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ORLANDO – Switching to mepolizumab resulted in a clinically significant benefit and a reduction in exacerbations for patients with severe eosinophilic asthma, according to late-breaking research presented at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.
Frank C. Albers, MD, PhD, of GlaxoSmithKline in Chapel Hill, N.C., and his colleagues examined safety and efficacy outcomes for 145 patients aged 12 years or older with severe eosinophilic asthma (SEA) that was not well-controlled with omalizumab.
“You see similar research in oncology where, if a patient doesn’t respond, you want to try a switch,” Dr. Albers said in an interview. “The key is deciphering which patients would benefit from a switch.”
The researchers discontinued omalizumab at baseline and treated patients with 100 mg of mepolizumab every 4 weeks for 28 weeks and observed patients for 4 more weeks following last treatment. They examined Asthma Control Questionnaire-5 and St. George’s Respiratory Questionnaire results. In a secondary analysis, the researchers also compared their results with placebo-arm data from previously published research.
At 32 weeks, the least squares mean ACQ-5 score changed by -1.45 (+/- 0.107) points and the SGRQ scores changed by -19.0 (+/- 1.64) points.
“But you also see that the improvement seems steady.”
At 4 weeks, 57% of patients experienced a minimum clinically important difference in ACQ-5 score and at 12 weeks, 69% of patients experienced a minimum clinically important difference in SGRQ response. At 32 weeks, minimum clinically important difference ACQ-5 and SGRQ scores were reported for 77% and 79% of patients, respectively.
Dr. Albers and his colleagues also analyzed how these results might look in a randomized phase 3 setting by comparing their results to previously reported data from the MENSA (mepolizumab treatment in patients with severe eosinophilic asthma) and epolizumab for severe eosinophilic asthma) DREAM studies. They reported that compared with the previously reported placebo cohorts, patients who switched to mepolizumab experienced an ACQ-5 score improvement of -0.90 (P less than 0.001).
The researchers presented safety results in an accompanying poster and reported a 65% (P less than 0.001) reduction in the rate of clinically significant exacerbations for patients with SAE who switched to mepolizumab. They also reported a 69% (P less than 0.001) reduction in exacerbations that required ED visits and/or hospitalizations.
“This study provides practical reassurance to clinicians considering substituting one biologic for another in the treatment of patients with SEA,” the researchers concluded.
This research was funded by GlaxoSmithKline, the makers of mepolizumab.
SOURCE: Albers FC et al. AAAAI/WAO Joint Congress, Posters L29 and L30.
http://www.jacionline.org/article/S0091-6749(17)32864-6/abstract
ORLANDO – Switching to mepolizumab resulted in a clinically significant benefit and a reduction in exacerbations for patients with severe eosinophilic asthma, according to late-breaking research presented at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.
Frank C. Albers, MD, PhD, of GlaxoSmithKline in Chapel Hill, N.C., and his colleagues examined safety and efficacy outcomes for 145 patients aged 12 years or older with severe eosinophilic asthma (SEA) that was not well-controlled with omalizumab.
“You see similar research in oncology where, if a patient doesn’t respond, you want to try a switch,” Dr. Albers said in an interview. “The key is deciphering which patients would benefit from a switch.”
The researchers discontinued omalizumab at baseline and treated patients with 100 mg of mepolizumab every 4 weeks for 28 weeks and observed patients for 4 more weeks following last treatment. They examined Asthma Control Questionnaire-5 and St. George’s Respiratory Questionnaire results. In a secondary analysis, the researchers also compared their results with placebo-arm data from previously published research.
At 32 weeks, the least squares mean ACQ-5 score changed by -1.45 (+/- 0.107) points and the SGRQ scores changed by -19.0 (+/- 1.64) points.
“But you also see that the improvement seems steady.”
At 4 weeks, 57% of patients experienced a minimum clinically important difference in ACQ-5 score and at 12 weeks, 69% of patients experienced a minimum clinically important difference in SGRQ response. At 32 weeks, minimum clinically important difference ACQ-5 and SGRQ scores were reported for 77% and 79% of patients, respectively.
Dr. Albers and his colleagues also analyzed how these results might look in a randomized phase 3 setting by comparing their results to previously reported data from the MENSA (mepolizumab treatment in patients with severe eosinophilic asthma) and epolizumab for severe eosinophilic asthma) DREAM studies. They reported that compared with the previously reported placebo cohorts, patients who switched to mepolizumab experienced an ACQ-5 score improvement of -0.90 (P less than 0.001).
The researchers presented safety results in an accompanying poster and reported a 65% (P less than 0.001) reduction in the rate of clinically significant exacerbations for patients with SAE who switched to mepolizumab. They also reported a 69% (P less than 0.001) reduction in exacerbations that required ED visits and/or hospitalizations.
“This study provides practical reassurance to clinicians considering substituting one biologic for another in the treatment of patients with SEA,” the researchers concluded.
This research was funded by GlaxoSmithKline, the makers of mepolizumab.
SOURCE: Albers FC et al. AAAAI/WAO Joint Congress, Posters L29 and L30.
http://www.jacionline.org/article/S0091-6749(17)32864-6/abstract
ORLANDO – Switching to mepolizumab resulted in a clinically significant benefit and a reduction in exacerbations for patients with severe eosinophilic asthma, according to late-breaking research presented at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.
Frank C. Albers, MD, PhD, of GlaxoSmithKline in Chapel Hill, N.C., and his colleagues examined safety and efficacy outcomes for 145 patients aged 12 years or older with severe eosinophilic asthma (SEA) that was not well-controlled with omalizumab.
“You see similar research in oncology where, if a patient doesn’t respond, you want to try a switch,” Dr. Albers said in an interview. “The key is deciphering which patients would benefit from a switch.”
The researchers discontinued omalizumab at baseline and treated patients with 100 mg of mepolizumab every 4 weeks for 28 weeks and observed patients for 4 more weeks following last treatment. They examined Asthma Control Questionnaire-5 and St. George’s Respiratory Questionnaire results. In a secondary analysis, the researchers also compared their results with placebo-arm data from previously published research.
At 32 weeks, the least squares mean ACQ-5 score changed by -1.45 (+/- 0.107) points and the SGRQ scores changed by -19.0 (+/- 1.64) points.
“But you also see that the improvement seems steady.”
At 4 weeks, 57% of patients experienced a minimum clinically important difference in ACQ-5 score and at 12 weeks, 69% of patients experienced a minimum clinically important difference in SGRQ response. At 32 weeks, minimum clinically important difference ACQ-5 and SGRQ scores were reported for 77% and 79% of patients, respectively.
Dr. Albers and his colleagues also analyzed how these results might look in a randomized phase 3 setting by comparing their results to previously reported data from the MENSA (mepolizumab treatment in patients with severe eosinophilic asthma) and epolizumab for severe eosinophilic asthma) DREAM studies. They reported that compared with the previously reported placebo cohorts, patients who switched to mepolizumab experienced an ACQ-5 score improvement of -0.90 (P less than 0.001).
The researchers presented safety results in an accompanying poster and reported a 65% (P less than 0.001) reduction in the rate of clinically significant exacerbations for patients with SAE who switched to mepolizumab. They also reported a 69% (P less than 0.001) reduction in exacerbations that required ED visits and/or hospitalizations.
“This study provides practical reassurance to clinicians considering substituting one biologic for another in the treatment of patients with SEA,” the researchers concluded.
This research was funded by GlaxoSmithKline, the makers of mepolizumab.
SOURCE: Albers FC et al. AAAAI/WAO Joint Congress, Posters L29 and L30.
http://www.jacionline.org/article/S0091-6749(17)32864-6/abstract
REPORTING FROM AAAAI/WAO JOINT CONGRESS
Key clinical point: Switching to mepolizumab was safe and effective for patients with severe eosinophilic asthma not responsive to omalizumab.
Major finding: Switching to mepolizumab was associated with a 65% (P less than 0.001) reduction in the rate of clinically significant exacerbations in patients not responding to omalizumab.
Study details: A multicenter, open-label, single-arm study.
Disclosures: The study was funded by GlaxoSmithKline. Dr. Frank C. Albers is an employee of GlaxoSmithKline.
Source: Albers FC et al. AAAAI/WAO Joint Congress, Poster L29/L30.