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Multicenter Study
. 2025 Jun;55(6):481-492.
doi: 10.1111/cea.70067. Epub 2025 May 5.

Spectrum and Impact of Reported Side Effects of Omalizumab in Patients With Chronic Urticaria: A Long-Term Multicentre Real-World Study

Reineke Soegiharto  1 , Esther Van der Wind  1 , Mehran Alizadeh Aghdam  1 , Jennifer A Sørensen  2 , Esmee Van Lindonk  3 , Ferhan Bulut Demir  4 , Nasser Mohammad Porras  5 , Yoshimi Matsuo  6 , Lea Kiefer  7   8 , André C Knulst  1 , Marcus Maurer  7   8 , Carla Ritchie  9 , Michael Rudenko  10 , Emek Kocatürk  7   8   11 , Roberta Fachini Jardim Criado  12 , Stamatis Gregoriou  13 , Tatjana Bobylev  14 , Andreas Kleinheinz  14 , Shunsuke Takahagi  6 , Michihiro Hide  6   15 , Ana M Giménez-Arnau  5 , Andaç Salman  4   16 , Rabia Oztas Kara  17 , Bahar Sevimli Dikicier  17 , Martijn B A Van Doorn  3   18 , Simon F Thomsen  2 , Juul M P A Van den Reek  19 , Heike Röckmann  1
Affiliations
Multicenter Study

Spectrum and Impact of Reported Side Effects of Omalizumab in Patients With Chronic Urticaria: A Long-Term Multicentre Real-World Study

Reineke Soegiharto et al. Clin Exp Allergy. 2025 Jun.

Abstract

Background: Chronic urticaria (CU) treatment with omalizumab is considered safe in short-term studies. Large real-world studies focusing on the long-term safety of omalizumab and associated factors are lacking. We aimed to investigate the spectrum of reported side effects in omalizumab-treated CU patients in a large long-term daily practice cohort.

Methods: A multinational multicentre retrospective study was conducted at 14 specialised urticaria centres (UCAREs), including all CU patients ever treated with omalizumab until centre-specific data lock. The prevalence of patient-reported side effects was assessed.

Results: A total of 1859 patients were included, of which 32.9% (n = 612) reported side effects during omalizumab treatment with a wide range across centres (0%-75.5%). Fatigue (15.8%, n = 293), headache (11.6%, n = 215) and flu-like symptoms (9.3%, n = 172) were most common. No events suggestive of anaphylaxis and no new notably prevalent side effects were reported. Hair loss was reported by 2.9% (n = 53/1859) of patients, leading to treatment adjustment in 21.1% (n = 8/38 with sufficient data). Patients who reported side effects were more often female (78.3% vs. 68.6%, p < 0.001), had worse disease control prior to omalizumab (Urticaria Control Test, UCT, 4.0 vs. 6.0, p < 0.001), and lower fast response (Weekly Urticaria Activity Score, UAS7, < 7 or UCT > 11 within 4 weeks, 42.6% vs. 59.5%, p < 0.001) and complete/good response rates (UAS7 < 7 or UCT > 11 at end of treatment, 72.3% vs. 84.4%, p < 0.001) compared to patients without side effects. While only 2.4% (n = 44/1859) of patients discontinued treatment due to side effects, 5.5% (n = 100/1859) and 12.8% (n = 238/1859) of patients reporting side effects with insufficient (UAS7 ≥ 7 or UCT 3-11 at end of treatment) and complete/good response, respectively, remained on omalizumab.

Conclusions: The safety and tolerability of omalizumab was confirmed. Notably, the wide variation in reported side effects across centres suggests that differences in awareness influence reporting. Hair loss was more prevalent than described before, warranting extra attention. Side effects were more often reported in patients whose characteristics suggest reduced effectiveness of omalizumab, possibly related to a negative association with omalizumab and suggesting increased disease burden. Availability of new therapies might increase the impact of side effects on treatment decisions, not only in omalizumab-refractory patients but potentially even among good responders.

Keywords: IgE; angioedema; dermatology; mast Cells; multicentre; nocebo; omalizumab; side effects; urticaria.

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Conflict of interest statement

A.C.K.: None, in relation to this work. A.C. Knulst received institutional sponsoring for research or consultancy from: ALK, Thermofisher, Nutricia/Danone, DBV technologies, Novartis, EUROIMMUN, Stallergenes Greer. A.M.G.‐A: is or recently was a speaker and/or advisor for and/or has received research funding from Almirall, Amgen, AstraZeneca, Avene, Blue ‐Print, Celldex, Escient Pharmaceutials, Genentech, GSK, Harmonic Bio, Instituto Carlos III‐ FEDER, Jaspers, Leo Pharma, Menarini, Mitsubishi Tanabe Pharma, Noucor, Novartis, Sanofi–Regeneron, Septerna, Servier, Thermo Fisher Scientific, Uriach Pharma. A.S.: None, in relation to this work. Outside of it, A.S. was speaker and/or advisor for Abbvie, Bayer, Menarini, Novartis, Pfizer, and Sanofi. E.K.: Speaker and advisor for Novartis, Menarini, LaRoche Posey, Sanofi, Bayer. H.R.: has received research funding from Novartis to support this work. She received institutional sponsoring for Research, consultancy or speakers fee outside the submitted work from Pharming and Novartis Pharma, Sanofi, Third Harmonic Bio, Abbvie, Leo Pharma. J.M.P.A.v.d.R.: carried out clinical trials for AbbVie, Celgene, Almirall, and Janssen and has received speaking fees/attended advisory boards from AbbVie, Janssen, BMS, Almirall, LEO Pharma, Novartis, UCB and Eli Lilly and reimbursement for attending or chairing a symposium from Janssen, Pfizer, Celgene and AbbVie. All funding is not personal but goes to the independent research fund of the department of dermatology of Radboudumc Nijmegen, the Netherlands. M.A.A.: Received speakers fee from Novartis to institution. M.M.: None, in relation to this work. Outside of it, M.M. is or recently was a speaker and/or advisor for and/or has received research funding from Allakos, Alexion, Alvotech, Almirall, Amgen, Aquestive, argenX, AstraZeneca, Celldex, Celltrion, Clinuvel, Escient, Evommune, Excellergy, GSK, Incyte, Jasper, Kashiv, Kyowa Kirin, Leo Pharma, Lilly, Menarini, Mitsubishi Tanabe Pharma, Moxie, Noucor, Novartis, Orion Biotechnology, Resoncance Medicine, Sanofi/Regeneron, Santa Ana Bio, Septerna, Servier, Third HarmonicBio, ValenzaBio, Vitalli Bio, Yuhan Corporation, and Zurabio. M.H.: None, in relation to this work. Outside of it, M.H. is or recently was a speaker and/or advisor for and/or has received research funding from Amgen, Centogene, CSL Behring, Eisai, GI‐Innovation, GSK, Kaken, Kyorin, Kyowa Kirin, Mitsubishi‐Tanabe, Novartis, Sanofi/Regeneron, Taiho, Teikoku, UCB, and Uriach. M.B.A.v.D.: has received grants from governmental research institutes NWO and ZonMW and has received consulting fees or honorarium from Novartis, Abbvie, Pfizer, Leopharma, Sanofi, Lilly, Janssen, BMS, Almiral and Celgene, has received a grant and payment for lectures including service on speakers bureaus from Novartis, Sanofi and Janssen outside the submitted work. R.F.J.C.: None in relation with this work. Outside of it, R.F.J.C. was a speaker and/or advisor for and/or has received research funding from, Abbvie, Amgen, Lilly, Mantecorp, Novartis, Pfizer, Sanofi/Regeneron, Takeda. R.O.K.: None, in relation to this work. Outside of it, A.S. was speaker and/or advisor for Abbvie, Novartis. RS: No conflicts of interest. S.F.T.: Outside the submitted work S.F.T. has been a speaker or has served on advisory boards for Sanofi, AbbVie, CSL, Incyte, LEO Pharma, Pfizer, Eli Lilly, Novartis, UCB Pharma, Union Therapeutics, Almirall, Galderma, Symphogen, and Janssen Pharmaceuticals, and has received research support from Sanofi, AbbVie, LEO Pharma, Novartis, UCB Pharma, and Janssen Pharmaceuticals. S.T.: None, in relation to this work. Outside of it, S.T. has received research grant from Takeda, Mitsubishi‐Tanabe, Maruho, Lilly, Sanofi and Taiho Pharma, and honorarium from Mitsubishi‐Tanabe, CSL Behring, Kaken, Maruho, Takeda and Abbvie. S.G.: Outside the submitted work S.G. has been a speaker or has served on advisory boards for Sanofi, AbbVie, LEO Pharma, Pfizer, Eli Lilly, Novartis, UCB Pharma and Amgen. A.K., B.S.D., C.R., E.v.L., F.B.D., J.A.S., L.K., M.R., N.M.P., T.B., Y.M. these authors declare no conflicts of interest.

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