Remibrutinib (LOU064) versus placebo in CSU patients: Study design of the two Phase 3 clinical trials, REMIX-I and REMIX-II

M. Maurer, A. Giménez-Arnau, S. Saini, M. Lebwohl, G. Sussman, M. Hide, K. Lheritier, A. Zharkov, A. Barron, K. Cook, E-D. Martzloff, S. Haemmerle

Poster Poster slides

No increased rate of infections and infestations with remibrutinib (LOU064) in Phase 2 studies in patients with chronic spontaneous urticaria

M. Metz, A. Giménez-Arnau, M. Maurer, A. Tolcachier, S. Haemmerle, K. Lheritier, A. Zharkov

Poster Poster slides

Remibrutinib (LOU064) treatment improves quality of life in patients with chronic spontaneous urticaria

M. Maurer, A. Giménez-Arnau, V. Jain, J. Tillinghast, A. Tolcachier, S. Nigen, K. Hayama, K. Lheritier, P. Walsh, S. Haemmerle

Poster Poster slides

Remibrutinib demonstrates faster time to complete urticaria control in patients with chronic spontaneous urticaria compared with placebo

M. Maurer, P. Yamauchi, H. Kanavy, A. Giménez-Arnau, J. Reed, P. Staubach, K. Lheritier, P. Walsh, I. Nikolaev, S. Haemmerle, M. Lebwohl

Poster Poster slides

Long-term safety and tolerability of remibrutinib (LOU064) in Phase 2b study in chronic spontaneous urticaria patients

A. Giménez-Arnau, M. Maurer, M. Metz, V. Jain, P. Walsh, K. Lheritier, S. Hugot, H. Zouater, S. Haemmerle, A. Zharkov

Poster Poster slides

Remibrutinib (LOU064) reduces the use of rescue medication in patients with chronic spontaneous urticaria: Findings from a Phase 2b study

M. Maurer, J. Reed, P. Staubach, K. Lheritier, P. Walsh, V. Meti, I. Nikolaev, S. Haemmerle, A. Giménez-Arnau

Poster Poster slides

Efficacy and safety of ligelizumab in patients with chronic spontaneous urticaria: Results of two Phase 3 randomized controlled trials

M. Maurer, A. M. Giménez-Arnau, G. Sussman, R. Saini, M. Hide, L. F. Ensina, V. Varanasi, A. Barve, E. Scosyrev, A. Burciu, E. Hua, M. Patekar, T. Severin

Oral presentation

Angioedema control with ligelizumab in patients with chronic spontaneous urticaria correlates with improvement of health-related quality-of-life

M. Metz, A. Gimenez-Arnau, M. Maurer, K. Sitz, M. Hide, C-E Ortmann, M-M. Balp, T. Severin

Poster Poster slides

Assessing contextual factors to guide an implementation science study aiming to improve management of patients with chronic spontaneous urticaria

P. A. Laires, M. Bartezaghi, O. Bonavita, E. Peruzzi, G. Dasari, N. Janssens, V. Herrera, E. Gibbons, J. N. Hill, C. Smith, I. Nikolaev, S. D. Geest

Poster Poster slides

Low quality of life scores on the urticaria control test are associated with poor response to antihistamines in real-world data

A. Rajan, P. A. Laires, N. Janssens, S. Rizvi, S. Smeets, A. Giménez-Arnau, K. Weller

Poster Poster slides

The lower the urticaria control test score is the higher the probability of poor response to antihistamines will be: Analysis from worldwide real-world data (AWARE study)

P. A. Laires, A. Rajan, N. Janssens, S. Rizvi, S. Smeets, K. Weller, A. Giménez-Arnau

Poster Poster slides

Urticaria voices: Design of a real-world study on the burden of chronic urticaria from patients’ and physicians’ perspectives

L. Pedro, M-M. Balp, K. Weller, T. A. Winders, J. A. Bernstein, J. E. M. O’Donoghue, J. Kleebach, L. Christen, S. Smeets

Poster

Burden of angioedema in patients with chronic spontaneous urticaria amongst the five European countries

M-M. Balp, K. Krupsky, B. L. Balkaran, S. Gupta, C. Lienhard, J. Loh, J. M. Rodriguez Barrios, A. Romero, D. Patil, S. Walsh, R. K. Kohli, F. Tétart, T. El-Shanawany, J. Reed

Oral presentation

Prevalence, clinical profile and burden of chronic inducible urticaria in EU5, US and Japan

M-M. Balp, K. Krupsky, B. L. Balkaran, S. Gupta, C. Lienhard, J. Loh, J. M. Rodriguez Barrios, A. Romero, D. Patil, S. Walsh, R. K. Kohli, A. Uda, F. Maki, F. Tétart, T. El-Shanawany, J. Reed, M. Hide

Poster

Comparative economic burden of chronic spontaneous urticaria, psoriasis and atopic dermatitis in the US

D. Patil, M-M. Balp, K. Freedle, S. Walsh, K. Krupsky, B. L. Balkaran, S. Gupta, A. Romero, B. J. Williams, W. Soong

Poster

Humanistic burden of chronic spontaneous urticaria relative to psoriasis and atopic dermatitis in the US

K. Freedle, M-M. Balp, D. Patil, S. Walsh, K. Krupsky, B. L. Balkaran, S. Gupta, A. Romero, W. Soong, B. J. Williams

Poster

Predicting time to clinical remission in chronic urticaria: Can it be done with a simplified model?

P. Irina, M-M. Balp, Y. Geissbühler, T. Severin, S. Smeets, J. Signorovitch, T. Cornwall, A. Danyliv, S. Walsh, W. Soong, A-M. Marsland

Poster

The CHOICE study: A real world study assessing patient insights and preferences towards injectable biologic treatments for CSU in USA, Germany and Spain

A. M. Giménez-Arnau, M-M. Balp, J. O’Donoghue, S. Smeets, S. Walsh, S. Morrison, L. Christen, M. Maurer, T. Winders, J. Bernstein

Poster

Symposia

Welcome and introduction

M. Maurer

The path to optimized management of chronic spontaneous urticaria

M. Maurer, S. Ferrucci and S. F. Thomsen

Q&A

M. Maurer, S. Ferrucci and S. F. Thomsen

Ligelizumab shows good stability of response in patients with chronic spontaneous urticaria: A novel exploratory analysis of urticaria flare-ups

M. Maurer, A. M. Giménez-Arnau, M. Metz, K. Sitz, S. Acharya, N. Barbier, A. Barve, T. Severin

Poster Poster slides

Complete symptom control in patients with chronic spontaneous urticaria is associated with an improvement in health-related quality of life: Data from the phase 2b ligelizumab study

J. A. Bernstein, A. Giménez-Arnau, M. Maurer, P. Staubach, N. Barbier, E. Hua, Y. Joubert, M. M. Balp, T. Severin

Poster Poster slides

A composite score combining symptoms with QoL to evaluate complete control of urticaria with ligelizumab

A. M. Giménez-Arnau, J. A. Bernstein, M. Hide, M. Maurer, K. Sitz, G. Sussman, P. Terradas-Montana, N. Barbier, T. Severin

Poster Poster slides

Efficacy, safety and pharmacokinetics of ligelizumab: Results from a dedicated Phase 2b study in adolescent patients with chronic spontaneous urticaria

B. E. Sekerel, P. Staubach, M. Alvaro-Lozano, M. Maurer, M. Ben-Shoshan, A. Drollmann, A. Bienczak, M. Porter, T. Liu, A. Burciu, T. Severin

Oral Presentation

The Bruton’s tyrosine kinase inhibitor remibrutinib (LOU064) in chronic spontaneous urticaria: Top line results of a phase 2b dose-finding study

M. Maurer, W. Berger, A. M. Giménez-Arnau, K. Hayama, V. Jain, A. Reich,
S. Haemmerle, K. Lheritier, P. Walsh, S. Xia, J. Storim

Oral Presentation

Clinical profiles of adult and paediatric patients with chronic spontaneous urticaria: A real-world study in the United States

M. Balp, Y. Geissbühler, A. Mcconnon, J. Schäl, J. Gomme, P. A. Laires, S. J. McKenna, W. Soong

Poster

Clinical profiles of adult and paediatric patients with chronic inducible urticaria: A real-world study in the United States

Y. Geissbühler, M. Balp, A. Mcconnon, J. Schäl, J. Gomme, P. A. Laires, S. J. McKenna, W. Soong

Poster

Early and sustained treatment with omalizumab significantly improves quality of life in patients with chronic spontaneous urticaria: Analysis from a worldwide real-world database (AWARE study)

P. A. Laires, N. Janssens, A. Kandra, N. Barbier, C. E. Ortmann, S. Smeets, M. M. Balp, K. Weller

Poster

Complete control of wheals and itch in CSU significantly correlates with better sleep quality: Analysis from a worldwide real-world database (AWARE study)

P. A. Laires, N. Janssens, A. Kandra, N. Barbier, C. E. Ortmann, S. Smeets, M. M. Balp, K. Weller

Poster

Complete control of wheals and itch in CSU significantly correlates with better patients´ quality of life: Analysis from a worldwide real-world database (AWARE study)

P. A. Laires, N. Janssens, A. Kandra, N. Barbier, C. E. Ortmann, S. Smeets, M. M Balp, K. Weller

Poster

Symposia

The patient journey in CSU: The challenges we face

A. M. Giménez-Arnau

Optimizing patient outcomes in CSU: Could new biologics help achieve this?

R. Saini

Exploring novel pathways in the journey to complete CSU control

J. Reed

2020

Treatment with ligelizumab achieves a higher complete response rate in chronic spontaneous urticaria patients originally treated with omalizumab

M. Maurer; A. Giménez-Arnau; W. Soong; J.A. Bernstein; G. Sussmann; M. Metz; M. Hide; K. Sitz; E. Hua; A. Barve; T. Severin; R. Janocha

Poster Poster slides

Quality of life improvements are correlated with improved disease control: Results from ligelizumab treatment in chronic spontaneous urticaria patients with angioedema

A Giménez-Arnau, M. Maurer, W. Soong, J.A. Bernstein, G. Sussman, M. Metz, M. Hide, K. Sitz, E. Hua, P. Gupta, A. Barve, T. Severin, R. Janocha, M.M. Balp

Poster Poster slides

High proportion of patients with moderate to severe chronic spontaneous urticaria achieved complete response with ligelizumab: Data from the phase 2b study

J. A. Bernstein, M. Maurer, A. Giménez -Arnau, W. Soong, G. Sussman, M. Metz, K. Sitz, M. Hide, E. Hua, A. Barve, T. Severin, R. Janocha

Poster Poster slides

Efficacy of ligelizumab in chronic spontaneous urticaria patients inadequately controlled with omalizumab; sub-analysis of the Phase 2 program

M. Metz, M. Hide, G. Sussmann, K. Sitz, M. Maurer, T. Severin, R. Janocha, E. Hua

Poster Poster slides

Complete symptom control in chronic spontaneous urticaria patients leads to improved sleep and quality of life: Results from the Phase 2b ligelizumab study

A. Giménez-Arnau; M. Maurer, J.A. Bernstein, N. Barbier, E. Hua, T. Severin, R. Janocha, M-M. Balp

Poster Poster slides

In chronic spontaneous urticaria, response to ligelizumab is determined by baseline disease activity and duration, and patient's body mass index: An exploratory multivariate analysis

M. Maurer, A. Giménez-Arnau, G. Sussmann, W. Soong, J.A. Bernstein, E. Hua, T. Liu,
A. Barve, R. Janocha, T. Severin

Poster Poster slides

Ligelizumab achieves fast control of symptoms in more patients with chronic spontaneous urticaria compared with omalizumab: Analysis of the first 12 weeks of the Phase 2b study

M. Maurer, A. Giménez-Arnau, W. Soong, M. Hide, J.A. Bernstein, E. Hua, A. Barve,
T. Severin, R. Janocha

Oral Presentation

Symposia

Be AWARE: Learnings from real-world evidence

A. Giménez-Arnau

Slides

IgE inhibition in CSU: Not all anti-IgEs are born equal

A. Eggel

Slides

IgE implications: How does this benefit patients with CSU?

M. Maurer

Slides

2019

Results from the phase 2b study demonstrate that ligelizumab achieves sustained control of CSU symptoms during treatment-free follow-up

S. Savic, Sussman G, J.A. Bernstein, J. Hebert, C. Katelaris, E. Hua, A. Barve, T. Severin, R. Janocha

Oral Presentation

Re-treatment with ligelizumab achieves high rates of completely- and well-controlled symptoms in chronic spontaneous urticaria

M. Metz, D.R. Baker, C.Y. Chu, I. Danilycheva, E. Hua, A. Barve, K. Kobayashi,
R. Janocha, T. Severin

Oral Presentation

Dose-finding Phase 2 study to evaluate efficacy and safety of the novel BTK inhibitor LOU064 in patients with CSU inadequately controlled by H1-antihistamines

J. Storim, K. Lheritier, S. Hugot, P. End, B. Bieth, B. Cenni, M. Kaul, A. Gimenez-Arnau, M. Maurer, T. Severin

Poster Poster slides

2018

Ligelizumab achieves rapid onset of action, improved and sustained efficacy compared with omalizumab in patients with chronic spontaneous urticaria not adequately controlled by H1-antihistamines

M. Maurer, A. Giménez -Arnau, G. Sussman, J. Loeffler, A. Barve, E. Hua, M.M. Balp,
T. Severin, R. Janocha

Poster

Burden of chronic spontaneous urticaria remains high - Baseline patient characteristics from a Phase 2b study with ligelizumab

M. Maurer, A. Giménez -Arnau, G. Sussman, J. Loeffler, A. Barve, E. Hua, M.M. Balp, T. Severin, R. Janocha

Poster