Omalizumab is effective and safe in chronic inducible urticaria (CIndU): Real-world data from a large multi-national UCARE study.
angioedema
chronic inducible urticaria
drug survival
omalizumab
predictor
Journal
Allergy
ISSN: 1398-9995
Titre abrégé: Allergy
Pays: Denmark
ID NLM: 7804028
Informations de publication
Date de publication:
08 Oct 2024
08 Oct 2024
Historique:
revised:
25
07
2024
received:
17
05
2024
accepted:
11
09
2024
medline:
8
10
2024
pubmed:
8
10
2024
entrez:
8
10
2024
Statut:
aheadofprint
Résumé
Long-term data on the effectiveness and safety of omalizumab for chronic inducible urticaria (CIndU) in large populations are lacking. 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. 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. 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. 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.
Sections du résumé
BACKGROUND
BACKGROUND
Long-term data on the effectiveness and safety of omalizumab for chronic inducible urticaria (CIndU) in large populations are lacking.
OBJECTIVE
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
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
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
CONCLUSIONS
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.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Novartis Pharma
Informations de copyright
© 2024 The Author(s). Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.
Références
Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA2LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy: European. J Allergy Clin Immunol. 2022;77(3):734‐766. doi:10.1111/all.15090
Magerl M, Altrichter S, Borzova E, et al. The definition, diagnostic testing, and management of chronic inducible urticarias ‐ the EAACI/GA2LEN/EDF/UNEV consensus recommendations 2016 update and revision. J Allergy Clin Immunol. 2016;71(6):780‐802. doi:10.1111/all.12884
Maurer M, Schütz A, Weller K, et al. Omalizumab is effective in symptomatic dermographism ‐ results of a radomized placebo‐controlled trial. J Allergy Clin Immunol. 2017;140(3):870‐873.e5. doi:10.1016/j.jaci.2017.01.042
Metz M, Schütz A, Weller K, et al. Omalizumab is effective in cold urticaria—results of a randomized placebo‐controlled trial. J Allergy Clin Immunol. 2017;140(3):864‐867.e5. doi:10.1016/j.jaci.2017.01.043
Gastaminza G, Azofra J, Nunez‐Cordoba JM, et al. Efficacy and safety of Omalizumab (Xolair) for cholinergic Urticaria in patients unresponsive to a double dose of antihistamines: a randomized mixed double‐blind and open‐label placebo‐controlled clinical trial. Journal of allergy and clinical immunology. In Pract. 2019;7(5):1599‐1609.e1. doi:10.1016/j.jaip.2018.12.025
Yu M, Terhorst‐Molawi D, Altrichter S, et al. Omalizumab in chronic inducible urticaria: a real‐life study of efficacy, safety, predictors of treatment outcome and time to response. Clin Exp Allergy. 2021;51(5):730‐734. doi:10.1111/cea.13838
Can P, Salman A, Hosgören‐Tekin S, Kocatürk E. Effectiveness of Omalizumab in patients with chronic inducible Urticaria: real‐life experience from two UCARE centres. J Eur Acad Dermatol Venereol. 2021;35(10):e679‐e682. doi:10.1111/jdv.17385
Kocatürk E, Can PK, Akbas PE, et al. Management of chronic inducible urticaria according to the guidelines: a prospective controlled study. J Dermatol Sci. 2017;87(1):60‐69. doi:10.1016/j.jdermsci.2017.02.283
Buters TP, van der Velden WAC, Abdisalaam I, van Maaren MS, van Doorn MBA. Effectiveness and tolerability of personalized omalizumab treatment in patients with chronic inducible urticaria. Journal of allergy and clinical immunology. In Pract. 2021;9(8):3227‐3229. doi:10.1016/j.jaip.2021.04.034
Exposito‐Serrano V, Curto‐Barredo L, Aguilera Peiro P, et al. Omalizumab for the treatment of chronic inducible urticaria in 80 patients. Br J Dermatol. 2021;184(1):167‐168. doi:10.1111/bjd.19425
Fialek M, Dezoteux F, Le Moing A, et al. Omalizumab in chronic inducible urticaria: a retrospective, real‐life study. Ann Dermatol Venereol. 2021;148(4):262‐265. doi:10.1016/j.annder.2021.04.010
Ghazanfar MN, Sand C, Thomsen SF. Effectiveness and safety of omalizumab in chronic spontaneous or inducible urticaria: evaluation of 154 patients. Br J Dermatol. 2016;175(2):404‐406. doi:10.1111/bjd.14540
Metz M, Ohanyan T, Church MK, Maurer M. Retreatment with omalizumab results in rapid remission in chronic spontaneous and inducible urticaria. JAMA Dermatol. 2014;150(3):288‐290. doi:10.1001/jamadermatol.2013.8705
Metz M, Ohanyan T, Church MK, Maurer M. Omalizumab is an effective and rapidly acting therapy in difficult‐to‐treat chronic urticaria: a retrospective clinical analysis. J Dermatol Sci. 2014;73(1):57‐62. doi:10.1016/j.jdermsci.2013.08.011
Jeong SH, Lim DJ, Chang SE, Kim KH, Kim KJ, Park EJ. Omalizumab on chronic spontaneous Urticaria and chronic inducible Urticaria: a real‐world study of efficacy and predictors of treatment outcome. J Korean Med Sci. 2022;37(27):e211. doi:10.3346/jkms.2022.37.e211
Global Allergy and Asthma Excellence Network. Urticaria Centers of Reference and Excellence. Accessed April 13, 2023. https://ga2len‐ucare.com/
Castor Electronic Data Capture. Accessed April 17, 2023. https://www.castoredc.com/
Weller K, Groffik A, Church MK, et al. Development and validation of the Urticaria control test: a patient‐reported outcome instrument for assessing urticaria control. J Allergy Clin Immunol. 2014;133(5):1365‐1372.e6. doi:10.1016/j.jaci.2013.12.1076
Ferrer M, Boccon‐Gibod I, Gonçalo M, et al. Expert opinion: defining response to omalizumab in patients with chronic spontaneous urticaria. Eur J Dermatol. 2017;27(5):455‐463. doi:10.1684/ejd.2017.3085
Ohanyan T, Schoepke N, Bolukbasi B, et al. Responsiveness and minimal important difference of the urticaria control test. J Allergy Clin Immunol. 2017;140(6):1710‐1713.e11. doi:10.1016/j.jaci.2017.04.050
Graham JW, Olchowski AE, Gilreath TD. How many imputations are really needed? Some practical clarifications of multiple imputation theory. Prev Sci. 2007;8(3):206‐213. doi:10.1007/s11121-007-0070-9
Bodner TE. What improves with increased missing data imputations? Struct Equ Model. 2008;15(4):651‐675. doi:10.1080/10705510802339072
Gericke J, Metz M, Ohanyan T, et al. Serum autoreactivity predicts time to response to omalizumab therapy in chronic spontaneous urticaria. J Allergy Clin Immunol. 2017;139(3):1059‐1061. doi:10.1016/j.jaci.2016.07.047
Nettis E, Cegolon L, Di Leo E, Lodi Rizzini F, Detoraki A, Canonica GW. Omalizumab chronic spontaneous urticaria: efficacy, safety, predictors of treatment outcome, and time to response. Ann Allergy Asthma Immunol. 2018;121(4):474‐478. doi:10.1016/j.anai.2018.06.014
Soegiharto R, Alizadeh Aghdam M, Sørensen JA, et al. Multinational drug survival study of omalizumab in patients with chronic urticaria and potential predictors for discontinuation. JAMA Dermatol. 2024;160(9): 927‐935. doi:10.1001/jamadermatol.2024.2056
Giménez‐Arnau AM, Ribas‐Llauradó C, Mohammad‐Porras N, Deza G, Pujol RM, Gimeno R. IgE and high‐affinity IgE receptor in chronic inducible urticaria, pathogenic, and management relevance. Clin Transl. Allergy. 2022;12(2):e12117. doi:10.1002/clt2.12117
Litovsky J, Hacard F, Tétart F, et al. Omalizumab drug survival in chronic Urticaria: a retrospective multicentric French study. J Allergy Clin Immunol. 2023;1:3752‐3762.e2. doi:10.1016/j.jaip.2023.08.033
Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous Urticaria. N Engl J Med. 2013;368(10):924‐935. doi:10.1056/nejmoa1215372
Curto‐Barredo L, Pujol RM, Roura‐Vives G, Gimenez‐Arnau AM. Chronic urticaria phenotypes: clinical differences regarding triggers, activity, prognosis and therapeutic response. Eur J Dermatol. 2019;29(6):627‐635. doi:10.1684/ejd.2019.3674
Maurer M, Hawro T, Krause K, et al. Diagnosis and treatment of chronic inducible urticaria. Allergy. 2019;74(12):2550‐2553. doi:10.1111/all.13878
Ye YM, Yoon J, Woo SD, et al. Clustering the clinical course of chronic urticaria using a longitudinal database: effects on urticaria remission. Allergy, Asthma Immunol Res. 2021;13(3):390‐403. doi:10.4168/AAIR.2021.13.3.390
Pivneva I, Balp MM, Geissbühler Y, et al. Predicting clinical remission of chronic Urticaria using random survival forests: machine learning applied to real‐world data. Dermatol Ther (Heidelb). 2022;12(12):2747‐2763. doi:10.1007/s13555-022-00827-6
Di Bona D, Nettis E, Bilancia M, et al. Duration of chronic spontaneous urticaria remission after omalizumab discontinuation: a long‐term observational study. Journal of allergy and clinical immunology In Pract. 2021;9(6):2482‐2485.e2. doi:10.1016/j.jaip.2021.02.044
Meertens MAJ, Luijf T, van Lindonk EAM, et al. Age and fast initial response predict omalizumab retreatment in chronic urticaria. Journal of allergy and clinical immunology In Pract. 2023;11(11):3556‐3558. doi:10.1016/j.jaip.2023.07.030
Sposato B, Scalese M, Latorre M, et al. Effects of omalizumab in severe asthmatics across ages: a real life Italian experience. Respir Med. 2016;119:141‐149. doi:10.1016/j.rmed.2016.09.005