Otezla May Give Oral Ulcer Relief in Patients With Recurrent Aphthous Stomatitis

By Reuters Staff

November 14, 2019

(Reuters Health) - A drug approved by the U.S. Food and Drug Administration in July to treat oral ulcers in patients with Behcet's syndrome may be a candidate for helping people with treatment-refractory recurrent aphthous stomatitis, according to correspondence from Swiss doctors published Wednesday online in The New England Journal of Medicine.

The report details how five stomatitis patients were helped by the Celgene drug apremilast, sold under the brand name Otezla for $3,398 per month.

Mouth ulcers -- also called canker sores -- are the hallmark of aphthous stomatitis and the sores can be a problem for several years. There's no clear cause, although the condition has been linked to infection, Behcet's disease, inflammatory bowel disease, and celiac disease.

All five patients had been treated unsuccessfully with topical glucocorticoids and colchicine. Alternative causes for the ulcers had been ruled out. Otezla was given off label.

After 2 to 6 weeks of giving 30 mg of the drug twice daily, 4 of the 5 volunteers were clear of oral ulcers. After 24 months of therapy, 4 out of 5 patients were rated as "almost clear" of ulcers and one of the four was able to throttle back therapy to 30 mg once a day.

One volunteer stopped taking the drug because of persistent headache and weight loss. The drug appeared to cause intermittent gastrointestinal side effects, with nausea and loose stools reported in four of the five.

Because of the results in the uncontrolled test, "trials of apremilast for treatment-resistant recurrent aphthous stomatitis may be appropriate," said the team, led by Dr. Antonios Kolios of University Hospital Zurich.

The Journal also includes the final report of the 207-person study that served as a basis for FDA approval of the drug in Behcet's, a chronic hard-to-treat autoimmune disease that affects 1 in 20,000 Americans and is marked by recurrent skin, blood vessel, and central nervous system inflammation, and mouth ulcers.

It generally took about two weeks of treatment for the ulcers to disappear in cases where the drug was effective. By the 12-week mark, 53% of Otezla recipients were ulcer-free versus 22% of placebo patients.

Diarrhea and nausea were roughly twice as common among Otezla patients. Headache was 35% more common, and the rate of upper respiratory tract infection was 135% greater.

Otezla is also used to great moderate to severe plaque psoriasis and active psoriatic arthritis.

SOURCE: https://bit.ly/2CtMgav and https://bit.ly/34MYUNX

N Engl J Med 2019.

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