Similar Improvements in Patient-Reported Outcomes Among Rheumatoid Arthritis Patients Treated with Two Different Doses of Methotrexate in Combination with Adalimumab: Results From the MUSICA Trial.

Gurjit S Kaeley,Shufang Liu,Kun Chen,Jasmina Kalabic,Daryl K Maccarter,Hartmut Kupper,Vishvas Garg,Jennifer Griffith,Janak R Goyal

doi:10.1007/s40744-018-0105-7

Abstract

In patients with rheumatoid arthritis (RA), combination treatment with methotrexate (MTX) and adalimumab is more effective than MTX monotherapy. From the patients' perspective, the impact of reduced MTX doses upon initiating adalimumab is not known. The objective was to evaluate the effects of low and high MTX doses in combination with adalimumab initiation on patient-reported outcomes (PROs), in MTX-inadequate responders (MTX-IR) with moderate-to-severe RA. MUSICA was a randomized, double-blind, controlled trial evaluating the efficacy of 7.5 or 20mg/week MTX, in combination with adalimumab for 24weeks in MTX-IR RA patients receiving prior MTX ≥ 15mg/week for ≥ 12weeks. PROs were recorded at each visit, including physical function, health-related quality-of-life, work productivity, quality-of-sleep, satisfaction with treatment medication, sexual impairment due to RA, patient global assessment of disease activity (PGA), and patient pain. Last observation carried forward was used to account for missing values. At baseline, patients in both MTX dosage groups had similar demographics, disease characteristics, and PRO scores. Overall, initiation of adalimumab led to significant improvements from baseline in the PROs assessed for both MTX dosage groups. Improvements in presenteeism from baseline were strongly correlated with corresponding improvements in SF-36 (vitality), pain, and physical function. Physical and mental well-being had a good correlation with improvement in sleep. Overall, improvements in disease activity from baseline were correlated with improvements in several PROs. The addition of adalimumab to MTX in MTX-IR patients with moderate-to-severe RA led to improvements in physical function, quality-of-life, work productivity, quality of sleep, satisfaction with treatment medication, and sexual impairment due to RA, regardless of the concomitant MTX dosage. AbbVie. Clinicaltrials.gov identifier, NCT01185288.

Highlights

Three-hundred and nine patients were randomized in MUSICA, patients in the 7.5 mg/week MTX plus adalimumab group, and patients in the 20 mg/week MTX plus adalimumab group
There were no significant differences in baseline demographics, disease characteristics, and patient-reported outcomes (PROs) between the two MTX dosage groups (Table S1 in the supplementary material)
In the MUSICA trial, we found that patients with established rheumatoid arthritis (RA) who were MTX-inadequate responders (MTX-IR) reported significant improvements in several aspects of their overall quality of life when adalimumab treatment was initiated in combination with MTX

Summary

Introduction

In patients with rheumatoid arthritis (RA), combination treatment with. Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease characterized by inflammation of the synovial membrane of the joints. Patients with RA experience a reduced quality of life compared with the general population, and the disease affects patients physically as well as psychologically. RA patients experience an increased prevalence of depression [3], and reduced sleep quality compared to the general US population [4]. Reduced ability to do one’s job, fewer hours worked, lower productivity, and loss of paid employment place an economic burden on both patients and society [5,6,7,8]

Methods

Results

Conclusion