Dupilumab Outcomes Similar in CRSwNP Among Treatment-Naïve, Postsurgical Patients

Among patients who did or did not undergo surgery to treat their chronic rhinosinusitis with nasal polyps (CRSwNP), dupilumab led to similar outcomes regarding nasal obstruction (NO), sense of smell, and local inflammation.

Study results were published recently in Journal of Personalized Medicine following an investigation among 47 patients (mean [SD] age, 51.8 [13.5] years), 14 of whom had no history of nasal surgery and 37 of whom were male patients. January 2021 marked the start of dupilumab treatment and patients were evaluated at 1, 3, 6, 9, and 12 months from first administration of the monoclonal antibody. At each of these visits, nasal endoscopy was performed; patients completed the Sinonasal Outcome Test (SNOT)-22, a Visual Analogue Scale (VAS) for smell/NO (VAS-smell, VAS-NO), the Nasal Congestion Score (NCS), and the Asthma Control Test. In addition, peak nasal inspiratory flow (PNIF), smell, nasal cytology, and blood eosinophilia were evaluated.

“In the most severe forms, CRSwNP is associated with a poor quality of life and a high rate of nasal polyps’ recurrence after surgery,” the study investigators wrote. “Dupilumab has been suggested as a treatment option for severe CRSwNP.”

All patients were evaluated at 1 and 3 months, 74.5% completed the 6-month follow-up, and 40.4% were examined at the 12-month mark. There were a mean 2.3 (1.5) endoscopic sinus surgeries in the postsurgical group, with time since the last surgery at just over 6 years.

At baseline, Lund-Mackay, VAS-smell, SNOT-22, and PNIF were slightly higher in the postsurgical group compared with the surgery-naïve group: 16.33 (3.82) vs 16.23 (5.26), 8.47 (2.59) vs 8.29 (2.46), 59.18 (23.71) vs 58.00 (15.97), and 139.52 (63.39) vs 105.36 (62.03), respectively. In addition, blood eosinophilia levels were 0.49 (0.30) and 0.54 (0.27), eosinophils cytology was 2.04 (3.87) and 4.3 (6.93), and neutrophils cytology was 54.27 (74.88) and 36.7 (20.61).

Total courses of oral corticosteroids (OCS) were 60% higher in the surgery-naïve group compared with the postsurgical group: 3.5 (3.13) vs 2.19 (1.74).

When comparing outcomes from baseline and throughout the final follow-up, the following overall changes were seen:

• VAS-NO:
  • Naïve group: –4.00 to 0.12
  • Postsurgical group: –4.00 to 0.20
• VAS-smell:
  • Naïve group: –3.71 to ­0.12
  • Postsurgical group: –3.64 to –0.50
• SNOT22:
  • Naïve group: –23.36 to –1.12
  • Postsurgical group: –28.84 to 1.36
• NCS:
  • Naïve group: –0.85 to 0.25
  • Postsurgical group: –1.17 to –0.20
• Nasal polyp score (NPS):
  • Naïve group: –1.21 to –1.29
  • Postsurgical group: –2.32 to –0.20
• PNIF:
  • Naïve group: 42.86 to –14.38
  • Postsurgical group: 38.06 to 0.20
• Sniffin’ sticks identification subtest:
  • Naïve group: 0.23 to 0.05
  • Postsurgical group: 0.16 to –0.01
• Blood eosinophilia:
  • Naïve group: –0.04 to –0.07
  • Postsurgical group: –0.07 to –0.11
• Eosinophils cytology:
  • Naïve group: –3.60 to 0.00
  • Postsurgical group: –1.21 to –1.10
• Neutrophils cytology:
  • Naïve group: –3.10 to –7.50
  • Postsurgical group: –28.50 to 56.40

The authors saw no statistically significant correlations between nasal airflow and perception of NO at baseline, but they did find negative correlations at the 1-, 3-, and 6-month follow-ups. For the 9- and 12-month follow-ups, no correlations were seen.

For correlations between olfactory function and smell perception, statistically significant correlations were seen at baseline and 3 and 6 months. Correlations were not seen between NPS and SNOT-22, NPS and PNIF, or nasal eosinophilia and blood eosinophilia.

No patients required OCS during the study, and only 2 patients stopped dupilumab due to nonresponse. There were no adverse events.

“In the present study, dupilumab was shown to be very effective in the treatment of severe and uncontrolled CRSwNP,” the investigators concluded. “Notably, these effects were equally comparable in both naïve and postsurgical patients.”

Larger multicenter studies are needed to confirm dupilumab’s efficacy on the 3 fronts investigated in this study—NO, sense of smell, nasal inflammation—to facilitate stratifying patients via phenotype and endotype and to quantify their treatment response.

Reference

Ottaviano G, Saccardo T, Roccusso G, et al. Effectiveness of dupilumab in the treatment of patients with uncontrolled severe CRSwNP: a “real-life” observational study in naïve and post-surgical patients. J Pers Med. Published online September 17, 2022. doi:10.3390/jpm12091526