Long-Term Efficacy And Safety Profile Of The Anti-TNF Golimumab Confirmed

MSD have announced that five-year data from pivotal Phase 3 clinical studies demonstrate that once-monthly, subcutaneous (SC) injections of Simponi® (golimumab) provided sustained improvements in the signs and symptoms of patients with both active ankylosing spondylitis (AS) and moderate to severe, active rheumatoid arthritis (RA) over five years.1, 2 The new findings from long-term extensions of the GO-FORWARD and GO-RAISE clinical studies were presented at the 2013 European League Against Rheumatism (EULAR) Annual Congress.

Professor Peter Taylor, Norman Collison Professor of Musculoskeletal Sciences, Kennedy Institute of Rheumatology, Oxford said: 'These five-year data provide us with important clinical evidence of how patients with debilitating diseases such as rheumatoid arthritis and ankylosing spondylitis respond over the long-term to golimumab, and also confirms that the safety profile of the therapy is consistent with previous results and with other anti-TNFs.'

Additionally, new published data3 from the observational GO-MORE study, also presented at EULAR4, showed improved efficacy and comprehensive disease control when once-monthly, subcutaneous (SC) injections of golimumab 50 mg were added to conventional disease-modifying anti-rheumatic drug (DMARD) therapy in adult patients with active RA for a period of six months, as measured by clinical indices and patient reported outcomes.4 More than 3,000 RA patients were enrolled in the open-label, multi-national, prospective study.4

Ruth Slack, Rheumatology Nurse, West Suffolk NHS Trust said: 'These findings are most reassuring - improving physical function is an important outcome for patients and achieving sustained, long-term reduction in symptoms of progressive rheumatological diseases is the desired goal of an effective therapy.'


The findings from the GO-RAISE (GOlimumab - A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection (SC) Given Every Four Weeks) study demonstrated that reductions in AS signs and symptoms, and improvements in physical function and range of motion, among patients receiving golimumab 50 mg or golimumab 100mg for active AS were sustained through five years.1 In the randomized, placebo-controlled Phase 3 study of 356 patients with active AS, patients were randomized to placebo, golimumab 50 mg or golimumab 100 mg; those randomized to placebo were switched to golimumab 50 mg at Week 16 or Week 24.1 Of the 356 patients originally randomized, 254 were evaluated at five years; reductions in AS signs and symptoms and improvements in physical function and range of motion were sustained through five years