xRead - Olfactory Disorders (September 2023)

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PATEL et al.

TABLE IX-7 Evidence for CRSwNP-related olfactory loss management with mepolizumab

Study design Study groups

Study

Year 2017

LOE

Clinical end point

Conclusions

Compared with placebo, the mepolizumab group did not demonstrate a significant benefit at week25 Compared with placebo, the mepolizumab group demonstrated significantly greater improvement in VAS at week 9 and this was sustained until week25 Compared with placebo, the mepolizumab group demonstrated a greater improvement in subjective symptom score, but this was not significant

VAS (0–10) SS-ID

Bachert

2

RCT

CRSwNP (N = 105) Mepolizumab 750 mg IV every 4 weeks for 24weeks + FPNS 100 μ g once daily (n = 54) Placebo + FPNS 100 μ g once daily (n = 51)

et al 1361

Data collection point: VAS: week 1, week 2, week 5, week 9,

week 13, week 17, week 21, week 25

SS-ID: week 25

Gevaert

2011

2

RCT

CRSwNP (N = 30) Mepolizumab 750 mg IV × 2 doses only, 28 days apart (n = 20)

Subjective symptom score (0–3) Data collection point: week 1, week 4, week 8, week 12, week 24, week 36, week 48

et al 1414

Placebo (n = 10)

Improvement was sustained until week48

Han

VAS UPSIT R SNOT-22 Endoscopic polyp score

Compared with placebo, the mepolizumab did not cause a clinically significant

2021

1

RCT

CRSwNP (N = 407) Mepolizumab 100 mg

et al 1440

IV × 13doses, 4 weeks apart (n = 206) Placebo (n = 201)

improvement in smelling ability,

despite significantly improving multiple other clinical end points

CRSwNP = chronic rhinosinusitis with nasal polyps; FP = fluticasone propionate; LOE = level of evidence; NS = nasal spray; RCT = randomized controlled trial; SNOT-22 = 22-item Sino-Nasal Outcome Test; SS-ID = Sniffin’ Sticks identification only; IV = intravenously; UPSIT R = University of Pennsylvania Smell Identification Test; VAS = visual analog scale.

Limited objective data are available. Additional benefits include reduced need for future surgical intervention, less medication use, and fewer physician visits. Harm : GI bleeding, increased morbidity in renal dis ease, and blood clotting issues at high maintenance doses, among others. Estimated 3% GI side effects with low-dose protocols. Cost : Direct: Moderate monetary cost of desensitization pro cedure. Minimal monetary costs of daily aspirin use. Indirect: Minimal. Benefits-harm assessment : Balance of benefit over harm. Value judgments : Aspirin desensitization followed by daily aspirin therapy is one of the very few disease modifying medical treatment options available for patients

with AERD. Benefits are typically most pronounced fol lowing sinus surgery. Policy level : Option for use in OD related to AERD. Intervention : Aspirin desensitization and daily ther apy should be considered an option in patients with AERD who have OD, particularly after surgical intervention. Oral corticosteroids for OD in patients with CRSsNP Aggregate Quality of Evidence : C (Level 4: two stud ies). Benefit : Benefit is unclear given limited investigation on oral corticosteroids in CRSsNP and lack of objective data. Corticosteroids appear to provide subjective improve ment in small case series. Harm : Corticosteroid risks include GI upset, hyper glycemia, rare severe reactions, cataracts, increased risk of infection, transient adrenal suppression, insomnia, and