Switzerland Study on Dupilumab Treatment

A recent study published in Allergy, European Journal of Allergy and Clinical Immunology, predicted treatment outcome as "highly favorable" after one-week treatment of Type 2 Chronic Rhinosinusitis (T2CRS) patients with dupilumab.

On 26 June 2019, the US Food and Drug Administration approved Dupixent (dupilumab) to treat chronic rhinosinusitis in adults with nasal polyps. The approval was granted to Regeneron Pharmaceuticals. Polyps are growths on the inner lining of the sinuses. The prolonged inflammation of sinuses and nasal cavities often accompanies nasal polyps in T2CRS with no clarity on serological markers.

Dupilumab is the first-line treatment in such cases, mainly where nasal polyps are not controlled by intranasal steroids and require surgery and oral steroids. No data exist on factors that predict outcomes in dupilumab treatment.

Against the above background, a study was conducted by Lead researcher Soyka et al. with co-researcher Ryser to clinically assess ultra-short- and short-term outcomes for up to 90 days in patients on dupilumab treatment. The treatment response was identified using the clinical and serological markers, and the comparison was made with healthy controls (HC).

Critical Points of the Study

• A total of 30 patients were included.
• Serum sample collection was done on day 0 and 30 days of treatment.
• Olink was used to perform proteomic analyses.
• On day 7, there was an improvement in SinoNasalOutcomeTest-20 (SNOT-20) scores and the total nasal polyp score. The p-value was significant (p<0.05).
• A sensitivity of 86% with an improvement of 2.5 points was recorded (during the first visit).
• In comparison to HC, significant changes were reported in the proteomic analyses.

Dr. Michael B Soyka from the Department of Otorhinolaryngology at Head and Neck Surgery University and University Hospital Zurich said, "We identified OPG from the serum of patients who were treated with dupilumab. It is a significant finding which may contribute as the 'predictor' of the clinical outcome in such patients."

Dr. Fabio S. Ryser from the Department of Immunology at University and University Hospital, Zurich, added, "We confirmed the predictive value of OPG in the second cohort."

The final conclusion from the researchers was, "we reported a highly associated favorable outcome after one week of dupilumab treatment. T2CRS-specific protein (dysregulated) in such patients can be identified with proteomic analyses, which are highly sensitive. Before initiating therapy in such patients, serum OPG should be detected to predict the treatment outcome."

References

Predicting Dupilumab Treatment Outcome in Patients with Primary diffuse Type 2 Chronic Rhinosinusitis. Michael B. Soyka, Fabio S. Ryser, Catrin Brühlmann, Danielle Fehr, Jacqueline Dülgeroglu, Peter Schmid-Grendelmeier, Marie-Charlotte Brüggen, Urs C. Steiner. First published: 26 September 2022

FDA Approves First Treatment for Chronic Rhinosinusitis with Nasal Polyps