Apremilast for Behçet’s Mouth Ulcers: What Did RELIEF Find?

Repeated mouth ulcers in someone with diagnosed Behçet’s disease belong in the specialist’s treatment review. The US apremilast indication covers these ulcers in adults. It does not cover ordinary recurrent canker sores.¹

What did RELIEF test?

207 adults, 61% women, received apremilast, titrated to 30 mg twice daily, or placebo for 12 weeks. Participants had diagnosed Behçet’s, with ulcers recurring at least three times in the previous year despite previous nonbiologic treatment. Active major-organ disease requiring systemic treatment was excluded.²

How did the main outcome change?

Investigators combined repeated ulcer counts with time into area under the curve (AUC), measured in ulcers × days. The same persisting sore could count at several visits. This was not a tally of new sores.²³

Adjusted AUC averaged 129.5 with apremilast versus 222.1 with placebo: difference −92.6, 95% confidence interval −130.6 to −54.6.²

96/104 versus 83/103 completed 12 weeks. Missing counts were statistically imputed. Celgene funded the trial; authors disclosed employment or financial ties.²

The result does not establish protection against organ damage or superiority to another active treatment.

Where does it fit in treatment?

EULAR’s⁴ 2025 update, published in 2026, places colchicine first for recurrent skin and mucosal lesions. It advises considering apremilast or a TNF inhibitor when colchicine fails or cannot be tolerated. Treatment choices depend on the organs affected, symptom burden and patient preferences.⁴

The September 2026 US label covers both immediate-release OTEZLA and extended-release OTEZLA XR. RELIEF tested immediate release. Ask about formulation, dose titration and kidney-function adjustments.¹

What needs monitoring?

Contact the prescriber for severe diarrhea, nausea or vomiting; dose reduction or suspension may be needed. Complications are more likely at 65 or older. Report new or worsening depression, suicidal thoughts or mood changes. Regular weight monitoring is required.¹

Discuss pregnancy plans and all medicines: the label warns of potential fetal loss based on animal findings, and strong enzyme-inducing drugs can reduce effectiveness.¹

Bring dates, ulcer locations, effects on eating, and previous treatment names to the review. Ask: “Are we treating the mouth ulcers alone, or does another part of my disease need a different plan?”

“What to Say at the Appointment” in Is It My Breath? helps organize symptom duration, associated changes and a medicine list. It supports preparing for an examination; it does not diagnose Behçet’s disease.