2019
DOI: 10.1056/nejmoa1816594
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Trial of Apremilast for Oral Ulcers in Behçet’s Syndrome

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Cited by 139 publications
(120 citation statements)
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“…However, this trial did not provide enough information on previous therapies and extra-mucocutaneous manifestations. A recent phase III trial has shown signi cant improvement of pain and number of oral ulcers in 104 patients treated with APR, resolution maintained over 12 weeks and in many cases also resolution of genital ulcers [16]. Because of that, the U.S. FDA has recently approved APR for BD ulcers (www.fda.gov).…”
Section: Discussionmentioning
confidence: 99%
See 3 more Smart Citations
“…However, this trial did not provide enough information on previous therapies and extra-mucocutaneous manifestations. A recent phase III trial has shown signi cant improvement of pain and number of oral ulcers in 104 patients treated with APR, resolution maintained over 12 weeks and in many cases also resolution of genital ulcers [16]. Because of that, the U.S. FDA has recently approved APR for BD ulcers (www.fda.gov).…”
Section: Discussionmentioning
confidence: 99%
“…Also, the time of follow-up was not very long. Moreover, to the best of our knowledge, both trials used APR in monotherapy and they did not assess the effect of APR on extra-mucocutaneous manifestations of BD [15,16]. Thus, the strict criteria required for inclusion may constitute a limitation at the time of considering APR in real-life patients.…”
Section: Discussionmentioning
confidence: 99%
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“…14 In a double-blind, randomized, phase 3, controlled study, the area under the curve of the total number of oral ulcers was significantly decreased after 12 weeks of apremilast (n = 104) compared with placebo (n = 103) (P < 0.0001). 15 In addition, the reduction in pain from the baseline and the complete remission rate were larger with apremilast (both P < 0.0001). Based on these findings, apremilast is recommended for oral aphthous ulcers in Behc ßet's disease.…”
Section: Cq7 Is Apremilast Effective For Oral Aphthous Ulcers In Behmentioning
confidence: 88%