Real-world failure rates in dupilumab for chronic rhinosinusitis with nasal polyposis (CRSwNP) may be considerably greater than rates reported in industry-sponsored trials. Patients with CRSwNP who did not improve with dupilumab were more likely to have started on dupilumab in a low-symptom state or to have been incorrectly diagnosed. These are among the study findings presented at the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) 2022 Annual Meeting and OTO Experience, held in Philadelphia, Pennsylvania, September 10 to 14, 2022.
Researchers sought to investigate the incidence of treatment failures and factors associated with such failures in patients started on dupilumab for CRSwNP.
The researchers conducted an analysis of 135 patients who were prescribed dupilumab for CRSwNP at the University of Rochester Medical Center in New York from 2018 to present. Participants were classified as “nonresponders” if they had discontinued treatment or if their Sino-Nasal Outcome Test (SNOT)-22 indicated a less than minimal clinically important difference (MCID).
Among the patients studied, 65 presented complete SNOT-22 data, and a third of those patients did not achieve a MCID on their SNOT-22 scores with at least 4 months follow-up. In 7 patients studied, side effects resulted in their discontinuation of dupilumab; in 6 other patients, dupilumab was discontinued due to a perceived lack of efficacy. Overall, the nonresponder rate was 43.1% among patients with completed SNOT-22 data and 25.2% in the entire cohort.
Researchers noted that those in the nonresponder group (14.3%) were more likely to have no polyps/wrong diagnosis vs those who responded to dupilumab treatment (2.3%; P <.01). Meningitis, neuromuscular symptoms, rash/hypersensitivity, severe conjunctivitis, and arthralgia were side effects that led to discontinuation.
Study limitations include the single-center design.
The researchers concluded that “Dupilumab failure rates in real-world settings may be much higher than reported in industry-sponsored trials,” and that “patients prescribed dupilumab for CRSwNP who did not improve were more likely to have an incorrect diagnosis or have dupilumab initiated in a low-symptom state.”
Schmale IL, Poulakis A, Abend A, Man LX. Real-world analysis of non-responders to dupilumab treatment for chronic rhinosinusitis with nasal polyposis. Otolaryngol Head Neck Surg. 2022;167(1 suppl):P148.