xRead - September 2022

Wise et al.

Page 114

administered with minimal adverse events, and with similar frequency to either agent as monotherapy. • Aggregate Grade of Evidence: A (Level 1a: 1 study; Level 1b: 11 studies; Level 2b: 1 study; Table IX.B.10.c). • Benefit: Inconsistent evidence that combination LTRA and oral antihistamine were superior in symptom reduction and QOL improvement than either agent as monotherapy. Combination therapy is inferior in symptom reduction compared to INCS alone. • Harm: No significant safety-related adverse events from combination therapy. • Costs: Generic montelukast was more expensive than either generic loratadine or cetirizine on a per dose basis, according to weekly National Average Drug Acquisition Cost (NADAC) data provided by the Centers for Medicare & Medicaid Services (CMS). • Benefits-Harm Assessment: Balance of benefit and harm. • Value Judgments: Combination therapy of LTRA and oral antihistamines does not result in consistently improved AR symptoms compared to either agent alone. There are few reported safety-related adverse events from combination therapy. The addition of an LTRA may have a role in management of comorbid asthma. • Policy Level: Option. • Intervention: Combination therapy of LTRA and oral antihistamines is an option for management of AR, particularly in patients with comorbid asthma or those who do not tolerate INCS and symptoms are not well-controlled on oral antihistamine monotherapy. IX.B.10.d. Intranasal corticosteroid and intranasal antihistamine.: The use of combination intranasal antihistamine and corticosteroid spray for AR has been well studied. One topical formulation is currently available in North America for intranasal use as a combination of azelastine hydrochloride and fluticasone propionate (AzeFlu; Mylan, Canonsburg, PA). This agent is also designated in the literature as MP-AzeFlu or MP29-02, and is marketed in the United States under the trade name Dymista. A systematic review of the English-language literature was performed for clinical trials of combination INCS and intranasal antihistamine for the treatment of AR. A total of 10 RCTs (9 double-blind, 1 non blinded) evaluated combination therapy against either placebo or active control. 1486-1495 An additional 2 observational studies in the allowable search date range for this document reported outcomes of AzeFlu as a single treatment arm 1496,1497 (Table IX.B.10.d). Outcome measures were predominantly patient-reported symptom scores or QOL assessments. The most common outcome measure was the TNSS (9 studies), which records the severity of runny nose, sneezing, itching, and congestion. Other outcome measures included the TOSS (4 studies), a VAS (3 studies), the RQLQ (2 studies), the Pediatric RQLQ (1 study), and a threshold/discrimination/identification (TDI) score (1 study).

Author Manuscript Author Manuscript Author Manuscript Author Manuscript

Int Forum Allergy Rhinol . Author manuscript; available in PMC 2020 June 10.