The Journal of investigative dermatology · 2020
Apremilast in Combination with Narrowband UVB in the Treatment of Vitiligo: A 52-Week Monocentric Prospective Randomized Placebo-Controlled Study.
Сравнительное исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Khemis Abdallah, Fontas Eric, Moulin Sophie, Montaudié Henri, Lacour Jean-Philippe, Passeron Thierry
Аннотация
BACKGROUND: Scientific rationale and encouraging first clinical results suggest the interest of using apremilast for treating vitiligo.
OBJECTIVE: This study aimed to compare the efficacy of apremilast in combination therapy with narrowband (NB)-UVB versus placebo and NB-UVB treatment for repigmentation in patients with nonsegmental vitiligo.
DESIGN: This was a 52-week prospective randomized placebo-controlled study.
PARTICIPANTS: Adult patients with vitiligo participated.
INTERVENTIONS: Group A received, in addition to phototherapy, apremilast at the label dosage, and group B received placebo. After 24 weeks, patients who responded (decreased Vitiligo Area Scoring Index >30%) were rerandomized to receive apremilast or placebo, combined with twice-weekly NB-UVB for 24 additional weeks. Main outcome and measure: The primary outcome measure was the comparison between the two groups of the Vitiligo Area Scoring Index score at 24 weeks.
RESULTS: Eighty patients were randomized (40 in each group). After 24 weeks, the mean Vitiligo Area Scoring Index score decreased from 23.63 to 19.49 (P = 0.011) in the apremilast + UVB group and from 21.57 to 15.25 (P < 0.0001) in the placebo + UVB group. The difference between the two groups was not statistically significant (P = 0.18). No statistically significant differences were observed between the two groups after an additional 24 weeks of treatment.
CONCLUSIONS AND RELEVANCE: Apremilast does not bring any benefit to NB-UVB for treating vitiligo.
OBJECTIVE: This study aimed to compare the efficacy of apremilast in combination therapy with narrowband (NB)-UVB versus placebo and NB-UVB treatment for repigmentation in patients with nonsegmental vitiligo.
DESIGN: This was a 52-week prospective randomized placebo-controlled study.
PARTICIPANTS: Adult patients with vitiligo participated.
INTERVENTIONS: Group A received, in addition to phototherapy, apremilast at the label dosage, and group B received placebo. After 24 weeks, patients who responded (decreased Vitiligo Area Scoring Index >30%) were rerandomized to receive apremilast or placebo, combined with twice-weekly NB-UVB for 24 additional weeks. Main outcome and measure: The primary outcome measure was the comparison between the two groups of the Vitiligo Area Scoring Index score at 24 weeks.
RESULTS: Eighty patients were randomized (40 in each group). After 24 weeks, the mean Vitiligo Area Scoring Index score decreased from 23.63 to 19.49 (P = 0.011) in the apremilast + UVB group and from 21.57 to 15.25 (P < 0.0001) in the placebo + UVB group. The difference between the two groups was not statistically significant (P = 0.18). No statistically significant differences were observed between the two groups after an additional 24 weeks of treatment.
CONCLUSIONS AND RELEVANCE: Apremilast does not bring any benefit to NB-UVB for treating vitiligo.
Предметные рубрики MeSH
Administration, OralAdultAnti-Inflammatory Agents, Non-SteroidalCombined Modality TherapyDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedPhosphodiesterase 4 InhibitorsPlacebosProspective StudiesSeverity of Illness IndexSkin PigmentationThalidomideTreatment OutcomeUltraviolet TherapyVitiligo