xRead - Olfactory Disorders (September 2023)

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558

INTERNATIONAL CONSENSUS ON OLFACTION

TABLE IX-4 (Continued)

Clinical end point

Study Topical

Year

LOE Study design Study groups

Conclusions

corticosteroid: sinus implant

Kern

2018

2

RCT

CRSwNP (N = 300) Bilateral MF sinus

Subjective

Compared with

et al 1413

symptom symptom (0–5)

placebo, the MF sinus implant group demonstrated significantly greater improvement in subjective symptom score at month 3

implants + MFNS once daily (n = 201) Sham placebo procedure + MF NS once daily (n = 99)

Data collection

points: month 3

BTS = Butanol Threshold Score; CCCRC = Connecticut Chemosensory Clinical Research Center; CRS = chronic rhinosinusitis; CRSsNP = chronic rhinosinusitis without nasal polyps; CRSwNP = chronic rhinosinusitis with nasal polyps; EDS = exhalation delivery system; FP = fluticasone propionate; LOE = level of evidence; MF = mometasone furoate; NS = nasal spray; OSIT-J = Japanese Odor Stick Identification Test; PEA = phenylethyl alcohol; VAS = visual analog scale; WTS =

Oral antibiotics for OD in patients with CRSwNP. Aggregate grade of evidence : B (Level 2: four studies; Level 3: one study). Benefit : No clear benefit in subjective or objective olfac tory outcomes. Harm : Relatively low but adverse events in the medi cation groups included GI upset, skin rash, insomnia, car diotoxicity, hepatotoxicity, ototoxicity, and headache. Risks vary by antibiotic class and duration. Cost : Direct: Variable monetary cost depending on the antibi otic. Indirect: Minimal. Benefits-harm assessment : Preponderance of harm over benefits. Value judgments : A lack of evidence and known adverse effects preclude routine use. Policy level : Recommendation against. Intervention : Oral antibiotics should generally not be prescribed specifically to treat OD in patients with CRSwNP. Dupilumab for OD in patients with CRSwNP Aggregate grade of evidence : A (Level 2: three stud ies). Benefit : Dupilumab improves subjective and objective measures of OD compared with placebo. Harm : Conjunctivitis, injection site reactions, keratitis, and hypereosinophilia, among others. Cost : Direct: High monetary cost per injection. Indirect: Relatively low with home injections. Benefits-harm assessment : Likely benefit over harm for OD in patients with CRSwNP not responsive to tradi tional medical and surgical treatments. Value judgments : Benefits are lost if therapy is discon tinued, and costs are an important consideration.

Policy level : Recommendation for use in patients with OD related to severe CRSwNP. Intervention : Dupilumab may be recommended for patients with OD related to severe CRSwNP who have not improved despite other medical and surgical treatment options as part of a shared decision-making process. Mepolizumab for OD in patients with CRSwNP Aggregate grade of evidence : B (Level 1: one study; 2: two studies). Benefit : Mepolizumab may or may not improve sub jective olfactory symptom scores, depending on other con tributing patient factors, but objective measures of olfac tion may not improve. Harm : Injection site reaction, eczema, flu-like symp toms, headache, and muscle spasms, among others. Cost : Benefits-harm assessment : Preponderance of poten tial harm versus potential benefit—specifically for smell loss—in those not responsive to traditional medical and surgical treatments. Value judgments : Benefits are lost if therapy is discon tinued and costs are an important consideration. Consider for CRSwNP in context of asthma or eosinophilic granulo matosis with polyangiitis; dosage used for trial in CRSwNP is higher than available for standard therapy of asthma and eosinophilic granulomatosis with polyangiitis. Policy level : Option for use in patients with OD related to severe CRSwNP, but other biologics with more robust olfactory outcomes may be a better choice for improve ment in this specific symptom. Intervention : May consider as an option for OD related to patients with severe CRSwNP who have not improved despite other medical and surgical treatment options as Direct: High monetary cost per injection. Indirect: Relatively low if home injections.