Pfizer has presented detailed results from two phase 3 clinical trials evaluating its oral Janus kinase (JAK) inhibitor Litfulo in patients with nonsegmental vitiligo. The findings were shared at the European Academy of Dermatology and Venereology (EADV) annual congress in Vienna and expand on topline data released in July.
Litfulo is already approved for alopecia areata. In the vitiligo studies, Tranquillo and Tranquillo 2, the drug was tested at 50-mg and 100-mg doses in patients with active and stable nonsegmental vitiligo. Vitiligo is a chronic autoimmune condition in which the immune system attacks melanocytes, resulting in patches of white skin.
Among patients treated with the 100-mg dose, 21.86% achieved more than 75% improvement on a measure of facial repigmentation. In addition, 13.02% experienced more than 50% improvement in total body pigmentation. In the placebo groups, 2.4% of patients reached those outcomes.
For patients receiving the 50-mg dose, 12.47% achieved at least 75% improvement in facial repigmentation, while 8.98% recorded more than 50% improvement in total body pigmentation. The comparable placebo results were 2.48% and 1.98%, respectively.
Both studies showed benefits as early as week 24, with improvements continuing through weeks 36 and 52. Patients receiving Litfulo also reported reductions in facial and overall disease severity and were more likely than placebo recipients to describe their vitiligo as substantially less noticeable or no longer noticeable by week 52.
Physician and Patient Outcomes
Michael Vincent, M.D., Ph.D., Pfizer’s chief inflammation and immunology officer, said the trials demonstrated improvements across measures assessed by physicians as well as those reported by patients.
“Importantly,” said Pfizer’s Vincent, “because of systemic absorption and hematological side effects, the quantity of the body surface area that you can use the topical therapy on is limited to a relatively small percentage.”
According to Pfizer, the Tranquillo program is the largest phase 3 program to evaluate an oral systemic therapy for vitiligo to date. The company has reaffirmed plans to submit the data to the U.S. Food and Drug Administration and said it will apply for review with the European Medicines Agency in parallel.
Regulatory Plans and Competitive Landscape
Vitiligo treatment has been led by Incyte’s Opzelura, a topical cream and the only FDA-approved treatment for the condition.
If approved, Litfulo could become the first oral systemic treatment for vitiligo. However, it may face competition from AbbVie’s oral JAK inhibitor Rinvoq, which received approval in the European Union for vitiligo and alopecia areata and is under FDA review for nonsegmental vitiligo.
Tilrekimig Produces Phase 2 Results in Atopic Dermatitis
Pfizer also presented phase 2 data for tilrekimig, a trispecific antibody that targets IL-4, IL-13 and thymic stromal lymphopoietin (TSLP).
The study evaluated monthly 50-mg, 200-mg and 400-mg doses in patients with moderate to severe atopic dermatitis. All three dose levels significantly increased the proportion of patients achieving at least a 75% reduction in eczema severity by week 16 compared with placebo.
Vincent said the two highest dose levels appeared favorable compared with historical standards, while noting the limitations of comparing results across separate studies.
Pfizer already markets Eucrisa and Cibinqo for atopic dermatitis, while Sanofi and Regeneron’s Dupixent holds the majority of the market. The company’s phase 3 program for tilrekimig in atopic dermatitis is already underway.
Expansion Into Respiratory Diseases
The recent dermatology results have also encouraged Pfizer to expand development of its immunology portfolio beyond skin disorders.
According to Vincent, validation of these pathways supported the company’s move into respiratory indications. Earlier this year, Pfizer launched a phase 3 trial of tilrekimig in asthma and a phase 2b/3 study in chronic obstructive pulmonary disease (COPD).
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Pfizer has reported encouraging clinical results for two important dermatology programs, highlighting continued progress in immune-mediated diseases. The latest updates cover Phase 3 results for LITFULO (ritlecitinib) in nonsegmental vitiligo and Phase 2 data for investigational tilrekimig in moderate-to-severe atopic dermatitis. Pfizer
Pfizer Reports Positive LITFULO Phase 3 Results
Pfizer announced positive topline results from two Phase 3 trials evaluating LITFULO in patients with nonsegmental vitiligo. The studies, TRANQUILLO and TRANQUILLO 2, met their co-primary endpoints, demonstrating significant improvements in facial and total-body repigmentation compared with placebo at Week 52. Pfizer
Across the two trials, 2,174 patients were evaluated at 271 sites worldwide. LITFULO is an oral JAK3 and TEC family kinase inhibitor and is already approved for severe alopecia areata in adults and adolescents aged 12 years and older. Pfizer is now evaluating its potential in vitiligo, another immune-mediated dermatologic condition. Pfizer
