TRIAL INFORMATION
TRIAL INFORMATION
TRIAL INFORMATION
Identical 28-week, randomized, double-blind, placebo-controlled studies evaluating the number of exacerbations in a total of 1071 patients aged 12 to 76 years with moderate to severe persistent allergic asthma who were symptomatic despite ICS treatment.4,10,11
Patients received XOLAIR or placebo every 2 or 4 weeks for 16 weeks with an unchanged BDP dose unless an acute exacerbation necessitated an increase. Patients then entered a 12-week ICS-reduction phase during which ICS dose reduction was attempted in a stepwise manner.4,10
Primary endpoint: number of exacerbations.4,10
A 32-week, randomized, double-blind, placebo-controlled study designed to evaluate ICS reduction in 341 patients aged 12 to 76 years with severe allergic asthma. Exacerbation reduction was also evaluated as a secondary endpoint; however, this study was not powered to show statistical differences in exacerbation reduction.4
Exacerbation was defined as a worsening of asthma that required treatment with systemic corticosteroids or a doubling of the patient’s baseline ICS dose.4
Patients were stratified by use of ICS only or ICS with concomitant OCS. Patients received XOLAIR for 16 weeks with an unchanged corticosteroid dose unless an acute exacerbation necessitated an increase. Patients then entered a 16-week ICS-reduction phase during which ICS dose reduction was attempted in a stepwise manner.4,8
Studies 1 and 2 evaluated patients with moderate to severe persistent asthma (1997 National Heart, Lung, and Blood Institute [NHLBI] Guidelines). Patients with FEV1 ≤65% of predicted and with a mean total symptom score of >4 at baseline were defined as severe; otherwise, they were defined as moderate. Study 3 evaluated patients with severe persistent asthma.4,8
*Dosing for XOLAIR in patients aged ≥12 years is based on pretreatment serum total IgE level (≥30 to 700 IU/mL) and body weight (66 to 330 pounds).4
A 52-week multicenter, randomized, double-blind, placebo-controlled study of 628 patients aged 6 to <12 years with moderate to severe allergic asthma evaluated XOLAIR as add-on therapy to ICS with or without additional controller medications. Patients received XOLAIR or placebo every 2 or 4 weeks for 24 weeks during the fixed-steroid treatment phase. Steroid doses remained constant from baseline unless an acute exacerbation necessitated an increase. Patients then entered a 28-week period during which steroid adjustment was allowed.4,31,32
Throughout the study, both groups were allowed to use additional controller medications, including inhaled and nebulized beta2-agonists and LTRA.31
Primary measure: rate of asthma exacerbations during the 24-week period.4
Exacerbation defined as: worsening of asthma symptoms requiring doubling of baseline ICS dose for at least 3 days and/or treatment with rescue systemic corticosteroids for at least 3 days.4
ICS=inhaled corticosteroid; LTRA=leukotriene receptor antagonist.
SABA=short-acting beta2 agonist.
*Study 4 evaluated patients with moderate to severe persistent asthma (1997 NHLBI Guidelines, National Asthma Education Prevention Program 2002 update).8
Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study [published correction appears in J Invest Dermatol. 2015;135(3):925]. J Invest Dermatol. 2015;135(1):67-75.
Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study [published correction appears in J Invest Dermatol. 2015;135(3):925]. J Invest Dermatol. 2015;135(1):67-75.
Maurer M, Rosén K, Hsieh H-J, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria [published correction appears in N Engl J Med. 2013;368(24)(suppl):2340-2341]. N Engl J Med. 2013;368(10):924-935.
Maurer M, Rosén K, Hsieh H-J, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria [published correction appears in N Engl J Med. 2013;368(24)(suppl):2340-2341]. N Engl J Med. 2013;368(10):924-935.
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Hoskin B, Ortiz B, Paknis B, Kavati A. Exploring the real-world profile of refractory and non-refractory chronic idiopathic urticaria in the USA: clinical burden and healthcare resource use. Curr Med Res Opin. 2019;35(8):1387-1395.
XOLAIR [prescribing information]. Genentech USA, Inc. and Novartis Pharmaceuticals Corporation.
XOLAIR [prescribing information]. Genentech USA, Inc. and Novartis Pharmaceuticals Corporation.
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Data on file. Genentech USA, Inc. South San Francisco, CA.
Data on file. Genentech USA, Inc. South San Francisco, CA.
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