Golimumab, the first once-monthly, injectable tumor necrosis factor-alpha antagonist, was recently approved for treating adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis, based on data from five studies of more than 2,500 patients.
The Food and Drug Administration approved the TNF inhibitor for use in combination with methotrexate in patients with RA; with or without methotrexate for psoriatic arthritis; and for use alone in patients with ankylosing spondylitis. It not been approved for pediatric use. Recommended dosage (50 mg administered subcutaneously once a month) is the same for all indications.
Golimumab will be marketed as Simponi by Centocor Ortho Biotech Inc., and has been available since its approval on April 24, according to a spokesperson for the company. The annual cost of golimumab is $18,900, which is based on the list price and is comparable with the cost of other subcutaneous biologics that are used to treat these three indications, he said.
Medicare and some private insurance carriers have adopted a fourth tier of copayment that requires patients to pay 40% of the price of particularly costly drugs.
Dr. John Kay, a lead investigator in the phase II and III trials, said in an interview that “having another TNF antagonist available allows patients who are inadequate responders to one or more of the currently available TNF agents to have an alternative agent to treat their disease.”
Golimumab “can be dosed less frequently, allowing the patient more flexibility,” said Dr. Kay, director of clinical trials in the rheumatology unit at Massachusetts General Hospital, Boston.
Dr. Kay served as a consultant to Centocor and as a member of the steering committee for clinical trials; he was on the steering committee for the GO-AFTER (Golimumab After Former Anti-TNF Therapy Evaluated in RA) study of 461 patients who were treated previously with at least one anti-TNF-alpha treatment and had stopped treatment for various reasons.
Approval for the three indications was based on five simultaneous phase III trials of more than 2,000 patients with RA, psoriatic arthritis, and ankylosing spondylitis, which included three studies of 1,542 patients with moderately to severely active RA who had had the disease for 1-9 years.
The three RA studies were the GO-AFTER study and two other studies (one that evaluated golimumab in 637 patients who were naive to methotrexate and who had not been previously treated with a TNF-blocker, and another that evaluated golimumab in 444 patients with inadequate responses to methotrexate). In the three studies, a greater proportion of patients achieved American College of Rheumatology responses at 14 weeks (in two studies) and at 24 weeks (all three studies), compared with the proportion of patients achieving those responses on methotrexate alone.
As with other TNF blockers, the label for golimumab has a boxed warning about the risk of tuberculosis and invasive fungal infections associated with treatment, and the FDA is requiring a risk evaluation mitigation strategy to address the potential serious risks associated with golimumab.