Otezla Receives FDA Approval for Treatment of Oral Sores that Characterize Behçet’s Disease

According to a press release from American biotechnology company Celgene Corporation, the American Food and Drug Administration (FDA) recently approved the Company’s drug Otezla (generic name apremilast) for the treatment of the canker sore-like ulcers frequently associated with Behçet’s disease.

About Behçet’s Disease

Behçet’s disease is poorly understood. Credible sources disagree over whether the condition is likely to be autoimmune or autoinflammatory in nature. The line between autoimmune and autoinflammatory conditions is blurry to begin with. However, it is certain that several genes have been found that are associated with future development of the disease. Some researchers believe that certain viruses or bacteria may have Behçet’s-triggering effects.

Despite existing genetic signatures and known symptoms, currently no medical tests can determine whether or not an individual has Behçet’s disease — diagnosis is made on a purely clinical basis. Because they are featured in nearly all confirmed cases of Behçet’s disease, physicians consider canker sore-like mouth ulcers to be a characteristic symptom. The most common severe complications of Behçet’s disease, however, involve the eyes. 50-90% of Behçet’s disease patients experience eye involvement, and particularly severe or untreated cases may result in seriously dysfunctional vision during attacks of what is called “Behçet’s uveitis,” which causes parts of the eyeballs themselves to swell.

This swelling of the eye is caused by a more general inflammation of a patient’s blood vessels. Veins, arteries, and capillaries can all be involved — and anywhere in the body.

In rare cases, the central nervous system or gastrointestinal tract may be affected too. Thrombotic events (blood clots) can occur, and can be life-threatening.

As you may have guessed from Behçet’s poorly-understood nature, there is no cure for the disease. Treatment focuses on managing symptoms, which typically involves the application of corticosteroids to the affected area.

Otezla Gains FDA Approval

Otezla, then, represents a change of pace from the standard of treatment for Behçet’s disease. A twice-daily 30mg dose of the small-molecule inhibitor is thought to limit the amount of inflammatory factors active in the body by inhibiting the activity of a substance called phosphodiesterase-4. In a phase 3 study of Otezla in 207 Behçet’s patients, participants in the control arm averaged about one more mouth sore than the participants in the Otezla arm over a period of twelve weeks. Considering only three sores in a 12-month period is a reason to clinically suspect the disease, a reduction of one sore in just three months could represent meaningful improvement for a patient.

Otezla has previously been approved for use in patients with moderate to severe plaque psoriasis or with active psoriatic arthritis.

Do you or does someone you know live with Behçet’s disease? What do you think of this exciting development? Share your thoughts with Patient Worthy!

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