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

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• 作者：Marcus Maurer MD^a ; ^{marcus.maurer@charite.de" rel="nofollow} ; Sabine Altrichter MD^a ; Thomas Bieber MD^b ; Tilo Biedermann MD^c ; Matthias Brä ; utigam PhD^d ; Stefan Seyfried PhD^e ; Randolf Brehler MD^f ; J&#xfc ; rgen Grabbe MD^g ; Nicolas Hunzelmann MD^h ; Thilo Jakob MDⁱ ; Andreas Jung MD^j ; Jö ; rg Kleine-Tebbe MD^k ; Martin Mempel MD^l ; Michael Meurer MD^m ; Kristian Reich MDⁿ ; Franziska Ruë ; ff MD^o ; Knut Schä ; kel MD^p ; Kaushik Sengupta BDS ; MScD^q ; Christian Sieder MSc^d ; Jan C. Simon MD^r ; Bettina Wedi MD^s ; Torsten Zuberbier MD^a ; Vera Mahler MD^t ; Petra Staubach MD^u
• 关键词：Urticaria ; wheals ; pruritus ; mast cells ; anti-IgE ; antihistamine ; CU-Q2oL
• 刊名：Journal of Allergy and Clinical Immunology
• 出版年：2011
• 出版时间：July 2011
• 年：2011
• 卷：128
• 期：1
• 页码：202-209.e5
• 全文大小：586 K

文摘

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.