Apremilast for Behcet's Syndrome - A Phase 2, Placebo-Controlled Study

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dc.contributor.authorHatemi, Gulen
dc.contributor.authorMelikoglu, Melike
dc.contributor.authorTunc, Recep
dc.contributor.authorKorkmaz, Cengiz
dc.contributor.authorOzturk, Banu Turgut
dc.contributor.authorMat, Cem
dc.contributor.authorMerkel, Peter A.
dc.date.accessioned2020-03-26T19:00:55Z
dc.date.available2020-03-26T19:00:55Z
dc.date.issued2015
dc.departmentSelçuk Üniversitesien_US
dc.description.abstractBACKGROUND Oral ulcers, the hallmark of Behcet's syndrome, can be resistant to conventional treatment; therefore, alternative agents are needed. Apremilast is an oral phosphodiesterase-4 inhibitor that modulates several inflammatory pathways. METHODS We conducted a phase 2, multicenter, placebo-controlled study in which 111 patients with Behcet's syndrome who had two or more oral ulcers were randomly assigned to receive 30 mg of apremilast twice daily or placebo for 12 weeks. This regimen was followed by a 12-week extension phase in which the placebo group was switched to apremilast and a 28-day post-treatment observational follow-up phase. The patients and clinicians were unaware of the study assignments throughout the trial. The primary end point was the number of oral ulcers at week 12. Secondary outcomes included pain from these ulcers (measured on a 100-mm visual-analogue scale, with higher scores indicating worse pain), the number of genital ulcers, overall disease activity, and quality of life. RESULTS The mean (+/- SD) number of oral ulcers per patient at week 12 was significantly lower in the apremilast group than in the placebo group (0.5 +/- 1.0 vs. 2.1 +/- 2.6) (P<0.001). The mean decline in pain from oral ulcers from baseline to week 12 was greater with apremilast than with placebo (-44.7 +/- 24.3 mm vs. -16.0 +/- 32.5 mm) (P<0.001). Nausea, vomiting, and diarrhea were more common in the apremilast group (with 22, 9, and 12 incidents, respectively, among 55 patients) than in the placebo group (with 10, 1, and 2 incidents, respectively, among 56 patients), findings that were similar to those in previous studies of apremilast. There were two serious adverse events in patients receiving apremilast. CONCLUSIONS Apremilast was effective in treating oral ulcers, which are the cardinal manifestation of Behcet's syndrome. This preliminary study was neither large enough nor long enough to assess long-term efficacy, the effect on other manifestations of Behcet's syndrome, or the risk of uncommon serious adverse events.en_US
dc.description.sponsorshipCelgeneen_US
dc.description.sponsorshipFunded by Celgene; ClinicalTrials.gov number, NCT00866359.en_US
dc.identifier.doi10.1056/NEJMoa1408684en_US
dc.identifier.endpage1518en_US
dc.identifier.issn0028-4793en_US
dc.identifier.issn1533-4406en_US
dc.identifier.issue16en_US
dc.identifier.pmid25875256en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage1510en_US
dc.identifier.urihttps://dx.doi.org/10.1056/NEJMoa1408684
dc.identifier.urihttps://hdl.handle.net/20.500.12395/31859
dc.identifier.volume372en_US
dc.identifier.wosWOS:000352856500006en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherMASSACHUSETTS MEDICAL SOCen_US
dc.relation.ispartofNEW ENGLAND JOURNAL OF MEDICINEen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.selcuk20240510_oaigen_US
dc.titleApremilast for Behcet's Syndrome - A Phase 2, Placebo-Controlled Studyen_US
dc.typeArticleen_US

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