How will biologic response modifiers change the treatment paradigm for patients with chronic rhinosinusitis with nasal polyposis? Otolaryngologists now have an expanded treatment armamentarium along with conventional surgical treatment, as new, immunomodulating drugs are approved to treat this condition.
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November 2019Biologics target and suppress specific drivers of inflammation in the immune system. They may work well in some patients to treat the symptoms of nasal polyps, but high cost and the need for regular injections for an indefinite period of time are two major concerns among otolaryngologists. Most patients experience significant symptom relief with complete surgical polypectomy followed by topical corticosteroid irrigation, they say.
Dupilumab Approved in 2019
In June 2019, dupilumab (Dupixent, Sanofi Genzyme) was approved by the U.S. Food and Drug Administration (FDA) to treat adults with nasal polyps accompanied by chronic rhinosinusitis. In the announcement of the drug’s approval for this indication, Sally Seymour, MD, director of the division of pulmonary, allergy and rheumatology products in the FDA’s Center for Drug Evaluation and Research, said that dupilumab “provides an important treatment option for patients whose nasal polyps are not adequately controlled with intranasal steroids. It also reduces the need for nasal polyp surgery and oral steroids.”
Other biologics are being studied in clinical trials for treatment of nasal polyps, including omalizumab (Xolair, Novartis) and mepolizumab (Nucala, GSK). Each targets a different inflammatory trigger (see “Biologics: Inflammatory Targets,” below). Biologics like dupilumab have already been approved for other indications, such as asthma and eczema. How do they work in patients with sinusitis and nasal polyps? Otolaryngologists have mixed views on their efficacy when compared with the conventional treatments of surgery and steroid irrigation.
“Biologics are highly targeted therapies to treat the inflammatory cascade in a subset of patients. But we don’t know which patients. Because they are targeted, there is a need for selective criteria to know which patients would benefit from this treatment. What we have are clinical trials run by pharmaceutical companies in a highly selective group of patients,” said Benjamin S. Bleier, MD, Claire and John Bertucci Chair in Otolaryngology/Head and Neck Surgery at Harvard Medical School in Boston. “There are several biologics on the market, and more are coming. We expect general efficacy, but when these drugs are prescribed across the patient spectrum, they may be less effective.”
Enthusiasm with Caution
Allergists have more enthusiasm for their effectiveness in patients with nasal polyps, which is estimated at 2.7% of the adult population, with higher prevalence in males, those older than 60, and people with asthma (Ann Otol Rhinol Laryngol. 2003;112:625–629).
Dupilumab “has shown close to magical success, with a patient response within two to four weeks of treatment. They are breathing better through their nose and regaining a sense of smell. For patients with severe asthma and nasal polyps, the response has often been quite remarkable,” said Tanya M. Laidlaw, MD, assistant professor of medicine at Harvard Medical School and director of translational research in allergy at Brigham and Women’s Hospital in Boston.