Iltefat H. Hamzavi, MD, discusses phase 3 Tranquillo data showing higher facial and total body repigmentation with ritlecitinib in vitiligo.
Oral ritlecitinib produced significantly higher facial and total body repigmentation rates than placebo at Week 52 in adults and adolescents with
Iltefat H. Hamzavi, MD, of the Multicultural Dermatology Center at Henry Ford Health and Hamzavi Dermatology Specialists in Detroit, Michigan, is the abstract's first author. He spoke with HCPLive at the meeting about why the program represents a milestone for the field.
Hamzavi described Tranquillo as the first systemic vitiligo study ever announced, unveiled at the Vitiligo International Symposium in Detroit around 2018. Bringing it to completion required years of effort to establish vitiligo as a disease worthy of this level of investment and to document its burden on patients, he explained.
The program enrolled 2174 patients across 271 sites, which Hamzavi said exceeds any prior randomized controlled trial in vitiligo.¹ He also expects it to be the largest study he knows of including patients with Fitzpatrick skin types 3 through 6, capturing disease burden in both lighter and darker skin.
Hamzavi credited patients, clinicians, industry, regulators, and especially patient communities for persisting through a lengthy study design. He noted he helped develop the Vitiligo Area Scoring Index (VASI) approach used for the primary end points and disclosed this as a conflict of interest.
Ritlecitinib is an oral Janus kinase 3 (JAK3) and TEC family kinase inhibitor. Eligible patients had nonsegmental vitiligo for at least 3 months, 4% - 60% body surface area involvement, and at least 0.5% facial involvement.¹
In Tranquillo 2 Part Ia (NCT06072183), adults were randomized 3:1:1 to ritlecitinib 100 mg (n = 622), ritlecitinib 50 mg (n = 206), or placebo (n = 208) for 52 weeks. At Week 52, 21.9% of the 100 mg group attained at least 75% improvement in Facial VASI (F-VASI75) versus 2.4% with placebo, and 13.0% versus 2.4% achieved Total VASI50 (T-VASI50; both P < .000001).¹
Patient-reported facial severity response was 42.9% with the 100 mg dose versus 18.3% with placebo, and overall vitiligo severity response was 32.3% versus 17.3% (P < .05 for both). Comparisons between the 50 mg dose and placebo in this analysis were not alpha-controlled.¹
In Tranquillo (NCT05583526), individuals aged 12 years and older were randomized 2:1 to be treated with ritlecitinib 50 mg (n = 401, including 26 adolescents) or a placebo (n = 202, including 13 adolescents). F-VASI75 rates at Week 52 were 12.5% as opposed to 2.5% (P < .000001), and T-VASI50 rates were 9.0% versus 2.0% (P = .000073).¹
Percent change in both F-VASI and T-VASI separated from placebo by Week 24 and continued improving through Week 52. Patient-reported severity responses favored ritlecitinib for both the face (35.0% vs 12.2%) and overall vitiligo (23.3% vs 16.6%; P < .05 for both).¹
In Tranquillo 2 Part Ia, treatment-emergent adverse events occurred in 67.7%, 60.0%, and 62.0% of the 100 mg, 50 mg, and placebo groups, respectively, with serious events in 3.4%, 2.9%, and 3.4%. Upper respiratory tract infection, nasopharyngitis, and headache were most common.¹
In Tranquillo, adverse event rates were 81.0% with ritlecitinib and 77.1% with placebo, and serious events occurred in 2.0% and 2.5%, respectively. Upper respiratory tract infection, increased blood creatine phosphokinase, and nasopharyngitis were reported most frequently.¹
Editor’s note: This summary has been edited for grammar and clarity using artificial intelligence tools. Iltefat Hamzavi is a consultant for AbbVie, Pfizer, Incyte, UCB, Boehringer Ingelheim, Sonoma, Merck, Takeda,Teva, Novartis, Jansen, Avita, Galderma, Vimela, and Almirall; an investigator for Pfizer, Incyte, Avita, L'Oréal/La Roche-Posay, ITN, and AbbVie; and a board member and past president of the Hidradenitis Suppurativa and Global Vitiligo foundations.
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