P195 Efficacy of ixekizumab versus adalimumab in psoriatic arthritis (PsA) patients with and without moderate-to-severe psoriasis: 52-week results from a multicentre, randomised open-label study

Abstract Background/Aims Ixekizumab (IXE), is approved for of active PsA, moderate-to-severe psoriasis (PsO), and radiographic/non-radiographic axial SpA treatment in adults. Efficacy of IXE was compared to adalimumab (ADA) in patients (pts) with PsA and concomitant PsO in SPIRIT-H2H (NCT03151551). We report results at week (wk) 24 and 52 from subgroup analysis based on baseline PsO severity. Methods SPIRIT-H2H was a 52-wk, multicenter, randomized, open-label, rater-blinded, parallel-group study of biologic DMARD-naïve pts (N = 566) with PsA and active PsO (≥3% body surface area). Pts were randomized (stratified by concomitant use of conventional synthetic DMARDs and PsO severity) to IXE or ADA. Pts received on label dosing according to PsO severity. We report efficacy outcomes at wk 24 and 52 for subgroup analysis of patients with/without moderate-to-severe PsO at baseline. The primary endpoint was the proportion of pts simultaneously achieving ACR50 and PASI PASI100 at wk 24. Additional post-hoc analysis was performed for other endpoints. Logistic regression models were performed with treatment, baseline PsO severity and treatment-by-baseline PsO severity interaction as independent variables. Differences in the proportion of responders were assessed using Fisher’s exact test. Results At baseline, 49/283 IXE-treated pts and 51/282 ADA-treated pts had moderate-to-severe PsO. A greater proportion of IXE-treated pts achieved the combined endpoint of ACR50+PASI100, and PASI100 compared to ADA at wk 24 and 52, regardless of baseline PsO severity (Table). Similar efficacy was observed on joints for IXE and ADA across subgroups. Faster improvement was observed for IXE vs. ADA in minimal disease activity (MDA) and Disease Activity in Psoriatic Arthritis (DAPSA) remission regardless of PsO severity, and very low disease activity (VLDA) in pts with moderate-to-severe PsO. Table. Other efficacy outcomes by subgroup based on PsO severity at baseline P195 Table 1:Proportion of pts, n/N (%)Week 24Week 52With moderate- to-severe PsOWithout moderate- to-severe PsOWith moderate- to-severe PsOWithout moderate- to-severe PsOIXEADAIXEADAIXEADAIXEADAACR50 + PASI10040.8*†17.635.030.338.8*17.639.3*28.1ACR5059.254.948.745.055.162.748.746.8PASI10059.2*†27.560.3*51.159.2***25.565.4***45.0ACR2037/49 (75.5)40/51 (78.4)158/234 (67.5)164/231 (71.0)36/49 (73.5)41/51 (80.4)161/234 (68.8)153/231 (66.2)ACR7021/49 (42.9)17/51 (33.3)69/234 (29.5)56/231 (24.2)21/49 (42.9)20/51 (39.2)79/234 (33.8)76/231 (32.9)PASI7544/49 (89.8)38/51 (74.5)183/234 (78.2)*157/231 (68.0)42/49 (85.7)41/51 (80.4)180/234 (76.9)*153/231 (66.2)PASI9041/49 (83.7)**30/51 (58.8)162/234 (69.2)**128/231 (55.4)40/49 (81.6)**31/51 (60.8)166/234 (70.9)***122/231 (52.8)MDA57.139.245.7*34.651.045.146.639.8VLDA32.7**9.814.110.426.519.622.618.6DAPSA LDA/Rem73.564.759.059.371.472.559.455.4DAPSA Rem38.821.623.917.336.739.228.625.5SPARCC enthesitis18/29 (62.1)†25/36 (69.4)89/160 (55.6)**52/134 (38.8)16/29 (55.2)22/36 (61.1)91/160 (56.9)*60/134 (44.8)LEI=015/25 (60.0)18/28 (64.3)80/134 (59.7)63/118 (53.4)14/25 (56.0)18/28 (64.3)84/134 (62.7)65/118 (55.1)LDI-B=09/9 (100.0)19/19 (100.0)28/33 (84.8)35/39 (89.7)8/9 (88.9)18/19 (94.7)27/33 (81.8)29/39 (74.4)NAPSI=028/37 (75.7)*†21/41 (51.2)83/154 (53.9)67/136 (49.3)29/37 (78.4)28/41 (68.3)100/154 (64.9)76/136 (55.9)DLQI (0,1)29/49 (59.2)*†17/51 (33.3)145/234 (62.0)129/231 (55.8)27/49 (55.1)19/51 (37.3)140/234 (59.8)118/231 (51.1)HAQ-DI MCID ≥0.3534/45 (75.6)37/45 (82.2)134/207 (64.7)129/209 (61.7)33/45 (73.3)35/45 (77.8)135/207 (65.2)129/209 (61.7)*p ≤ 0.05,**p ≤ 0.01,***p ≤ 0.001 vs. ADA. P-values from Fisher''s exact test. †Interaction p ≤ 0.10. Other efficacy outcome assessed in a post-hoc analysis.Patients with moderate-to-severe PsO (PASI ≥12, sPGA ≥3, BSA involvement ≥10%) received either IXE (160 mg at week 0, then 80 mg Q2W to week 12 and Q4W thereafter) or ADA (80 mg at week 0 then 40 mg Q2W). Patients without moderate-to-severe PsO received either IXE (160 mg at week 0, then 80 mg Q4W) or ADA (40 mg Q2W).ACR20/70, ≥20%/≥50%/≥70% improvement in American College of Rheumatology criteria; ADA, adalimumab; BSA, body surface area; DLQI (0,1), DAPSA, Disease Activity in PSoriatic Arthritis; Dermatology Life Quality Index 0 or 1; HAQ-DI MCID ≥0.35, Health Assessment Questionnaire-Disability Index minimal clinically important difference of ≥ 0.35 points; IXE, ixekizumab; LDA, low disease activity; LDI-B=0, complete resolution in Leeds Dactylitis Index-Basic; LEI=0, complete resolution in Leeds Enthesitis Index; MDA, Minimal disease activity (18 entheseal points); n, number of patients in each subgroup; N, number of patients in the analysis population; NAPSI=0, complete resolution in Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; PASI75/90/, ≥75%/≥90% improvement in PASI; PsA, psoriatic arthritis; PsO, psoriasis; pts, patients; Q2W, every 2 weeks; Q4W, every 4 weeks; SPARCC, Spondyloarthritis Research Consortium of Canada criteria; sPGA, static Physician’s Global Assessment; VLDA, very low disease activity (18 entheseal points). Conclusion In pts with active PsA, a significantly higher proportion of IXE-treated pts achieved the combined ACR50+PASI100 endpoint, and PASI100 at wk 52 vs. ADA, regardless of baseline PsO severity. ACR50 response at wk 24 and 52 was not influenced by IXE dosing. Faster improvements in MDA and DAPSA remission were observed with IXE than with ADA. These results were consistent with the overall SPIRIT-H2H population. Disclosure L. Kristensen: Consultancies; LE. Kristensen is a consultant for Amgen, Biogen, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Forward Pharma, Janssen, Merck and Co., Novartis, Pfizer, UCB. M. Okada: Consultancies; M. Okada is a consultant for Eli Lilly and Company. Member of speakers’ bureau; M. Okada is on the speaker’s bureau of: Santen Pharmaceutical, Mitsubishi Tanabe Pharma, Pfizer, Abbott Japan. W. Tillett: Honoraria; W. Tillett has received grants/speaker fees and/or honoraria from Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. S. Liu Leage: Shareholder/stock ownership; S.L. League is a shareholder and employee of Eli Lilly and Company. C. El Baou: Shareholder/stock ownership; C. El Baou is a shareholder and employee of Eli Lilly and Company. A.J. Bradley: Shareholder/stock ownership; A. Bradley is a shareholder and employee of Eli Lilly and Company. G. Meszaros: Shareholder/stock ownership; G. Meszaros is a shareholder and employee of Eli Lilly and Company. K. de Vlam: Consultancies; K. de Vlam is a consultant for Celgene, Eli Lilly and Company, Galapagos NV, Novartis, Pfizer, and UCB Pharma. Grants/research support; K. de Vlam has received grant/research support from Celgene.

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