TY - JOUR
T1 - Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on h 1 antihistamines
T2 - A randomized, placebo-controlled study
AU - Saini, Sarbjit S.
AU - Bindslev-Jensen, Carsten
AU - Maurer, Marcus
AU - Grob, Jean Jacques
AU - Bülbül Baskan, Emel
AU - Bradley, Mary S.
AU - Canvin, Janice
AU - Rahmaoui, Abdelkader
AU - Georgiou, Panayiotis
AU - Alpan, Oral
AU - Spector, Sheldon
AU - Rosén, Karin
N1 - Funding Information:
The ASTERIA I study was funded by Genentech, Inc., South San Francisco, CA, and Novartis Pharma AG, Basel, Switzerland. Medical writing support for this manuscript was provided by Alison Gagnon of Excel Scientific Solutions and funded by Genentech, Inc., and Novartis Pharma AG. The trial was registered with ClinicalTrials.gov, number NCT01287117. This project was funded by Genentech, Inc. and Novartis Pharma AG. ASTERIA I Investigators: Denmark: Carsten Bindslev-Jensen, Tonny Karlsmark; France: Jean-Jacques Grob, Ziad Reguiai, Alain Taieb; Germany: Randolf Brehler, Thomas Hoelting, Marcus Maurer, Franziska Rueff, Knutt Schaekel; Italy: Adriano Mari; Poland: Piotr Kuna, Krystyna Obtulowicz, Ewa Trebas-Pietras, Jolanta Weglowska; Spain: Ana Maria Gimenez Arnau, Esther Serra Baldrich; Turkey: Emel Bülbül Baskan; US: Oral Alpan, Robert Chrzanowski, Pramila Daftary, Daniel Ein, Sandra M. Gawchik, Pinkus Goldberg, Alan Goldsobel, Michael Kaplan, Alan Kaufman, Adina Knight, Phillip E. Korenblat, Bobby Lanier, Miguel Lanz, Fu-Tong Liu, Patricia Lugar, Michael Marcus, Donald McNeil, Isaac Melamed, Steven Meltzer, Anthony Montanaro, Mark Moss, Thomas Murphy, Andrew Pedinoff, Syed Rehman, David Riester, Ronald Saff, Sarbjit Saini, Joseph Shapiro, Dareen Siri, David Skoner, Ricardo Tan, Kay Walker, Steven M. Weinstein, Hugh Windom.
Publisher Copyright:
© 2015 The Society for Investigative Dermatology.
PY - 2015/1/1
Y1 - 2015/1/1
N2 - ASTERIA I was a 40-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous omalizumab as add-on therapy for 24 weeks in patients with chronic idiopathic urticaria/spontaneous urticaria (CIU/CSU) who remained symptomatic despite H 1 antihistamine treatment at licensed doses. Patients aged 12-75 years with CIU/CSU who remained symptomatic despite treatment with approved doses of H 1 antihistamines were randomized (1:1:1:1) in a double-blind manner to subcutaneous omalizumab 75 mg, 150 mg, or 300 mg or placebo every 4 weeks for 24 weeks followed by 16 weeks of follow-up. The primary end point was change from baseline in weekly itch severity score (ISS) at week 12. Among randomized patients (N=319: placebo n=80, omalizumab 75 mg n=78, 150 mg n=80, 300 mg n=81), 262 (82.1%) completed the study. Compared with placebo (n=80), mean weekly ISS was reduced from baseline to week 12 by an additional 2.96 points (95% confidence interval (CI): -4.71 to -1.21; P=0.0010), 2.95 points (95% CI: -4.72 to -1.18; P=0.0012), and 5.80 points (95% CI: -7.49 to -4.10; P<0.0001) in the omalizumab 75-mg (n=77), 150-mg (n=80), and 300-mg groups (n=81), respectively. The omalizumab 300-mg group met all nine secondary end points, including a significant decrease in the duration of time to reach minimally important difference response (≥5-point decrease) in weekly ISS (P<0.0001) and higher percentages of patients with well-controlled symptoms (urticaria activity score over 7 days (UAS7) ≤6: 51.9% vs. 11.3%; P<0.0001) and complete response (UAS7=0: 35.8% vs. 8.8%; P<0.0001) versus placebo. During the 24-week treatment period, 2 (2.9%), 3 (3.4%), 0, and 4 (5.0%) patients in the omalizumab 75-mg, 150-mg, 300-mg, and placebo groups, respectively, experienced a serious adverse event. Omalizumab 300 mg administered subcutaneously every 4 weeks reduced weekly ISS and other symptom scores versus placebo in CIU/CSU patients who remained symptomatic despite treatment with approved doses of H 1 antihistamines.
AB - ASTERIA I was a 40-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous omalizumab as add-on therapy for 24 weeks in patients with chronic idiopathic urticaria/spontaneous urticaria (CIU/CSU) who remained symptomatic despite H 1 antihistamine treatment at licensed doses. Patients aged 12-75 years with CIU/CSU who remained symptomatic despite treatment with approved doses of H 1 antihistamines were randomized (1:1:1:1) in a double-blind manner to subcutaneous omalizumab 75 mg, 150 mg, or 300 mg or placebo every 4 weeks for 24 weeks followed by 16 weeks of follow-up. The primary end point was change from baseline in weekly itch severity score (ISS) at week 12. Among randomized patients (N=319: placebo n=80, omalizumab 75 mg n=78, 150 mg n=80, 300 mg n=81), 262 (82.1%) completed the study. Compared with placebo (n=80), mean weekly ISS was reduced from baseline to week 12 by an additional 2.96 points (95% confidence interval (CI): -4.71 to -1.21; P=0.0010), 2.95 points (95% CI: -4.72 to -1.18; P=0.0012), and 5.80 points (95% CI: -7.49 to -4.10; P<0.0001) in the omalizumab 75-mg (n=77), 150-mg (n=80), and 300-mg groups (n=81), respectively. The omalizumab 300-mg group met all nine secondary end points, including a significant decrease in the duration of time to reach minimally important difference response (≥5-point decrease) in weekly ISS (P<0.0001) and higher percentages of patients with well-controlled symptoms (urticaria activity score over 7 days (UAS7) ≤6: 51.9% vs. 11.3%; P<0.0001) and complete response (UAS7=0: 35.8% vs. 8.8%; P<0.0001) versus placebo. During the 24-week treatment period, 2 (2.9%), 3 (3.4%), 0, and 4 (5.0%) patients in the omalizumab 75-mg, 150-mg, 300-mg, and placebo groups, respectively, experienced a serious adverse event. Omalizumab 300 mg administered subcutaneously every 4 weeks reduced weekly ISS and other symptom scores versus placebo in CIU/CSU patients who remained symptomatic despite treatment with approved doses of H 1 antihistamines.
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U2 - 10.1038/jid.2014.306
DO - 10.1038/jid.2014.306
M3 - Article
C2 - 25046337
AN - SCOPUS:84925876197
SN - 0022-202X
VL - 135
SP - 67
EP - 75
JO - Journal of Investigative Dermatology
JF - Journal of Investigative Dermatology
IS - 1
ER -