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Efficacy and safety of omalizumab in patients with chronicurticaria who exhibit IgE against thyroperoxidaseMarcus Maurer, MD, a Sabine Altrichter, MD, a Thomas Bieber, MD, b Tilo Biedermann, MD, c Matthias Br€autigam, PhD, dStefan Seyfried, PhD, e Randolf Brehler, MD, f J€urgen Grabbe, MD, g Nicolas Hunzelmann, MD, h Thilo Jakob, MD, iAndreas Jung, MD, j J€org Kleine-Tebbe, MD, k Martin Mempel, MD, l Michael Meurer, MD, m Kristian Reich, MD, nFranziska Ru€eff, MD, o Knut Sch€akel, MD, p Kaushik Sengupta, BDS, MScD, q Christian Sieder, MSc, d Jan C. Simon, MD, rBettina Wedi, MD, s Torsten Zuberbier, MD, a Vera Mahler, MD, t and Petra Staubach, MD u Berlin, Bonn, T€ubingen, N€urnberg,M€unster, L€ubeck, K€oln, Freiburg, Gießen, G€ottingen, Munich, Dresden, Hamburg, Heidelberg, Leipzig, Hannover, Erlangen, and Mainz,Germany, Basel, Switzerland, and Hyderabad, IndiaBackground: A subgroup of patients with chronic spontaneousurticaria (CU) exhibits IgE antibodies directed againstautoantigens, such as thyroperoxidase (TPO). We conductedthis study to investigate whether such patients with CU with IgEagainst TPO benefit from treatment with omalizumab, ahumanized anti-IgE mAb licensed for the treatment of severepersistent allergic (IgE-mediated) asthma.Objectives: We sought to assess the efficacy of omalizumabtreatment in patients with CU with IgE autoantibodies againstTPO.Methods: In this multicenter, randomized, double-blind,placebo-controlled study patients with CU (male/female, 18-70years of age) with IgE autoantibodies against TPO who hadpersistent symptoms (wheals and pruritus) despite standardantihistamine therapy were randomized to receive eitheromalizumab (75-375 mg, dose determined by using theapproved asthma dosing table) or placebo subcutaneously onceevery 2 or 4 weeks for 24 weeks. The primary end point was thechange from baseline in mean weekly urticaria activity scoreafter 24 weeks of treatment, as calculated from patients’diaries. The safety and tolerability of omalizumab were alsoassessed.Results: Of the 49 randomized patients (omalizumab, n 5 27;placebo, n 5 22), 42 completed the study. At week 24, patientsdemonstrated a mean reduction in the weekly urticaria activityscore from baseline of 17.8 with omalizumab and 7.9 with placebo(P 5 .0089). Complete protection from wheal development wasobserved in 19 (70.4%) patients in the omalizumab groupcompared with only 1 (4.5%) patient in the placebo group. The rateof adverse events was similar in both groups.Conclusions: The results of this study indicate that omalizumabis an effective treatment option for patients with CU with IgEautoantibodies against TPO who are refractory to conventionaltreatment. (J Allergy Clin Immunol 2011;128:202-9.)Key words: Urticaria, wheals, pruritus, mast cells, anti-IgE, antihistamine,CU-Q2oLChronic spontaneous urticaria (CU) is a common and disablingdisease characterized by recurrent, itchy, wheal and flare–typeskin reactions; angioedema; or both. 1 H 1 -antihistamines are themainstay of symptomatic therapy. However, less than half of patientswith CU achieve sufficient symptom control with antihistaminesat standard doses, the only licensed treatment for CU. 2,3CU symptoms are brought about by the degranulation of skinmast cells. During the past decade, several mechanisms of mastcell activation in CU have been identified. For example, IgGautoantibodies directed against IgE, which are detectable in asubset of patients with CU, can cause cross-linking of mast cell–bound IgE and subsequent mast cell degranulation. 4,5 Anothersubgroup of patients with CU exhibits IgG autoantibodies directedagainst the a-subunit of the high-affinity IgE receptorFceRI on mast cells. 4,6,7 Very recently, we have identified a subgroupof patients with CU who exhibit IgE autoantibodies againstthyroperoxidase (TPO), and IgE antibodies against TPO (IgE–anti-TPO)–positive patients with CU exhibit significantly higherFrom a Charite–Universit€atsmedizin Berlin, Allergie-Centrum-Charite, Klinik f€urDermatologie, Venerologie und Allergologie, Berlin; b Universit€atsklinikum Bonn,Klinik und Poliklinik f€ur Dermatologie und Allergologie, Bonn; c Universit€ats-Hautklinik,Eberhard Karls University T€ubingen; d Novartis Pharma AG, N€urnberg; e NovartisPharma AG, Basel; f Universit€atsklinikum M€unster, Klinik und Poliklinik f€urHautkrankheiten, M€unster; g Universit€atsklinikum Schleswig-Holstein, Klinik f€ur Dermatologie,Venerologieund Allergologie, L€ubeck; h Klinik und Poliklinik f€ur Dermatologieund Venerologie des Universit€atsklinikums K€oln; i Allergy Research Group,Department of Dermatology, University Medical Center Freiburg, Freiburg; j Zentrumder Dermatologie und Andrologie (Hautklinik), Universit€atsklinikum Gießen undMarburg GmbH, Gießen; k Untersuchungszentrum Dermatologie, Allergologie undAsthma (UZDAA), Berlin; l the Department of Dermatology, Venereology, UMGG€ottingen;m Universit€ats Allergie Centrum Dresden, Klinik und Poliklinik f€urDermatologie, Dresden; n Dermatologikum Hamburg; o Klinik und Poliklinik f€urDermatologie und Allergologie, Ludwig-Maximilians-Universit€at, Munich;p Universit€ats-Hautklinik, Universit€atsklinikum Heidelberg, Heidelberg;q NovartisHealthcare Pvt Ltd, Hyderabad; r Klinik f€ur Dermatologie,Venerologie und Allergologie,Universit€atsklinikum Leipzig A€oR, Leipzig; s the Department of Dermatology andAllergy, Hannover Medical School, Hannover; t the Department of Dermatology,University Hospital Erlangen; and u the University Medical Center of the JohannesGutenberg-University Mainz, Department of Dermatology and Allergy, Mainz.Sponsored by Novartis Pharma GmbH, Germany.Disclosure of potential conflict of interest: T. Biedermann, T. Jakob, J. Kleine-Tebbe, andB. Wedi receive research support from Novartis. M. Br€autigam, S. Seyfried, andK. Sengupta are Novartis employees. R. Brehler, M. Maurer, and K. Sch€akel receivedhonoraria for lectures and research support from Novartis. T. Zuberbier has recievedhonoraria for consulting for Novartis. The rest of the authors have declared that theyhave no conflict of interest.Received for publication September 1, 2010; revised March 22, 2011; accepted for publicationApril 1, 2011.Available online June 6, 2011.Reprint requests: Marcus Maurer, MD, Allergie-Centrum-Charite, Department of Dermatologyand Allergy, Charite–Universit€atsmedizin Berlin, Chariteplatz 1, 10117Berlin, Germany. E-mail: marcus.maurer@charite.de.0091-6749/$36.00Ó 2011 American Academy of Allergy, Asthma & Immunologydoi:10.1016/j.jaci.2011.04.038202

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