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Otezla Now Approved for All Severity Levels of Psoriasis

Posted on January 12, 2022
See how 336 members reacted on this article
Medically reviewed by
Ariel D. Teitel, M.D., M.B.A.
Article written by
Maureen McNulty
(Adobe Stock)

  • The U.S. Food and Drug Administration (FDA) recently approved a new use for Otezla (apremilast).
  • Apremilast can now be used to treat mild to moderate plaque psoriasis, making it the only drug currently approved for all severity levels of psoriasis.
  • A clinical trial found that apremilast improved psoriasis signs and symptoms in people with milder disease cases.

The FDA recently approved Otezla as a treatment for adults with mild to moderate plaque psoriasis who are eligible to receive phototherapy (light treatments) or systemic therapy (medications that travel throughout the bloodstream). The decision was announced on Dec. 20.

Otezla was originally approved in March 2014 to treat psoriatic arthritis. A few months later, the FDA approved the drug as a treatment option for people with moderate to severe plaque psoriasis.

This expanded approval is good news for people with milder cases of psoriasis, according to Dr. David M. Reese, executive vice president of research and development at Amgen — the company that makes Otezla.

“A substantial unmet need remains for mild to moderate plaque psoriasis patients for whom topical therapies may not be sufficient, especially for those with difficult-to-treat areas, like the scalp,” said Dr. Reese in a recent press release. “With this expanded indication for Otezla, patients across all levels of disease severity now have an oral, systemic option that has already been used by more than 650,000 people worldwide.”

Is Otezla Effective?

Otezla’s new approval came after Amgen reported positive results from its phase 3 ADVANCE trial, which measured safety and effectiveness of the drug in people with mild or moderate psoriasis. There have been a few key findings from this trial so far:

  • People who took apremilast were five times more likely to have less severe disease after four months of therapy, compared to people who took a placebo (sugar pill).
  • Those who used apremilast were more likely to have smaller areas of their skin affected by psoriasis plaques and were less likely to have an affected scalp.
  • People using apremilast had improved symptoms, such as less itching.

This trial also showed that apremilast is safe. Researchers identified a few potential side effects, including headache, nausea, diarrhea, and cold symptoms.

Ariel D. Teitel, M.D., M.B.A. is the clinical associate professor of medicine at the NYU Langone Medical Center in New York. Review provided by VeriMed Healthcare Network. Learn more about him here.
Maureen McNulty studied molecular genetics and English at Ohio State University. Learn more about her here.

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