Biologic use low among patients with chronic rhinosinusitis with nasal polyps

Key takeaways:

• Dupilumab was the most used biologic.
• Allergists/immunologists prescribed the most biologics.
• Biologic discontinuation rates were high.

BOSTON — Patients with chronic rhinosinusitis with nasal polyps showed low biologics use and high discontinuation rates, according to a presentation at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting.

“Chronic rhinosinusitis with nasal polyps affects about 1.1% of the adult population in the U.S.,” Anju T. Peters, MD, MS, director of clinical research in the division of allergy and immunology at Northwestern University Feinberg School of Medicine, said.

“These patients often have persistent symptoms and have reduced health-related quality of life despite standard treatment,” she said.

Peters explained that three biologics are currently approved in the U.S. including dupilumab (Dupixent; Regeneron, Sanofi), mepolizumab (Nucala, GSK) and omalizumab (Xolair; Genentech, Novartis) for uncontrolled CRSwNP.

“They’ve all shown that they can reduce nasal polyp size and improve symptoms in phase 3 clinical trials,” she said. “However, real world data describing residual disease burden and outcomes in biologic patients in the U.S. are limited.”

This retrospective cohort study used health care claims data on patients with CRSwNP in the U.S. Researchers looked at the data to “describe the use of approved biologics,” “characterize patients who received biologics” and “evaluate real-world outcomes following biologic initiation,” Anju said. Real-world outcomes included biologic discontinuation/switch, oral corticosteroid or antibiotics use and NP surgery.

The CRSwNP cohort included 74,480 adult patients (mean age, 57.6 years; 46.1% women) with a CRSwNP diagnosis during the study period from July 1, 2018, to June 30, 2023.

“About 12% were prescribed biologics,” Peters said.

There were 8,716 patients with at least one claim for dupilumab, mepolizumab or omalizumab during the biologic selection window from July 1, 2019, to June 30, 2022.

The biologic cohort consisted of 2,208 patients (mean age, 52.6 years; 54% women) who met the inclusion criteria and were then divided into a dupilumab cohort (n = 1,983; 89.8%), a mepolizumab cohort (n = 118; 5.3%) and an omalizumab cohort (n = 107; 4.8%).

Inclusion criteria included having at least 12 months of continuous data before biologic use, at least one CRSwNP diagnosis before biologic use, at least 24 months of continuous data after biologic use and at least two claims for the first biologic during the follow-up.

The CRSwNP cohort had 62.5% patients diagnosed by an ENT and 18.9% by an allergist/immunologist. However, in the biologic group, the most common biologic prescriber was an allergist/immunologist (61%) followed by an ENT specialist (23.5%).

Within 12 months, 30.7% of patients in the biologic cohort stopped using their initial biologic and 1.6% switched to a different one during follow-up. Between months 13 and 24, 18.6% discontinued their initial biologic and 1% switched to a different one.

Oral corticosteroid and antibiotic use in the biologic cohort were similar during months 1 to 12 and 13 to 24. In 24 months, oral corticosteroids were used by 65.6% of patients, and 77.9% reported antibiotic use.

Through the first 12 months of follow-up, NP surgery was done in 5.3% of patients with evidence of NP surgery before biologic initiation and in 5% of patients without evidence of NP surgery before biologic initiation in the biologic cohort.

Between months 13 and 24, 1.8% of the patients who had evidence of NP surgery and 2.1% of the patients who did not have evidence of NP surgery both before starting biologic treatment had NP surgery.

Study authors also described the treatment pathways in the 12 months before and 24 months after dupilumab initiation, as it was the most prescribed biologic.

Among dupilumab patients, 16% had NP surgery in the 12 months before dupilumab initiation and 6.5% had NP surgery during the 24 months after initiation. Only 2.1% switched to mepolizumab and 1% to omalizumab after dupilumab initiation.

There was no history of NP surgery or of mepolizumab or omalizumab use in 82.6% of patients on dupilumab in the 12 months before dupilumab initiation. Among these patients, 50% continued dupilumab, 13.8% stopped and then restarted it and 26.7% discontinued it, did not get surgery or switched to another biologic.

“Biologic use was low among U.S. patients with CRSwNP, and biologics were mostly prescribed by allergist immunologists compared to our ENT colleagues who make the diagnosis,” Peters said.

She noted that biologic recipients were younger and had a higher prevalence of comorbid asthma, allergic rhinitis, prior nasal polyp surgery, oral corticosteroid use and antibiotic use than the full CRSwNP cohort.

“Compared to the overall CRSwNP population, biologic discontinuation rates were high and oral corticosteroids and antibiotic use among patients with CRSwNP remained substantial despite use of approved biologics,” Peters said. “These results highlight an unmet need for improved treatment options for our patients with CRSwNP.”