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Başlık: Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on h 1 antihistamines: A randomized, placebo-controlled study
Yazarlar: Saini, Sarbjit S.
Bindslev, Carsten Jensen
Maurer, Marcus
Grob, Jean Jacques
Bradley, Mary S.
Canvin, Janice
Rahmaoui, Abdelkader
Georgiou, Panayiotis
Alpan, Oral
Spector, Sheldon
Rosén, Karin
Uludağ Üniversitesi/Tıp Fakültesi/Dermatoloji Anabilim Dalı.
0000-0002-0144-3263
Başkan, Emel Bülbül
AAH-1388-2021
6602518817
Anahtar kelimeler: Chronic idiopathic urticaria
Anti-ige omalizumab
Diagnosis
Therapy
Dermatology
Yayın Tarihi: Oca-2015
Yayıncı: Elsevier Science
Atıf: Saini, S. S. vd. (2015). "Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on h 1 antihistamines: A randomized, placebo-controlled study". Journal of Investigative Dermatology, 135(1), 67-75.
Özet: 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 (Cl): -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% Cl: -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.
URI: https://doi.org/10.1038/jid.2014.306
https://www.sciencedirect.com/science/article/pii/S0022202X15370652
http://hdl.handle.net/11452/26392
ISSN: 0022-202X
Koleksiyonlarda Görünür:Scopus
Web of Science

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