Clinically Relevant Effect of a New Intranasal Therapy (MP29-02) in Allergic Rhinitis Assessed by Responder Analysis

Abstract

Background: It is unclear what constitutes a clinically meaningful response for allergic rhinitis (AR) outcomes. The objectives of these post hoc analyses were (1) to define a clinically meaningful response using novel efficacy analyses (including a responder analysis), and (2) to compare the efficacy of MP29-02 [a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP)] with commercially available FP, AZE and placebo in seasonal AR (SAR) patients, using these novel analyses. Methods: 610 moderate-to-severe SAR patients (≥12 years old) were randomized into a double-blind, placebo-controlled, 14-day, parallel-group trial. Change from baseline in the reflective total nasal symptom score (rTNSS) over 14 days was the primary outcome. Post hoc endpoints included the sum of nasal and ocular symptoms (rT7SS), efficacy by disease severity and by predominant nasal symptom, and a set of responder analyses. Results: MP29-02 most effectively reduced rT7SS (relative greater improvement: 52% to FP; 56% to AZE) and both nasal and ocular symptoms irrespective of severity. More MP29-02 patients achieved a ≥30, ≥50, ≥60, ≥75 and ≥90% rTNSS reduction, which occurred days faster than with either active comparator; MP29-02 alone was superior to placebo at the ≥60% (or higher) threshold. One in 2 MP29-02 patients achieved a ≥50% rTNSS reduction and 1 in 6 achieved complete/near-to-complete response. Only MP29-02 was consistently superior to placebo for all patients, whatever their predominant symptom. Conclusions: MP29-02 provided faster and more complete symptom control than first-line therapies. It was consistently superior irrespective of severity, response criteria or patient-type, and may be considered the drug of choice for moderate-to-severe AR. These measures define a new standard for assessing relevance in AR.

Real‐life effectiveness of MP‐AzeFlu in Irish patients with persistent allergic rhinitis, assessed by visual analogue scale and endoscopy

“…Earlier real‐world studies in patients with moderate‐to‐severe AR found mean reductions in VAS score over approximately 14 days of 31,8 50,9 54,6 and >60 points,7 demonstrating a consistent pattern of substantial improvement in symptoms with MP‐AzeFlu therapy. These findings are consistent with earlier clinical trials of MP‐AzeFlu that found significantly greater reductions in nasal symptoms, including nasal congestion, with MP‐AzeFlu than with FP alone 10, 11…”

“…Optimal pharmacotherapy for PER will not only control symptoms but also help patients function better (via improved sleep) and improve their quality of life. The findings of this study, which add to the body of evidence of previous real‐world and clinical studies of MP‐AzeFlu,6, 7, 8, 9, 10, 11, 29, 30, 31 further support MP‐AzeFlu as a treatment with broad benefits for this patient population.…”

“…In a double‐blind clinical trial of MP‐AzeFlu among patients with moderate‐to‐severe SAR, 18% of patients treated with MP‐AzeFlu experienced complete or near‐complete nasal symptom resolution after 14 days 10. Therefore, it appears that symptom control with MP‐AzeFlu in the real world may be even greater than that found in clinical studies.…”

“…Although some differences in data reporting and baseline characteristics were noted, the results of this study are consistent with the findings of the same NIS conducted in Sweden 20. Sleep impairment has been well established as a debilitating symptom associated with AR21, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26; therefore, the improvement in sleep quality with MP‐AzeFlu observed in these real‐world studies has the potential to greatly improve AR patients’ quality of life.…”

Safety of a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in children: A randomized clinical trial

“…12 In adults and adolescents, MP-AzeFlu provides twice the nasal and ocular symptom relief as INS or intranasal antihistamine monotherapy, and better long-term nasal symptom relief than FP in adults with perennial AR (PAR) or non-AR. 13,14 Its short-and long-term safety in these populations is well established. 13,15,16 The short-and long-term efficacy of MP-AzeFlu in pediatric AR has also been assessed.…”