At the recent American Rhinologic Society Meeting in Philadelphia (Sep 9-10, 2022), a team of researchers from King’s College, London, presented their discoveries in a poster titled “Improvement in Symptom-free Days in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps Treated with Dupilumab.” The study results indicated that treatment with Dupilumab significantly reduces the severity of symptoms in patients with Chronic rhinosinusitis with nasal polyps (CRSwNP).
CRSwNP is a Type 2 inflammatory disease of the nasal cavity and paranasal sinuses, associated with multiple symptoms, including nasal congestion (NC), anterior and posterior rhinorrhea, and loss of smell (LoS).
Dupilumab is a fully human monoclonal antibody that blocks the shared receptor component for interleukin key and central drivers of type 2 inflammation. It is reported that Dupilumab treatment led to significant improvements in patient-reported daily symptom severity scores in the Phase 3 SINUS-24 and SINUS-52 studies.
While the assessment of “symptom-free days (SFD)” is a novel patient-centric approach for investigating the treatment effects in patients with CRSwNP, this study was conducted to assess the effects of dupilumab on the proportions of patients reporting Symptom- Free- Days in SINUS-24 and SINUS-52 post hoc analysis.
In this study, the researchers conducted a post hoc analysis in which they included patients receiving dupilumab 300 mg once every two weeks or placebo to Week 24 (pooled SINUS-24 and SINUS-52 population) and Week 52 (SINUS-52 only). The study randomized a total of 724 patients, out of which 437 were treated with dupilumab and 286 were treated with a placebo. The study’s primary outcomes were NC, LoS, and rhinorrhea (anterior and posterior) scores. The mean number of days for the severity of symptoms was calculated for the 28-day periods.
Based on the analysis of the data presented in this study, the following results were derived for symptom severity.
- For both nasal congestion and loss of smell, Dupilumab treatment over 52 weeks led to a reduction in the mean number of days with moderate or severe symptoms and an increase in the mean number of days with mild or no symptoms in the 28 days.
- Symptom severity showed little change over 52 weeks in the placebo group.
While for the mild symptoms and Symptom-Free Days, the following result was derived,
- Dupilumab-treated patients were significantly more likely than the placebo-treated patients to report mild or SFD for all symptoms in the 28 days before Week 24 and Week 52.
The researchers concluded their study with the following findings,
- Symptoms of nasal congestion, rhinorrhea, and loss of smell are a burden for patients with CRSwNP.
- Symptom-free days (SFD) can be an effective way of assessing treatment efficacy in reducing the symptom burden.
- Dupilumab treatment reduced the number of days with severe symptoms.
- For all symptoms assessed, Dupilumab increased the proportions of patients reporting mild or SFD versus placebo at Weeks 24 and 52.
Finally, the authors concluded that Dupilumab could be a vital option for patients suffering from chronic rhinosinusitis who currently have few therapeutic alternatives to reduce their symptoms.