Patient-reported outcomes from a phase III study of baricitinib in patients with conventional synthetic DMARD-refractory rheumatoid arthritis

Paul Emery, Ricardo Blanco, Jose Maldonado Cocco, Ying-Chou Chen, Carol L Gaich, Amy M DeLozier, Stephanie de Bono, Jiajun Liu, Terence Rooney, Cecile Hsiao-Chun Chang, Maxime Dougados, Paul Emery, Ricardo Blanco, Jose Maldonado Cocco, Ying-Chou Chen, Carol L Gaich, Amy M DeLozier, Stephanie de Bono, Jiajun Liu, Terence Rooney, Cecile Hsiao-Chun Chang, Maxime Dougados

Abstract

Objectives: To evaluate the effect of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis (RA) and an inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs.

Methods: In this phase III study, patients were randomised 1:1:1 to placebo (N=228), baricitinib 2 mg once daily (QD, N=229) or baricitinib 4 mg QD (N=227). PROs included the Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, measures from patient electronic daily diaries (duration and severity of morning joint stiffness (MJS), Worst Tiredness, Worst Joint Pain), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), SF-36, EuroQol 5-D index scores and visual analogue scales (VAS) and the Work Productivity and Activity Impairment Questionnaire-RA. The primary time point for the study was week 12. Treatment comparisons were assessed with logistic regression for categorical measures and analysis of covariance for continuous variables.

Results: Statistically significant improvements were observed for both baricitinib groups versus placebo in HAQ-DI, PtGA, pain, daily diary measures, EuroQoL index scores and SF-36 physical component score at week 12 and for those measures when assessed at week 24. Baricitinib 2 mg and baricitinib 4 mg were statistically significantly improved versus placebo for the EuroQoL VAS and FACIT-F, respectively, at week 24.

Conclusions: Baricitinib 2 or 4 mg provided significant improvement versus placebo in PROs across different domains of RA, including physical function, MJS, fatigue, pain and quality of life.

Trial registration number: NCT01721057; Results.

Keywords: DMARDs (synthetic); Patient perspective; Rheumatoid Arthritis.

Conflict of interest statement

Competing interests: PE has received grant/research support or consulting support from Abbott, AbbVie, Bristol Myers Squibb, Eli Lilly and Company, MSD, Novartis, Pfizer, Roche, Samsung, Takeda and UCB. RB has received research grants and/or participated in advisory boards from Abbvie, BMS, Janssen, Novartis, Pfizer, Lilly, MSD and Roche. JMC has received research grants and speaker fees from Abbott (AbbVie), Bristol Myers Squibb, Boehringer Ingelheim, Eli-Lilly, Merck Sharp Dohme, Novartis, Pfizer, Roche, Sanofi-Aventis, Schering-Plough and UCB. Y-CC has received speaker's bureau fees and/or grant research support from AbbVie, Bristol Myers Squibb, Eli Lilly and Company and Pfizer. CLG, AMD, SdB, JL, TR and CH-CC are full-time employees of Eli Lilly and Company and may own stock or stock options in Eli Lilly and Company. MD has received grant/research support or consulting support from AbbVie, Bristol Myers Squibb, Eli Lilly and Company, Novartis, Pfizer, Roche, Sanofi and UCB.

Figures

Figure 1
Figure 1
Change from baseline for Functional Assessment of Chronic Illness Therapy-Fatigue.
Figure 2
Figure 2
Change from baseline for the physical and mental component score for the SF-36. (A) Physical component score. (B) Mental component score.

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