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Multicenter Study
. 2025 Feb;80(2):489-499.
doi: 10.1111/all.16334. Epub 2024 Oct 8.

Omalizumab is effective and safe in chronic inducible urticaria (CIndU): Real-world data from a large multi-national UCARE study

R Soegiharto  1 , M Alizadeh Aghdam  1 , J A Sørensen  2 , E van Lindonk  3 , F Bulut Demir  4 , N Mohammad Porras  5 , Y Matsuo  6 , L Kiefer  7   8 , A C Knulst  1 , M Maurer  7   8 , C Ritchie  9 , M Rudenko  10 , E Kocatürk  7   11 , R F J Criado  12 , S Gregoriou  13 , T Bobylev  14 , A Kleinheinz  14 , S Takahagi  6 , M Hide  6   15 , A M Giménez-Arnau  5 , A Salman  4   16 , R Oztas Kara  17 , B S Dikicier  17 , M B A van Doorn  3   18 , S F Thomsen  2 , J M P A van den Reek  19 , H Röckmann  1
Affiliations
Multicenter Study

Omalizumab is effective and safe in chronic inducible urticaria (CIndU): Real-world data from a large multi-national UCARE study

R Soegiharto et al. Allergy. 2025 Feb.

Abstract

Background: Long-term data on the effectiveness and safety of omalizumab for chronic inducible urticaria (CIndU) in large populations are lacking.

Objective: To evaluate the effectiveness, safety, estimated omalizumab treatment duration and its predictors, as well as differences between CIndU subtypes, in a large long-term CIndU cohort.

Methods: A multinational multicenter study was conducted at 14 specialized urticaria centres (UCAREs), including all CIndU patients ever treated with omalizumab from 2009 until July 2022. Kaplan-Meier survival and regression analyses were performed.

Results: Across 234 CIndU patients (55% female; mean age 37 years), 76% (n = 178) had standalone CIndU and 24% (n = 56) had predominant CIndU plus minor CSU, with an observation period up to 13 years. Most CIndU patients (73%, n = 145/200 with available data on response) had complete/good response to omalizumab treatment, without significant differences between CIndU subtypes. Sixty-two (26%) patients discontinued omalizumab; due to well-controlled disease (47%, n = 29), ineffectiveness (34%, n = 21), side effects (3%, n = 2), combination of ineffectiveness and side effects (3%, n = 2) and other reasons (13%, n = 8). The median estimated omalizumab treatment duration exceeded 5 years (54% drug survival at 5 years) and was mostly determined by well-controlled disease. Higher age predicted a lower chance to discontinue omalizumab due to well-controlled disease (HR 0.969, 95%CI 0.945-0.995). CIndU subtype and presence of minor CSU were not related to response and time until omalizumab discontinuation for any reason.

Conclusion: Omalizumab is highly effective and safe in CIndU patients, with long estimated treatment duration mainly reflecting long disease duration. Our data show omalizumab's high potential as treatment in any subtype of CIndU and support its clinical use for these patients.

Keywords: angioedema; chronic inducible urticaria; drug survival; omalizumab; predictor.

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Conflict of interest statement

ACK: None, in relation to this work. ACK received institutional sponsoring for research or consultancy from: ALK, Thermofisher, Nutricia/Danone, DBV technologies, Novartis, EUROIMMUN, Stallergenes Greer. AGA 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. AK: No conflicts of interest. AS: None, in relation to this work. Outside of it, AS was speaker and/or advisor for Abbvie, Bayer, Menarini, Novartis, Pfizer, and Sanofi. BSD: No conflicts of interest. CR: No conflicts of interest. EK: Speaker and advisor for Novartis, Menarini, LaRoche Posey, Sanofi, Bayer. EvL: No conflicts of interest. FBD: No conflicts of interest. HR 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. JAS: No conflicts of interest. JvdR: J M.P.A. van den Reek 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. LK: No conflicts of interest. MAA: No conflicts of interest. MM: None, in relation to this work. Outside of it, MM 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. MH: None, in relation to this work. Outside of it, MH 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. MR: No conflicts of interest. MvD: 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. NMP: No conflicts of interest. RFJC: None in relation with this work. Outside of it, RFJC was a speaker and/or advisor for and/or has received research funding from, Abbvie, Amgen, Lilly, Mantecorp, Novartis, Pfizer, Sanofi/Regeneron, Takeda. ROK: None, in relation to this work. Outside of it, AS was speaker and/or advisor for Abbvie, Novartis. RS: No conflicts of interest. SFT: Outside the submitted work SFT has been a speaker or has served on advisory boards for Sanofi, AbbVie, 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. ST: None, in relation to this work. Outside of it, ST 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. SG: Outside the submitted work SG has been a speaker or has served on advisory boards for Sanofi, AbbVie, LEO Pharma, Pfizer, Eli Lilly, Novartis, UCB Pharma and Amgen. TB: No conflicts of interest. YM: No conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Estimated omalizumab treatment duration (drug survival) in CIndU patients differentiated per reason for discontinuation. The overall estimated omalizumab treatment duration (total) and differentiated per reason for discontinuation: Well‐controlled disease, side effects and ineffectiveness. The numbers in italic represent the number of active patients on omalizumab at that specific time point.
FIGURE 2
FIGURE 2
Predictors of omalizumab discontinuation due to well‐controlled disease and ineffectiveness. OMA, omalizumab; max, maximum. All variables with a p‐value ≤.2 in the univariate cox regression analysis were included in the multivariate cox regression analysis. The outcome of the multivariate cox regression analysis is presented in this figure. Due to few (n = 4) discontinuations for side effects, no predictors thereof were analysed. I The treating physician in a particular center was allowed to prescribe a dose higher than 300 mg.
See this image and copyright information in PMC

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