Search results for "OMALIZUMAB"

Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one‐year extension study

2021

Background: Ligelizumab, a next-generation, humanized anti-immunoglobulin E (IgE) monoclonal antibody is in development as a treatment for patients with chronic spontaneous urticaria, whose symptoms are inadequately controlled with standard-of-care therapy. Objective: To evaluate the long-term safety and re-treatment efficacy of ligelizumab 240 mg in patients who completed the core study and extension study. Methods: This open-label, single-arm, long-term Phase 2b extension study was designed to assess patients who were previously administered various doses of ligelizumab, omalizumab or placebo in the Phase 2b, dose-finding core study and who presented with active disease after Week 32. In …

Real world evidence on treatment of chronic spontaneous urticaria with omalizumab: Preliminary data.

2020

Long-term efficacy of omalizumab (OMA) for patients with severe allergic asthma (SAA). Clinical assessment and relationship to serum IgE concentratio…

2015

Background: OMA is an effective treatment option in SAA. However, little data are available on the long-term-efficacy oft the drug. Objective: To determine the long-term efficacy of OMA in respect to clinical parameters and IgE serum levels. Methods: This was a retrospective, open-label, uncontrolled, multi-center observational study according to the definition of non-interventional studies. 22 non-smoking patients (10 m, 12 f; mean age 47,9 yrs) with SAA were enrolled. Pat were treated with OMA up to for 4 years and total serum IgE levels were assessed at initiation of therapy, after 2-6 ms and 3-5 yrs. Data were recorded on standardized CRFs by the treating physician. Results: The average…

Responsiveness and minimal important difference of the urticaria control test

2017

This study demonstrates the responsiveness of the Urticaria Control Test (UCT). Changes of its score by 3 points or more reflect a clinically relevant change of disease control (minimal important difference).

COVID-19 in Severe Asthma Network in Italy (SANI) patients: Clinical features, impact of comorbidities and treatments

2020

To the Editor Since the end of February 2020 Italy, first non- Asian Country, has reported an ever increasing number of COronaVIrus Disease 19 (COVID-19) patients, which has reached over 200,000 confirmed Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) infected subjects and resulted in more than 34000 deaths (data updated to June 19th, 20201).Patients with asthma are potentially more severely affected by by SARS-CoV-2 infection 2 and it is well established that respiratory viral infections are associated with severe adverse outcomes in patients with asthma, including increased risk of asthma exacerbation episodes 3. Nonetheless, according to the epidemiological studies publishe…

Omalizumab outcomes for up to 6 years in pediatric patients with severe persistent allergic asthma

2021

BACKGROUND: Various studies have assessed omalizumab outcomes in the clinical practice setting but follow-up and/or number of patients included were limited. We aim to describe the long-term outcomes of pediatric patients with severe persistent allergic asthma receiving omalizumab in the largest real-life cohort reported to date. METHODS: ANCHORS was a multicenter, observational, retrospective cohort study conducted in 25 Pediatric Allergy and Pulmonology units in Spain. We collected data of patients < 18 years and initiating omalizumab between 2006 and 2018, from the year prior to omalizumab initiation to discontinuation or last available follow-up. The primary outcome was the evolution of…