Weinblatt ME, Westhovens R, Mendelsohn AM, et al., Radiographic benefit and maintenance of clinical benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate(Drug information on methotrexate) therapy: results up to 1 year of the phase 3, randomised, multicentre, double blind, placebo controlled GO-FURTHER trial. Ann Rheum Dis. 2013 Sep 3. doi: 10.1136/annrheumdis-2013-203742. [Epub ahead of print]
Intravenous golimumab plus methotrexate produces sustained apparent clinical benefits and inhibits radiographic progression with few adverse events in patients with active rheumatoid arthritis (RA), according to 1-year results from a multinational phase III trial.
The GO-FURTHER trial is a randomized, double blind, placebo controlled crossover study conducted and being reported in several stages among 592 RA patients on stable methotrexate (mostly white women, median age 52, median disease duration at study entry 4.7 years).
Initial 2:1 randomization to IV golimumab 2 mg/kg or placebo infusions for 4 weeks was followed by 8-week maintenance therapy with continuing methotrexate. Placebo patients began golimumab 2 mg/kg at week 16 or 24 if they had <10% improvement in tender and swollen joints despite ongoing methotrexate use. IV golimumab rapidly and significantly improved RA signs and symptoms and physical function scores on the Health Assessment Questionnaire–Disability Index (HAQ-DI).
Investigators now report that at 24 and 52 weeks, patients on IV golimumab plus methotrexate (n = 197) showed fewer tender and swollen joints, less erosion and joint space narrowing, and improved van der Heijde–Sharp radiographic scores and function than those starting on methotrexate plus placebo (n = 395). Specifically:
• 70.6% of patients randomized to IV golimumab plus methotrexate had improved radiographic scores compared with 57.4% of placebo plus methotrexate patients at 24 weeks and minimal changes at 1 year.
• 65% of golimumab patients achieved American College of Rheumatology response rates of ≥20% (ACR20) at 1 year, with 82% maintaining ACR20 responses between weeks 24 and 52.
• 88% of patients with good to moderate responses in 28-joint disease activity scores and levels of C-reactive protein at week 24 maintained that level of efficacy at 1 year.
• While most patients had high disease activity at baseline, 75% of those started on golimumab plus methotrexate achieved remission (low to moderate activity) at 1 year and maintained early improvements in function (HAQ-DI scores).
Adverse events (mostly non-serious infections) occurred in 64.6% of golimumab- methotrexate patients in the 1st year.