BACKGROUND: Many children with asthma continue to experience symptoms despite available therapies. OBJECTIVE: This study evaluated the efficacy and safety of omalizumab, a humanized anti-IgE mAb, in children with moderate-to-severe persistent allergic (IgE-mediated) asthma that was inadequately controlled despite treatment with medium-dose or high-dose inhaled corticosteroids (ICSs) with or without other controller medications. METHODS: A randomized, double-blind, placebo-controlled trial enrolled children age 6 to <12 years with perennial allergen sensitivity and history of exacerbations and asthma symptoms despite at least medium-dose ICSs. Patients were randomized 2:1 to receive omalizumab (75-375 mg sc, q2 or q4 wk) or placebo over a period of 52 weeks (24-week fixed-steroid phase followed by a 28-week adjustable-steroid phase). RESULTS: A total of 627 patients (omalizumab, n = 421; placebo, n = 206) were randomized, with efficacy analyzed in 576 (omalizumab, n = 384; placebo, n = 192). Over the 24-week fixed-steroid phase, omalizumab reduced the rate of clinically significant asthma exacerbations (worsening symptoms requiring doubling of baseline ICS dose and/or systemic steroids) by 31% versus placebo (0.45 vs 0.64; rate ratio, 0.69; P = .007). Over a period of 52 weeks, the exacerbation rate was reduced by 43% versus placebo (P < .001). Omalizumab significantly reduced severe exacerbations. Over a period of 52 weeks, omalizumab had an acceptable safety profile, with no difference in overall incidence of adverse events compared with placebo. CONCLUSION: Add-on omalizumab is effective and well tolerated as maintenance therapy in children (6 to <12 years) with moderate-to-severe persistent allergic (IgE-mediated) asthma whose symptoms are inadequately controlled despite medium to high doses of ICSs.
RCT Entities:
BACKGROUND: Many children with asthma continue to experience symptoms despite available therapies. OBJECTIVE: This study evaluated the efficacy and safety of omalizumab, a humanized anti-IgE mAb, in children with moderate-to-severe persistent allergic (IgE-mediated) asthma that was inadequately controlled despite treatment with medium-dose or high-dose inhaled corticosteroids (ICSs) with or without other controller medications. METHODS: A randomized, double-blind, placebo-controlled trial enrolled children age 6 to <12 years with perennial allergen sensitivity and history of exacerbations and asthma symptoms despite at least medium-dose ICSs. Patients were randomized 2:1 to receive omalizumab (75-375 mg sc, q2 or q4 wk) or placebo over a period of 52 weeks (24-week fixed-steroid phase followed by a 28-week adjustable-steroid phase). RESULTS: A total of 627 patients (omalizumab, n = 421; placebo, n = 206) were randomized, with efficacy analyzed in 576 (omalizumab, n = 384; placebo, n = 192). Over the 24-week fixed-steroid phase, omalizumab reduced the rate of clinically significant asthma exacerbations (worsening symptoms requiring doubling of baseline ICS dose and/or systemic steroids) by 31% versus placebo (0.45 vs 0.64; rate ratio, 0.69; P = .007). Over a period of 52 weeks, the exacerbation rate was reduced by 43% versus placebo (P < .001). Omalizumab significantly reduced severe exacerbations. Over a period of 52 weeks, omalizumab had an acceptable safety profile, with no difference in overall incidence of adverse events compared with placebo. CONCLUSION: Add-on omalizumab is effective and well tolerated as maintenance therapy in children (6 to <12 years) with moderate-to-severe persistent allergic (IgE-mediated) asthma whose symptoms are inadequately controlled despite medium to high doses of ICSs.
Authors: Daniel A Kelmenson; Vanessa J Kelly; Tilo Winkler; Mamary T Kone; Guido Musch; Marcos F Vidal Melo; Jose G Venegas; R Scott Harris Journal: Am J Nucl Med Mol Imaging Date: 2013-07-10
Authors: Christine A Sorkness; Jeremy J Wildfire; Agustin Calatroni; Herman E Mitchell; William W Busse; George T O'Connor; Jacqueline A Pongracic; Kristie Ross; Michelle A Gill; Meyer Kattan; Wayne J Morgan; Stephen J Teach; Peter J Gergen; Andrew H Liu; Stanley J Szefler Journal: J Allergy Clin Immunol Pract Date: 2013-02-26
Authors: Mohamed S Al-Moamary; Sami A Alhaider; Abdullah A Alangari; Mohammed O Al Ghobain; Mohammed O Zeitouni; Majdy M Idrees; Abdullah F Alanazi; Adel S Al-Harbi; Abdullah A Yousef; Hassan S Alorainy; Mohamed S Al-Hajjaj Journal: Ann Thorac Med Date: 2019 Jan-Mar Impact factor: 2.219
Authors: Maria Pino-Yanes; Christopher R Gignoux; Joshua M Galanter; Albert M Levin; Catarina D Campbell; Celeste Eng; Scott Huntsman; Katherine K Nishimura; Pierre-Antoine Gourraud; Kiana Mohajeri; Brian J O'Roak; Donglei Hu; Rasika A Mathias; Elizabeth A Nguyen; Lindsey A Roth; Badri Padhukasahasram; Andres Moreno-Estrada; Karla Sandoval; Cheryl A Winkler; Fred Lurmann; Adam Davis; Harold J Farber; Kelley Meade; Pedro C Avila; Denise Serebrisky; Rocio Chapela; Jean G Ford; Michael A Lenoir; Shannon M Thyne; Emerita Brigino-Buenaventura; Luisa N Borrell; William Rodriguez-Cintron; Saunak Sen; Rajesh Kumar; Jose R Rodriguez-Santana; Carlos D Bustamante; Fernando D Martinez; Benjamin A Raby; Scott T Weiss; Dan L Nicolae; Carole Ober; Deborah A Meyers; Eugene R Bleecker; Steven J Mack; Ryan D Hernandez; Evan E Eichler; Kathleen C Barnes; L Keoki Williams; Dara G Torgerson; Esteban G Burchard Journal: J Allergy Clin Immunol Date: 2014-12-06 Impact factor: 10.793