Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase

Marcus Maurer; Sabine Altrichter; Thomas Bieber; Tilo Biedermann; Matthias Bräutigam; Stefan Seyfried; Randolf Brehler; Jürgen Grabbe; Nicolas Hunzelmann; Thilo Jakob; Andreas Jung; Jörg Kleine-Tebbe; Martin Mempel; Michael Meurer; Kristian Reich; Franziska Ruëff; Knut Schäkel; Kaushik Sengupta; Christian Sieder; Jan C Simon; Bettina Wedi; Torsten Zuberbier; Vera Mahler; Petra Staubach

doi:10.1016/j.jaci.2011.04.038

Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase

Marcus Maurer, Sabine Altrichter, Thomas Bieber, Tilo Biedermann, Matthias Bräutigam, Stefan Seyfried, Randolf Brehler, Jürgen Grabbe, Nicolas Hunzelmann, Thilo Jakob, Andreas Jung, Jörg Kleine-Tebbe, Martin Mempel, Michael Meurer, Kristian Reich, Franziska Ruëff, Knut Schäkel, Kaushik Sengupta, Christian Sieder, Jan C SimonBettina Wedi, Torsten Zuberbier, Vera Mahler, Petra Staubach

245 Citationer (Scopus)

Abstract

BACKGROUND: A subgroup of patients with chronic spontaneous urticaria (CU) exhibits IgE antibodies directed against autoantigens, such as thyroperoxidase (TPO). We conducted this study to investigate whether such patients with CU with IgE against TPO benefit from treatment with omalizumab, a humanized anti-IgE mAb licensed for the treatment of severe persistent allergic (IgE-mediated) asthma.

OBJECTIVES: We sought to assess the efficacy of omalizumab treatment in patients with CU with IgE autoantibodies against TPO.

METHODS: In this multicenter, randomized, double-blind, placebo-controlled study patients with CU (male/female, 18-70 years of age) with IgE autoantibodies against TPO who had persistent symptoms (wheals and pruritus) despite standard antihistamine therapy were randomized to receive either omalizumab (75-375 mg, dose determined by using the approved asthma dosing table) or placebo subcutaneously once every 2 or 4 weeks for 24 weeks. The primary end point was the change from baseline in mean weekly urticaria activity score after 24 weeks of treatment, as calculated from patients' diaries. The safety and tolerability of omalizumab were also assessed.

RESULTS: Of the 49 randomized patients (omalizumab, n = 27; placebo, n = 22), 42 completed the study. At week 24, patients demonstrated a mean reduction in the weekly urticaria activity score from baseline of 17.8 with omalizumab and 7.9 with placebo (P = .0089). Complete protection from wheal development was observed in 19 (70.4%) patients in the omalizumab group compared with only 1 (4.5%) patient in the placebo group. The rate of adverse events was similar in both groups.

CONCLUSIONS: The results of this study indicate that omalizumab is an effective treatment option for patients with CU with IgE autoantibodies against TPO who are refractory to conventional treatment.

Originalsprog	Engelsk
Tidsskrift	The Journal of allergy and clinical immunology
Vol/bind	128
Udgave nummer	1
Sider (fra-til)	202-209.e5
ISSN	0091-6749
DOI	https://doi.org/10.1016/j.jaci.2011.04.038
Status	Udgivet - jul. 2011

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10.1016/j.jaci.2011.04.038

http://www.jacionline.org/article/S0091674911006762/pdf

Citationsformater

Maurer, M., Altrichter, S., Bieber, T., Biedermann, T., Bräutigam, M., Seyfried, S., Brehler, R., Grabbe, J., Hunzelmann, N., Jakob, T., Jung, A., Kleine-Tebbe, J., Mempel, M., Meurer, M., Reich, K., Ruëff, F., Schäkel, K., Sengupta, K., Sieder, C., ... Staubach, P. (2011). Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase. The Journal of allergy and clinical immunology, 128(1), 202-209.e5. https://doi.org/10.1016/j.jaci.2011.04.038

Maurer, M, Altrichter, S, Bieber, T, Biedermann, T, Bräutigam, M, Seyfried, S, Brehler, R, Grabbe, J, Hunzelmann, N, Jakob, T, Jung, A, Kleine-Tebbe, J, Mempel, M, Meurer, M, Reich, K, Ruëff, F, Schäkel, K, Sengupta, K, Sieder, C, Simon, JC, Wedi, B, Zuberbier, T, Mahler, V & Staubach, P 2011, 'Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase', The Journal of allergy and clinical immunology, bind 128, nr. 1, s. 202-209.e5. https://doi.org/10.1016/j.jaci.2011.04.038

@article{60731189d5ed4d02a57f050f1f8d6a47,

title = "Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase",

abstract = "BACKGROUND: A subgroup of patients with chronic spontaneous urticaria (CU) exhibits IgE antibodies directed against autoantigens, such as thyroperoxidase (TPO). We conducted this study to investigate whether such patients with CU with IgE against TPO benefit from treatment with omalizumab, a humanized anti-IgE mAb licensed for the treatment of severe persistent allergic (IgE-mediated) asthma.OBJECTIVES: We sought to assess the efficacy of omalizumab treatment in patients with CU with IgE autoantibodies against TPO.METHODS: In this multicenter, randomized, double-blind, placebo-controlled study patients with CU (male/female, 18-70 years of age) with IgE autoantibodies against TPO who had persistent symptoms (wheals and pruritus) despite standard antihistamine therapy were randomized to receive either omalizumab (75-375 mg, dose determined by using the approved asthma dosing table) or placebo subcutaneously once every 2 or 4 weeks for 24 weeks. The primary end point was the change from baseline in mean weekly urticaria activity score after 24 weeks of treatment, as calculated from patients' diaries. The safety and tolerability of omalizumab were also assessed.RESULTS: Of the 49 randomized patients (omalizumab, n = 27; placebo, n = 22), 42 completed the study. At week 24, patients demonstrated a mean reduction in the weekly urticaria activity score from baseline of 17.8 with omalizumab and 7.9 with placebo (P = .0089). Complete protection from wheal development was observed in 19 (70.4%) patients in the omalizumab group compared with only 1 (4.5%) patient in the placebo group. The rate of adverse events was similar in both groups.CONCLUSIONS: The results of this study indicate that omalizumab is an effective treatment option for patients with CU with IgE autoantibodies against TPO who are refractory to conventional treatment.",

keywords = "Adolescent, Adult, Aged, Anti-Allergic Agents, Antibodies, Anti-Idiotypic, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Autoantibodies, Autoantigens, Female, Humans, Immunoglobulin E, Male, Middle Aged, Omalizumab, Urticaria, Young Adult, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",

author = "Marcus Maurer and Sabine Altrichter and Thomas Bieber and Tilo Biedermann and Matthias Br{\"a}utigam and Stefan Seyfried and Randolf Brehler and J{\"u}rgen Grabbe and Nicolas Hunzelmann and Thilo Jakob and Andreas Jung and J{\"o}rg Kleine-Tebbe and Martin Mempel and Michael Meurer and Kristian Reich and Franziska Ru{\"e}ff and Knut Sch{\"a}kel and Kaushik Sengupta and Christian Sieder and Simon, {Jan C} and Bettina Wedi and Torsten Zuberbier and Vera Mahler and Petra Staubach",

year = "2011",

month = jul,

doi = "10.1016/j.jaci.2011.04.038",

language = "English",

volume = "128",

pages = "202--209.e5",

journal = "The Journal of allergy and clinical immunology",

issn = "0091-6749",

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TY - JOUR

T1 - Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase

AU - Maurer, Marcus

AU - Altrichter, Sabine

AU - Bieber, Thomas

AU - Biedermann, Tilo

AU - Bräutigam, Matthias

AU - Seyfried, Stefan

AU - Brehler, Randolf

AU - Grabbe, Jürgen

AU - Hunzelmann, Nicolas

AU - Jakob, Thilo

AU - Jung, Andreas

AU - Kleine-Tebbe, Jörg

AU - Mempel, Martin

AU - Meurer, Michael

AU - Reich, Kristian

AU - Ruëff, Franziska

AU - Schäkel, Knut

AU - Sengupta, Kaushik

AU - Sieder, Christian

AU - Simon, Jan C

AU - Wedi, Bettina

AU - Zuberbier, Torsten

AU - Mahler, Vera

AU - Staubach, Petra

PY - 2011/7

Y1 - 2011/7

N2 - BACKGROUND: A subgroup of patients with chronic spontaneous urticaria (CU) exhibits IgE antibodies directed against autoantigens, such as thyroperoxidase (TPO). We conducted this study to investigate whether such patients with CU with IgE against TPO benefit from treatment with omalizumab, a humanized anti-IgE mAb licensed for the treatment of severe persistent allergic (IgE-mediated) asthma.OBJECTIVES: We sought to assess the efficacy of omalizumab treatment in patients with CU with IgE autoantibodies against TPO.METHODS: In this multicenter, randomized, double-blind, placebo-controlled study patients with CU (male/female, 18-70 years of age) with IgE autoantibodies against TPO who had persistent symptoms (wheals and pruritus) despite standard antihistamine therapy were randomized to receive either omalizumab (75-375 mg, dose determined by using the approved asthma dosing table) or placebo subcutaneously once every 2 or 4 weeks for 24 weeks. The primary end point was the change from baseline in mean weekly urticaria activity score after 24 weeks of treatment, as calculated from patients' diaries. The safety and tolerability of omalizumab were also assessed.RESULTS: Of the 49 randomized patients (omalizumab, n = 27; placebo, n = 22), 42 completed the study. At week 24, patients demonstrated a mean reduction in the weekly urticaria activity score from baseline of 17.8 with omalizumab and 7.9 with placebo (P = .0089). Complete protection from wheal development was observed in 19 (70.4%) patients in the omalizumab group compared with only 1 (4.5%) patient in the placebo group. The rate of adverse events was similar in both groups.CONCLUSIONS: The results of this study indicate that omalizumab is an effective treatment option for patients with CU with IgE autoantibodies against TPO who are refractory to conventional treatment.

AB - BACKGROUND: A subgroup of patients with chronic spontaneous urticaria (CU) exhibits IgE antibodies directed against autoantigens, such as thyroperoxidase (TPO). We conducted this study to investigate whether such patients with CU with IgE against TPO benefit from treatment with omalizumab, a humanized anti-IgE mAb licensed for the treatment of severe persistent allergic (IgE-mediated) asthma.OBJECTIVES: We sought to assess the efficacy of omalizumab treatment in patients with CU with IgE autoantibodies against TPO.METHODS: In this multicenter, randomized, double-blind, placebo-controlled study patients with CU (male/female, 18-70 years of age) with IgE autoantibodies against TPO who had persistent symptoms (wheals and pruritus) despite standard antihistamine therapy were randomized to receive either omalizumab (75-375 mg, dose determined by using the approved asthma dosing table) or placebo subcutaneously once every 2 or 4 weeks for 24 weeks. The primary end point was the change from baseline in mean weekly urticaria activity score after 24 weeks of treatment, as calculated from patients' diaries. The safety and tolerability of omalizumab were also assessed.RESULTS: Of the 49 randomized patients (omalizumab, n = 27; placebo, n = 22), 42 completed the study. At week 24, patients demonstrated a mean reduction in the weekly urticaria activity score from baseline of 17.8 with omalizumab and 7.9 with placebo (P = .0089). Complete protection from wheal development was observed in 19 (70.4%) patients in the omalizumab group compared with only 1 (4.5%) patient in the placebo group. The rate of adverse events was similar in both groups.CONCLUSIONS: The results of this study indicate that omalizumab is an effective treatment option for patients with CU with IgE autoantibodies against TPO who are refractory to conventional treatment.

KW - Adolescent

KW - Adult

KW - Aged

KW - Anti-Allergic Agents

KW - Antibodies, Anti-Idiotypic

KW - Antibodies, Monoclonal

KW - Antibodies, Monoclonal, Humanized

KW - Autoantibodies

KW - Autoantigens

KW - Female

KW - Humans

KW - Immunoglobulin E

KW - Male

KW - Middle Aged

KW - Omalizumab

KW - Urticaria

KW - Young Adult

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1016/j.jaci.2011.04.038

DO - 10.1016/j.jaci.2011.04.038

M3 - Journal article

C2 - 21636116

SN - 0091-6749

VL - 128

SP - 202-209.e5

JO - The Journal of allergy and clinical immunology

JF - The Journal of allergy and clinical immunology

IS - 1

ER -

Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase

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