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

Background/AimsIxekizumab (IXE), is approved for of active PsA, moderate-to-severepsoriasis (PsO), and radiographic/non-radiographic axial SpA treatment in adults. Efficacy of IXE was compared to adalimumab (ADA) inpatients (pts) with PsA and concomitant PsO in SPIRIT-H2H(NCT03151551). We report results at week (wk) 24 and 52 fromsubgroup analysis based on baseline PsO severity.MethodsSPIRIT-H2H was a 52-wk, multicenter, randomized, open-label, raterblinded, parallel-group study of biologic DMARD-naïve pts (N = 566)with PsA and active PsO (3% body surface area). Pts wererandomized (stratified by concomitant use of conventional syntheticDMARDs and PsO severity) to IXE or ADA. Pts received on labeldosing according to PsO severity. We report efficacy outcomes at wk24 and 52 for subgroup analysis of patients with/without moderate-tosevere PsO at baseline. The primary endpoint was the proportion ofpts 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, baselinePsO severity and treatment-by-baseline PsO severity interaction asindependent variables. Differences in the proportion of responderswere assessed using Fisher's exact test.ResultsAt baseline, 49/283 IXE-treated pts and 51/282 ADA-treated pts hadmoderate-to-severe PsO. A greater proportion of IXE-treated ptsachieved the combined endpoint of ACR50+PASI100, and PASI100compared to ADA at wk 24 and 52, regardless of baseline PsO severity(Table). Similar efficacy was observed on joints for IXE and ADA acrosssubgroups. Faster improvement was observed for IXE vs. ADA inminimal disease activity (MDA) and Disease Activity in PsoriaticArthritis (DAPSA) remission regardless of PsO severity, and very lowdisease activity (VLDA) in pts with moderate-to-severe PsO. Other efficacy outcomes by subgroup based on PsO severity atbaselineConclusionIn pts with active PsA, a significantly higher proportion of IXE-treatedpts achieved the combined ACR50+PASI100 endpoint, and PASI100at wk 52 vs. ADA, regardless of baseline PsO severity. ACR50response at wk 24 and 52 was not influenced by IXE dosing. Fasterimprovements in MDA and DAPSA remission were observed with IXEthan with ADA. These results were consistent with the overall SPIRITH2H population.