Otilimab

Unassigned

New Medicines

Moderate to severe rheumatoid arthritis (RA), inadequate response to current therapy

Information

New molecular entry
GlaxoSmithKline
GlaxoSmithKline

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Phase III Clinical Trials

Jul 19: two PIII trials have started recruiting, both currently intended to be US only (NCT03970837 and NCT03980483) [5].


Jul 19: GSK has announced the start of a phase III clinical development programme with otilimab [4].

Category

Human monoclonal antibody that inhibits granulocyte-macrophage colony-stimulating factor (GM-CSF), a protein that mediates immune mediated diseases, including RA

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 [3].

Moderate to severe rheumatoid arthritis (RA), inadequate response to current therapy
Subcutaneous injection

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 [6].


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) [4].


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) [1].