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Efficacy and Safety of Omalizumab in Patients with Chronic Idiopathic/Spontaneous Urticaria Who Remain Symptomatic on H1 Antihistamines: A Randomized,

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Presentation on theme: "Efficacy and Safety of Omalizumab in Patients with Chronic Idiopathic/Spontaneous Urticaria Who Remain Symptomatic on H1 Antihistamines: A Randomized,"— Presentation transcript:

1 Efficacy and Safety of Omalizumab in Patients with Chronic Idiopathic/Spontaneous Urticaria Who Remain Symptomatic on H1 Antihistamines: A Randomized, Placebo- Controlled Study  Sarbjit S. Saini, Carsten Bindslev-Jensen, Marcus Maurer, Jean-Jacques Grob, Emel Bülbül Baskan, Mary S. Bradley, Janice Canvin, Abdelkader Rahmaoui, Panayiotis Georgiou, Oral Alpan, Sheldon Spector, Karin Rosén  Journal of Investigative Dermatology  Volume 135, Issue 1, Pages (January 2015) DOI: /jid Copyright © 2015 The Society for Investigative Dermatology, Inc Terms and Conditions

2 Figure 1 Patient disposition and study. Gray arrowheads denote study drug treatment on day 1 and at weeks 4, 8, 12, 16, and 20. Black arrow indicates primary end point assessment at week 12. 1Reasons for screen failure: 14.0% of patients were unwilling to give written informed consent, adhere to the visit schedules, and meet study requirements; 10.5% of patients were not diagnosed with chronic idiopathic urticaria/spontaneous urticaria refractory to H1 antihistamines at the time of randomization; and 27.5% of patients were categorized as “Other, not defined.” 2Patient did not receive study drug as a result of not meeting all study eligibility criteria and was therefore not included in the modified intention-to-treat population. 3Defined as either the worsening of or no improvement in symptoms. 4Seven patients randomized to the omalizumab 75-mg group received at least one dose of omalizumab 150 mg during the treatment period and were included in the omalizumab 150-mg group for the safety and pharmacokinetic analyses. Journal of Investigative Dermatology  , 67-75DOI: ( /jid ) Copyright © 2015 The Society for Investigative Dermatology, Inc Terms and Conditions

3 Figure 2 Mean weekly itch severity score by study week. Error bars represent standard error of the mean. Arrows indicate study drug injection day. Analyzed on the basis of the modified intention-to-treat population with missing weekly scores imputed using baseline weekly itch severity scores. Journal of Investigative Dermatology  , 67-75DOI: ( /jid ) Copyright © 2015 The Society for Investigative Dermatology, Inc Terms and Conditions

4 Figure 3 Responder analysis. P-value versus placebo derived from the Cochran–Mantel–Haenszel χ2-test stratified by baseline UAS7 (<median, ⩾median) and baseline weight (<80 kg, ⩾80 kg). 1Not evaluated for statistical significance in accordance with the type I error control plan. UAS7, urticaria activity score over 7 days. Journal of Investigative Dermatology  , 67-75DOI: ( /jid ) Copyright © 2015 The Society for Investigative Dermatology, Inc Terms and Conditions

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