Tilrekimig Phase 2 Data Show EASI 75 Gains in Atopic Dermatitis

Tilrekimig (PF-07275315; Pfizer), an investigational trispecific antibody, met its primary end point in a phase 2 study of adults with moderate to severe atopic dermatitis (AD), according to Pfizer. A significantly greater percentage of patients achieved a 75% reduction in the Eczema Area and Severity Index (EASI 75) at week 16 across all evaluated doses vs placebo. Detailed results were presented at the 35th European Academy of Dermatology and Venereology (EADV) Annual Congress in Vienna, Austria.^1,2

Tilrekimig simultaneously binds interleukin-4 (IL-4), IL-13, and thymic stromal lymphopoietin (TSLP), targeting upstream and downstream drivers of type 2 inflammation. According to Pfizer, the design is intended to provide broader cytokine pathway coverage and potentially more durable clinical responses. The antibody has an extended half-life of about 37 days, which the company anticipates will support monthly administration.¹

The ongoing randomized, double-blind, placebo-controlled trial is evaluating adults with moderate to severe AD. Data presented at EADV reflect the first 2 stages, both of which enrolled biologic-naive patients. Stage 1 evaluated subcutaneous tilrekimig 450 mg every 2 weeks (Q2W) vs placebo, and Stage 2 was a dose-ranging evaluation of tilrekimig 400 mg, 200 mg, or 50 mg every 4 weeks (Q4W) vs placebo.¹

In Stage 1, 62.5% of patients receiving tilrekimig 450 mg Q2W achieved EASI 75 at week 16, compared with 19.9% receiving placebo (P = .0008). In Stage 2, EASI 75 was achieved by 58.5% of patients receiving 400 mg Q4W, 61.0% receiving 200 mg Q4W, and 47.8% receiving 50 mg Q4W, compared with 9.1% receiving placebo (all P < .003). Absolute improvements over placebo were 49.4%, 51.9%, and 38.7%, respectively.¹

Tilrekimig Secondary End Points, Itch Reduction, and Safety Profile

The key secondary end point was a validated Investigator Global Assessment (vIGA) score of 0 or 1 (clear or almost clear skin) with at least a 2-point improvement. In Stage 1, 30.3% of patients in the 450 mg Q2W group achieved vIGA 0/1, compared with 11.8% receiving placebo (P = .0251). In Stage 2, 26%–27% of patients across the Q4W groups reached vIGA 0/1, compared with 0% receiving placebo (all P < .006).¹

In an exploratory analysis, a reduction of at least 4 points in the weekly average Peak Pruritus Numerical Rating Scale (PP-NRS4) was achieved by 42.5% of patients receiving 400 mg Q4W and 50.8% receiving 200 mg Q4W, compared with 7.2% receiving placebo. Treatment differences were 35.3% and 43.6%, respectively.¹

Pfizer characterized tilrekimig as well tolerated, with no dose-dependent safety signals and treatment-emergent adverse event (TEAE) rates comparable between treatment and placebo groups. In Stage 1, TEAEs were reported in 46.7% of patients receiving 450 mg Q2W vs 28.9% receiving placebo. In Stage 2, TEAEs were reported in 42.2%, 47.7%, and 47.8% of patients receiving 400 mg, 200 mg, and 50 mg Q4W, respectively, vs 52.2% receiving placebo.¹

At doses up to 400 mg Q4W, Pfizer reported lower frequencies of conjunctivitis and injection-site reactions than rates reported with IL-4 receptor alpha inhibitors, and rates comparable to placebo. No serious adverse events related to tilrekimig occurred in either stage.¹

Eric Simpson, MD, MCR, of the department of dermatology at Oregon Health & Science University, said in the Pfizer announcement: "Atopic dermatitis is driven by several inflammatory signals, and a substantial proportion of patients still live with persistent itch and extensive skin involvement. The week 16 results presented today are meaningful at this stage of development, with tilrekimig's tolerability profile supporting continued study in a larger patient population."¹

Pfizer has dosed patients in 3 phase 3 studies of tilrekimig, 2 in AD, including one with dupilumab as an active comparator, and 1 in asthma. The company is also conducting a phase 2b/3 study in chronic obstructive pulmonary disease.¹

References

1. Pfizer's tilrekimig shows significant skin clearance in phase 2. News release. Pfizer. October 1, 2026. Accessed October 1, 2026. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-tilrekimig-shows-significant-skin-clearance-phase-2
2. Simspon E, et al. Phase 2 study of novel trispecific tilrekimig (PF-07275315) in patients with moderate-severe atopic dermatitis: Interim efficacy and safety results at 16 weeks. Presented at: 35th European Academy of Dermatology and Venereology Annual Congress; October 1, 2026; Vienna, Austria.