Otilimab Begins Phase 3 Clinical Studies for RA

Otilimab is an investigational antigranulocyte macrophage, colonystimulating factor (anti GM-CSF) monoclonal antibody, which has begun phase 3 clinical trials in the so-called ContRAst clinical program. The treatment is being investigated in patients with moderate to severe rheumatoid arthritis (RA) who have had inadequate responses to disease-modifying anti-rheumatic drugs (DMARDs) or other therapies.¹

The clinical program will compare otilimab head to head with specific treatments. Researchers will assess the effects and outcomes of the following in patients: 90 mg and 150 mg of subcutaneous otilimab given weekly with placebo; compared with 5 mg of tofacitinib capsules given twice daily; and compared with 200 mg of subcutaneous sarilumab given every other week. These treatments will also be assessed in combination with methotrexate or conventional synthetic DMARDs.

The Studies
The 52-week ContRAst-1 study will compare the safety and efficacy of otilimab with placebo and the JAKinhibitor tofacitinib, combined with methotrexate. This study will be in RA patients who have had inadequate responses to methotrexate and may enroll 1,500–1,700 adults.

The ContRAst-2 study will compare the safety and efficacy of otilimab with placebo and tofacitinib, combined with conventional synthetic DMARDs, in a 52-week study. Researchers plan to enroll 1,500–1,800 patients who have had inadequate responses to conventional synthetic or biologic DMARDs.

In a 24-week study, ContRAst-3 will compare the safety and efficacy of otilimab to placebo and sarilumab, combined with conventional synthetic DMARDs. Researchers plan to enroll 500–600 patients with moderate to severe active RA who have had inadequate responses to biologic DMARDs and/or JAK inhibitors.

A long-term extension study, ContRAst-X, will further evaluate the safety and efficacy of otilimab for up to four years.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

Reference

1. GlaxoSmithKline Plc. News release: GSK announces phase 3 start for its anti GM-CSF antibody, otilimab, in patients with rheumatoid arthritis. 2019 Jul 3.