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FDA approves drug for treating ankylosing spondylitis
Clinical trials of Abbott’s Humira showed a safety profile for treating ankylosing spondylitis similar to rheumatoid arthritis trials.
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The FDA has approved Abbott’s arthritis drug Humira as a treatment for reducing signs and symptoms of active ankylosing spondylitis, the company announced.
The approval represents the third indication among six autoimmune diseases Abbott has targeted for treatment with Humira (adalimumab), a TNF-blocking agent. The drug is also approved for treating rheumatoid arthritis (RA) and psoriatic arthritis (PsA), and it received European approval for treating patients with severe, active ankylosing spondylitis (AS) in June. Abbott is conducting additional clinical trials investigating the drug for treating other autoimmune diseases.
The FDA based the approval on data from the Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS (ATLAS) trial, a randomized, placebo-controlled, double-blind, phase 3 study conducted in Europe and the United States. The results showed that the drug was effective in reducing pain and inflammation in AS patients after 12 weeks of treatment, meeting the trial's primary endpoint.
The study also found that the drug caused significant improvements in measures of disease activity for many patients after 2 weeks of treatment, which were maintained through 24 weeks follow-up. It also produced significant improvements in Maastricht Ankylosing Spondylitis Enthesitis Score at 24 weeks follow-up, according to the release.
Similar treatment-emergent adverse event rates that led to drug discontinuation were noted between placebo-treated (1.9%) and Humira-treated (1.4%) patients. Humira-treated patients did have a higher overall adverse event incidence, most commonly nasopharyngitis, injection site reactions and headache. However, clinical trial results for ankylosing spondylitis and psoriatic arthritis showed a similar safety profile to that seen in trials for rheumatoid arthritis, company officials noted.
In the RA trials, 20% of Humira patients and 14% of placebo patients experienced injection site reactions. Other adverse events included the following:
- upper respiratory infection: 17% of Humira patients vs. 13% of placebo patients;
- injection site pain: 12% of Humira patients and 12% of placebo patients;
- headache: 12% of Humira patients vs. 8% of placebo patients;
- rash: 12% of Humira patients vs. 6% of placebo patients; and
- sinusitis: 11% of Humira patients vs. 9% of placebo patients.
Adverse events caused 7% of Humira patients and 4% of placebo patients to discontinue treatment, according to the release.
For more information:
- Abbott Laboratories; Web site: abbott.com.