Alexander V Karaulov1, Natalia I Ilina2, Natalia Shartanova3, Aleksandr Maslakov3, Luiz Lucio4. 1. Department of Clinical Immunology and Allergology of I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation. 2. National Research Centre, Institute of Immunology Federal Medical-Biological Agency of Russia, Moscow, Russian Federation. 3. Medical Department, Sanofi Consumer Healthcare, Medical Affairs, Moscow, Russian Federation. 4. Medical Department, Sanofi Consumer Healthcare, São Paulo, Brazil.
Abstract
INTRODUCTION: Allergic rhinitis (AR) is a disease which affects >24% of the population in Russia. Triamcinolone acetonide (TAA) is a corticosteroid used for treating AR. This post hoc analysis assesses the efficacy of intranasal TAA in improving perennial AR (PAR) symptom scores over 4 weeks. METHODS: NASANIF (NCT03317015) was a double-blind, parallel-group, multicenter, prospective, non-inferiority, phase III clinical trial in which patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) over 4 weeks. Our post hoc analysis evaluates weekly change in PAR symptoms using the reflective Total Nasal Symptom Score (rTNSS), overall and for individual symptoms (sneezing, nasal itching, rhinorrhoea, and nasal obstruction). Proportion of patients and time to achieve a ≥50 or ≥75% reduction in rTNSS were assessed. For rTNSS endpoints, a linear mixed-model methodology was used; for time-to-event endpoints, cumulative incidence functions were estimated using the Kaplan-Meier method, in the per-protocol population. RESULTS: Of 260 patients, 128 each completed the study and were randomized to receive TAA or FP. From baseline to week 4, the changes in total rTNSS were -7.78 (95% CI: -8.1701 to -7.3967; p < 0.001) and -7.52 (-7.9053 to -7.1320; p < 0.001) for TAA and FP, respectively. Individual symptoms improved significantly from baseline. The proportion of patients achieving ≥50 and ≥75% reductions in total rTNSS was 88.0 and 67.2%, respectively in the TAA group. No significant differences were observed between the TAA and FP in any analyses. CONCLUSIONS: TAA produced effective and prolonged improvement of PAR symptoms over a 4-week treatment period.
INTRODUCTION: Allergic rhinitis (AR) is a disease which affects >24% of the population in Russia. Triamcinolone acetonide (TAA) is a corticosteroid used for treating AR. This post hoc analysis assesses the efficacy of intranasal TAA in improving perennial AR (PAR) symptom scores over 4 weeks. METHODS: NASANIF (NCT03317015) was a double-blind, parallel-group, multicenter, prospective, non-inferiority, phase III clinical trial in which patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) over 4 weeks. Our post hoc analysis evaluates weekly change in PAR symptoms using the reflective Total Nasal Symptom Score (rTNSS), overall and for individual symptoms (sneezing, nasal itching, rhinorrhoea, and nasal obstruction). Proportion of patients and time to achieve a ≥50 or ≥75% reduction in rTNSS were assessed. For rTNSS endpoints, a linear mixed-model methodology was used; for time-to-event endpoints, cumulative incidence functions were estimated using the Kaplan-Meier method, in the per-protocol population. RESULTS: Of 260 patients, 128 each completed the study and were randomized to receive TAA or FP. From baseline to week 4, the changes in total rTNSS were -7.78 (95% CI: -8.1701 to -7.3967; p < 0.001) and -7.52 (-7.9053 to -7.1320; p < 0.001) for TAA and FP, respectively. Individual symptoms improved significantly from baseline. The proportion of patients achieving ≥50 and ≥75% reductions in total rTNSS was 88.0 and 67.2%, respectively in the TAA group. No significant differences were observed between the TAA and FP in any analyses. CONCLUSIONS: TAA produced effective and prolonged improvement of PAR symptoms over a 4-week treatment period.
Authors: Mark S Dykewicz; Dana V Wallace; David J Amrol; Fuad M Baroody; Jonathan A Bernstein; Timothy J Craig; Chitra Dinakar; Anne K Ellis; Ira Finegold; David B K Golden; Matthew J Greenhawt; John B Hagan; Caroline C Horner; David A Khan; David M Lang; Desiree E S Larenas-Linnemann; Jay A Lieberman; Eli O Meltzer; John J Oppenheimer; Matthew A Rank; Marcus S Shaker; Jeffrey L Shaw; Gary C Steven; David R Stukus; Julie Wang; Mark S Dykewicz; Dana V Wallace; Chitra Dinakar; Anne K Ellis; David B K Golden; Matthew J Greenhawt; Caroline C Horner; David A Khan; David M Lang; Jay A Lieberman; John J Oppenheimer; Matthew A Rank; Marcus S Shaker; David R Stukus; Julie Wang; Mark S Dykewicz; Dana V Wallace; David J Amrol; Fuad M Baroody; Jonathan A Bernstein; Timothy J Craig; Ira Finegold; John B Hagan; Desiree E S Larenas-Linnemann; Eli O Meltzer; Jeffrey L Shaw; Gary C Steven Journal: J Allergy Clin Immunol Date: 2020-07-22 Impact factor: 10.793
Authors: G Settipane; P E Korenblat; J Winder; W Lumry; J Murphree; V B Alderfer; B Simpson; J A Smith Journal: Clin Ther Date: 1995 Mar-Apr Impact factor: 3.393
Authors: Alexander V Karaulov; Natalia Nenasheva; Yury Smolkin; Aleksandr Maslakov; Luiz Lucio Journal: Int Arch Allergy Immunol Date: 2021-09-06 Impact factor: 2.749