Dupilumab improves sleep, function in people with chronic rhinosinusitis with nasal polyps

Patients with chronic rhinosinusitis with nasal polyps experienced improved sleep and functioning after 52 weeks of treatment with dupilumab, according to research published in The Journal of Allergy and Clinical Immunology: In Practice.

These improvements in turn improved health-related quality of life, William Busse, MD, honorary associate and fellow in the department of medicine, division of allergy, pulmonary and critical care at University of Wisconsin School of Medicine and Public Health, and colleagues wrote.

The randomized, placebo-controlled phase 3 SINUS-24 and SINUS-52 studies showed an association between treatment with dupilumab (Dupixent; Sanofi, Regeneron), a monoclonal antibody that inhibits IL-4 and IL-13 signaling, and a significant reduction in nasal polyp score and nasal congestion compared with placebo.

The researchers conducted a post-hoc analysis of the 22-item Sino-Nasal Outcome Test sleep and function domain scores for SINUS-24 and SINUS-52 study participants who received 300 mg doses of subcutaneous dupilumab for their CRSwNP.

SNOT-22 asked participants about their difficulty in falling asleep, waking up at night, lack of a good night’s sleep and waking up tired, as well as about fatigue, reduced productivity and reduced concentration. These factors were scored on scales from no problem, at a score of 0, to problems as bad as they could be, at a score of 5.

Participants taking dupilumab saw greater improvements in average SNOT-22 sleep domain scores compared with those taking placebo at week 24 in the SINUS-24 study (–1.38 vs. –0.41; least square [LS] mean difference vs. placebo, –0.97; 95% CI, –1.24 to –0.71) and at week 52 in SINUS-52 (–1.27 vs. –0.34; LS mean difference vs. placebo, –0.93; 95% CI, –1.18 to –0.68), with differences observable starting at week 8 (P < .0001).

Similarly, those taking dupilumab experienced greater changes in sleep domain score from baseline compared with placebo at week 24 (–53.03% vs. –3.76%; P < .0001) and week 52 (–27.23% vs. 13.82%; P = .0023).

Those assigned dupilumab further saw greater improvements in their function domain scores than those on placebo at week 24 (–1.31 vs. –0.44; LS mean difference vs. placebo, –0.86; 95% CI, –1.11 to –0.61) and at week 52 (–1.08 vs. –0.32; LS mean difference vs. placebo, –0.76; 95% CI, –1.01 to –0.51) with observable differences at week 8 (P < .0001).

Regardless of nasal polyp scores, participants assigned dupilumab saw improvements in all their sleep and function scores at weeks 24 and 52 compared with those taking placebo.

Participants with asthma saw numerically greater improvements in function compared with those without asthma, and participants with prior nasal polyp surgery also saw numerically greater improvements compared with those who had not had such surgery, both at week 52.

Noting how these positive effects occurred regardless of comorbid asthma, NSAID-exacerbated respiratory disease, allergic rhinitis, prior surgery or systemic corticosteroid use, the researchers said their results indicate that dupilumab has a broader effect on health-related quality of life beyond symptomatic relief from CRSwNP.

The researchers cautioned that they were not able to evaluate how these changes might impact overall improvements in general health and function and that they could not consider how obstructive sleep apnea may have contributed to their results.

However, the researchers hypothesized that the reductions in daily CRSwNP symptoms that dupilumab produced — such as with congestion — may have been responsible for improvements in sleep, which then led to improvements in function.