Biologics, which are medicines that target specific genes or protein receptors, work better than traditional treatments for many complicated, chronic diseases. Biologic therapies are more expensive and targeted than traditional treatments. It is critical to follow the guidelines to translate the benefits shown in clinical trials into clinical practice. To confirm how poor compliance can lower the effectiveness of biologics, researchers from University of Rochester recently presented their real-world analysis of dupilumab in nasal polyposis at American Rhinologic Society Meeting in Philadelphia (Sep 9-10, 2022).
Nasal polyposis is soft, painless, noncancerous growths arising from the nose or sinuses. They are most common in people with asthma, allergies, recurring infections, or nasal inflammation and affect up to 4% of the population. Medicines like corticosteroids or surgery can be used to treat the condition. However, recurrences are common with both treatments. Dupilumab from Sanofi and Regeneron is an FDA-approved biologic therapy for nasal polyposis with uncontrolled symptoms. Clinical trials showed that it clears up stuffy noses, improves sinus drainage, and brings back the ability to smell and taste.
This study included 131 patients treated with dupilumab for nasal polyposis, with 29 (22%) failing to meet biological initiation criteria. First, the demographic analysis compares these 29 patients with the overall cohort in terms of median age (56 vs. 52), rate of receiving endoscopic sinus surgery (83% vs. 95%), and failure in other biological therapy (31% vs. 35%).
The reasons for failing to meet biologic use guidelines included:
- Uncontrolled chronic rhinosinusitis (6/29).
- Unachieved residual surgical goals (3/29).
- Lack of appropriate medication (6/29).
- Lack of necessary surgery (4/29).
- Misdiagnosis with nasal polyposis (10/29).
These 29 prescriptions that did not meet the guidelines came from allergology/immunology (17/29), pulmonology (7/29), and non-rhinology otolaryngology (5/29). Notably, none were recommended by a rhinologist.
The researchers used nasal polyp score (NPS) and the 22-item Sinonasal Outcome Test (SNOT-22) score to assess the treatment response to dupilumab. NPS is a physician-reported tool to evaluate the extent/severity of nasal polyps using nasal endoscopy. Each nostril is scored from 0 to 4, with a total score ranging from 0 to 8. SNOT-22 is a subjective questionnaire that measures how a nasal disease affects the health-related quality of life. It includes classic nasal and extra nasal symptoms; each item is scored between 0 (no problem) and 5 (worst possible problem). The findings showed that in non-compliant patients, the data collection rates after dupilumab initiation were only 20% (6/29) on SNOT-22 and 24% (7/29) on NPS. In contrast, these indicators in compliant patients were 67% (68/102) and 57% (58/102), respectively. Poor compliance lowered the effectiveness of dupilumab.
Finally, Dr. Schmale introduced five special non-compliant cases: while dupilumab helped two of them, it made the SNOT-22 score worse in a patient misdiagnosed with nasal polyposis. “Dupilumab initiation for nasal polyposis is relatively common, but it varies greatly depending on the prescriber’s specialty,” the speaker concluded, “Treatment response assessments in the real world will provide an opportunity for future improvement.”