P192 Secukinumab provides rapid and sustained improvements in subgroup analyses of joint tenderness and swelling in patients with psoriatic arthritis: 2-year results from the Phase 3 FUTURE 5 study

Abstract

Abstract Background/Aims We report the 2-year effects of secukinumab on 78 tender joint count (TJC)/76 swollen joint count (SJC) scores in key subgroups of FUTURE 5: patients naive/with prior inadequate response (IR) to tumour necrosis factor inhibitors (TNFis), and patients with/without concomitant methotrexate (MTX) use. Methods 996 patients with active psoriatic arthritis, who received ≤3 prior TNFis and/or concomitant MTX, were randomised to secukinumab 300 or 150 mg with loading dose (LD), 150 mg without LD or placebo. Treatments were given at baseline, Weeks 1-4 and every 4 weeks thereafter. Placebo-treated patients were re-randomised to secukinumab 300/150 mg at Week 16 (non-responders) or 24 (responders). Secukinumab dose could be escalated from 150 to 300 mg from Week 60 and maintained thereafter. ACR20 response and changes in 78 TJC/76 SJC are reported over 2 years in TNFi-naive/IR and with/without concomitant MTX subgroups. Results The primary endpoint, ACR20 response at Week 16, is reported elsewhere. At Week 104, 78.1%, 81.8% and 80.8% of TNFi-naive patients achieved an ACR20 response versus 74.0%, 72.1% and 69.8% of TNFi-IR patients with secukinumab 300, 150 and 150 mg no LD, respectively. At the same timepoint, 76.5%, 80.2% and 78.3% of patients with concomitant MTX achieved an ACR20 response versus 77.6%, 78.6% and 77.6% of patients without concomitant MTX with secukinumab 300, 150 and 150 mg no LD, respectively. At Week 104, mean change from baseline in adjusted 78 TJC/76 SJC scores for TNFi-naive and TNFi-IR patients was -14.1/-8.6 and -19.0/-9.1 for secukinumab 300 mg, -15.7/-9.6 and -19.1/-12.2 for secukinumab 150 mg, and -17.7/-10.9 and -17.9/-9.9 for secukinumab 150 mg no LD, respectively (Table 1). At Week 104, mean change from baseline in adjusted 78 TJC/76 SJC scores for patients with and without concomitant MTX was -15.7/-8.5 and -15.1/-3.4 for secukinumab 300 mg, -16.4/-10.4 and -16.8/-10.1 for secukinumab 150 mg, and -17.0/-10.3 and -18.6/-11.1 for secukinumab 150 mg no LD, respectively. Conclusion Secukinumab provided rapid improvements in TJC and SJC at Week 16, which were sustained through Week 104, irrespective of TNFi history/concomitant MTX use. P192 Table 1:Selected baseline characteristics and 78 TJC and 76 SJC Results at Week 104Selected baseline characteristicsVariableSEC 300 mg (N = 222)SEC 150 mg (N = 220)SEC 150 mgno LD (N = 222)PBO (N = 332)Mean adjusted 78 TJC scoreTotal population19.821.221.821.2Mean adjusted 76 SJC scoreTotal population10.012.111.911.778 TJC and 76 SJC Results at Week 104EndpointSECPBO-SEC300 mg SC(N = 100)150 mg SCa(N = 100)150 mg SCno LDb(N = 222)300 mg SC (N = 153)150 mgc (N = 153)Adjusted 78 TJC (total population)Change from baseline (SD)-15.4 (12.5)-16.6 (14.3)-17.7 (15.3)-17.2 (14.9)-15.2 (13.0)Adjusted 76 SJC (total population)Change from baseline (SD)-8.7 (7.3)-10.3 (10.5)-10.6 (9.6)-10.7 (10.0)-9.6 (9.2)Adjusted 78 TJC (TNF status)TNFi-naiveChange from baseline (SD)-14.1 (11.6)-15.7 (14.1)-17.7 (15.0)-16.6 (13.7)-14.5 (12.6)TNFi-IRChange from baseline (SD)-19.0 (14.3)-19.1 (14.7)-17.9 (16.3)-18.9 (18.1)-17.6 (14.5)Adjusted 76 SJC (TNF status)TNFi-naiveChange from baseline (SD)-8.6 (7.2)-9.6 (9.6)-10.9 (10.1)-10.5 (8.6)-9.2 (7.5)TNFi-IRChange from baseline (SD)-9.1 (7.8)-12.2 (12.8)-9.9 (7.9)-11.0 (13.4)-10.9 (13.4)Adjusted 78 TJC (MTX use)Concomitant MTX useChange from baseline (SD)-15.7 (12.3)-16.4 (14.7)-17.0 (14.0)-17.8 (16.0)-15.8 (14.2)No concomitant MTX useChange from baseline (SD)-15.1 (12.8)-16.8 (13.9)-18.6 (16.8)-16.4 (14.0)-14.7 (12.1)Adjusted 76 SJC (MTX use)Concomitant MTX useChange from baseline (SD)-8.5 (5.9)-10.4 (11.1)-10.3 (8.6)-10.7 (9.6)-8.9 (7.8)No concomitant MTX useChange from baseline (SD)-8.9 (8.7)-10.1 (10.0)-11.1 (10.8)-10.6 (10.6)-10.1 (10.2)aIncludes 76 patients who were uptitrated to SEC 300 mg starting at Week 60;bIncludes 77 patients who were uptitrated to SEC 300 mg starting at Week 60;cIncludes 52 patients who were uptitrated to SEC 300 mg starting at Week 60. Data are reported as observed. N=number of randomised patients; n=number of patients with evaluation. IR, inadequate response; LD, loading dose; MTX, methotrexate; PBO, placebo; PsA, psoriatic arthritis; SD, standard deviation; SEC, secukinumab; SJC, swollen joint count; TJC, tender joint count; TNFi, tumour necrosis factor inhibitor. Disclosure I. McInnes: Grants/research support; AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB. H. Chinoy: Grants/research support; AbbVie, Amgen, Biogen, BMS, Janssen, Lilly, Novartis, UCB. D. Asquith: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Shareholder of Novartis. A. White: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Shareholder of Novartis. C. Gaillez: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Shareholder of Novartis and Bristol Myers Squibb.