Topical Calcineurin Inhibitors Effective for Vitiligo as Monotherapy or With Phototherapy

By Marilynn Larkin

June 07, 2019

NEW YORK (Reuters Health) - Patients with vitiligo can be safely and effectively treated with topical calcineurin inhibitors (TCIs), with or without phototherapy, say authors of a systematic review and meta-analysis.

The findings should be considered practice-changing, coauthor Dr. Jung Min Bae of the Catholic University of Korea in Suwon told Reuters Health in an email. "Despite ample evidence for the use of TCIs for the treatment of vitiligo, they currently are used only off-label, because they are not approved for that indication by regulatory agencies," he said.

"TCI monotherapy is worth attempting for the treatment of face and neck lesions, particularly in children, when phototherapy is not available," he said by email. "Moreover, TCI treatment should also be encouraged in vitiligo patients undergoing phototherapy because of the synergistic effects."

"Many patients with vitiligo would be helped if regulatory agencies would consider approving the use of TCIs for this condition," he concluded.

Dr. Bae and colleagues analyzed data from 56 studies: 11 on the TCI mechanism, 36 on TCI monotherapy, 12 on TCI plus phototherapy, and one on TCI maintenance therapy. The primary outcomes were rates of repigmentation responses that were judged to be at least mild (at least 25%), at least moderate (50%), and marked (75%).

As reported online May 29 in JAMA Dermatology, 46 of the included studies involving 1,499 patients were selected to evaluate treatment response. For TCI monotherapy given for a median of three months, an "at least mild" response was achieved in 55% of 560 patients in 21 studies; an "at least moderate" response was seen in 38.5% of 619 patients in 23 studies; and a "marked response" in 18.1% of 520 patients in 19 studies.

In subgroup analyses, face and neck lesions showed an "at least mild" response in 73.1% of patients and a "marked" response in 35.4%.

For TCI plus phototherapy, an "at least mild" response was achieved in 89.5% of patients, and a "marked" response in 47.5%.

Dr. Erica Dommasch, a dermatologist at Beth Israel Deaconess Medical Center in Boston, told Reuters Health by email, "There have been many prospective studies evaluating the efficacy of TCIs in treating vitiligo both alone and in combination with phototherapy. However, these studies have been limited by small population sizes. By pooling data across multiple studies, this systematic review and meta-analysis provides more substantial evidence that TCIs are effective in treating vitiligo, especially when combined with phototherapy."

"However," she noted, "the studies included in the meta-analysis were highly variable in regards to study protocols and duration of treatment. The meta-analysis pooled results across studies using pimecrolimus and tacrolimus - two different TCIs - and did not examine these medications separately. Thus, it's difficult to know if they're equally effective in treating vitiligo."


JAMA Dermatol 2019.