Background/Purpose: Ixekizumab (IXE), a high-affinity mAb that selectively targets IL-17A, has shown improvements compared to placebo not only in disease activity but also in various patient-reported outcomes (PROs) assessing physical function, fatigue, quality of life, and work productivity in PsA patients treated for 24 weeks.¹ Herein, we report the effects of treatment with IXE on these PROs after up to 3 years of treatment.

Methods: In SPIRIT-P1¹ (NCT01695239), a Phase 3 trial, 417 biologic-DMARD-naive patients with active PsA were randomized to IXE 80 mg every 4 weeks (IXE Q4W; N=107) or every 2 weeks (IXE Q2W; N=103), adalimumab 40 mg every 2 weeks (ADA; N=101), or placebo (PBO; N=106) in the double-blind treatment period (Weeks 0-24). Both IXE regimens had a starting dose of 160 mg. Results are reported from a subset of the intent-to-treat population defined as patients randomized to IXE at baseline (Week 0). The following PROs were assessed in the study (during Weeks 0-156): HAQ-DI (minimally clinically important difference [MCID]: improvement ≥0.35 from baseline), medical outcomes survey Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS), European Quality of Life 5 Dimensions Visual Analog Scale (EQ-5D VAS; 0-100 scale), fatigue Numeric Rating Scale (NRS; 0 [no fatigue] to 10 [as bad as you can imagine] scale), and Work Productivity and Activity Impairment Questionnaire-Specific Health Problem (WPAI-SHP; absenteeism, presenteeism, work productivity, and activity impairment). Missing values were imputed by modified nonresponder imputation (mNRI) for categorical data and by modified baseline observation carried forward (mBOCF) for continuous data.

Results: Mean baseline (Week 0) scores for HAQ-DI, SF-36 (PCS and MCS), fatigue NRS, WPAI-SHP, and EQ-5D VAS (Table) indicated impaired physical function and quality of life. Patients receiving IXE up to 3 years reported improvements in SF-36 (PCS and MCS), EQ-5D VAS, fatigue NRS, and WPAI-SHP (presenteeism, work productivity, and activity impairment) (Table). The percentage of IXE patients achieving MCID for HAQ DI (improvement >0.35) was sustained at 3 years.

Conclusion: In bDMARD-naive patients with active PsA, improvements with IXE in all the measured PROs, including physical and mental function, quality of life, fatigue, and work productivity are maintained up to 3 years.

Reference:

¹Mease PJ, et al. Ann Rheum Dis. 2017;76(1):79-87.