AT ATS 2015

DENVER (FRONTLINE MEDICAL NEWS) – The rate of asthma exacerbations was reduced more among elderly patients than among younger patients treated with mepolizumab vs. placebo as part of the Mepolizumab as Adjunctive Therapy in Patients with Severe Asthma ( MENSA ) trial, according to a post hoc analysis of the trial data.

The analysis also demonstrated that mepolizumab improved quality of life, compared with standard care, in both older and younger patients, although little differentiation was seen with respect to asthma control, Dr. Hector Ortega reported in a poster at an international conference of the American Thoracic Society.

A 76% greater reduction in clinically significant exacerbations was seen in 54 mepolizumab-treated patients aged 65 years and older in the trial, compared with 26 in that age group who received placebo (mean exacerbation rate per year, 0.92 vs. 1.65); a 44% greater reduction was seen in 331 mepolizumab-treated patients under age 65 years, compared with 165 in that age group who received placebo (mean exacerbation rate per year, 0.42 vs. 1.78), said Dr. Ortega, medical director at GlaxoSmithKline, Research Triangle Park, N.C.

The adjusted mean difference vs. placebo in change in St. George’s Respiratory Questionnaire scores from baseline to 32 weeks was -4.5 in the older patients, and -7.3 in the younger patients, and the adjusted mean difference vs. placebo in change in Asthma Control Questionnaire scores from baseline to 32 weeks was -0.1 and -0.5 in the older and younger patients, respectively, he noted.

The older patients, as expected, suffered more frequently from comorbidities, and this may have been accentuated by the chronic use of inhaled and oral corticosteroids in the older patients.

However, comorbidities had no impact on the response to treatment, and the safety profile of mepolizumab was similar to placebo in both age groups, he said.

Patients in the multicenter, randomized, placebo-controlled MENSA trial received high dose inhaled corticosteroids plus at least one additional controller, had a history of frequent exacerbations and a predefined eosinophilic threshold, and were randomized to receive add-on therapy with either 75 mg of intravenous mepolizumab, 100 mg subcutaneous mepolizumab, or corresponding placebo every 4 weeks for 32 weeks. In the primary planned analysis, the responses to the two doses of mepolizumab were similar, but efficacy in older patients had not been previously reported.

The MENSA trial and post hoc analysis were funded by GSK. Dr. Ortega is employed by GSK.

sworcester@frontlinemedcom.com

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