Dupilumab improves sleep among patients with chronic rhinosinusitis with nasal polyps
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Key takeaways:
- 93.1% had overall altered sleep quality at baseline.
- Excessive daytime sleepiness and insomnia improved after 1 month.
- Sleep latency and daytime dysfunction improved after 3 months.
Sleep improved for patients with chronic rhinosinusitis with nasal polyps after a month of treatment with dupilumab, according to a study published in Annals of Allergy, Asthma & Immunology.
Physicians should more carefully assess sleep disturbances as an additional outcome in these patients, Sebastian Ferri, MD, research assistant in personalized medicine, asthma and allergy at IRCCS Humanitas Research Hospital, and colleagues wrote.
Patients at baseline
The 29 patients (55.2% female; mean age, 54 ± 9.8 years ) with CRSwNP in the cohort included 24 (82.8%) with asthma, 20 (69%) who were atopic and 16 (55.2%) who were former smokers.
Also, 25 (86.2%) had at least one previous surgical intervention for CRSwNP with a mean of 2.2 ± 1.7 surgeries (range, 1-7), and 27 (93.1%) had received three or more courses of oral corticosteroids in the previous year.
Mean questionnaire scores at baseline included 6.4 ± 1.3 for the nasal polyps score (NPS), 11.9 ± 5.2 for the nasal obstruction symptom evaluation (NOSE) scale, 62.5 ± 17 for the sinonasal outcome test-22 (SNOT-22) and 64.8 ± 22.3 for the nasal polyposis quality of life questionnaire (NPQ).
Seven patients (24.1%) had an Epworth sleepiness scale (ESS) score over 10, indicating significant excessive daytime sleepiness, and 23 (79.3%) had insomnia severity index (ISI) scores greater than 7, indicating significant insomnia.
Also, 27 (93.1%) had Pittsburgh sleep quality index (PSQI) scores of 5 or higher, indicating overall altered sleep quality.
The researchers found no statistical correlations between the ESS, ISI, PSQI and NPS or NOSE scores, nor were there any statistical differences between the patients who had asthma and those who did not.
Treatment with dupilumab
Patients with uncontrolled CRSwNP but no asthma received a subcutaneous 300 mg dose of dupilumab (Dupixent; Regeneron/Sanofi) every 15 days. The patients who had CRSwNP with severe asthma had a 600 mg loading dose and then biweekly 300 mg doses.
After 1 month of treatment, researchers found that patients experienced significant improvements in NPS, SNOT-22, NPQ and NOSE scores, with continued improvements for NPS and NPQ after 3 months.
Asthma Control Test scores for the patients with asthma improved from 17 ± 4.3 at baseline to 21 ± 3.5 at 1 month (P < .001) and to 23.1 ± 2.5 at 3 months (P = .009 for comparison with 1-month data).
ESS scores significantly improved from 7.9 ± 4.5 at baseline to 6.17 ± 4.8 at 1 month (P = .008) and to 4.3 ± 3.4 at 3 months (P = .01 vs. 1 month).
From baseline to 1 month, ISI improved from 13.1 ± 6.2 to 8.1 ± 5.7, PSQI improved from 9.2 ± 3.7 to 6.6 ± 3.6, and the sleep domain of the SNOT-22 improved from 12.1 ± 4.2 to 7 ± 4.9 (P < .001 for all), with no further improvements at 3 months.
The number of patients with excessive daytime sleepiness fell to five (17.2%) at 1 month and then to two (6.9%) at 3 months.
Similarly, the number of patients with insomnia fell to 15 (51.7%) at 1 month (P = .03) and then to 11 (37.9%) at 3 months (P = .001).
The numbers of patients with overall altered sleep quality fell to 20 (69%) at 1 month (P = .002) and to 16 (55.2) at month 3 (P < .001).
Specifically, from baseline to 1 month, the sleep quality domain in the PSQI improved from 1.8 ± 0.8 to 1.1 ± 0.6 (P = .001), and the efficacy domain improved from 1.1 ± 1.1 to 0.5 ± 0.8 (P = .03). There were improvements in the sleep latency (1.3 ± 0.9 to 0.6 ± 0.7; P = .002) and daytime dysfunction (1.1 ± 0.7 to 0.6 ± 0.6; P = .003) domains from baseline to 3 months as well. There were no improvements in sleep duration through 3 months.
Conclusions
The findings indicated that 93.1% of patients had globally impaired quality of sleep, 79.3% had insomnia and 24.1% had excessive daytime sleepiness, indicative of possible obstructive sleep apnea.
Yet dupilumab was associated with rapid and sustained improvement in all sleep quality parameters, the researchers wrote, indicating that physicians should evaluate sleep among patients with CRSwNP.
Further, the researchers called for studies that would confirm these findings in a larger number of patients and explore whether these results would continue beyond 3 months, because dupilumab is a long-term therapy.
Perspective
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Sleep quality disturbances are an under-reported symptom of chronic rhinitis, with and without nasal polyposis and including allergic rhinitis. Patients often characterize rhinitis symptoms as a nuisance, without fully understanding the impact on sleep and subsequent quality of life. These findings are not surprising, but they are significant because they show that allergists need to do more evaluations of sleep quality and quality of life with our patients.
From my own experience with dupilumab, it is very effective for chronic rhinosinusitis with nasal polyps.
Doctors can use this study for sleep quality screening and evaluation. They should also consider the use of wearable devices to measure baselines before and after treatment, in addition to asking subjective screening questions in discussions with their patients.
The next step for this research would be more, larger scale studies with more heterogeneous populations.
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