New Guidance Supports 3 Therapies for CRSwNP

Evidence-based decision making by patients, their family members, and clinicians is thoroughly supported in new guidance that hopes to shape future treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP), according to the results of a systematic review of 3 recommended treatment options: intranasal corticosteroids (INCS), biologics, and aspirin therapy after desensitization (ATAD). Current surgical methods were not included in the investigation.

The investigators compiled this guidance after they saw a need for more comprehensive direction on CRSwnP management—for patients, clinicians, and other stakeholders—on the heels of new trial evidence supporting CRSwNP interventions and because guidance for the chronic inflammatory condition as it pertains to patient outcomes “has historically not explicitly considered summaries of all available evidence.” Certainty of the evidence and the formulation of recommendations were assessed using the Grading of Recommendations Assessment, Development and Evaluation approach, with the study authors shaping their analysis with 3 questions:

• Should INCS (topical corticosteroids), rather than no INCS, be used in CRSwNP?
• Should biologics, rather than no biologics, be used in CRSwNP?
• Should ATAD, rather than no ATAD, be used in people with aspirin-exaerbated respiratory disease (AERD)?

Findings were published recently in The Journal of Allergy and Clinical Immunology, with the authors clarifying the 2 types of recommendation strength, and that they apply to patients 18 years and older, clinicians, and policy makers:

• Strong, indicating “the guideline panel recommends”
• Conditional, indicating “the guideline panel suggests”

The SinoNasal Outcome Test, both the 20-item (SNOT-20) and the 22-item (SNOT-22), and the University of Pennsylvania Smell Identification Test were used to gauge disease-specific quality of life. With SNOT-22, a mean difference (MD) of 8.9 or more points was considered significant for INCS and biologics, and –10.61 for ATAD.

Should INCS (topical corticosteroids), rather than no INCS, be used in CRSwNP?

When evaluating the effect of INCS on disease-specific quality of life, the study investigators noted that the MD (baseline to September 1, 2021) compared with placebo of intervention with INCS rinse and exhalation delivery system were the most beneficial. A similar conclusion was drawn for the effects of stent, spray, and exhalation delivery systems on nasal obstruction score. The guideline panel evaluating proposed recommendations for INCS noted that “sense of smell and quality of sleep may be the most important outcomes for some people.”

The recommendation for INCS use was conditional, because of a small to moderate treatment effect size, low-certainty evidence, and uncertain but anticipated variability in patient values and preferences. Future research priorities should include more large collaborative multicenter randomized control trials (RCTs) that directly compare INCS and other CRSwNP treatment options and research on which outcomes are most important to patients.

Should biologics, rather than no biologics, be used in CRSwNP?

Using the 8.9-or-more-point change in SNOT-22 score, the study investigators saw that dupilumab and omalizumab were the most beneficial when evaluating disease-specific quality of life (baseline to August 4, 2021). And for nasal symptoms score, dupilumab, omalizumab, and mepolizumab were most beneficial. Adverse event rates of these treatments did not differ much from placebo, but the study authors highlighted that the evidence on this was low or very low. Some data did indicate infrequent risks of anaphylaxis with omalizumab and conjunctivitis with dupilumab.

Evidence certainty was low or very low, and the panel evaluating potential recommendations said the evidence did not favor one biologic over the other. However, they members also added that for “those who value the improvement in nasal symptoms and disease-specific quality of life more than the small and varying risk of adverse effects,” biologics could be beneficial. Future research should, as with INCS, comprise more RCTs of active treatments, research on patients’ top preferred outcomes, and tools that can better predict and quantify treatment response.

The recommendation for biologic use was conditional, because of a moderate certainty of evidence.

Should ATAD, rather than no ATAD, be used in people with AERD?

With a higher point estimate marking symptom improvement as it has an impact on disease-specific quality of life, the study authors noted that the evidence they reviewed suggested patient-important improvement in nasal obstruction by even the average patient. Compared with placebo, aspirin-related adverse events were more common, with an overall relative risk of 3.84 (95% CI, 1.11-13.22); a proposed reason for this was the higher aspirin dose used vs the 81 mg used most often to treat cardiovascular disease.

The panel evaluating the proposed guidelines emphasized that patient and caregiver preference may heavily influence uptake of ATAD, but that the balance may tip in favor of ATAD because of the great improvement in disease-specific quality of life and nasal symptoms may outweigh the higher risks of gastrointestinal adverse effects and bleeding. Future research should include large RCTs to clarify how ATAD affects other treatments, investigations that compare ATAD and other biologics, and evaluations of patient outcome preference

The recommendation for ATAD use was conditional, again based on a moderate certainty of evidence.

Reference

Rank MA, Chu DK, Bognanni A, et al. The Joint Task Force on Practice Parameters GRADE guidelines for the medical management of chronic rhinosinusitis with nasal polyposis. J Allergy Clin Immunol. 2023;151(2):386-398. doi:10.1016/j.jaci.2022.10.026