OP0052 THE EFFECT OF TOFACITINIB ON RESIDUAL PAIN IN PATIENTS WITH RHEUMATOID ARTHRITIS AND PSORIATIC ARTHRITIS WITH COMPLETE CONTROL OF INFLAMMATION

Abstract

BackgroundResidual pain often remains in patients (pts) with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) who achieve low disease activity or remission.1,2 Tofacitinib is an oral JAK inhibitor for the treatment of RA and PsA. A descriptive analysis showed that tofacitinib may have a beneficial effect on residual pain in pts with PsA with abrogated inflammation.3ObjectivesTo assess efficacy of tofacitinib, adalimumab (ADA) and placebo (PBO) on residual pain in pts with RA and PsA with abrogated inflammation, using a network meta-analysis (NMA).MethodsData were pooled from 9 randomised clinical trials of pts with RA (NCT00960440/NCT00847613/NCT00814307/NCT00856544/NCT00853385/NCT01039688/NCT02187055) or PsA (NCT01877668/NCT01882439). This analysis included pts who received ≥1 dose of tofacitinib 5 mg twice daily (BID), ADA 40 mg once every 2 weeks or PBO with background therapy, and had abrogated inflammation (swollen joint count [SJC] = 0 and C-reactive protein [CRP] <6 mg/L) at Month (M)3. ADA was included in NCT00853385/NCT02187055/NCT01877668; NCT02187055 performed tofacitinib/ADA non-inferiority/superiority comparisons. Primary outcome was pt assessment of Pain (visual analogue scale [VAS] 0 [no pain] – 100 mm [most severe pain]) at M3; scores were summarised descriptively; treatment comparisons were assessed by Bayesian NMA on individual pt-level data, accounting for within-trial imbalances and treatment effect modifiers.ResultsAbrogated inflammation at M3 was achieved in 14.1% (328/2330), 14.9% (87/585) and 3.0% (20/673) of RA and 22.7% (54/238), 29.2% (31/106) and 12.7% (30/236) of PsA pts receiving tofacitinib, ADA and PBO, respectively. RA and PsA pts receiving tofacitinib/ADA had higher CRP vs pts receiving PBO. RA pts receiving tofacitinib/ADA had lower SJC and longer disease duration vs pts receiving PBO. PsA pts receiving tofacitinib had a longer disease duration and higher Pain VAS vs pts receiving ADA/PBO. In both groups, a lower % of female pts received tofacitinib/ADA vs PBO (Table 1). Observed median (Q1; Q3) values for Pain VAS at M3 were 17.0 (6.0; 31.0), 19.0 (7.0; 31.0) and 33.5 (7.0; 48.0) in RA and 24.0 (8.0; 44.0), 21.0 (9.0; 49.0) and 27.0 (8.0; 52.0) in PsA pts treated with tofacitinib, ADA or PBO, respectively. Differences between active treatments and PBO were less prominent in PsA vs RA pts, per posterior probability values (Fig).Table 1.Demographics and baseline characteristics of pts with abrogated inflammation at M3RAPSATofacitinib 5 mg BID (N=328)ADAa 40 mg Q2W (N=87)PBO(N=20)Tofacitinib 5 mg BID (N=54)ADAa 40 mg Q2W (N=31)PBO(N=30)Age, yrs, mean (SD)50.7(12.8)49.2(13.9)44.6(9.9)51.1(11.7)47.4(11.6)49.7(11.6)Female, %79.077.090.044.435.570.0Weight, kg, mean (SD)68.9(16.9)72.5(21.8)71.4(25.0)89.1(22.7)83.2(19.0)76.7(15.7)Disease duration, yrs, median (Q1; Q3)4.8(1.4; 9.5)5.8(2.4; 11.1)2.6(1.7; 8.5)7.8(4.0; 14.3)2.7(1.0; 6.0)4.3(2.7; 10.0)SJC, median(Q1; Q3)9.0(7.0; 14.0)8.0(6.0; 12.0)10.5(9.0; 19.5)6.0(4.0; 10.0)5.0(4.0; 8.0)5.0(4.0; 7.0)CRP, mg/L, median (Q1; Q3)8.0(3.6; 20.0)8.6(3.6; 15.7)3.9(1.4; 6.4)3.7(1.1; 9.2)3.6(1.2; 12.5)2.2(1.2; 4.5)Pain VAS, median (Q1; Q3)57.0(39.0; 72.7)52.5(35.0; 69.0)62.0(38.5; 67.0)58.0(51.0; 75.0)48.0(36.0; 65.0)48.5(21.0; 61.0)aADA was included in NCT00853385/NCT02187055/NCT01877668; NCT02187055 performed tofacitinib/ADA non-inferiority/superiority comparisons.N, number of pts; Q1, 1st quartile (25th percentile); Q2W, once every 2 weeks; Q3, 3rd quartile (75th percentile); SD, standard deviation.ConclusionIn this NMA, pts with RA and PsA achieving abrogated inflammation with tofacitinib or ADA at M3 had greater residual pain reduction vs those receiving PBO. This may imply that tofacitinib/ADA have analgesic benefits beyond those related to inflammation reduction.