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JAMA Dermatol. 2015 Jan;151(1):42-50. doi: 10.1001/jamadermatol.2014.1875.

Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial.

Author information

1
Multicultural Dermatology Center, Department of Dermatology, Henry Ford Hospital, Detroit, Michigan.
2
Vitiligo and Pigmentation Institute of Southern California, Los Angeles.
3
Multicultural Dermatology Center, Department of Dermatology, Henry Ford Hospital, Detroit, Michigan3Department of Dermatology, University of California, Davis, Sacramento.
4
Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.

Abstract

IMPORTANCE:

Narrowband UV-B (NB-UV-B) phototherapy is used extensively to treat vitiligo. Afamelanotide, an analogue of α-melanocyte-stimulating hormone, is known to induce tanning of the skin.

OBJECTIVE:

To evaluate the efficacy and safety of combination therapy for generalized vitiligo consisting of afamelanotide implant and NB-UV-B phototherapy.

DESIGN, SETTING, AND PARTICIPANTS:

This study was performed in 2 academic outpatient dermatology centers and 1 private dermatology practice. We enrolled men and women 18 years or older with Fitzpatrick skin phototypes (SPTs) III to VI and a confirmed diagnosis of nonsegmental vitiligo that involved 15% to 50% of total body surface area. Vitiligo was stable or slowly progressive for 3 months. Patients were randomized to combination therapy (n = 28) vs NB-UV-B monotherapy (n = 27). After 1 month of NB-UV-B phototherapy, 16 mg of afamelanotide was administered subcutaneously to the combination therapy group monthly for 4 months while NB-UV-B phototherapy continued; the other group continued to receive NB-UV-B monotherapy.

INTERVENTIONS:

Narrowband UV-B monotherapy vs combined NB-UV-B phototherapy and afamelanotide.

MAIN OUTCOMES AND MEASURES:

Response on the Vitiligo Area Scoring Index and Vitiligo European Task Force scoring system.

RESULTS:

Response in the combination therapy group was superior to that in the NB-UV-B monotherapy group (P < .05) at day 56. For the face and upper extremities, a significantly higher percentage of patients in the combination therapy group achieved repigmentation, and at earlier times (face, 41.0 vs 61.0 days [P = .001]; upper extremities, 46.0 vs 69.0 days [P = .003]). In the combination therapy group, repigmentation was 48.64% (95% CI, 39.49%-57.80%) at day 168 vs 33.26% (95% CI, 24.18%-42.33%) in the NB-UV-B monotherapy group. Notable adverse events included erythema in both groups and minor infections and nausea in the combination therapy group. Comparison between Fitzpatrick SPTs showed patients with SPTs IV to VI in the combination therapy group had improvement in the Vitiligo Area Scoring Index at days 56 and 84 (P < .05); no significant difference was noted in patients with SPT III.

CONCLUSIONS AND RELEVANCE:

A combination of afamelanotide implant and NB-UV-B phototherapy resulted in clinically apparent, statistically significant superior and faster repigmentation compared with NB-UV-B monotherapy. The response was more noticeable in patients with SPTs IV to VI.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT01430195.

PMID:
25230094
DOI:
10.1001/jamadermatol.2014.1875
[Indexed for MEDLINE]

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