Genovese MC et al. – Patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) had significant improvement in physical function, general health, and fatigue following golimumab + MTX therapy; improvements in physical function and general health were maintained through Week 52.Methods
- In the multicenter, randomized, placebo–controlled GO–FORWARD study, 444 adults with active RA despite MTX received subcutaneous placebo + MTX (crossover to golimumab 50 mg at Week 24), golimumab 100 mg + placebo, golimumab 50 mg + MTX, or golimumab 100 mg + MTX every 4 weeks.
- Physical function and general health were assessed using the Health Assessment Questionnaire–Disability Index (HAQ–DI) and Physical and Mental Component Summary (PCS, MCS) scores of the Medical Outcomes Study Short Form–36 questionnaire (SF–36), respectively, through Week 52.
- Fatigue was measured through Week 24 using the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT–Fatigue) questionnaire.
- Mean improvements from baseline in HAQ–DI, SF–36 PCS, and FACIT–Fatigue scores (Weeks 14 and 24) were significantly greater for golimumab 50 mg + MTX and 100 mg + MTX versus placebo + MTX.
- Significantly greater proportions of patients treated with golimumab + MTX achieved clinically meaningful improvements from baseline to Weeks 14 and 24 in HAQ–DI, PCS, and FACITFatigue scores.
- Mean improvements in SF–36 PCS (Week 14), MCS (Week 24), and FACIT–Fatigue (Weeks 14 and 24) scores were significantly greater for golimumab 100 mg + placebo versus placebo + MTX.
- Mean improvements from baseline in HAQ–DI, SF–36 PCS, and MCS scores through Week 24 were sustained through Week 52.