New data show ritlecitinib plus phototherapy beneficial for nonsegmental vitiligo
Key takeaways:
- Ritlecitinib alone or paired with twice weekly phototherapy was safe and effective for adults with nonsegmental vitiligo.
- Add-on phototherapy may improve ritlecitinib efficacy, but more study is needed.
SAN DIEGO — In patients with active nonsegmental vitiligo, ritlecitinib monotherapy or paired with twice weekly narrowband ultraviolet B phototherapy improved facial and total body repigmentation, according to a speaker here.
Current treatments for vitiligo remain limited and include narrowband UVB, topical and systemic immune suppressants, topical ruxolitinib and surgery, Emma Guttman-Yassky, MD, PhD, the Waldman Professor and System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at Icahn School of Medicine at Mount Sinai, said during a late-breaking research presentation at the American Academy of Dermatology Annual Meeting. Data show narrowband UVB induces melanocyte differentiation and repigmentation, whereas ritlecitinib (Litfulo, Pfizer), a selective dual Janus kinase 3 and tyrosine family kinase inhibitor under investigation for treatment of nonsegmental vitiligo, has been shown to be safe and effective in a phase 2b trial.
“For many years, we knew that phototherapy helps in vitiligo,” Guttman-Yassky told Healio. “With new medications for vitiligo we did not know if there is an added benefit to use both a medication, like an oral medication, and to add phototherapy. This is the first study that shows that there is actually an added benefit for phototherapy. If we use both, [results are] even better. Not everyone has access to phototherapy, and there are, of course, practical constraints. But, if it is possible, the combination would be something feasible.”
Guttman-Yassky and colleagues analyzed data from 230 adults with nonsegmental vitiligo who completed an extension study after a 24-week dose-ranging period of the phase 2b study. Researchers randomly assigned patients to receive ritlecitinib 50 mg once daily with a 4-week, 200 mg once daily loading dose (n = 187; mean age, 44.7 years; 57.2% women; 67.4% white), or to ritlecitinib plus narrowband UVB phototherapy twice weekly (n = 43; mean age, 46.3 years; 55.8% women; 60.5% white). Outcomes included percent change from baseline to week 24 in facial Vitiligo Area Scoring Index (F-VASI), total VASI (T-VASI), patients’ global impressions of change in vitiligo and safety.
“Patients who were randomized in this trial were those who did not achieve total VASI of 50% or more or those who had less than 50% improvement during the 16 weeks of the dose-ranging period,” Guttman-Yassky said during the presentation.
Due to a protocol-required lack-of-efficacy dropout at extension week 12 for the narrowband UVB group, researchers conducted supportive analyses using last observation carried forward (LOCF) to adjust for a dropout effect on the efficacy of add-on UVB against monotherapy, Guttman-Yassky said.
Researchers found that mean percent change from baseline to 24 weeks in F-VASI was –55.1% vs. –69.6% for participants in the ritlecitinib monotherapy and combination phototherapy groups, respectively (P = .009). At week 24, 29.2% of patients in the ritlecitinib monotherapy group and 60.9% of patients in the combination therapy group met a score of F-VASI 75 (P = .007).
“It strikes us here that this was a very nice response, regardless of narrowband UVB,” Guttman-Yassky said.
Mean percent change from baseline to 24 weeks in T-VASI was –24.5% vs. –46.8% for participants in the ritlecitinib monotherapy and combination phototherapy groups, respectively (P < .001).
The percentage of participants reporting “much improved” or “very much improved” on the patients’ global impressions of change in vitiligo was 30% and 57.7% for those in the ritlecitinib monotherapy and combination therapy groups, respectively (P = .012). There was also a trend for significance in the LOCF analyses. There were no new safety events observed.
“This answers a million-dollar question that all of us in dermatology felt might be the case, but we never actually had the proof,” Guttman-Yassky said during the presentation.
Guttman-Yassky noted that add-on narrowband UVB therapy appeared to improve ritlecitinib efficacy; however, more study is needed with larger cohorts. Yet, Guttman-Yassky said she would recommend combination therapy for patients who would be good candidates.
“If it is possible for the patient to receive oral [medication] and phototherapy, this would be my preference,” Guttman-Yassky told Healio.