The maker of Simponi (golimumab), a biologic drug used to treat moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis, has submitted an application to the FDA for approval of an intravenous formulation of the drug. Simponi is a TNF blocker which was approved in April 2009 as a subcutaneous injection.
The biologics license application is backed by results of a Phase III randomized, double-blind, placebo-controlled clinical trial referred to as GO-FURTHER. In the trial, patients with active rheumatoid arthritis, despite treatment with methotrexate, received a 30-minute infusion of Simponi at 0, 4 weeks, and every 8 weeks thereafter. The results were compared to patients who received placebo. At week 14, 59% of patients receiving the Simponi infusion achieved ACR20 (20% improvement in signs and symptoms) compared to 25% of those receiving placebo.
If you use one of the biologic drugs, do you prefer self-injectable drugs or those available by intravenous infusion? What's the reason for your preference?
- Simponi (Golimumab) - What You Should Know
- Biologics Explained
- TNF Blockers - What You Need to Know
- Self-Injection of Arthritis Drugs
- TNF Blockers - Test Your Knowledge
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