Biologics used as an asthma treatment also appear to improve symptoms of coexisting chronic rhinosinusitis in some patients, according to results from a real-world study published in the International Forum of Allergy & Rhinology.
Although patients with asthma commonly have coexisting chronic rhinosinusitis (CRS) with nasal polyps (CRSwNP) or without nasal polyps (CRSsNP), research on the effect of biologics has focused on CRSwNP, according to Devyani Lal, MD, of the Department of Otolaryngology, Division of Rhinology, Mayo Clinic, Phoenix, Arizona, and colleagues.
The researchers evaluated how the use of omalizumab, mepolizumab, benralizumab, reslizumab, and dupilumab affected a group of 181 patients with asthma and CRSwNP and 66 patients with asthma and CRSsNP in a retrospective review of electronic health records at the Mayo Clinic. Over a period of at least 12 months, most patients in the study received omalizumab (51%), mepolizumab (46.6%), benralizumab (10.5%) or a combination of omalizumab and mepolizumab (6.9%).
Of the 247 patients studied, 206 (84.1%) underwent endoscopic sinus surgery (ESS) and 189 of those patients had the surgery performed prior to receiving biologic therapy. Matched-pair analyses were performed to identify changes from baseline in Lund-Mackay CT scores, SNOT-22 scores, serum eosinophil counts, and serum immunoglobulin E (IgE) levels.
Lal and colleagues found treatment with an anti-interleukin-5 (anti-IL-5) biologic such as mepolizumab, benralizumab, or reslizumab significantly improved Lund-Mackay CT scores when analyzing the proportion of patients with both CRSwNP and CRSsNP, and SNOT-22 scores for patients with CRS overall and CRSwNP. Patients who received the anti-IgE biologic omalizumab had improved Lund-Mackay CT scores, but SNOT-22 scores did not significantly improve at any follow-up time, including the longest follow-up at mean 23.7 months.
In an interview with Medscape Medical News, Aaron N. Pearlman, MD, an otolaryngologist at Weill Cornell Medicine and NewYork-Presbyterian in New York City, said the finding of objective and subjective improvement in a real-world study is important.
“It shows you that these monoclonal antibodies are having a positive effect on diffuse chronic inflammatory conditions,” said Pearlman, was not involved in the study. “Where asthma and chronic sinusitis with nasal polyps in many patients have a similar inflammatory pathway, we think that these medications would work on both systems. With this retrospective data, they’ve shown that there is some improvement even in patients [where] the indicated use was not for nasal polyps.”
Pearlman said the inclusion of patients with a confirmed diagnosis of asthma with CRS strengthens the data. “I think what you have here is a real pure cohort of patients who have asthma and chronic rhinosinusitis,” he said. “That’s sometimes pretty hard to do because if you’re doing a simple chart review, the patient may have a diagnosis in the computer system of chronic rhinosinusitis, but they may not actually have it. Here, in this case, most of these patients had the diagnosis made by an otolaryngologist.”
Payel Gupta, MD, assistant clinical professor at SUNY Downstate Medical Center and Mt. Sinai Medical Center in New York City, said the study shows there may be a place for biologic therapy for any patient with CRS regardless of whether they have nasal polyps or not. Of the biologics evaluated in the review, only the anti-IL-4 and IL-13 monoclonal antibody dupilumab (Dupixent) — the least used biologic in the study — has been approved for CRSwNP by the US Food and Drug Administration.
“Historically, studies have focused on asthma patients with CRSwNP, and we know that these patients are likely to benefit from treatment with a biologic agent for both their asthma and CRSwNP,” said Gupta, who was also not associated with the study. “This study states that we should look at all patients with CRS to evaluate benefit for possible biologic therapy.”
“Based on this study, it may be beneficial to look at both patients with and without NP for studies on biologic therapy,” Gupta said. “There may be some benefit to their underlying CRS with treatment with a biologic.”
Lal and colleagues noted their results might mean categorizing CRS differently in the future to identify which patients will benefit from which biologic treatment. “Our study highlights the need to further direct therapy based on the biological characteristics of CRS, not just the endoscopic visualization of the presence or absence of polyps,” they write. “Trials should utilize criteria beyond the CRSwNP phenotype, using biomarkers and other clinical data.”
Determining which patient has what endotype, however, is easier said than done. “At this point, that is all experimental. We don’t have a way to screen for the various differences within each group,” Pearlman said. “I think that becomes a limitation of not just this study, but really of any study about biologics, because it is one of the reasons why we are confused as to why some people are getting better and some people aren’t.”
Future research, therefore, “should go into trying to hammer out the differences on the molecular level between the patients, broadening this endotype theory, and then applying the biologics towards each endotype,” he said.
The study authors, Gupta, and Pearlman have disclosed no relevant financial relationships.
Int Forum Allergy Rhinol. Published online February 1, 2021. Abstract
Jeff Craven is an independent journalist living in Wilmington, Delaware.