Drug intelligence / Profile preview

otilimab + csDMARD(s)

Development stage
Unknown
Lead developer
GSK
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Subcutaneous, Oral
01

Overview

A combination therapy consisting of **otilimab**, an investigational human monoclonal antibody targeting granulocyte-macrophage colony-stimulating factor (GM-CSF), administered in combination with **conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)**, for the treatment of moderate to severe rheumatoid arthritis. Otilimab acts by neutralizing GM-CSF, a cytokine involved in the inflammatory processes underlying rheumatoid arthritis, thereby reducing immune cell-driven joint inflammation. csDMARDs, such as methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine, are standard oral agents that suppress the immune system and modify the course of disease. The combination has been evaluated in multiple phase 3 clinical trials, particularly in patients with active rheumatoid arthritis who have an inadequate response to prior DMARDs or targeted therapies. Trials show otilimab plus csDMARDs improves clinical symptoms compared to placebo, but is generally inferior to more established targeted therapies like tofacitinib and sarilumab. The long-term safety profile does not show increased risk of pulmonary alveolar proteinosis or other new safety signals.

Other names
otilimab + csDMARD(s)
02

Targets

GM-CSF (Granulocyte-macrophage colony-stimulating factor)

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