TOPLINE

Patients with moderate-to-severe seasonal allergic rhinitis who received 1.2 mg and 2.0 mg of pumecitinib nasal spray experienced reduced nasal and eye symptoms, improved quality of life over 2 weeks, generally mild adverse events, and low blood drug levels.

METHODOLOGY

• Researchers conducted a phase 2, randomized, double-blind trial to assess the efficacy, safety, and pharmacokinetics of pumecitinib nasal spray in patients with seasonal allergic rhinitis.
• The final analysis included 168 adults with moderate-to-severe seasonal allergic rhinitis (mean age, 36.7 years; 55% men) at 20 sites across China from March to June 2024.
• Patients were randomly assigned to receive placebo or 0.2, 1.2, or 2.0 mg doses of pumecitinib (two sprays per nostril, twice daily) for 14 days. The trial had a 6-day screening, 4-day single-blind placebo run-in, 14-day double-blind treatment, and 7-day follow-up, with loratadine allowed as rescue.
• The primary efficacy endpoint was the mean change from baseline in daily reflective total nasal symptom score (rTNSS) over the 14-day treatment period.
• Secondary outcomes included changes in instantaneous total nasal symptom score (iTNSS), reflective total ocular symptom score (rTOSS), and scores of rhinoconjunctivitis-related quality of life questionnaire. Safety and pharmacokinetics were also assessed.

TAKEAWAY

• Patients who received 1.2 mg and 2.0 mg pumecitinib showed greater reduction in rTNSS than those who received placebo (least square [LS] mean difference, -1.2 for both; P < .05 for both); iTNSS improved with both doses (P < .05 for both).
• Ocular symptoms (rTOSS) improved with both 1.2 mg and 2.0 mg pumecitinib compared with placebo (LS mean difference, -0.8 for both; P < .01 for both).
• Scores for rhinoconjunctivitis-related quality of life improved significantly with all active doses compared with placebo (P < .05 for all).
• Treatment-emergent adverse events occurred in 15%, 33%, 21%, and 24% of patients who received 0.2 mg, 1.2 mg, 2.0 mg, and placebo, respectively, and were mostly mild. Pumecitinib reached peak plasma at about 2 hours, had about a 3-hour half-life, and showed low, less than dose-proportional systemic exposure.

IN PRACTICE

"Pumecitinib nasal spray significantly alleviated both nasal and ocular symptoms, which substantially improved the quality of life," the authors wrote.

SOURCE

The study was led by Jingyun Li, Menglin Wang, and Xu Zhang, all from Capital Medical University in Beijing, China. It was published online on August 23 in The Lancet Regional Health: Western Pacific.

LIMITATIONS

The sample size may not have been adequate to assess some secondary endpoints or infrequent adverse events. The study included only Chinese patients and was conducted in a single pollen season. Treatment lasted 14 days and did not assess longer-term efficacy or safety.

DISCLOSURES

The study received funding from PrimeGenX Therapeutics Co., Ltd. One author reported serving on advisory boards for Keymed and GSK and receiving clinical trial funding from multiple pharmaceutical companies, including the study sponsor. Three authors reported being employees of the funding company. Detailed author disclosures are reported in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.