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Apremilast improves oral ulcers in patients with Behçet’s syndrome

Elaine Soliven
08 Jul 2020

Treatment with apremilast, an oral phosphodiesterase 4 inhibitor, significantly reduced the number of oral ulcers in patients with Behçet’s syndrome, according to the RELIEF* study presented at EULAR 2020.

This phase III, double-blind, placebo-controlled trial enrolled 207 adults (aged ≥18 years) with active oral ulcers related to Behçet’s syndrome. Participants were randomized to receive either oral apremilast 30 mg twice daily (n=104) or placebo (n=103) for 12 weeks, followed by a 52-week extension phase. [EULAR 2020, abstract OP0028]

At 12 weeks, patients who received apremilast had a significant reduction in the number of oral ulcers, as shown by a lower AUCWk0-12** (129.5 vs 222.1; p<0.0001), than those who received placebo.

Apremilast-treated patients also had significantly reduced pain associated with oral ulcers, as indicated by a negative change from baseline in the visual analog scale, compared with the placebo-treated patients (least-squares mean difference, -40.7 vs -15.9; p<0.0001).

Moreover, a higher percentage of patients on apremilast had reduced oral ulcer pain based on MCID*** thresholds of ≥10 mm (77.9 percent vs 48.5 percent), ≥30 mm (74.0 percent vs 42.7 percent), and ≥50 mm change from baseline (67.3 percent vs 36.9 percent) than those on placebo at 12 weeks.

“In this population of patients with moderate oral ulcer pain scores at baseline, despite prior treatment with ≥1 nonbiologic therapy, apremilast [therapy] … provided significantly greater improvements [in the number of oral ulcer and pain associated with oral ulcer at week 12],” according to Dr Gülen Hatemi from Istanbul University–Cerrahpaşa, Cerrahpaşa Medical School and Behçet’s Disease Research Center in Istanbul, Turkey.

“Oral ulcers associated with Behçet’s syndrome are often painful, may interfere with the ability to eat and can negatively affect quality of life, … [our] results indicate a clinically meaningful treatment effect of apremilast on oral ulcer associated with Behçet’s syndrome,” she added.

 

*RELIEF: A phase 3 randomized, double-blind study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with active Behçet's disease

**AUCWk0-12: Area under the curve for the number of oral ulcer through week 12

***MCID: Minimal clinically important difference

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Most Read Articles
29 Jul 2020
Adjunctive perampanel appears to be safe and effective for long-term treatment of patients with tonic‐clonic seizures, according to a posthoc analysis.
11 Aug 2020
During the Allergic Rhinitis (AR) Boot Camp held in conjunction with the Bayer Pharmacist Congress 2020, Professor Dr Baharudin Abdullah discussed the management of AR in the primary care setting and the importance of using patient profiles to guide the choice of antihistamines.
Elaine Soliven, 18 Sep 2020
Adding mepolizumab to standard of care treatment significantly reduces nasal polyp size and obstruction in adults with chronic rhinosinusitis with nasal polyps (CRSwNP), according to the SYNAPSE* study presented at ERS 2020.
Jairia Dela Cruz, 18 Feb 2020
Administering daily oral doses of adjunctive perampanel is safe and well tolerated in the treatment of young and older children with focal seizures or generalized tonic‐clonic seizures, in addition to yielding about 40–70 percent reduction in seizure frequency, according to data from the open-label 311 Core Study.