December 07−09, 2023, São Paulo, Brazil

GA2LEN UCARE Conference 2023

December 07−08, 2022, Berlin
(Hybrid congress)

GA2LEN Global Urticaria Forum

GA²LEN Global Urticaria Forum/ UCARE

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Efficacy and safety of remibrutinib in CSU: REMIX 1&2 Studies

S. Saini, A.M. Giménez-Arnau, M. Hide, M. Lebwohl, G. Sussman, A. Barron, S. Haemmerle,
I. Hampele, K. Lheritier, E-D Martzloff, A. Zharkov, M. Maurer
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Long-term safety and efficacy of remibrutinib in patients with CSU

A.M. Giménez-Arnau, J. Tillinghast, V. Jain, S. Haemmerle, K. Lheritier P. Walsh, S. Hugot, M. Wells, A. Zharkov, W. Carr
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Remibrutinib improves hive severity in patients with CSU

M. Maurer, K. Sitz, A.M. Giménez-Arnau, K. Hayama, V. Jain, K. Lheritier, P. Walsh, S. Haemmerle
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Study design of remibrutinib Phase-3b extension trial in CSU patients

M. Hide, M. Maurer, A. M Giménez-Arnau, S. Saini, M. Lebwohl, G. Sussman, K. Lheritier,
A. Zharkov, L. Wei, E-D. Martzloff, S. Haemmerle
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Remibrutinib achieves early and high response rates in CSU patients

A.M. Giménez-Arnau, M. Maurer, R. Snyder, C-E Ortmann, B. Suryawanshi, I. Nikolaev,
M. Kuruvilla, S. Haemmerle
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Remibrutinib provides fast, clinically important improvement of CSU disease activity

M. Maurer, J. Jacobs, A.M. Giménez-Arnau, S. Savic, C-E. Ortmann, B. Suryawanshi, I. Nikolaev,
S. Haemmerle
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Remibrutinib showed good stability of response in patients with CSU

M. Maurer, J. Tillinghast, V. Jain, A. M. Giménez-Arnau, A. Reich, C-E Ortmann, P. Walsh,
S. Haemmerle
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Remibrutinib improves itch, sleep and activity in patients with CSU

M. Maurer, A.M. Giménez-Arnau, C. Hsu, R. Snyder, L. Clore, V. Jain, K. Lheritier, P. Walsh,
S. Haemmerle, I. Nikolaev
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Remibrutinib showed no impact on blood counts in CSU patients

A.M. Giménez-Arnau, J. Leflein, M. Hide, K. Lheritier, S. Haemmerle, M. Kuruvilla, A. Zharkov
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Remibrutinib showed no impact on serum immunoglobulin in CSU patients

A.M. Giménez-Arnau, W. Carr, K. Lheritier, S. Haemmerle, A. Zharkov, S. Dahale, K. Hayama
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Remibrutinib improves CSU symptoms irrespective of previous anti-IgE treatment

M. Maurer, A. Greiner, S. Guduri, J. Leflein, S. Haemmerle, K. Lheritier, P. Walsh, I. Nikolaev,
A.M, Giménez-Arnau
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Pooled safety analysis of remibrutinib in inflammatory immune-mediated diseases

M. Hide, S. Saini, M. Maurer, A.M. Giménez-Arnau, G. Sussman, S. Haemmerle, N. Barbier,
A. Zharkov
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Remibrutinib improves CSU in patients regardless of prior oral treatments

A.M. Giménez-Arnau, L. Clore, M. Maurer, C-E. Ortmann, B. Suryawanshi, M. Kuruvilla,
S. Haemmerle
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Systemic manifestations during symptomatic episodes in CSU: Urticaria Voices Study

J.A. Bernstein, T.A. Winders, T. Raftery, P. Saraswat, J. McCarthy, M. Kuruvilla, M-M Balp, K. Weller
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Urticaria Voices: Patient-reported outcome measures for monitoring CSU in clinic

J.A. Bernstein, P. Laires, M-M. Balp, P. Saraswat, T. Raftery, J. McCarthy, M. Dricu, T.A. Winders,
K. Weller
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Antihistamine treatment patterns and patient reported control In CSU

K. Weller, J.A Bernstein, M-M. Balp, J. McCarthy, M. Kuruvilla, P. Saraswat, T. Raftery, T.A. Winders
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Patients’ perspective on negative impact of CSU on their lives

K. Weller, P. Laires, M-M Balp, T. Raftery, P. Saraswat, J. McCarthy, M. Dricu, T.A. Winders,
J.A. Bernstein
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Remission and relapse profiles in chronic urticaria: PREDICT-CU study

A. Marsland, M-M.Balp, I. Pivneva, A. Danyliv, K. Chen, T. Cornwall, J. Signorovitch, D. Patil,
R. Kohli, T. Severin, W. Soong
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Remibrutinib improves quality of life in CSU patients

M. Maurer, A.M. Giménez-Arnau, V. Jain, J. Tillinghast, A. Tolcachier, S. Nigen, K. Hayama,
K. Lheritier, P. Walsh, S. Haemmerle
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Remibrutinib for chronic spontaneous urticaria: Time to complete urticaria control

P. Staubach, M. Maurer, P. Yamauchi, H. Kanavy, A.M. Giménez-Arnau, J. Reed, K. Lheritier,
P. Walsh, I. Nikolaev, S. Haemmerle, M. Lebwohl
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More patients achieve absence of angioedema with remibrutinib than placebo

M. Maurer, J. Reed, P. Staubach, K. Lheritier, P. Walsh, I. Nikolaev, S. Haemmerle, A. Giménez-Arnau
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Remibrutinib reduces the use of rescue medication in CSU patients

P. Staubach, M. Maurer, J. Reed, K. Lheritier, P. Walsh, I. Nikolaev, S. Haemmerle, A.M. Giménez-Arnau
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Long-term safety and tolerability of remibrutinib in CSU patients

A.M. Giménez-Arnau, M. Maurer, M. Metz, V. Jain, P. Walsh, K. Lheritier, S. Hugot, H. Zouater,
S. Haemmerle, A. Zharkov
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No increase of infections and infestations with remibrutinib in CSU

M. Metz, A.M. Giménez-Arnau, M. Maurer, A. Tolcachier, S. Haemmerle, K. Lheritier, A. Zharkov
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Remibrutinib versus placebo in CSU patients: REMIX-1 and REMIX-2 trials

M. Hide, M. Maurer, A.M. Giménez-Arnau, S. Saini, M. Lebwohl, G. Sussman, E.D. Martzloff,
K. Lheritier, A. Zharkov, S. Haemmerle
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Remibrutinib improves CSU in patients with low or high IgE

M. Hide, K. Hayama, A. Ramsey, M. Maurer, K. Lheritier, A. Zharkov, S. Haemmerle, I. Nikolaev
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Remibrutinib improves CSU irrespective of baseline
CU-Index status

M. Maurer, W. Carr, K. Sitz, V. Jain, A.M. Giménez-Arnau, K. Lheritier, I. Nikolaev, S. Haemmerle
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Remibrutinib improves sleep and activity in patients with CSU

A.M. Giménez-Arnau, L. Clore, V. Jain, K. Lheritier, P. Walsh, S. Haemmerle, M. Maurer
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Ligelizumab in chronic spontaneous urticaria: Phase-3 PEARL study results

A.M. Giménez-Arnau, M. Maurer, G. Sussman, S. Saini, M. Hide, L.F. Ensina, V. Varanasi, A. Barve, E. Scosyrev, A. Burciu, E. Hua, M. Patekar, T. Severin
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Angioedema control in CSU correlates with improved health-related QoL

M. Metz, A.M. Giménez-Arnau, M. Maurer, M. Hide, K. Sitz, C.E. Ortmann, M.M. Balp, T. Severin
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Contextual factors analysis guiding an implementation science study in CSU

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. De Geest
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Low QoL scores on UCT associated with poor antihistamine response

A. Rajan, P.A. Laires, N. Janssens, S. Rizvi, S. Smeets, A.M. Giménez-Arnau, K. Weller
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Low UCT scores predicted higher probability of poor antihistamine response

P.A. Laires, A. Rajan, N. Janssens, S. Rizvi, S. Smeets, K. Weller, A.M. Giménez-Arnau
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Low UCT scores predict poor antihistamine response in CSU

A. Rajan, P.A. Laires, N. Janssens, S. Rizvi, S. Smeets, K. Weller
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Urticaria voices: Patients’ and physicians’ perceptions of chronic urticaria

P.A. Laires, M.M. Balp, K. Weller, T.A. Winders, J.A. Bernstein, J.E.M. O’Donoghue, J. Kleebach,
L. Christen, S. Smeets
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CSU has a similar impact on QoL as plaque psoriasis

I. Nikolaev, N. Barbier, C.E. Ortmann, N. Janssens, N. Chapman-Rothe, N. Hajizadeh, O. Hsine,
A. Rajan, P.A. Laires, H. Edgren
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Impact of CSU on patients’ lives: Social media listening analysis

E. Kocaturk, M. Bizjak, E.S. Baldrich, L. Walter, P.T. Montana, L. Christen, N. Janssens, S. Smeets
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PREDICT-CU: Predicting time to clinical remission in chronic urticaria

I. Pivneva, M.M. Balp, Y. Geissbühler, T. Severin, S. Smeets, J. Signorovitch, T. Cornwall,
A. Danyliv, S. Walsh, W. Soong, A. Marsland
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Remission and comorbidities in chronic spontaneous and chronic inducible urticaria

I. Pivneva, M.M. Balp, A. Danyliv, K. Chen, T. Cornwall, J. Signorovitch, T. Severin, W. Soong,
A. Marsland
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Burden of angioedema in European patients with chronic spontaneous urticaria

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
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Comparative economic burden of chronic spontaneous urticaria, psoriasis, atopic dermatitis

S. Gupta S., M.M. Balp, S. Walsh, B.L. Balkaran, C. Lienhard, J. Loh, J. M. Rodriguez Barrios,
K. Krupsky, A. Romero, T. El-Shanawany, F. Tétart, J. Reed
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Comparative humanistic burden of chronic spontaneous urticaria, psoriasis, atopic dermatitis

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

2021

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Ligelizumab achieves freedom from CSU-symptoms regardless of previous H1-antihistamine dose

A. M. Giménez-Arnau, M. Maurer, W. Soong, K. Sitz, J. A. Bernstein, E. Hua, T. Severin
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Ligelizumab further improves disease-activity in CSU patients previously on omalizumab

M. Hide, M. Maurer, K. Sitz, G. Sussman, M. Metz, N. Barbier, E. Hua, T. Severin
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Ligelizumab further improves sleep in CSU patients previously on omalizumab

M. Metz, A. Giménez-Arnau, M. Hide, M. Maurer, K. Sitz, G. Sussman, N. Barbier, E. Hua, M-M. Balp, T. Severin
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Ligelizumab achieves fast symptom control in CSU: Rolling UAS7 analysis

J. A. Bernstein, M. Hide, M. Maurer, A. Giménez-Arnau, W. Soong, S. Acharya, A. Barve, T. Severin
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Complete response with ligelizumab in CSU: A composite score analysis

M. Hide, A. Giménez-Arnau, M. Maurer, J. A. Bernstein, K. Sitz, G. Sussman, P.T. Montana, S. Acharya, T. Severin
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Ligelizumab for adolescent CSU patients: A dedicated Phase 2b study

P. Staubach, B. E. Sekerel, M. Alvaro-Lozano, M. Maurer, M. Ben-Shoshan, A. Drollmann, A. Bienczak, M. Porter, T. Liu, A. Burciu, T. Severin
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Ligelizumab shows good stability of response in CSU: Flare-up analysis

M. Maurer, A. Giménez-Arnau, M. Metz, K. Sitz, S. Acharya, N. Barbier, A. Barve, T. Severin
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Complete symptom control is associated with improved health-related-quality-of-life in CSU

M. Maurer, A. Giménez-Arnau, J. A. Bernstein, P. Staubach, N. Barbier, E. Hua, Y. Joubert, M-M. Balp, T. Severin
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Ligelizumab in chronic inducible urticaria: Phase-3 study design and rationale

M. Metz, M. Bizjak, T. Hawro, S. Altrichter, M. Maurer, S. S. Saini, G. Sussman, A. Giménez-Arnau, M. Hide, A. Barve, M. Porter, S. Smeets, T. Liu, E. Hua, M. Patekar, T. Severin
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QoL of CSU patients refractory to H1- antihistamine: AWARE-LACan study

L. F. C. Ensina, F. Dabove, M. Velásquez-Lopera, L. M. T. Quijano, F. DiTata, P. Tassinari
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Pooled analysis of AWARE, LaCAN and AMAC studies: CSU insights

A. M. Giménez-Arnau, M. Maurer, L. F. Ensina, C-Yu Chu, X. Jaumont, P. Tassinari
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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
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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
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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
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Predicting time to remission and identifying influencing factors from a machine learning real-world study

M-M. Balp, I. Pivneva, Y. Geissbühler, T. Severin, S. Smeets, J. Signorovitch, J. Royer, Y. Liang, T. Cornwall, J. Pan, A. Danyliv, W. Soong, A. Marsland
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Clinical profiles of patients with CSU - a real-world study in the United States

M-M. Balp, Y. Geissbühler, A. Mcconnon, J. Schäl, J. Gomme, P. A. Laires, S. J. McKenna, W. Soong
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Clinical profiles of patients with chronic inducible urticaria: A real-world study in the USA

Y. Geissbühler, M-M. Balp, A. Mcconnon, J. Schäl, J. Gomme, P. A. Laires, S. J. McKenna, W. Soong
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Prevalence and burden of chronic inducible urticaria in Japan

M. Hide, A. Uda, S. Tanaka, F. Maki, N. Miyakawa, S. J. McKenna, S. Gupta, B. Balkaran, M-M. Balp
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Prevalence and burden of chronic spontaneous urticaria in Japan

M. Hide, A. Uda, S. Tanaka, F. Maki, N. Miyakawa, S. J. McKenna, S. Gupta, B. Balkaran, M-M. Balp
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The bruton’s tyrosine kinase inhibitor remibrutinib (LOU064) in chronic spontaneous urticaria: Top line results of a Phase 2b dose-finding study

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

2020

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Moderate-to-severe CSU patients achieve high complete response rate with ligelizumab

M. Maurer, J.A. Bernstein, A. Giménez-Arnau, W. Soong, G. Sussman, M. Metz, K. Sitz, M. Hide, E. Hua, A. Barve, T. Severin, R. Janocha
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Ligelizumab retreatment achieves high rate of complete response in CSU

M. Metz, M. Maurer, A. Giménez-Arnau, W. Soong, J.A. Bernstein, G. Sussman, M. Hide, K. Sitz, E. Hua, A. Barve, T. Severin, R. Janocha
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Long-term ligelizumab treatment maintains post-treatment symptom-control in CSU patients

A. Giménez-Arnau, M. Metz, W. Soong, J.A. Bernstein, G. Sussman, K. Sitz, M. Maurer, E. Hua, A. Barve, T. Severin, R. Janocha
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Ligelizumab in CSU: Design and rationale of Phase-3b extension study

T. Severin, M. Maurer, A. Giménez-Arnau, M. Hide, G. Sussman, S.S. Saini, E. Hua, A. Barve, Y. Joubert, I. Indermuehle, R. Janocha
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Ligelizumab is effective in CSU patients incompletely controlled with omalizumab

M. Metz, M. Hide, G.L. Sussman, K. Sitz, M. Maurer, T. Severin, R. Janocha, E. Hua
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Fast and complete symptom control with ligelizumab in CSU

A. Giménez-Arnau, M. Maurer, W. Soong, M. Hide, J.A. Bernstein, E. Hua, A. Barve, T. Severin, R. Janocha
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Sleep-interference and urticaria symptoms correlated in the ligelizumab Phase-2b study

A. Giménez-Arnau, M. Maurer, J.A. Bernstein, T. Severin, R. Janocha, M-M Balp, E. Hua
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Complete CSU control with ligelizumab helps normalize quality of life

M. Maurer, J.A. Bernstein, A. Giménez-Arnau, W. Soong, M. Metz, N. Barbier, A. Barve, T. Severin, M.-M. Balp, R. Janocha
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Quality-of-Life correlates with urticaria symptom control: Ligelizumab Phase-2b study data

M. Maurer, A. Giménez-Arnau, J.A. Bernstein, T. Severin, R. Janocha, M-M. Balp, E. Hua
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Exploratory multivariate analysis to predict ligelizumab treatment outcome in CSU

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

2019

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More patients treated with ligelizumab are angioedema-free compared with omalizumab: Results of a phase 2b clinical trial

A. Giménez-Arnau, G. Sussman, M. Maurer, E. Hua, K. Kobayashi, T. Severin, R. Janocha, M-M. Balp
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Ligelizumab achieves sustained control of chronic spontaneous urticaria symptoms of hives, itch and angioedema: 1-year treatment results

J.A. Bernstein, D. Baker, M. Maurer, A. Giménez-Arnau, G. Sussman, A. Barve, E. Hua, T. Severin, R. Janocha
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Ligelizumab reduces rescue medication use in patients with chronic spontaneous urticaria: Phase 2b study results

K. Sitz, W. Soong, B. Lanier, K. Kobayashi, A. Barve, E. Hua, T. Severin, R. Janocha
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Ligelizumab Re-treatment is Highly Effective in Patients with Chronic Spontaneous Urticaria

M. Metz, D. Baker, C. Chu, I. Danilycheva, E. Hua, K. Kobayashi, T. Severin, R. Janocha
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Ligelizumab retreatment is highly effective in patients with chronic spontaneous urticaria

M. Maurer, A. Giménez-Arnau, G. Sussman, E. Hua, T. Severin, R. Janocha
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Ligelizumab is well tolerated and exhibits a safety profile similar to omalizumab and placebo in patients with chronic spontaneous urticaria

G. Sussman, M. Maurer, A. Giménez-Arnau, E. Hua, T. Severin, R. Janocha
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Results from the phase 2b study demonstrate that ligelizumab achieves sustained control of CSU symptoms during treatment-free follow-up

S. Savic, G. Sussman, J.A. Bernstein, J. Hebert, C. Katelaris, E. Hua, A. Barve, T. Severin, R. Janocha
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Study design and rationale of a phase 2b dose-finding study of ligelizumab (QGE031) in adolescent patients with chronic spontaneous urticaria

B. E. Sekerel, A. Drollmann, M. Porter, N. Kataoka, S. Koehne-Voss, M. Maurer, P. Staubach, M. Ben-Shoshan, T. Severin, R. Janocha
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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

2018

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High Burden of CSU in a Ligelizumab Phase 2b Study

M. Maurer, A. Giménez -Arnau, G. Sussman, J. Loeffler, A. Barve, E. Hua, M.M. Balp, T. Severin, R. Janocha
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Next generation anti-IgE antibody Ligelizumab in CSU: Phase 2b results

M. Maurer, A. Giménez -Arnau, G. Sussman, J. Loeffler, A. Barve, T. Severin, R. Janocha
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Ligelizumab versus omalizumab in CSU: Phase 3 design and rationale

T. Severin, M. Maurer, A. Giménez -Arnau, G. Sussman, S. Saini, M. Hide, P. Busse, K. Kobayashi, A. Barve, E. Hua, N. Kataoka, R. Janocha
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