Findings presented from a Phase 3 study showed that patients with moderately-to-severely active rheumatoid arthritis (RA) who previously were treated with anti-tumor necrosis factor (TNF)-alpha agents, experienced significant improvements in signs and symptoms and physical function after receiving subcutaneous injections of golimumab every four-weeks. Investigators also reported that the patients who received golimumab showed sustained improvements in disease activity and physical function through six months. The study was presented at the European League Against Rheumatism (EULAR) Annual Congress of Rheumatology.
"Our findings show that golimumab holds great promise in various RA patient populations, including those patients who have previously discontinued other TNF inhibitors," said Josef S. Smolen, MD, professor and Chairman, Department of Rheumatology, Medical University of Vienna and lead study investigator. "Golimumab may provide an appropriate treatment option to the many people facing the consequences of this debilitating disease."
In the study, 35 percent and 38 percent of patients receiving golimumab 50 mg and 100 mg, respectively, achieved the primary endpoint of at least 20 percent improvement in arthritis symptoms at week 14, compared with 18 percent of patients receiving placebo. These results were maintained through six months. Importantly, among the 58 percent of patients whose prior anti-TNF-alpha therapy had been discontinued due to lack of efficacy, 36 percent receiving golimumab 50 mg and 43 percent receiving golimumab 100 mg achieved 20 percent improvement as compared to 18 percent of patients treated with placebo.
"When treating patients with progressive rheumatoid arthritis, our goal is to reduce pain and improve physical function," said Jonathan Kay, MD, Director, Clinical Trials, Rheumatology Unit, Massachusetts General Hospital; Associate Clinical Professor of Medicine, Harvard Medical School and lead study investigator. "We are encouraged by the results of these trials which suggest that golimumab may offer a significant benefit to a growing population of RA patients with prior TNF inhibitor experience."
Patients in both treatment groups receiving golimumab also experienced significant improvement in physical function and disease activity through six months as measured by the Health Assessment Questionnaire (HAQ) and the Disease Activity Score (DAS28), respectively.
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