2015
DOI: 10.1056/nejmoa1408684
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Apremilast for Behçet’s Syndrome — A Phase 2, Placebo-Controlled Study

Abstract: Apremilast was effective in treating oral ulcers, which are the cardinal manifestation of Behçet's syndrome. This preliminary study was neither large enough nor long enough to assess long-term efficacy, the effect on other manifestations of Behçet's syndrome, or the risk of uncommon serious adverse events. (Funded by Celgene; ClinicalTrials.gov number, NCT00866359.).

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Cited by 215 publications
(139 citation statements)
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“…Apremilast is a phosphodiesterase-4 inhibitor that has been successfully used in the treatment of psoriasis and oral ulceration in Behcet's disease. 5,6 Apremilast effectively inhibits the production of TNF-alpha, IFN-gamma, IL-2, IL-5, IL-8, and IL-12, all of which contribute to the pathogenesis of OLP by activation of cytotoxic T-cells, and mediating basal keratinocytes apoptosis in OLP. 4,5,7 In a recent study, ten patients with biopsy-proven cutaneous LP received 20 mg of apremilast orally twice daily for 12 weeks with 4 weeks of treatment-free follow-up.…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…Apremilast is a phosphodiesterase-4 inhibitor that has been successfully used in the treatment of psoriasis and oral ulceration in Behcet's disease. 5,6 Apremilast effectively inhibits the production of TNF-alpha, IFN-gamma, IL-2, IL-5, IL-8, and IL-12, all of which contribute to the pathogenesis of OLP by activation of cytotoxic T-cells, and mediating basal keratinocytes apoptosis in OLP. 4,5,7 In a recent study, ten patients with biopsy-proven cutaneous LP received 20 mg of apremilast orally twice daily for 12 weeks with 4 weeks of treatment-free follow-up.…”
Section: Discussionmentioning
confidence: 99%
“…There were no serious adverse effects reported in large studies of apremilast when used for psoriasis and psoriatic arthritis. 5,6,9 Apremilast therefore would be an ideal systemic agent for this chronic disease given its good safety profile. Up to now cases reports of patients with oral lichen planus treated with apremilast were published, both in 2016.…”
Section: Discussionmentioning
confidence: 99%
“…4 These disorders may show dramatic responses to systemic antiinflammatory agents such as corticosteroids, colchicine, thalidomide or biologics 5 but unfortunately adverse effects -some serious -are possible with these agents. Now a new agent apremilast, currently used in psoriasis, has appeared to give some hope at least in Behcet syndrome 6 and has proved effective in treating oral ulcers, the cardinal manifestation of Behcet syndrome. Whether apremilast could be beneficial in aphthous ulceration is unclear as yet but this possible advance, appearing in the medical literature, should also be flagged up to the dental world.…”
Section: A New Therapeutic Agentmentioning
confidence: 99%
“…Colchicine has also been used to prevent mucocutaneous relapse [23]. For severe mucocutaneous lesions, systemic corticosteroids, azathioprine, pentoxifylline, dapsone, interferon-alfa, colchicine, and thalidomide have demonstrat TNF-α blockers, cyclosporine A, interferon-alfa, cyclophosphamide, rituximab, alemtuzumab, and golimumab [24][25][26].…”
Section: Treatmentmentioning
confidence: 99%