Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials.

Background: Many patients with chronic spontaneous urticaria (CSU) do not achieve complete control of their symptoms with current available treatments. In a dose-finding phase 2b study, ligelizumab improved urticaria symptoms in patients with H1-antihistamine (H1-AH) refractory CSU. Here, we report the efficacy and safety outcomes from two ligelizumab phase 3 studies.

Adrenal function recovery after durable oral corticosteroid sparing with benralizumab in the PONENTE study.

Background: Oral corticosteroid (OCS) dependence among patients with severe eosinophilic asthma can cause adverse outcomes, including adrenal insufficiency. PONENTE's OCS reduction phase showed that, following benralizumab initiation, 91.5% of patients eliminated corticosteroids or achieved a final dosage ≤5 mg·day (median (range) 0.

Fenebrutinib in H antihistamine-refractory chronic spontaneous urticaria: a randomized phase 2 trial.

Bruton's tyrosine kinase (BTK) is crucial for FcεRI-mediated mast cell activation and essential for autoantibody production by B cells in chronic spontaneous urticaria (CSU). Fenebrutinib, an orally administered, potent, highly selective, reversible BTK inhibitor, may be effective in CSU. This double-blind, placebo-controlled, phase 2 trial (EudraCT ID 2016-004624-35 ) randomized 93 adults with antihistamine-refractory CSU to 50 mg daily, 150 mg daily and 200 mg twice daily of fenebrutinib or placebo for 8 weeks.

Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study.

Background: No consensus exists on how to reduce oral corticosteroids after the initiation of biologics in severe asthma. The PONENTE trial evaluated the effectiveness and safety of a rapid, individualised steroid-reduction algorithm, including adrenal insufficiency monitoring, after benralizumab initiation.

Methods: This multicentre, open-label, single-arm study was done at 138 clinical asthma treatment centres across 17 countries.

Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial.

Benralizumab is an interleukin-5 receptor α-directed cytolytic monoclonal antibody approved in several countries for the add-on maintenance treatment of patients with severe eosinophilic asthma aged 12 years and older. In the 28-week Phase III ZONDA trial (ClinicalTrials.gov identifier: NCT02075255), benralizumab produced a median 75% reduction from baseline in oral corticosteroid (OCS) dosage ( 25% for placebo) while maintaining asthma control for patients with OCS-dependent severe asthma.

A randomized, double-blind, comparative study to assess the safety and efficacy of topical retapamulin ointment 1% versus oral linezolid in the treatment of secondarily infected traumatic lesions and impetigo due to methicillin-resistant Staphylococcus aureus.

Objective: To evaluate the clinical and bacteriological efficacy of topical retapamulin ointment 1% versus oral linezolid in the treatment of patients with secondarily infected traumatic lesions (SITLs; excluding abscesses) or impetigo due to methicillin-resistant Staphylococcus aureus (MRSA).

Design: A randomized, double-blind, double-dummy, multicenter, comparative study (NCT00852540).

Setting: Patients recruited from 36 study centers in the United States.

Efficacy and safety of fluticasone/formoterol combination therapy in patients with moderate-to-severe asthma.

Background: The inhaled corticosteroid, fluticasone propionate, and the long-acting β(2)-adrenergic agonist, formoterol fumarate, are both highly effective treatments for bronchial asthma. This study (NCT00393952/EudraCT number: 2006-005989-39) compared the efficacy and safety of fluticasone/formoterol combination therapy (flutiform(®); 250/10 μg) administered twice daily (b.i.

Anti-interleukin-5 antibody therapy in asthma and allergies.

Purpose Of Review: Interleukin 5 (IL-5) has been shown to play an instrumental role in eosinophilic inflammation in allergic diseases. The purpose of this review is to explore clinical trials of anti-IL-5 antibody therapy that have been conducted in patients with asthma, hypereosinophilic syndromes, eosinophilic esophagitis, atopic dermatitis, Churg-Strauss syndrome, and nasal polyposis.

Recent Findings: Recent trials of anti-IL-5 in patients with severe asthma refractory to existing therapies and prominent sputum eosinophilia experienced significant reductions in asthma exacerbations.

Cytokine inhibition in severe asthma: current knowledge and future directions.

Purpose Of Review: A growing list of cytokines that contribute to the pathogenesis of asthma has been identified. The purpose of this review is to explore the specific cytokines involved in asthma, including their functions, cell sources, and clinical evidence that they participate in asthma. Existing data from clinical trials of cytokine antagonists in asthmatic patients are then reviewed to determine the efficacy and safety of these compounds.