P196 Secukinumab provides sustained improvements in subgroup analyses of joint tenderness and swelling in patients with psoriatic arthritis: 5year results from the Phase3 FUTURE 2 study

Abstract

Abstract Background/Aims We report the 5-year efficacy of secukinumab, an anti-interleukin17A inhibitor with long-term efficacy and tolerability in patients with psoriatic arthritis (PsA), on reduction of 78 tender joint count (TJC)/76 swollen joint count (SJC) scores in key subgroups of FUTURE 2: patients naive/with a prior inadequate response (IR) to tumour necrosis factor inhibitors (TNFis), and patients with/without concomitant methotrexate (MTX) use. Methods 397 patients with active PsA, who received ≤3 prior TNFis and/or concomitant MTX, were randomised to secukinumab (300, 150, 75 mg) or placebo at baseline, Weeks 1-4, and every 4 weeks thereafter. Placebo-treated patients were rerandomised to secukinumab 300 or 150 mg at Week 16 (nonresponders) or 24 (responders). Secukinumab dose could be escalated from 150 to 300 mg or from 75 to 150/300 mg following physician’s assessment from Week 128 and maintained thereafter. ACR20 response and changes in 78 TJC/76 SJC are reported over 5 years for secukinumab 300 and 150 mg (approved PsA doses) in TNFi-naive/IR and with/without concomitant MTX subgroups. Results The primary endpoint, ACR20 response at Week 24, is reported elsewhere. In the secukinumab 300 and 150 mg arms, 79.6% and 77.1% of TNFinaive patients achieved an ACR20 response versus 56.3% and 66.7% of TNFi-IR patients at Week 260. At the same timepoint, 62.5% and 73.5% of patients with concomitant MTX use achieved an ACR20 response versus 84.8% and 75.0% of patients without concomitant MTX use in the secukinumab 300 and 150 mg arms, respectively. At Week 260, mean change from baseline in adjusted 78 TJC/76 SJC scores for TNFi-naive and TNFi-IR patients was −13.1/−9.5 and −12.0/−8.9 for secukinumab 300 mg and −15.3/−8.8 and −14.4/−7.9 for secukinumab 150 mg, respectively (Table 1). At Week 260, mean change from baseline in adjusted 78 TJC/76 SJC scores for patients with and without concomitant MTX was −11.2/−8.9 and −14.4/−9.7 for secukinumab 300 mg and −14.7/−9.5 and −15.4/−7.5 for secukinumab 150 mg, respectively. P196 Table 1:Selected baseline characteristics and 78 TJC and 76 SJC results at Week 24 and Week 260Selected baseline characteristicsVariableSEC 300 mg SC(N = 100)SEC 150 mg SC (N = 100)PBO (N = 98)Mean adjusted 78 TJC scoreTotal population20.224.123.4Mean adjusted 76 SJC scoreTotal population11.211.912.178 TJC and 76 SJC results at Week 24 and Week 260EndpointWeek 24Week 260SEC300 mg SC (N = 100)SEC150 mg SC (N = 100)PBO-SEC300 mg SC (N = 45)PBO-SEC150 mg (N = 43)SEC300 mg SC (N = 100)SEC150 mg SCa (N = 100)PBO-SEC 300 mg SC (N = 45)PBO-SEC 150 mgb (N = 43)Adjusted 78 TJC (total population)Change from baseline (SD)−10.4 (10.8)−12.1 (16.5)−10.6 (14.1)−9.7 (13.6)−12.8 (10.7)−15.1 (15.9)−14.5 (15.4)−12.5 (10.6)Adjusted 76 SJC (total population)Change from baseline (SD)−7.2 (5.8)−6.3 (7.7)−9.7 (9.5)−9.6 (10.7)−9.3 (6.1)−8.5 (7.9)−9.5 (8.1)−8.3 (6.3)Adjusted 78 TJC (TNF status)TNFi-naiveChange from baseline (SD)−10.7 (10.8)−13.0 (16.6)−3.5 (13.9)−8.0 (10.7)−13.1 (11.1)−15.3 (16.7)−14.8 (16.0)−11.5 (10.2)TNFi-IRChange from baseline (SD)−9.8 (10.9)−10.3 (16.4)−11.0 (11.4)−13.4 (19.5)−12.0 (9.6)−14.4 (14.0)−14.0 (15.1)−15.7 (12.0)Adjusted 76 SJC (TNF status)TNFi-naiveChange from baseline (SD)−6.9 (4.8)−6.7 (8.2)−10.5 (11.0)−6.8 (6.2)−9.5 (5.7)−8.8 (8.8)−9.4 (9.0)−8.4 (6.9)TNFi-IRChange from baseline (SD)−7.8 (7.4)−5.7 (6.5)−7.8 (5.0)−15.6 (16.3)−8.9 (7.4)−7.9 (5.1)−9.6 (6.1)−7.9 (4.6)Adjusted 78 TJC (MTX use)Concomitant MTX useChange from baseline (SD)−10.3 (8.7)−10.6 (16.7)−8.7 (13.1)−7.6 (14.3)−11.2 (9.1)−14.7 (14.5)−12.7 (12.5)−11.4 (11.4)No concomitant MTX useChange from baseline (SD)−10.5 (12.3)−13.3 (16.4)−15.2 (16.8)−14.2 (12.0)−14.4 (12.0)−15.4 (17.5)−16.8 (18.6)−14.1 (9.6)Adjusted 76 SJC (MTX use)Concomitant MTX useChange from baseline (SD)−6.9 (6.1)−6.0 (8.5)−8.9 (8.6)−8.8 (9.7)−8.9 (6.0)−9.5 (9.1)−8.6 (5.3)−9.4 (7.2)No concomitant MTX useChange from baseline (SD)−7.4 (5.7)−6.6 (6.9)−11.6 (12.4)−11.2 (13.8)−9.7 (6.2)−7.5 (6.5)−10.6 (10.7)−6.6 (4.6)aSEC 150 mg arm includes 42 patients who were uptitrated to SEC 300 mg from Week 128.bPBO-SEC 150 mg arm includes 19 patients who were uptitrated to SEC 300 mg from Week 128. Data are reported as observed.N=number of randomised patients; n=number of patients with evaluation. IR, inadequate response; MTX, methotrexate; PBO, placebo; PsA, psoriatic arthritis; SC, subcutaneous; SD, standard deviation; SEC, secukinumab; SJC, swollen joint count; TJC, tender joint count; TNFi, tumour necrosis factor inhibitor. Conclusion Analysis of 78 TJC/76 SJC scores demonstrated that treatment with secukinumab significantly reduced joint tenderness and swelling at Week 24, which were sustained over 5 years, irrespective of TNFi history/concomitant MTX use. Disclosure I. McInnes: Grants/research support; Research grants, consultation fees, or speaker honoraria: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB. H. Chinoy: Grants/research support; Research grants, travel grants, consultancy or speaker honoraria: AbbVie, Amgen, Biogen, BMS, Janssen, Lilly, Novartis and UCB. D. Asquith: Shareholder/stock ownership; Employee of Novartis. Shareholder of Novartis. A. White: Shareholder/stock ownership; Employee of Novartis. Shareholder of Novartis. C. Gaillez: Shareholder/stock ownership; Employee of Novartis. Shareholder of Novartis and Bristol Myers Squibb.