IMPROVED PAIN AND FATIGUE WITH IXEKIZUMAB TREATMENT IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS AND PREVIOUS INADEQUATE RESPONSE TO TNF INHIBITORS: THREE YEAR FOLLOW-UP FROM A PHASE 3 STUDY (SPIRIT-P2)

Ana Maria Orbai,1 Kurt de Vlam,2 Peter Nash,3 Julie Birt,4 Gaia Gallo,4 Keri Stenger,4 Vladimir J. Geneus,4 and Bernard Combe5

1 Johns Hopkins University School of Medicine, Baltimore, USA
2 Universitaire Ziekenhuizen, Leuven, Belgium
3 School of Medicine, Griffith University, Brisbane, Australia
4 Eli Lilly and Company, Indianapolis, USA
5 CHU Montpellier and Montpellier University, Montpellier, France

Background: Psoriatic arthritis (PsA) is a chronic and complex inflammatory disease with both articular and extra-articular symptoms. Pain and fatigue are two of the most common patient-reported symptoms. Improvements in pain and fatigue have been demonstrated with up to 2 years of treatment with ixekizumab (IXE) in patients who had an inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi).^1,2

Objective: To report improvements in pain and fatigue in TNFi-experienced patients with PsA who were treated with IXE for 3 years (156 weeks).

Methods: SPIRIT-P2 (NCT02349295) was a 156-week, Phase 3 study that included patients who met the Classification Criteria for Psoriatic Arthritis (CASPAR) and had an inadequate response or intolerance to 1 or 2 TNFi. Although there was a placebo group through Week 24, these data were derived only from patients in the intent-to-treat population randomized to IXE at baseline. After a 160-mg starting dose, patients received 80 mg subcutaneous IXE every 2 or 4 weeks (Q2W or Q4W). Patients self-rated their symptoms using the Joint Pain Visual Analog Scale (Joint Pain VAS; 0 [none] to 100 [worst imaginable]), the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36; with the domains ranging from 0 [worst] to 100 [best]), and the Fatigue Severity Numeric Rating Scale (Fatigue NRS; 0 [none] to 10 [worst imaginable]). Minimum clinically important difference (MCID) cutoffs were ≥10 for Joint Pain VAS, ≥5 for SF-36 domains, and ≥3 for Fatigue NRS. Missing values were imputed by modified baseline observation carried forward for continuous variables and modified non-responder imputation for categorical variables.

Results: The proportions of patients who completed Week 156 were 70/122 (57.4%) in the IXE Q4W group and 55/123 (44.7%) in the IXE Q2W group.  At Week 156, mean change from baseline for the Joint Pain VAS was -28.9 (IXE Q4W) and -25.3 (IXE Q2W) (Fig. A). In addition, 51.8% of patients on IXE reported clinically meaningful improvement of joint pain (56.1% IXE Q4W, 47.5% IXE Q2W) at Week 156. Patients reported an 18-point mean improvement in the SF-36 bodily pain domain at Week 156 (Fig. B). Patients also reported improvements in fatigue up to Week 156 (Fig. C), with 35.0% of patients achieving the MCID on the Fatigue NRS (39.4% IXE Q4W, 30.6% IXE Q2W). Improvement in fatigue was supported by a14-point mean improvement in the vitality domain of the SF-36 at Week 156 (Fig. D).

Conclusions: In patients with PsA who had an inadequate response or intolerance to TNFi, improvements in pain and fatigue were sustained through 3 years of IXE treatment in both the Q2W and Q4W treatment groups.

References:

1. Kavanaugh A, Marzo-Ortega H, Vender R, et al. Clin Exp Rheumatol. 2019;37(4):566-574.
2. Turkiewicz A, Gellett A, Kerr L, et al. [abstract] Arthritis Rheumatol. 2018;70(S9):2577.

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