Pfizer’s Litfulo (ritlecitinib) could be set for a label expansion after it met the endpoints of two Phase III studies in both active and stable nonsegmental vitiligo (NSV).
The drug was investigated in the TRANQUILLO study (NCT05583526), which included patients aged 12 years and older, and the TRANQUILLO 2 trial (NCT06072183), which enrolled adults only.
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Across the studies, both the 50mg and 100mg doses of Litfulo delivered significant, clinically meaningful improvements over placebo on co-primary endpoints for the facial and total body Vitiligo Area Scoring Index (VASI).
Across both studies, significantly more patients treated with Litfulo achieved F-VASI75 (≥75% improvement in Facial Vitiligo Area Scoring Index) and T-VASI50 (≥50% improvement in total VASI) after 52 weeks compared with placebo.
In the US, the co-primary endpoints were the proportion of patients with F-VASI75 and the proportion of patients with T-VASI50, while in other countries F-VASI75 was the primary endpoint and T-VASI50 was a key secondary endpoint.
Based on these results, Pfizer intends to submit global regulatory filings for Litfulo as a potential new oral systemic therapy for NSV for adults.
NSV is a chronic autoimmune disease in which the immune system attacks melanin-producing cells, leading to a loss of pigment and resulting in white macules and patches on the skin/hair over time. NSV can appear at any age and in all skin types, causing depigmentation anywhere on the skin, often affecting highly visible areas such as the face, neck, and hands.
Dr Iltefat Hamzavi, senior staff physician in the department of dermatology at Henry Ford Health and Hamzavi Dermatology Specialists, said: “Living with NSV can have a profound impact on patients’ daily lives. Many patients experience frustration due to the unpredictable nature of NSV as well as the limitations of currently available treatments and are seeking additional options that can address the underlying disease.”
Additional results from TRANQUILLO and TRANQUILLO 2 will be presented at a future medical meeting.
Litfulo was approved in 2023 by the US Food and Drug Administration (FDA) for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Pfizer also plans to initiate a pivotal study evaluating the drug for the treatment of moderate alopecia areata in 2026.
This readout comes as AbbVie’s Janus kinase (JAK) inhibitor, Rinvoq (upadacitinib), recently gained approval from the European Commission (EC) in both NSV and alopecia areata – notching another two indications onto the drug’s growing list. Incyte’s Opzelura (topical ruxolitinib cream) also has approval in NSV in the US and EU.
According to a GlobalData report, across the 16 major pharmaceutical markets (16MM: Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Russia, South Africa, South Korea, Spain, UK, and US), the number of NSV cases is expected to reach 35 million in 2029.
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