Background: The Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate-to-Severe Asthma ( EXCELS ) assessed the long-term safety of omalizumab in a clinical practice setting as part of a phase IV US Food and Drug Administration postmarketing commitment. Objective: We sought to evaluate long-term safety in omalizumab-treated …
11/11/2005 · This study is a multicenter, prospective, observational cohort study of ~5000 Xolair -treated and ~2500 non- Xolair -treated patients with moderate to severe persistent asthma and a positive skin test or in vitro reactivity to an aeroallergen.
5/18/2010 · This was a randomized, double-blind, placebo-controlled, 2-arm, 1-year study of participants who completed the EXCELS study (NCT00252135) and had received long-term treatment with Xolair . In addition, participants who did not participate in the EXCELS study but received long-term (~5 years) treatment with Xolair were allowed to enter the study .
In the EXCELS study , the incidence rates of primary malignancies per 1,000 patient years were similar among Xolair -treated (12.3) and non- Xolair -treated patients (13.0).
7/17/2009 · The on-going study , Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma ( EXCELS ), is a Genentech observational study of 7,500 subjects. EXCELS …
FDA Drug Safety Communication: FDA approves label changes …
FDA Drug Safety Communication: FDA approves label changes …
FDA Drug Safety Communication: FDA approves label changes …
As you stated the EXCELS study did not find an association between Xolair and malignancy. Additionally, in a pooled analysis of over 11,000 participants, in 42 RDBPC trials, Busse W, et al. (1) found no association between omalizumab treatment and risk of malignancy.
9/1/2011 · Methods: EXCELS is an ongoing prospective observational study of approximately 5000 omalizumab-treated and 2500 non-omalizumab-treated moderate-to-severe persistent allergic asthma patients aged ?12 years from 448 US centers who are followed for up to 5 years. All reported potential malignancies are reviewed by an independent oncology panel.
FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) titled Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma ( EXCELS ) that suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension …
analyses of an observational study ( EXCELS ), a numerical imbalance of ATE was observed. In the final analysis of the observational study , the rate of ATE per 1,000 patient years was 7.52 (115/15,286 patient years) for Xolair -treated patients and 5.12 (51/9,963 patient years) for control patients. In a multivariate analysis controlling for available, Iribarren, et al (1) reported on the cardiovascular and cerebrovascular events among patients receiving omalizumab in the EXCELS study . In this prospective cohort study in moderate to severe asthma, it was identified that there is a modest increase in the risk of Cardiovascular Events CV) and Cerebrovascular Events CBV) events among patients …
