Ligelizumab en UCE

Published in Dermatology and 

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Journal Scan / Research · October 15, 2019

Ligelizumab for Chronic Spontaneous Urticaria

The New England Journal of Medicine

TAKE-HOME MESSAGE

• In this phase IIb dose-finding study, the investigators randomized 382 patients with moderate to severe chronic spontaneous urticaria to either ligelizumab 24 mg, 72 mg, or 240 mg, omalizumab 300 mg, or placebo every 4 weeks for 20 weeks or to a single dose of ligelizumab 120 mg. When assessed at week 12, complete control of symptoms was achieved by a higher proportion of patients in the ligelizumab 24-mg, 72-mg, or 240-mg groups compared with the omalizumab or placebo groups, with no safety concerns.

• Ligelizumab dosed at 72 mg or 240 mg was associated with complete control symptoms, a result that needs to be validated in further studies.

Abstract

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 H1-antihistamines at approved or increased doses, alone or in combination with H2-antihistamines or leukotriene-receptor antagonists.

METHODS

In a phase 2b dose-finding trial, we randomly assigned patients to receive ligelizumab at a dose of 24 mg, 72 mg, or 240 mg, omalizumab at a dose of 300 mg, or placebo, administered subcutaneously every 4 weeks for a period of 20 weeks, or a single 120-mg dose of ligelizumab. Disease symptoms of hives, itch, and angioedema were monitored by means of weekly activity scores. The main objective was to determine a dose–response relationship for the complete control of hives (indicated by a weekly hives-severity score of 0, on a scale from 0 to 21, with higher scores indicating greater severity); the primary end point of this response was assessed at week 12. Complete symptom control was indicated by a weekly urticaria activity score of 0 (on a scale from 0 to 42, with higher scores indicating greater severity). Safety was analyzed throughout the trial.

RESULTS

A total of 382 patients underwent randomization. At week 12, a total of 30%, 51%, and 42% of the patients treated with 24 mg, 72 mg, and 240 mg, respectively, of ligelizumab had complete control of hives, as compared with 26% of the patients in the omalizumab group and no patients in the placebo group. A dose–response relationship was established. At week 12, a total of 30%, 44%, and 40% of the patients treated with 24 mg, 72 mg, and 240 mg, respectively, of ligelizumab had complete control of symptoms, as compared with 26% of the patients in the omalizumab group and no patients in the placebo group. In this small and short trial, no safety concerns regarding ligelizumab or omalizumab emerged.

CONCLUSIONS

A higher percentage of patients had complete control of symptoms of chronic spontaneous urticaria with ligelizumab therapy of 72 mg or 240 mg than with omalizumab or placebo.

The New England Journal of Medicine

Ligelizumab for Chronic Spontaneous Urticaria

N. Engl. J. Med 2019 Oct 03;381(14)1321-1332, M Maurer, AM Giménez‑Arnau, G Sussman, M Metz, DR Baker, A Bauer, JA Bernstein, R Brehler, C-Y Chu, W-H Chung, I Danilycheva, C Grattan, J Hébert, C Katelaris, M Makris, R Meshkova, S Savic, R Sinclair, K Sitz, P Staubach, B Wedi, J Löffler, A Barve, K Kobayashi, E Hua, T Severin, R Janocha 

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Benjamin Hidalgo-Matlock
Skin Care Physicians of Costa Rica

Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574

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