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Reslizumab High-Responder and Super-Responder Asthma Patients
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A1375 - Reslizumab High-Responder and Super-Responder Asthma Patients
Author Block: M. Wechsler1, M. McDonald2, M. C. Garin2; 1National Jewish Health, Denver, CO, United States, 2Teva Pharmaceuticals, Malvern, PA, United States.
Rationale: Reslizumab (RES) is an anti-interleukin-5 monoclonal antibody that reduced asthma exacerbations, and improved lung function and asthma control in uncontrolled eosinophilic asthma (Castro et al., Lancet Respir Med. 2015). This post-hoc analysis assessed the proportion of RES patients who reached three levels of treatment response. Methods: Data were pooled from two 52-week Phase 3 trials in asthma patients aged 12-75 years, with a screening blood eosinophil count ≥400/µL, ≥1 clinical asthma exacerbation (CAE) in the prior year, and baseline ACQ-6 score of ≥1.5, on at least a medium dose ICS ± another controller, treated with either intravenous RES (3.0mg/kg Q4W) or placebo (PBO). Patients were characterized as non-responder (NR), moderate-responder (MR), high-responder (HR) or super-responder (SR) based on meeting 0, 1, 2, or 3 of the following at week 52: ≥10% FEV1 improvement or ≥5% percent predicted FEV1 improvement, no CAE during the 52 weeks of study, or >1.5 improvement (reduction) of ACQ-6. Results: Of the 477 and 476 patients who received RES and PBO, 87% vs 73% were responders: 168 vs 183 were MR (35% vs 38%), 165 vs 117 were HR (35% vs 25%), and 80 vs 48 were SR (17% vs 10%). Overall 53% vs 42% met the lung function criterion, 68% vs 50% met the CAE criterion, and 33% vs 26% met the ACQ-6 criterion. The RES HR group was made up of 62% lung function/CAE, 16% lung function/ACQ, and 22% CAE/ACQ. In the PBO group, SR compared to NR tended to have younger age; no history of nasal polyps (NP); and higher baseline ACQ-6, with no significant differences in BMI; age of asthma onset; gender; baseline lung function; or baseline medications. In the RES group, SR compared to NR tended to have lower BMI; history of NP; later age of asthma onset, and higher baseline ACQ-6, with no significant differences in age; gender; baseline lung function; or baseline medications. Conclusion: RES treatment resulted in a high efficacy response rate compared to PBO, with 87% responders and, of those, 17% meeting the criteria for “super-responder.” Notably the RES super-responders had a higher proportion of patients with NP and had a later mean age of asthma onset compared to RES non-responders.
Author Block: M. Wechsler1, M. McDonald2, M. C. Garin2; 1National Jewish Health, Denver, CO, United States, 2Teva Pharmaceuticals, Malvern, PA, United States.
Rationale: Reslizumab (RES) is an anti-interleukin-5 monoclonal antibody that reduced asthma exacerbations, and improved lung function and asthma control in uncontrolled eosinophilic asthma (Castro et al., Lancet Respir Med. 2015). This post-hoc analysis assessed the proportion of RES patients who reached three levels of treatment response. Methods: Data were pooled from two 52-week Phase 3 trials in asthma patients aged 12-75 years, with a screening blood eosinophil count ≥400/µL, ≥1 clinical asthma exacerbation (CAE) in the prior year, and baseline ACQ-6 score of ≥1.5, on at least a medium dose ICS ± another controller, treated with either intravenous RES (3.0mg/kg Q4W) or placebo (PBO). Patients were characterized as non-responder (NR), moderate-responder (MR), high-responder (HR) or super-responder (SR) based on meeting 0, 1, 2, or 3 of the following at week 52: ≥10% FEV1 improvement or ≥5% percent predicted FEV1 improvement, no CAE during the 52 weeks of study, or >1.5 improvement (reduction) of ACQ-6. Results: Of the 477 and 476 patients who received RES and PBO, 87% vs 73% were responders: 168 vs 183 were MR (35% vs 38%), 165 vs 117 were HR (35% vs 25%), and 80 vs 48 were SR (17% vs 10%). Overall 53% vs 42% met the lung function criterion, 68% vs 50% met the CAE criterion, and 33% vs 26% met the ACQ-6 criterion. The RES HR group was made up of 62% lung function/CAE, 16% lung function/ACQ, and 22% CAE/ACQ. In the PBO group, SR compared to NR tended to have younger age; no history of nasal polyps (NP); and higher baseline ACQ-6, with no significant differences in BMI; age of asthma onset; gender; baseline lung function; or baseline medications. In the RES group, SR compared to NR tended to have lower BMI; history of NP; later age of asthma onset, and higher baseline ACQ-6, with no significant differences in age; gender; baseline lung function; or baseline medications. Conclusion: RES treatment resulted in a high efficacy response rate compared to PBO, with 87% responders and, of those, 17% meeting the criteria for “super-responder.” Notably the RES super-responders had a higher proportion of patients with NP and had a later mean age of asthma onset compared to RES non-responders.
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