Ruxolitinib improves repigmentation in vitiligo through 52 weeks

Long-term use of ruxolitinib cream continued to improve facial and total body repigmentation in patients with nonsegmental vitiligo from 24 to 52 weeks, according to an updated pooled analysis of the phase III TRuE-V1* and TRuE-V2** studies presented at EADV 2022.

Ruxolitinib cream, a Janus kinase 1/2 inhibitor, is US-FDA approved for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, said lead author Dr Albert Wolkerstorfer from Amsterdam University Medical Center in Amsterdam, Netherlands.

Ruxolitinib cream is the first FDA-approved pharmacologic treatment addressing repigmentation in patients with vitiligo. [https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-topical-treatment-addressing-repigmentation-vitiligo-patients-aged-12-and-older]

This pooled analysis involved 673 patients (mean age 39.5 years, 53.2 percent female) with nonsegmental vitiligo who were randomly assigned to either ruxolitinib cream 1.5% twice daily (continuous ruxolitinib group; n=449) or vehicle (n=224) for 24 weeks. After which, vehicle recipients crossed over to ruxolitinib through week 52 (vehicle-ruxolitinib group). [EADV 2022, abstract 554]

At baseline, the ruxolitinib and vehicle groups had similar mean facial Vitiligo Area Scoring Index (F-VASI; 0.92 for both) and total-VASI (T-VASI) scores (6.67 and 6.73).

At week 24, more patients on ruxolitinib achieved a ≥75-percent improvement in F-VASI score (F-VASI75) than those on vehicle treatment (31.0 percent vs 9.6 percent). The F-VASI75 response rate in the ruxolitinib group increased to 50.3 percent by week 52.

In the vehicle-ruxolitinib group, F-VASI75 response rate increased from week 24 to week 52 (from 9.6 percent to 28.2 percent). This rate was comparable to the week-24 results in the continuous ruxolitinib group.

The percentage of ruxolitinib recipients who achieved F-VASI90 at week 24 (16.2 percent [continuous ruxolitinib] and 1.6 percent [vehicle-ruxolitinib]) also increased by week 52 (30.3 percent and 14.1 percent, respectively).

T-VASI50 response rates increased from week 24 to week 52 in both the continuous ruxolitinib (from 23.4 percent to 51.1 percent) and vehicle-ruxolitinib groups (from 5.9 percent to 27.0 percent).

The rate of Vitiligo Noticeability Scale response (defined as “a lot less noticeable” or “no longer noticeable”) also increased from 22.8 percent at week 24 to 36.3 percent at week 52 in the continuous ruxolitinib group. A similar effect was seen in the vehicle-ruxolitinib group between these two timepoints (from 4.3 percent to 16.6 percent).

In addition, mean percentage change in facial-body surface area at week 24 further decreased by week 52 in both the continuous ruxolitinib (from -28.5 percent to -43.3 percent) and vehicle-ruxolitinib groups (from -9.2 percent to -28.0 percent).

“Among patients who crossed over from vehicle after week 24 (28 weeks of ruxolitinib cream treatment), [overall] efficacy was consistent with week 24 data in patients who applied ruxolitinib cream from day 1,” said Wolkerstorfer.

The most commonly reported treatment-emergent adverse events (TEAEs) associated with ruxolitinib cream were application site acne (4.4 percent) and pruritus (3.5 percent), but all were considered mild or moderate in severity.

Ruxolitinib cream was generally well tolerated, with no serious TEAEs related to the study drug reported.

Overall, adolescent and adult patients with nonsegmental vitiligo had a substantial improvement in facial and total body repigmentation, with half of the ruxolitinib cream users achieving F-VASI75 and T-VASI50 responses,” Wolkerstorfer concluded.

*TRuE-V1: Topical Ruxolitinib Evaluation in Vitiligo Study 1

**TRuE-V2: Topical Ruxolitinib Evaluation in Vitiligo Study 2