TY - JOUR
T1 - Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy
AU - Kaplan, Allen P
AU - Ledford, Dennis
AU - Ashby, Mark
AU - Canvin, Janice
AU - Zazzali, James L
AU - Conner, Edward
AU - Veith, Joachim
AU - Kamath, Nikhil
AU - Staubach, Petra
AU - Jakob, Thilo
AU - Stirling, Robert G
AU - Kuna, Piotr
AU - Berger, William E
AU - Maurer, Marcus
AU - Rosen, Karin
PY - 2013
Y1 - 2013
N2 - Background: Patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) often continue to experience symptoms despite receiving standard-of-care therapy with H1-antihistamines along with 1 or more add-on therapies. Objectives: We sought to evaluate the safety and efficacy of 24 weeks of treatment with omalizumab in patients with persistent CIU/CSU despite treatment with H1-antihistamines at up to 4 times the approved dose plus H2-antihistamines, leukotriene receptor antagonists, or both. Methods: In this phase III study patients were randomized to receive 6 subcutaneous injections at 4-week intervals of either 300 mg of omalizumab or placebo, followed by a 16-week observation period. The primary objective of the study was to evaluate the overall safety of omalizumab compared with placebo. Efficacy (itch severity, hive, and urticaria activity scores) was evaluated at weeks 12 and 24. Results: The overall incidence and severity of adverse events and serious adverse events were similar between omalizumab and placebo recipients; the safety profile was consistent with omalizumab in patients with allergic asthma. At week 12, the mean change from baseline in weekly itch severity score was 28.6 (95 CI, 29.3 to 27.8) in the omalizumab group compared with 24.0 (95 CI, 25.3 to 22.7) in the placebo group (P
AB - Background: Patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) often continue to experience symptoms despite receiving standard-of-care therapy with H1-antihistamines along with 1 or more add-on therapies. Objectives: We sought to evaluate the safety and efficacy of 24 weeks of treatment with omalizumab in patients with persistent CIU/CSU despite treatment with H1-antihistamines at up to 4 times the approved dose plus H2-antihistamines, leukotriene receptor antagonists, or both. Methods: In this phase III study patients were randomized to receive 6 subcutaneous injections at 4-week intervals of either 300 mg of omalizumab or placebo, followed by a 16-week observation period. The primary objective of the study was to evaluate the overall safety of omalizumab compared with placebo. Efficacy (itch severity, hive, and urticaria activity scores) was evaluated at weeks 12 and 24. Results: The overall incidence and severity of adverse events and serious adverse events were similar between omalizumab and placebo recipients; the safety profile was consistent with omalizumab in patients with allergic asthma. At week 12, the mean change from baseline in weekly itch severity score was 28.6 (95 CI, 29.3 to 27.8) in the omalizumab group compared with 24.0 (95 CI, 25.3 to 22.7) in the placebo group (P
UR - http://www.ncbi.nlm.nih.gov/pubmed/23810097
U2 - 10.1016/j.jaci.2013.05.013
DO - 10.1016/j.jaci.2013.05.013
M3 - Article
SN - 0091-6749
VL - 132
SP - 101
EP - 109
JO - The Journal of Allergy and Clinical Immunology
JF - The Journal of Allergy and Clinical Immunology
IS - 1
ER -