Dupilumab Treatment Effective for Chronic Rhinosinusitis with Nasal Polyps

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Dupilumab therapy administered over 3 years is effective for patients with chronic rhinosinusitis with nasal polyps (CRSwNP), according to new findings, with long-term improvements for CRSwNP including symptoms, disease-related impairment, burden of nasal polyps, and olfactory function.¹

These results were the conclusion of new research into dupilumab therapy for CRSwNP authored in part by Patrick Huber from the department of otorhinolaryngology at the Ludwig Maximilian University of Munich in München, Germany. Huber et al. noted that dupilumab impedes the signaling pathways for interleukin (IL)-4 and IL-13, diminishing type 2 inflammation.²

“Utilizing real-world data, the investigation will scrutinize patient-reported outcomes, disease-specific indices, and clinical measures, focusing on therapeutic response persistence, adverse events, and factors affecting treatment continuity,” Huber and colleagues wrote.¹

Study Design

The research team carried out a multicenter, retrospective analysis to evaluate real-world data drawn from a set of 5 tertiary referral centers located within Germany. Adult subjects in the age range of 18 years and older who also had CRSwNP were included in this research.

These patients were required to specifically have inadequate disease control and had to have met the team’s criteria for biologic treatment. These criteria were based upon the European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS2020) guidelines.

In the period prior to dupilumab administration, the research team compiled an extended medical history for each of the trial participants. They specifically delved into details related to oral corticosteroids utilization before biologic therapy, previous sinus surgeries, evidence of the presence of blood eosinophilia, and the presence of comorbidities related to type 2 inflammatory such as allergic rhinitis, asthma, urticaria, and eczema.

Dupilumab therapy was begun by all subjects as their primary biologic treatment, though they would continue to implement intranasal corticosteroids. The investigators would only involve subjects who had finished out a 36-month follow-up by December 2023.

Dupilumab was specifically administered to subjects in a 300 mg subcutaneous injection, and it could be self-administered by subjects following the manufacturer’s recommendations. The participants followed an every-2-weeks dosing schedule, though tapering was needed in some cases for those who responded strongly.

All throughout their research, the team made subjective and objective assessments, looking at biomarkers connected to respiratory conditions at treatment initiation and then at the follow-up time points.

Findings

The team’s results indicated that those treated with the biologic showed significant improvements in their clinical measures from the point of baseline among the 150 adult patients enrolled. They specifically noted that sustained effectiveness of the drug was seen by the 36-month mark (n = 138).

The investigators highlighted the substantial disease-related impairment decreases seen among those treated, a result which had been reflected in subjects’ scores on the Visual Analog Scale (VAS). VAS scores had dropped from 7.5 ± 2.5 to 1.6 ± 1.3, specifically.

The team additionally showed that subjects’ Nasal Polyp Scores (NPS) were reduced from 5.3 ± 1.8 to 0.7 ± 1.1. Rhinosinusitis symptoms among those treated with dupilumab were reported to have improved as well, as the research team found that scores on the Sinonasal Outcome Test−22 (SNOT-22) dipped from 59.4 ± 19.4 to 18.0 ± 15.0.

The investigators further reported that participants’ olfactory function had notable improvements, with score increases from 3.2 ± 2.5 to 8.4 ± 2.8 being highlighted and around 75% of individuals having either normosmia or hyposmia by the 36-month follow-up.

Based upon the European Forum for Research and Education in Allergy and Airway Diseases (EUFOREA23) criteria, the research team found that a treatment response labeled as ‘excellent’ was given to 76.5% of subjects following 36 months.

They did also note that discontinuation occurred among 16 participants, with 12 such individuals doing so permanently. There were 69 adverse events noted by the team among 48 subjects, most of which were found to be self-limiting.

“Revealing sustained improvements across clinical parameters, this study shows the enduring effectiveness of dupilumab on disease-related impairment, rhinosinusitis symptoms, nasal polyp burden, and olfactory function,” they concluded.

References

1. ^{Huber P, Förster-Ruhrmann U, Olze H, et al. Real-world data show sustained therapeutic effects of dupilumab in chronic rhinosinusitis with nasal polyps (CRSwNP) over 3 years. Allergy. 2024; 00: 1-10. doi:10.1111/all.16263.}
2. ^{Harb H, Chatila TA. Mechanisms of Dupilumab. Clin Exp Allergy. 2020; 50(1): 5-14.}