Pfizer has presented results from two phase 3 trials evaluating the efficacy and safety of Litfulo (ritlecitinib) as a once-daily oral treatment across a wide range of disease extent.
In the two studies, TRANQUILLO 2 and TRANQUILLO, LITFULO 100mg and 50mg, respectively, significantly improved facial and total body repigmentation compared to placebo.
These improvements were supported by patient-reported outcomes indicating reduced disease severity and meaningful change in facial and total body vitiligo, as well as greater disease stabilization compared to placebo.
These results from the largest phase 3 programme to date evaluating an oral systemic therapy for nonsegmental vitiligo (NSV) were presented today in a late-breaking oral presentation at the 35th European Academy of Dermatology and Venereology (EADV) Annual Congress in Vienna, Austria.
Pfizer intends to submit the data to regulatory authorities globally, including the US FDA and the European Medicines Agency for review.
Michael Vincent, Chief Inflammation & Immunology Officer, Pfizer, said: “Litfulo has dual selectivity for JAK3 and the TEC family kinases, signals that immune cells use to attack pigment-producing cells in the skin, so it addresses a root cause of nonsegmental vitiligo rather than its visible effects alone.
“Across the largest phase 3 programme to date evaluating an oral systemic therapy for nonsegmental vitiligo, both TRANQUILLO 2 and TRANQUILLO demonstrated strong and increasing improvements in facial and total body repigmentation over time and also improved patients’ own perception of facial and overall disease severity.”
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.
While vitiligo is frequently treated as a cosmetic condition, it is a serious autoimmune disease that can have a considerable impact on patients’ lives well beyond the physical symptoms. Because NSV is a chronic disease, systemic treatment options may be needed to help patients restore skin pigmentation and maintain repigmentation over time.