]BaselineWeek 12[change from baseline to week 12]SF-36 PCS33.242.5[9.3**]33.334.7[1.4]≥50SF-36 MCS48.149.8[1.6]46.648.4[1.2]≥50SF-6D0.6530.724[0.071]0.6410.659[0.018]—PtGA47.125.9[–21.7**]48.147.5[0.2]—Pt pain51.126.8[–24.1**]48.849.1[1.3]—HAQ-DI1.00.6[–0.4**]1.00.9[–0.1]≤0.25Baseline(vs A/G norms)Week 12(vs A/G norms)Baseline(vs A/G norms)Week 12(vs A/G norms)Physical Functioning50.8(−31.5)65.9***(−16.4)48.2(−34.1)52.0(−30.3)82.3Role Physical37.1(−45.9)65.9***(−17.1)32.6(−50.4)40.6(−42.4)83.0Bodily Pain41.3(−31.6)61.0***(−11.9)40.2(−32.7)43.7(−29.2)72.9General Health49.5(−20.8)62.1***(−8.2)52.1(−18.2)53.0(−17.3)70.3Vitality41.4(−17.8)55.1***(−4.1)41.6(−17.6)45.0(−14.2)59.2Social Functioning66.3(−19.0)77.8†(−7.5)61.7(−23.6)66.7(−18.6)85.3Role Emotional65.1(−23.4)70.4(−18.1)59.1(−29.4)66.0(−22.5)88.5Mental Health67.6(−8.5)72.9(−3.2)64.9(−11.2)67.3(−8.8)76.1ADA, adalimumab; A/G norm, age-and gender-matched normative value; eow, every other week; DI, disability index; MCS, mental component summary; MID, minimally important difference; PBO, placebo; PCS, physical component summary; PtGA, Patient Global Assessment of disease activity; SF-36, 36-item Short-Form Health Survey; SF-6D, Short-Form 6D.SF-6D MID=0.041.Statistical analysis ADA vs PBO:†P<0.05; *P<0.01; **P<0.001; ***P<0.0001.Conclusion:Statistically significant and clinically meaningful improvements and scores ≥A/G norms(higher definition of response) at week 12 were reported with ADA vs PBO in pts with moderately to severely active PsA.Disclosure of Interests:Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Pankaj Patel Shareholder of: AbbVie, Employee of: AbbVie, Naijun Chen Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, Elizabeth Lesser Shareholder of: AbbVie Inc, Employee of: AbbVie Inc