Dupilumab Demonstrates Efficacy for Severe Uncontrolled CRSwNP Up Until 1 Year

Paolo Russo, MD

Credit: ResearchGate

A new study demonstrated the high therapeutic efficacy and safety of dupilumab for severe chronic rhinosinusitis with nasal polyps (CRSwNP) in the first 6 – 13 months, sustaining up to 24 months.¹

CRSwNP r is a complex immunological disease linked to significant morbidity and lower health-related quality of life.

“These patients suffer greatly from loss of smell, they can't breathe, they can't taste,” Stella Lee, MD, from Brigham and Women’s Hospital, told HCPLive—then MD Magazine—at the American Thoracic Society 2019 Annual Meeting.² “Their nose has taken over their lives—imagine if you had a cold that never went away, compounded by times 100.”

The US Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent), an anti-T2-inflammatory biological drug, as a therapy for adults with inadequately controlled CRSwNP on June 26, 2019.^2,3 5 years later on September 13, 2024, the FDA approved dupilumab as an add-on maintenance therapy for individuals aged 12 – 17 years with CRSwNP.⁴

Although dupilumab is already approved for CRSwNP, investigators conducted a study to confirm the long-term efficacy of dupilumab in the treatment of severe uncontrolled CRSwNP.¹ Investigators, led by Paolo Russo, MD, from the Otorhinolaryngology Head and Neck Surgery Department at the IRCCS Arcispedale Santamaria Nuova, in Italy, retrospectively performed multicentric collection of patients with severe uncontrolled CRSwNP treated with dupilumab. A Mixed Model Anova test was used to assess biological therapy’s effect on the improvement of the Nasal Polyp Score and quality of life measured with the Sinonasal Outcome Test-22 (SNOT-22) and visual analog scale (VAS) scores.

Participants on dupilumab had a statistically significant and continuous improvement in the Nasal Polyp Score, with a reduction from baseline of 6 (IQR, 5 – 6) to 0 (IQR, 0 – 2) at 2 months. Meaningful improvement was also evident in the SNOT-22 scores from baseline, reducing from 62 ± 19 at baseline to 15± 11 at 6 months. After the 6-month mark, investigators observed further minor changes in the SNOT-22 scores at later time points, however the score differences were nonsignificant.

When examining the quality of life, the study found VAS scores of nasal obstructions, rhinorrhea, sleep disorders, and craniofacial pain showed significant—and consistent—improvements over time for 1 year of treatment.

“[This confirms] substantial relief for the most pertinent symptoms of the condition,” investigators concluded. “The results of this study show high therapeutic efficacy and safety of dupilumab for severe CRswNP particularly in the first 6-12 months, with sustained benefits up to 24 months.”

References

1. ^{Russo P, Bassano E, Menichetti M, et al. Long-Term Effectiveness of Dupilumab in Severe Uncontrolled Chronic Rhinosinusitis with Nasal Polyps: A Multicenter Retrospective Study. American Journal of Rhinology & Allergy. 2025;0(0). doi:10.1177/19458924251313493}
2. ^{Kunzmann, K. FDA Approves Dupilumab for Severe CRSwNP. HCPLive. June 26, 2019. https://www.hcplive.com/view/fda-approves-dupilumab-severe-crswnp. Accessed January 21, 2025.}
3. ^{FDA approves first treatment for chronic rhinosinusitis with nasal polyps. FDA. June 26, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-chronic-rhinosinusitis-nasal-polyps. Accessed January 21, 2025.}
4. ^{Smith, T. FDA Approves Dupilumab for Adolescents with Chronic Rhinosinusitis with Nasal Polyps. HCPLive. September 13, 2024. https://www.hcplive.com/view/fda-approves-dupilumab-for-adolescents-chronic-rhinosinusitis-with-nasal-polyps. Accessed January 21, 2025.}