xRead - Olfactory Disorders (September 2023)

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INTERNATIONAL CONSENSUS ON OLFACTION

TABLE IX.6 Evidence for CRSwNP-related olfactory loss management with dupilumab

Study design

Study

Year 2019

LOE

Study groups

Clinical end point Subjective symptom score (0–3) UPSIT R Data collection points: week52

Conclusions Compared with placebo, the

Bachert

2

RCT

CRSwNP (N = 448) Dupilumab 300 mg every 2 weeks × 52 weeks (n = 150) Dupilumab 300 mg

et al 219

dupilumab arms demonstrated significant improvement in UPSIT R and subjective symptom score at week52 dupilimab arm demonstrated significant improvement in UPSIT R and subjective symptom sore at week24

every 2 weeks × 24 weeks then every 4 weeks × 28weeks (n = 145)

Placebo (n = 133)

Hanet al 1360

2019

2

RCT

CRSwNP (N = 276) Dupilumab 300 mg every 2 weeks × 24 weeks (n = 143) Placebo (n = 133)

Subjective symptom score (0–3) UPSIT R Data collection points: week24

Compared with placebo, the

Subjective symptom score (0–3) UPSIT R Data collection point: week 16

Bachert

2016

2

RCT

CRSwNP (N = 60) Dupilumab 600 mg

Compared with placebo, the

et al 218

loading then 300 mg weekly for a total of 16 weeks + MFNS (n = 30) Placebo + MFNS (n = 30) dupilumab arm demonstrated significant improvement in UPSIT R and subjective symptom score at week 16 CRSwNP = chronic rhinosinusitis with nasal polyps; LOE = level of evidence; MF = mometasone furoate; NS = nasal spray; RCT = randomized controlled trial; UPSIT R = University of Pennsylvania Smell Identification Test.

tant poorly controlled allergic asthma who have not improved despite other medical and surgical treatment options. Policy level : Recommendation for use in patients with OD related to severe CRSwNP. Intervention : Omalizumab may be recommended for OD related to patients with severe CRSwNP who have not improved despite other medical and surgical treatment options as part of a shared decision-making process. Antileukotriene therapy for OD in patients with CRSwNP Aggregate grade of evidence : B (Level 2: three stud ies). Benefit : No clear benefit on olfaction but data limited. Zileuton may have added benefit for subjective olfaction when used as an adjunct to intranasal corticosteroids in AERD. Harm : Montelukast has been associated with rare neu ropsychiatric events in postmarketing reports. Zileuton

may cause elevated liver enzymes requiring monitoring during therapy. Cost : Direct: Low to moderate monetary costs depending on formulation. Indirect: Minimal. Benefits-harm assessment : Unclear given relative lack of available efficacy data. Value judgments :None. Policy level : No recommendation. Intervention : Lack of available data precludes a recom mendation on antileukotriene used specifically for olfac tion. Aspirin desensitization for OD in patients with AERD Aggregate grade of evidence : B (Level 1: one study; Level 2: three studies; Level 3: one study). Benefit : In patients with AERD, aspirin desensitiza tion appears to improve OD based on subjective measures.