Abstract
BackgroundIxekizumab improves signs/symptoms of psoriatic arthritis (PsA). We present an integrated analysis of baseline disease burden and post-baseline outcomes in ixekizumab-treated patients with enthesitis or dactylitis.MethodsData from SPIRIT-P1 and SPIRIT-P2 were integrated. Patients with PsA were randomized to 80-mg ixekizumab every 4 weeks (IXEQ4W) or 2 weeks (IXEQ2W), after a 160-mg starting dose, or to placebo. Inadequate responders at week 16 received rescue therapy. Among patients with baseline enthesitis (Leeds Enthesitis Index [LEI] > 0) or dactylitis (Leeds Dactylitis Index-Basic [LDI-B] > 0), baseline characteristics and disease burden were reported. At week 24, LEI and LDI-B (percentage of patients with resolution [LEI = 0, LDI-B = 0]) were assessed. In pooled treatment groups, the impact of enthesitis or dactylitis resolution on health-related quality of life (HRQoL) (EuroQol-5 Dimensions Visual Analogue Scale [EQ-5D VAS]), physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI]), and pain was assessed.ResultsThe integrated analysis set comprised 679 patients; of these, 60% (n = 403 of 675) had baseline enthesitis (LEI > 0) and 23% (n = 155 of 676) had baseline dactylitis (LDI > 0). At week 24, ixekizumab-treated patients experienced significantly more resolution than placebo of enthesitis (39% IXEQ4W, 35% IXEQ2W, 21% placebo) and dactylitis (78% IXEQ4W, 65% IXEQ2W, 24% placebo). Furthermore, at entheseal points measured by the LEI, ixekizumab-treated patients had significantly higher resolution of enthesitis compared to placebo. At week 24, among all placebo- and ixekizumab-treated patients, resolution of enthesitis was associated with improvements in function and HRQoL whereas dactylitis resolution was associated with more limited improvements. The least squares mean HAQ-DI improvements from baseline were − 0.44 and − 0.25 for patients who did/did not resolve enthesitis, and − 0.41 and − 0.31 for patients who did/did not resolve dactylitis. EQ-5D VAS improvements were 12.3 and 5.8 for patients who did/did not resolve enthesitis, and 10.8 and 9.8 for patients who did/did not resolve dactylitis.ConclusionsAmong patients with pre-existing enthesitis or dactylitis, IXEQ2W- and IXEQ4W-treatment resulted in significant improvements in enthesitis and dactylitis. Enthesitis resolution was associated with improvements in patients’ function, pain, and HRQoL.Trial registrationClinicalTrials.gov, NCT01695239, registered on September 25, 2012, and NCT02349295, registered on October 10, 2014.
Highlights
Ixekizumab improves signs/symptoms of psoriatic arthritis (PsA)
Clinical features of PsA include enthesitis and dactylitis [1], which were highlighted by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) as two of the six commonly accepted clinical domains of PsA that should be considered in treatment decisions [3]
It should be noted that the Leeds Enthesitis Index (LEI) limits detection to 6 sites, whereas other enthesitis indices measure more sites. While these results indicate that ixekizumab is effective for the treatment of enthesitis and dactylitis, the SPIRIT studies were not designed to evaluate enthesitis and dactylitis as primary endpoints
Summary
Ixekizumab improves signs/symptoms of psoriatic arthritis (PsA). We present an integrated analysis of baseline disease burden and post-baseline outcomes in ixekizumab-treated patients with enthesitis or dactylitis. Psoriatic arthritis (PsA) is a chronic, inflammatory musculoskeletal disease that frequently affects multiple joints in the peripheral and axial skeleton, with clinical and radiological damage progressing over time [1, 2]. Ixekizumab is an anti-interleukin-17A (IL-17A) antagonist that has recently been approved for the treatment of active PsA [11,12,13,14]. We present a post hoc integrated analysis of SPIRIT-P1 [13] and SPIRIT-P2 [14] to describe the baseline disease burden of enthesitis and dactylitis and outcomes in patients with enthesitis and dactylitis
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