Publications by authors named "K V Sitz"

Background: Disease burden is particularly high in Chronic Spontaneous Urticaria (CSU) patients with angioedema, and patients whose signs and symptoms are inadequately controlled by H-antihistamines need new treatment options. Here we report an exploratory analysis, from the ligelizumab Phase 2b study, investigating angioedema occurrence in patients with CSU and describe the changes in angioedema following treatment with ligelizumab, omalizumab, or placebo.

Methods: Data from the ligelizumab Phase 2b core (ligelizumab 72 mg, 240 mg, omalizumab 300 mg and placebo) and extension study (ligelizumab 240 mg) were used.

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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.

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Article Synopsis
  • Berotralstat (BCX7353) is an oral medication under investigation for preventing hereditary angioedema (HAE) attacks, aimed at assessing its efficacy and safety over a 24-week study (APeX-2 trial).
  • The trial involved 121 patients who were randomly assigned to receive either a daily dose of 110 mg or 150 mg of berotralstat, or a placebo, with the primary goal of measuring the frequency of HAE attacks.
  • Results indicated that both doses of berotralstat significantly reduced attack rates compared to placebo, with minimal side effects, and the higher 150 mg dosage showed the best safety profile.
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Background: In the majority of patients with chronic spontaneous urticaria, most currently available therapies do not result in complete symptom control. Ligelizumab is a next-generation high-affinity humanized monoclonal anti-IgE antibody. Data are limited regarding the dose-response relationship of ligelizumab and the efficacy and safety of ligelizumab as compared with omalizumab and placebo in patients who have moderate-to-severe chronic spontaneous urticaria that is inadequately controlled with H-antihistamines at approved or increased doses, alone or in combination with H-antihistamines or leukotriene-receptor antagonists.

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Insulin allergy is a well-documented complication of insulin therapy. A 67-year-old man presented with symptoms suggestive of insulin anaphylaxis. In an attempt to allow him to continue insulin therapy, he underwent a desensitization protocol.

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