TBA (17A120)

Ixekizumab Provides Improvements Through 52 Weeks in Physical Function, Quality of Life, and Work Productivity in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients with Active Psoriatic Arthritis

Author(s)

Erica Tierney (non-author presenter)1, Alice B. Gottlieb2, M. Elaine Husni3, Catherine L. Shuler4, Russel Burge4, Chen-Yen Lin4, Chin H. Lee4, Dafna D. Gladman5

Department(s)/Institutions

1Eli Lilly and Company Limited, Lilly Ireland, Dublin, Ireland; 2Department of Dermatology, New York Medical College, Metropolitan Hospital New York, New York, USA; 3Cleveland Clinic, Cleveland, United States; 4Eli Lilly and Company, Indianapolis, United States; 5University of Toronto, Toronto, Canada

Introduction

In the phase 3 trial, SPIRIT P1, previously reported results showed that IXE treatment significantly improved (versus placebo), at Week 24, PRO measures of the Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 Health Survey Physical Component Summary (SF-36 PCS), European Quality of Life 5 Dimensions Visual Analog Scale (EQ-5D VAS), and Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SHP; presenteeism, work productivity, and activity impairment).

Aims/Background

To evaluate whether the monoclonal antibody ixekizumab (IXE), a high-affinity interleukin-17A antagonist, improves patient-reported outcomes (PROs) over 52 weeks in biologic disease-modifying antirheumatic drug (bDMARD)-naive patients with active psoriatic arthritis (PsA) in a phase 3 study (SPIRIT-P1).

Method

417 bDMARD-naive patients with active PsA were randomly assigned 1:1:1:1 to subcutaneous IXE 80mg every 4 weeks (Q4W) or 2 weeks (Q2W), each with a 160mg starting dose; adalimumab 40mg Q2W (active reference); or placebo in the double-blind treatment period (Weeks 0 to 24). Of these patients, 381 continued into the extension period (EP; Weeks 24 to 52). Placebo- and adalimumab-treated patients were randomly re-assigned (1:1) to 80mg IXEQ4W or IXEQ2W at Week 16 (inadequate responders) or Week 24. Analyses for the EP were conducted on the EP population (patients who received at least 1 dose of study drug during the EP). Missing values were imputed by nonresponder imputation for categorical data and modified baseline observation carried forward for continuous data.

Results

Baseline demographics and clinical characteristics were generally similar between treatment groups; population mean baseline (Week 0) scores for HAQ-DI, SF-36 PCS, and EQ-5D VAS indicated impaired physical function and quality of life. Physician-assessed American College of Rheumatology (ACR) 20 response was achieved by 69% of patients treated with IXE for 52 weeks. Patients receiving IXEQ4W or IXEQ2W for 52 weeks reported similar improvements from baseline in HAQ-DI (IXEQ4W: -0.53, IXEQ2W: -0.55), SF-36 PCS (9.5, 9.2) EQ-5D VAS (14.7, 14.4), and WPAI-SHP (presenteeism [-23.6, -25.4], work productivity [-25.3, -24.9], and activity impairment [-26.2, -29.1]) as reported at Week 24. The percentage of patients receiving IXE for 52 weeks with improvement from baseline HAQ-DI score ≥0.35 who achieved a minimally clinically important difference for HAQ-DI was sustained at Week 52 (57.1%) compared with Week 24. At Week 52, patients receiving adalimumab/IXE showed similar improvements in ACR20 response and most PRO measures to those observed at Week 24.

Conclusions

IXE provided sustained improvement over 52 weeks in physical function, quality of life, and work productivity in bDMARD-naive patients with active PsA.