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"In this group of patients with eosinophilic inflammation, we see an important benefit in reduction of exacerbations and important clinical endpoints like quality of life and asthma control," said Dr. Ortega.
In the SIRIUS study, researchers looked at the effect of mepolizumab on 135 patients with severe eosinophilic asthma who used oral glucocorticoids.
Mepolizumab performed very well, according to presenter Elisabeth Bel, MD, from the University of Amsterdam in the Netherlands. "Patients are amazingly happy with the drug; they can stop prednisone, and they say, 'my asthma is gone,'" Dr. Bel told Medscape Medical News.
SIRIUS
Patients received a 100-mg dose of mepolizumab or a placebo subcutaneously every 4 weeks for 20 weeks.
The results showed significant decreases in oral glucocorticoid steroid dependence in the mepolizumab group compared with placebo (odds ratio, 2.39; 95% confidence interval, 1.25 - 4.56; P = .008). The median percentage reduction from baseline in the glucocorticoid dose was 50% in the mepolizumab group compared with no reduction in the placebo group (P = .007).
Table 2. Reduction in Glucocorticoid Use With Mepolizumab
Reduction at 20 to 24 Weeks (%) Placebo (n = 66) (%) Mepolizumab (n = 69) (%)
90-100 11 23
75-90 8 17
50-75 15 13
0-50 11 10
No reduction or trial withdrawal 56 36
In an accompanying editorial, Parameswaran Nair, MD, writes, "The studies illustrate two new clinical observations that have important practical applications. First, the subcutaneous administration of a lower dose of the drug (100 mg) than was previously reported was shown to be efficacious. Second, characterization of the eosinophilic phenotype on the basis of a blood eosinophil count of more than 300 cells per microliter despite concurrent treatment with high doses of glucocorticoids was sufficient to select patients who were likely to have a response to this therapy."
The population of patients taking oral steroids for severe asthma is quite small, but "for them, mepolizumab is a huge advance because they're less likely to get side effects," said Peter Barnes, MD, head of respiratory medicine at Imperial College, London, United Kingdom.
"I'm a true believer," said Gertrude Mller, MD, pulmonologist and immunologist at Wilhelmina Hospital in Utrecht, the Netherlands. "It's one of the promising anti-eosinophilic drug treatments in eosinophilic asthmatics," she told Medscape Medical News.
This study was funded by GlaxoSmithKline. Dr. Ortega is an employee of GlaxoSmithKline. Dr. Bel has received grants and personal fees from GlaxoSmithKline, grant support from Chiesi, grant support and personal fees from Novartis, and personal fees from Regeneron/Sanofi and CIPLA. Dr. Mller has been on an advisory board for Novartis. Dr. Barnes conducted an early study of mepolizumab that was funded by GlaxoSmithKline.
European Respiratory Society (ERS) International Congress 2014. Abstracts 2906 and 2907. Presented September 8, 2014.
N Engl J Med. Published online September 8, 2014. MENSA abstract SIRIUS abstract Editorial
In the SIRIUS study, researchers looked at the effect of mepolizumab on 135 patients with severe eosinophilic asthma who used oral glucocorticoids.
Mepolizumab performed very well, according to presenter Elisabeth Bel, MD, from the University of Amsterdam in the Netherlands. "Patients are amazingly happy with the drug; they can stop prednisone, and they say, 'my asthma is gone,'" Dr. Bel told Medscape Medical News.
SIRIUS
Patients received a 100-mg dose of mepolizumab or a placebo subcutaneously every 4 weeks for 20 weeks.
The results showed significant decreases in oral glucocorticoid steroid dependence in the mepolizumab group compared with placebo (odds ratio, 2.39; 95% confidence interval, 1.25 - 4.56; P = .008). The median percentage reduction from baseline in the glucocorticoid dose was 50% in the mepolizumab group compared with no reduction in the placebo group (P = .007).
Table 2. Reduction in Glucocorticoid Use With Mepolizumab
Reduction at 20 to 24 Weeks (%) Placebo (n = 66) (%) Mepolizumab (n = 69) (%)
90-100 11 23
75-90 8 17
50-75 15 13
0-50 11 10
No reduction or trial withdrawal 56 36
In an accompanying editorial, Parameswaran Nair, MD, writes, "The studies illustrate two new clinical observations that have important practical applications. First, the subcutaneous administration of a lower dose of the drug (100 mg) than was previously reported was shown to be efficacious. Second, characterization of the eosinophilic phenotype on the basis of a blood eosinophil count of more than 300 cells per microliter despite concurrent treatment with high doses of glucocorticoids was sufficient to select patients who were likely to have a response to this therapy."
The population of patients taking oral steroids for severe asthma is quite small, but "for them, mepolizumab is a huge advance because they're less likely to get side effects," said Peter Barnes, MD, head of respiratory medicine at Imperial College, London, United Kingdom.
"I'm a true believer," said Gertrude Mller, MD, pulmonologist and immunologist at Wilhelmina Hospital in Utrecht, the Netherlands. "It's one of the promising anti-eosinophilic drug treatments in eosinophilic asthmatics," she told Medscape Medical News.
This study was funded by GlaxoSmithKline. Dr. Ortega is an employee of GlaxoSmithKline. Dr. Bel has received grants and personal fees from GlaxoSmithKline, grant support from Chiesi, grant support and personal fees from Novartis, and personal fees from Regeneron/Sanofi and CIPLA. Dr. Mller has been on an advisory board for Novartis. Dr. Barnes conducted an early study of mepolizumab that was funded by GlaxoSmithKline.
European Respiratory Society (ERS) International Congress 2014. Abstracts 2906 and 2907. Presented September 8, 2014.
N Engl J Med. Published online September 8, 2014. MENSA abstract SIRIUS abstract Editorial
I hope im on the real thing n not the placebo lol.
yay for those of us that can't take steriods.
bless you peter for participating in this study, you give me hope!!
This article is 4 years old but helped me understand. So Gwapo, I have a question. Is your eosiniphilia part of your COPD or in addition to?
Thanks for being part of a trial. That's awesome. I hope you're getting the real thing too. Do you feel better?
That would be the first sign. I'm glad you got to take part in this triial.
All the symptoms asthma sufferers have are a big part of my COPD esp. the allergy n mucous bit.
The only thing left is a lung transplant as im past the LVRS option, so its basically maintenance at this stage and hopefully the coils....
take care....Peter