MADRID — Ixekizumab has demonstrated superiority to adalimumab in treating psoriatic arthritis and plaque psoriasis, according to research presented at the 2019 European League Against Rheumatism (EULAR) Congress, held June 12-15, in Madrid, Spain.
This randomized, open-label, assessor-blinded head-to-head study (ClinicalTrials.gov identifier: NCT03151551) included 566 individuals with both psoriatic arthritis and plaque psoriasis who had not been treated with biologic disease-modifying antirheumatic drugs (bDMARDs) and had shown an inadequate response to conventional synthetic DMARDs. The participants were randomly assigned to ixekizumab (n=283) or adalimumab (n=283). Treatment lasted 52 weeks, with dosing dependent on severity of psoriasis.
The primary end point was to determine the percentage of participants who simultaneously achieved a psoriasis area and severity index score of 100 (PASI100) and a 50% decrease in American College of Rheumatology response rate (ACR50) at week 24.
In addition to the primary study end point, the outcomes were evaluated for safety, skin and psoriatic arthritis, composite treat-to-target, and patient-reported psoriatic arthritis disease activity scores. Participants with baseline PASI=0 and BSA≥3% who had PASI=0 and BSA=0 at week 24 were considered PASI100 responders. Logistic regression analyses were used to assess categorical variables, while mixed models for repeated measure analysis were used to assess continuous variables.
Both groups showed similar baseline disease characteristics and demographic features. Among those treated with ixekizumab, 36% achieved both PASI100 and ACR50, compared with 28% of the adalimumab cohort (P <.05). Ixekizumab was superior to adalimumab for PASI10 and non-inferior for ACR50. Composite treat-to-target outcomes, skin outcomes, enthesitis resolution, and quality of life related to skin were significantly better for the ixekizumab cohort compared with the adalimumab cohort. There were no unexpected safety issues.
The study researchers concluded that “[in] bDMARD naive [patients] with active [psoriatic arthritis] and skin disease, [ixekizumab] showed superior efficacy to [adalimumab] based on simultaneous achievement of ACR50 and PASI100 responses at [week] 24. Greater improvements with [ixekizumab] vs [adalimumab] were also attained in individual [psoriatic arthritis] domains and composite [treat-to-target] outcomes.”
Disclosure: The authors of this study report numerous financial associations with pharmaceutical companies.
Mease PJ, Smolen JS, Behrens F, et al. Multicentre, randomised, open-label, assessor-blinded, parallel-group head-to-head comparison of the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naive to biologic disease-modifying anti-rheumatic drugs: 24-week results. Presented at: European League Against Rheumatism (EULAR) Congress 2019; June 12-15, 2019; Madrid, Spain. Abstract LB0005.