Stratification of eosinophilic asthma patients treated with reslizumab and GINA Step 4 or 5 therapy
Reslizumab, an anti-interleukin-5 monoclonal antibody, significantly reduces exacerbation frequency and improves lung function, asthma control and quality of life in adults with severe eosinophilic asthma, as demonstrated in Phase III studies. This secondary analysis assessed reslizumab's efficacy in patients receiving baseline treatment per Global Initiative for Asthma (GINA) Step 4 and Step 5 guidelines. Pooled data from duplicate, Phase III, reslizumab versus placebo studies in patients with severe eosinophilic asthma (blood eosinophils ≥400 cells·µL−1) were stratified by baseline therapy. Efficacy assessments were exacerbation rates and changes from baseline forced expiratory volume in …
Reslizumab (RES) in asthma patients (pts) with severe eosinophilic asthma stratified by GINA asthma steps 4 and 5: Analysis of two phase 3, placebo (PBO)-controlled trials
Background: RES reduced exacerbation frequency and improved lung function and asthma control in pts with inadequately controlled asthma and elevated blood eosinophils (EOS) in two PBO-controlled, phase 3 trials (Castro et al. Lancet Resp Med 2015). Aims/objectives: To determine the efficacy of RES in asthma pts stratified by GINA Step 4 (G4) and Step 5 (G5) categories of asthma severity. Methods: Pooled data from two 52-week, PBO-controlled trials of RES (3mg/kg IV Q4W) in pts with inadequately controlled asthma and blood EOS ≥400/µL on inhaled corticosteroid (ICS) ± another controller; primary results have been reported. Current analysis includes pts stratified by G4 (medium/high-dose ICS …
Effect of omalizumab on angioedema in H1-antihistamine-resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled trial
Background Chronic spontaneous urticaria (CSU) severely impacts quality of life (QoL), especially in patients with wheals and angioedema. Omalizumab is approved as add-on therapy for CSU patients; however, its effect on patients who are double-positive for wheals and angioedema has not been systematically studied. Objective The primary objective was to evaluate the efficacy of omalizumab vs placebo at week 28 using the Chronic Urticaria Quality of Life (CU-Q2oL) questionnaire. Number of angioedema-burdened days, time interval between successive angioedema episodes, disease activity, angioedema-specific and overall QoL impairment were secondary objectives. Methods X-ACT was a phase III, rand…
Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy
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.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.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 object…
Omalizumab and the risk of malignancy: results from a pooled analysis.
Background Since initial registration, the omalizumab clinical trial database has expanded considerably, with a doubling of patients exposed in the clinical trial environment. Previous pooled data (2003) from phase I to III studies of omalizumab showed a numeric imbalance in malignancies arising in omalizumab recipients (0.5%) compared with control subjects (0.2%). The previous analysis was based on limited available data, warranting further investigation. Objective We sought to examine the incidence of malignancy using comprehensive pooled data from clinical trials of omalizumab-treated patients. Methods This pooled analysis included data from 67 phase I to IV clinical trials. The prespeci…
Predicting Responders to Reslizumab after 16 Weeks of Treatment Using an Algorithm Derived from Clinical Studies of Patients with Severe Eosinophilic Asthma.
Reslizumab is a humanized anti-IL-5 monoclonal antibody used as add-on maintenance treatment for patients with uncontrolled eosinophilic asthma.To predict response and nonresponse to intravenous reslizumab at 52 weeks with an algorithm we developed based on clinical indicators from pivotal clinical trials.Patients aged 18 years and older who met Global Initiative for Asthma 4 or 5 criteria and received intravenous reslizumab (n = 321) in two trials ( www.clinicaltrials.gov identifiers, NCT01287039 and NCT01285323) were selected as the data source. A mathematical model was constructed that was based on change from baseline to 16 weeks in Asthma Control Questionnaire and Asthma Quality of Lif…