Golimumab for the treatment of psoriatic arthritis: A NICE single technology appraisal

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of golimumab (Schering-PloughCentocor) to submit evidence for the clinical and cost effectiveness of this drug for the treatment of active and progressive psoriatic arthritis (PsA) in patients who have responded inadequately to previous disease-modifying anti-rheumatic drugs (DMARDs). The Centre for Reviews and Dissemination and the Centre for Health Economics at the University of York were commissioned to act as the Evidence Review Group (ERG) to critically appraise the evidence presented by the manufacturer. This article provides a description of the company submission, the ERG review and the resulting NICE guidance. The ERG critically reviewed the evidence presented in the manufacturers submission and identified areas requiring clarification, for which the manufacturer provided additional evidence.The main clinical effectiveness data were derived from a single phase III randomized controlled trial (GO-REVEAL) that compared golimumab with placebo for the treatment of active and progressive patients who were symptomatic despite the use of previous DMARDs or NSAIDs. The 14-week data showed that, compared with placebo, golimumab 50mg significantly improved joint disease response as measured by American College of Rheumatology (ACR) 20 (relative risk RR 5.73, 95 CI 3.24, 10.56) and Psoriatic Arthritis Response Criteria (PsARC) RR 3.45, 95 CI 2.49, 4.87, and significantly improved skin disease response as measured by Psoriasis Area and Severity Index (PASI) 75 (RR 15.95, 95 CI 4.62, 59.11). The 24-week absolute data showed that these treatment benefits were maintained. There was a significant improvement in patients functional status as measured by Health Assessment Questionnaire change from baseline at 24 weeks (-0.33; p