Novel JAK3/TEC blocker leads to maintained re-pigmentation in vitiligo

Current treatment modalities of vitiligo are limited and insufficiently efficacious. Results of a phase 2b study demonstrated the efficacy of oral treatment with the JAK3/TEC inhibitor ritlecitinib in non-segmental vitiligo. At week 48, almost a third of patients achieved a re-pigmentation in the face by 75%.

The chronic autoimmune disease vitiligo targets melanocytes, resulting in patches of skin depigmentation [1]. Ritlecitinib is a selective inhibitor of the JAK3 and TEC kinase family. Prof. Khaled Ezzedine (University Hospital Henri Mondor, France) reported first results of the double-blind, randomised, placebo-controlled, 24-week period of a phase 2b study (NCT03715829) on ritlecitinib in 366 patients with active, non-segmental vitiligo [2]. The first 24 weeks of the study was a dose-ranging phase in which 5 doses of ritlecitinib were tested (from 10 to 50 mg) with or without induction (100 mg or 200 mg daily for 4 weeks). In the following maintenance phase, all participants will be treated with 50 mg ritlecitinib.

The primary endpoint was the change from baseline in the Vitiligo Area Scoring Index in the face (F-VASI) at week 24. Several secondary endpoints were assessed, including the proportion of patients achieving ≥75% improvement in the F-VASI and safety and tolerability. A total of 364 patients were treated; 68% of them White.

At week 24, ritlecitinib in the highest dose of 50 mg daily with or without induction met the primary endpoint. The percentage change from baseline ranged from -21 to -23 in the F-VASI among these 3 treatment groups. Moreover, ≥75% improvement in F-VASI ranged from 8 to 12% in these groups (P<0.05 for each group). “We noticed that the treatment effect was much larger during the following extension period than in the dose-ranging period,” Prof. Ezzedine said. At week 48, around 30% of participants achieved an F-VASI 75 response. The percentage change from baseline in F-VASI ranged from -60 to -66.

The high efficacy was also reflected in the patient´s perception: the proportion of patients who were “much improved” or “very much improved” in the patient global impression of change scale increased from week 24 to week 48 in all treatment sequences with a range from 10.7% to 57.9%.

A total of 756 adverse events were observed. The proportion was similar across treatment groups. Treatment was discontinued by 19 participants. Prof. Ezzedine concluded that ritlecitinib was effective and well-tolerated in patients with vitiligo who received continuous treatment for up to 48 weeks.

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   1. Taieb A, Picardo M. N Engl J Med. 2009;360:160–169.
   2. Ezzedine K. Efficacy and safety of the oral Janus kinase 3/TEC inhibitor ritlecitinib (PF-06651600) in adults with active non-segmental vitiligo: results from a phase 2b, randomized, dose-ranging study with an extension period. D1T01.4B, EADV Congress 2021, 29 Sept–2 Oct.

 

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Posted on 18 November 202117 May 2024