Moderate to severe rheumatoid arthritis (RA), inadequate response to current therapy
Development and Regulatory status
Jul 19: two PIII trials have started recruiting, both currently intended to be US only (NCT03970837 and NCT03980483) .
Jul 19: GSK has announced the start of a phase III clinical development programme with otilimab .
One study in the UK found the population minimum prevalence of RA to be 1.16% in women and 0.44% in men. The incidence of the condition is low, with around 1.5 men and 3.6 women developing RA per 10,000 people per year .
Trial or other data
Jul 19: the first two PIII trials initiated in patients with moderate to severe RA, estimated n=1500 for both. NCT03970837 compares otilimab to tofacitinib and placebo in patients with inadequate response to conventional synthetic DMARD (csDMARD) or biologic DMARD; all patients to receive csDMARD as standard of care. NCT03980483 compares otilimab to tofacitinib and placebo in patients with inadequate response to methotrexate (MTX); all patients to receive MTX. For both trials, primary outcome is proportion achieving ACR20 at 12 weeks vs. placebo, and estimated primary completion is July 2021 .
Jul 19: PIII clinical programme starts (named ‘ContRAst’) includes head-to-head and placebo comparisons of otilimab with tofacitinib (a Janus Kinase (JAK) inhibitor) and sarilumab (an anti-IL6) .
Oct 18: PII trial results in 222 patients randomised to receive placebo or GSK165 found primary objective of dose-ranging efficacy study in adult patients with active, moderate to severe RA was met. An improvement in efficacy was statistically significant at Week 24 (DAS28(CRP): -1.82 difference for GSK165 180mg from placebo, 95% CI: -2.05, -0.23; p<0.001) .