dm+d

Unassigned

New Medicines

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

Information

New molecular entry
GlaxoSmithKline
GlaxoSmithKline

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Oct 22Development discontinued after otilimab failed to show the desired level of efficacy in two PIII trials. GSK concluded that the limited efficacy demonstrated does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA, and it would not be pressing ahead with filings [8].

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

Oct 22The PIII clinical programme for otilimab, named ContRAst, was the first in RA to include head-to-head comparisons of otilimab with current treatments, hoping to build a niche for otilimab among hard-to-treat patients who have an inadequate response to or cannot tolerate available drugs. Otilimab did show efficacy in the ContRast-1 and ContRast-2 studies, working better than placebo at reducing symptoms of RA in patients who did not respond to conventional disease-modifying antirheumatic drugs (DMARDs), like methotrexate. However, GSK was looking for a greater level of activity in the two trials, which compared the drug to Xeljanz (tofacitinib) and Kevzara (sarilumab) [8].

Evidence based evaluations