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Publication Metadata only Sex matters in CSU: Women face greater burden and poorer urticaria control, especially in midlife-CURE insights(WILEY, 2025) Kocaturk, Emek; Salameh, Pascale; Asero, Riccardo; Bizjak, Mojca; Gimenez-Arnau, Ana; Grattan, Clive; Pesque, David; Planella-Fontanillas, Nidia; Herzog, Leonie Shirin; Buttgereit, Thomas; Bonnekoh, Hanna; Fomina, Daria; Kovalkova, Elena; Lebedkina, Marina; Kasperska-Zajac, Alicja; Zajac, Magdalena; Zamlynsk, Mateusz; Kulthanan, Kanokvalai; Tuchinda, Papapit; Khoshkhui, Maryam; Hassanpour, Zohreh; Peter, Jonny; Du-Thanh, Aurelie; Meshkova, Raisa; Abuzakouk, Mohamed; Makris, Michael; Bouillet, Laurence; Bocquet, Alexis; Gregoriou, Stamatios; Thomsen, Simon Francis; Dissemond, Joachim; Staubach, Petra; Bauer, Andrea; Danilycheva, Inna; van Doorn, Martijn; Parisi, Claudio; Metz, Martin; Fluhr, Joachim W.; Zuberbier, Torsten; Weller, Karsten; Kolkhir, Pavel; Free University of Berlin; Humboldt University of Berlin; Charite Universitatsmedizin Berlin; Free University of Berlin; Humboldt University of Berlin; Bahcesehir University; Lebanese American University; University of Nicosia; University Clinic Golnik; Pompeu Fabra University; Hospital del Mar Research Institute; Hospital del Mar; Sechenov First Moscow State Medical University; Astana Medical University; Medical University of Silesia; Mahidol University; Mashhad University of Medical Sciences; Ahvaz Jundishapur University of Medical Sciences (AJUMS); University of Cape Town; Universite de Montpellier; Cleveland Clinic Foundation; National & Kapodistrian University of Athens; University Hospital Attikon; CHU Grenoble Alpes; Communaute Universite Grenoble Alpes; Universite Grenoble Alpes (UGA); National & Kapodistrian University of Athens; University of Copenhagen; Copenhagen University Hospital; Bispebjerg Hospital; University of Copenhagen; University of Duisburg Essen; Johannes Gutenberg University of Mainz; Technische Universitat Dresden; Carl Gustav Carus University Hospital; NRC Institute of Immunology FMBA of Russia; Erasmus University Rotterdam; Erasmus MC; Hospital Italiano de Buenos Aires; University of Buenos Aires; University of Buenos Aires HospitalBackground: Chronic spontaneous urticaria (CSU), a disease predominantly affecting females, has limited information available on its differences between females and males of varying ages.Objective To investigate sex differences in age groups regarding disease activity, comorbidities, quality of life (QoL) and treatment patterns in CSU patients. Methods: We analysed Chronic Urticaria Registry (CURE) data, an international real-world registry for patients with chronic urticaria. Patients were recruited via an online platform using a standardized questionnaire. The data were analysed for demographics, age of onset, duration of urticaria, (Urticaria Activity Score [UAS], Urticaria Control Test [UCT], Chronic Urticaria Quality of Life Questionnaire [CU-Q2oL]), family history, systemic symptoms, aggravating factors, comorbidities, smoking and alcohol consumption, laboratory parameters, burden of disease, treatment distribution and response rates, compliance to treatment and adverse events. Comparisons were made among age groups <13, 13-17, 18-30, 31-50, 51-65 and >65 years. Results: Across 4136 CSU patients (from 58 sites across 29 countries), 2994 (72.4%) were female. Statistically significant female predominance started at age 31 (<0.001). Compared with males, females showed higher rates of angioedema (59.6 vs. 51.7%, p < 0.001), systemic symptoms (34.6 vs. 25.4%, p < 0.001), sleep disturbance (38.9 vs. 32.5%, p < 0.001), QoL impairment (CU-Q2oL score 32 vs. 27.7, p < 0.001) and lower rates of urticaria control than males in all medication categories (p < 0.05 for all). Females had more concomitant diseases, including asthma, thyroid disease, obesity, autoimmune disease, gastrointestinal disease and depression (p < 0.05 for all). The disease was especially more burdensome and refractory in females aged 51-65 years than males, evidenced by more angioedema and systemic symptoms, worse QoL, lower UCT scores and more emergency visits (p < 0.05 for all). However, these differences were not prominent in the elderly females (>65 years).Conclusion Compared with males, female CSU patients experience more burdensome disease, which gets worse in midlife.Publication Metadata only Efficacy of Omalizumab, Dupilumab, and Remibrutinib in Chronic Spontaneous Urticaria: Phase Data and Placebo Response(WILEY, 2025) Turk, Murat; Yilmaz, Insu; Ertas, Ragip; Kocaturk, Emek; Erciyes University; University of Health Sciences Turkey; Free University of Berlin; Humboldt University of Berlin; Charite Universitatsmedizin Berlin; Free University of Berlin; Humboldt University of Berlin; Bahcesehir UniversityPublication Metadata only Spectrum and Impact of Reported Side Effects of Omalizumab in Patients With Chronic Urticaria: A Long-Term Multicentre Real-World Study(WILEY, 2025) Soegiharto, Reineke; Van der Wind, Esther; Alizadeh Aghdam, Mehran; Sorensen, Jennifer A.; Van Lindonk, Esmee; Bulut Demir, Ferhan; Mohammad Porras, Nasser; Matsuo, Yoshimi; Kiefer, Lea; Knulst, Andre C.; Maurer, Marcus; Ritchie, Carla; Rudenko, Michael; Kocatuerk, Emek; Criado, Roberta Fachini Jardim; Gregoriou, Stamatis; Bobylev, Tatjana; Kleinheinz, Andreas; Takahagi, Shunsuke; Hide, Michihiro; Gimenez-Arnau, Ana M.; Salman, Andac; Oztas Kara, Rabia; Sevimli Dikicier, Bahar; Van Doorn, Martijn B. A.; Thomsen, Simon F.; Van den Reek, Juul M. P. A.; Roeckmann, Heike; Utrecht University; Utrecht University Medical Center; University of Copenhagen; Copenhagen University Hospital; Bispebjerg Hospital; University of Copenhagen; Bispebjerg Hospital; Copenhagen University Hospital; Erasmus University Rotterdam; Erasmus MC; Marmara University; Hospital del Mar Research Institute; Hospital del Mar; Pompeu Fabra University; Hiroshima University; Free University of Berlin; Humboldt University of Berlin; Charite Universitatsmedizin Berlin; Free University of Berlin; Humboldt University of Berlin; University of Buenos Aires; University of Buenos Aires Hospital; Hospital Italiano de Buenos Aires; Bahcesehir University; National & Kapodistrian University of Athens; Hiroshima City Hospital; Acibadem University; Sakarya University; Radboud University NijmegenBackgroundChronic 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. MethodsA 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. ResultsA 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. ConclusionsThe 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.Publication Metadata only Sex matters in CSU: Women face greater burden and poorer urticaria control, especially in midlife-CURE insights(WILEY, 2025) Kocaturk, Emek; Salameh, Pascale; Asero, Riccardo; Bizjak, Mojca; Gimenez-Arnau, Ana; Grattan, Clive; Pesque, David; Planella-Fontanillas, Nidia; Herzog, Leonie Shirin; Buttgereit, Thomas; Bonnekoh, Hanna; Fomina, Daria; Kovalkova, Elena; Lebedkina, Marina; Kasperska-Zajac, Alicja; Zajac, Magdalena; Zamlynsk, Mateusz; Kulthanan, Kanokvalai; Tuchinda, Papapit; Khoshkhui, Maryam; Hassanpour, Zohreh; Peter, Jonny; Du-Thanh, Aurelie; Meshkova, Raisa; Abuzakouk, Mohamed; Makris, Michael; Bouillet, Laurence; Bocquet, Alexis; Gregoriou, Stamatios; Thomsen, Simon Francis; Dissemond, Joachim; Staubach, Petra; Bauer, Andrea; Danilycheva, Inna; van Doorn, Martijn; Parisi, Claudio; Metz, Martin; Fluhr, Joachim W.; Zuberbier, Torsten; Weller, Karsten; Kolkhir, Pavel; Free University of Berlin; Humboldt University of Berlin; Charite Universitatsmedizin Berlin; Free University of Berlin; Humboldt University of Berlin; Bahcesehir University; Lebanese American University; University of Nicosia; University Clinic Golnik; Pompeu Fabra University; Hospital del Mar Research Institute; Hospital del Mar; Sechenov First Moscow State Medical University; Astana Medical University; Medical University of Silesia; Mahidol University; Mashhad University of Medical Sciences; Ahvaz Jundishapur University of Medical Sciences (AJUMS); University of Cape Town; Universite de Montpellier; Cleveland Clinic Foundation; National & Kapodistrian University of Athens; University Hospital Attikon; CHU Grenoble Alpes; Communaute Universite Grenoble Alpes; Universite Grenoble Alpes (UGA); National & Kapodistrian University of Athens; University of Copenhagen; Copenhagen University Hospital; Bispebjerg Hospital; University of Copenhagen; University of Duisburg Essen; Johannes Gutenberg University of Mainz; Technische Universitat Dresden; Carl Gustav Carus University Hospital; NRC Institute of Immunology FMBA of Russia; Erasmus University Rotterdam; Erasmus MC; Hospital Italiano de Buenos Aires; University of Buenos Aires; University of Buenos Aires HospitalBackground: Chronic spontaneous urticaria (CSU), a disease predominantly affecting females, has limited information available on its differences between females and males of varying ages.Objective To investigate sex differences in age groups regarding disease activity, comorbidities, quality of life (QoL) and treatment patterns in CSU patients. Methods: We analysed Chronic Urticaria Registry (CURE) data, an international real-world registry for patients with chronic urticaria. Patients were recruited via an online platform using a standardized questionnaire. The data were analysed for demographics, age of onset, duration of urticaria, (Urticaria Activity Score [UAS], Urticaria Control Test [UCT], Chronic Urticaria Quality of Life Questionnaire [CU-Q2oL]), family history, systemic symptoms, aggravating factors, comorbidities, smoking and alcohol consumption, laboratory parameters, burden of disease, treatment distribution and response rates, compliance to treatment and adverse events. Comparisons were made among age groups <13, 13-17, 18-30, 31-50, 51-65 and >65 years. Results: Across 4136 CSU patients (from 58 sites across 29 countries), 2994 (72.4%) were female. Statistically significant female predominance started at age 31 (<0.001). Compared with males, females showed higher rates of angioedema (59.6 vs. 51.7%, p < 0.001), systemic symptoms (34.6 vs. 25.4%, p < 0.001), sleep disturbance (38.9 vs. 32.5%, p < 0.001), QoL impairment (CU-Q2oL score 32 vs. 27.7, p < 0.001) and lower rates of urticaria control than males in all medication categories (p < 0.05 for all). Females had more concomitant diseases, including asthma, thyroid disease, obesity, autoimmune disease, gastrointestinal disease and depression (p < 0.05 for all). The disease was especially more burdensome and refractory in females aged 51-65 years than males, evidenced by more angioedema and systemic symptoms, worse QoL, lower UCT scores and more emergency visits (p < 0.05 for all). However, these differences were not prominent in the elderly females (>65 years).Conclusion Compared with males, female CSU patients experience more burdensome disease, which gets worse in midlife.Publication Metadata only Navigating Non-Response: Prognosis and Strategies in Chronic Spontaneous Urticaria Management(WILEY, 2025) Kocatuerk, Emek; Zuberbier, Torsten; Free University of Berlin; Humboldt University of Berlin; Charite Universitatsmedizin Berlin; Free University of Berlin; Humboldt University of Berlin; Bahcesehir UniversityPublication Metadata only Mucosal angioedema involving the oropharynx signals severe cold urticaria: COLD-CE study insights(WILEY, 2025) Bizjak, Mojca; Fomina, Daria; Peter, Jonny; Gimenez-Arnau, Ana Maria; Pesque, David; Goncalo, Margarida; Aarestrup, Fernando Monteiro; Ahsan, Dalia Melina; Al-Ahmad, Mona; Altrichter, Sabine; Andrenova, Gerelma; Bauer, Andrea; Borzova, Elena; Costa, Celia; Fachini Criado, Roberta; Demir, Semra; Dinevski, Dejan; Ensina, Luis Felipe; Gelincik, Asli; Gotua, Maia; Holm, Jesper Gronlund; Inomata, Naoko; Khoshkhui, Maryam; Klyucharova, Aliya; Kocatuerk, Emek; Kosnik, Mitja; Kulthanan, Kanokvalai; de Souza Lima, Eduardo M.; Lu, Rongbiao; Makris, Michael; Meshkova, Raisa; Pasali, Maria; Paulino, Marisa; Ramon, German Dario; Ritchie, Carla; Rudenko, Michael; Thomsen, Simon Francis; Rodrigues Valle, Solange Oliveira; Wagner, Nicola; Xepapadaki, Paraskevi; Xue, Xiaoyang; Kasperska-Zajac, Alicja; Zhao, Zuotao; Terhorst-Molawi, Dorothea; University Clinic Golnik; University of Ljubljana; Sechenov First Moscow State Medical University; University of Cape Town; University of Cape Town; Pompeu Fabra University; Hospital del Mar Research Institute; Hospital del Mar; Hospital del Mar Research Institute; Hospital del Mar; Autonomous University of Barcelona; Hospital Universitari Vall d'Hebron; Universidade de Coimbra; Centro Hospitalar e Universitario de Coimbra (CHUC); Humboldt University of Berlin; Free University of Berlin; Charite Universitatsmedizin Berlin; Berlin Institute of Health; Kuwait University; Kepler University Hospital; Johannes Kepler University Linz; Technische Universitat Dresden; Carl Gustav Carus University Hospital; Niigata University; Universidade de Lisboa; Hospital Santa Maria; Faculdade de Medicina do ABC; Istanbul University; University of Maribor; Universidade Federal de Sao Paulo (UNIFESP); University of Copenhagen; Copenhagen University Hospital; Bispebjerg Hospital; Yokohama City University; Mashhad University of Medical Sciences; Kazan Federal University; Bahcesehir University; Mahidol University; Sun Yat Sen University; National & Kapodistrian University of Athens; University Hospital Attikon; University of Buenos Aires; University of Buenos Aires Hospital; Hospital Italiano de Buenos Aires; Universidade Federal do Rio de Janeiro; University of Erlangen Nuremberg; National & Kapodistrian University of Athens; Community Health Service Center; Medical University of SilesiaPublication Metadata only Spectrum and Impact of Reported Side Effects of Omalizumab in Patients With Chronic Urticaria: A Long-Term Multicentre Real-World Study(WILEY, 2025) Soegiharto, Reineke; Van der Wind, Esther; Alizadeh Aghdam, Mehran; Sorensen, Jennifer A.; Van Lindonk, Esmee; Bulut Demir, Ferhan; Mohammad Porras, Nasser; Matsuo, Yoshimi; Kiefer, Lea; Knulst, Andre C.; Maurer, Marcus; Ritchie, Carla; Rudenko, Michael; Kocatuerk, Emek; Criado, Roberta Fachini Jardim; Gregoriou, Stamatis; Bobylev, Tatjana; Kleinheinz, Andreas; Takahagi, Shunsuke; Hide, Michihiro; Gimenez-Arnau, Ana M.; Salman, Andac; Oztas Kara, Rabia; Sevimli Dikicier, Bahar; Van Doorn, Martijn B. A.; Thomsen, Simon F.; Van den Reek, Juul M. P. A.; Roeckmann, Heike; Utrecht University; Utrecht University Medical Center; University of Copenhagen; Copenhagen University Hospital; Bispebjerg Hospital; University of Copenhagen; Bispebjerg Hospital; Copenhagen University Hospital; Erasmus University Rotterdam; Erasmus MC; Marmara University; Hospital del Mar Research Institute; Hospital del Mar; Pompeu Fabra University; Hiroshima University; Free University of Berlin; Humboldt University of Berlin; Charite Universitatsmedizin Berlin; Free University of Berlin; Humboldt University of Berlin; University of Buenos Aires; University of Buenos Aires Hospital; Hospital Italiano de Buenos Aires; Bahcesehir University; National & Kapodistrian University of Athens; Hiroshima City Hospital; Acibadem University; Sakarya University; Radboud University NijmegenBackgroundChronic 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. MethodsA 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. ResultsA 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. ConclusionsThe 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.Publication Metadata only Chronic inducible urticaria - having more than one is common and clinically relevant(FRONTIERS MEDIA SA, 2025) Lebedkina, Marina; Kovalkova, Elena; Andrenova, Gerelma; Dushkin, Alexander; Chernov, Anton; Nikitina, Ekaterina; Karaulov, Alexander; Lysenko, Maryana; Maurer, Marcus; Kocatuerk, Emek; Fomina, Daria; Free University of Berlin; Humboldt University of Berlin; Charite Universitatsmedizin Berlin; Bahcesehir University; Astana Medical UniversityBackground Chronic inducible urticaria (CIndU) is characterized by wheals and/or angioedema (AE) for 6 weeks or more in response to specific and definite triggers. Individual patients can have more than one type of CIndU. Reports on this come from single cases or small case series, most epidemiological studies did not assess whether these urticaria are standalone or mixed. Objective Determine the features of mixed CIndU and how they differ from standalone forms. Methods In a prospective cohort study we performed provocative testing in 210 patients with CIndU. A total of 188 patients were included (125 with the standalone CIndU and 63 with the mixed CIndU. Within each group, patients were divided into subgroups: symptomatic dermographism (SD), cold (ColdU) and cholinergic urticaria (CholU). Results Mixed CIndU most commonly were SD+ColdU (n=19, 30.2%), SD+CholU (n=15, 23.8%), SD+DPU (n=12, 19%) and ColdU+CholU (n=9, 14.3%). Comorbid chronic spontaneous urticaria (CSU) (50.8% vs 20.8, p<0.001) and AE (36.5% vs. 20%, p=0.014) were more common in patients with mixed CIndUs. In patients with mixed CIndUs, their onset time is more closely linked to each other (n=43, 68.2%) as compared to that of comorbid CSU (12 of 32, 37.5%). MixedSD patients are younger, show earlier onset of disease and have higher rates of AE and lower rates of atopic dermatitis (AtD), as compared to patients with standalone SD. MixedColdU patients have higher rates of comorbid CSU and lower rates of AtD, higher levels of total IgE and eosinophils. MixedCholU patients are older, have a high rate of comorbid CSU, a lower incidence of allergic disease. Conclusion This study shows for the first time that each combinations of mixed CIndU represent a distinct phenotype with its own features. These phenotypes require special attention of specialists.Publication Metadata only How Infection and Vaccination Are Linked to Acute and Chronic Urticaria: A Special Focus on COVID-19(MDPI, 2023) Kocatuerk, Emek; Munoz, Melba; Elieh-Ali-Komi, Daniel; Criado, Paulo Ricardo; Peter, Jonny; Kolkhir, Pavel; Can, Pelin; Gotua, Maia; Wedi, Bettina; Rudenko, Michael; Ensina, Luis Felipe; Grattan, Clive; Maurer, Marcus; Free University of Berlin; Humboldt University of Berlin; Charite Universitatsmedizin Berlin; Koc University; University of Cape Town; Bahcesehir University; Hannover Medical School; Universidade Federal de Sao Paulo (UNIFESP); University of London; King's College London; Guy's & St Thomas' NHS Foundation TrustSince more than a century ago, there has been awareness of the connection between viral infections and the onset and exacerbation of urticaria. Our knowledge about the role of viral infection and vaccination in acute and chronic urticaria improved as a result of the COVID-19 pandemic but it has also highlighted knowledge gaps. Viral infections, especially respiratory tract infections like COVID-19, can trigger the onset of acute urticaria (AU) and the exacerbation of chronic urticaria (CU). Less frequently, vaccination against viruses including SARS-CoV-2 can also lead to new onset urticaria as well as worsening of CU in minority. Here, with a particular focus on COVID-19, we review what is known about the role of viral infections and vaccinations as triggers and causes of acute and chronic urticaria. We also discuss possible mechanistic pathways and outline the unmet needs in our knowledge. Although the underlying mechanisms are not clearly understood, it is believed that viral signals, medications, and stress can activate skin mast cells (MCs). Further studies are needed to fully understand the relevance of viral infections and vaccinations in acute and chronic urticaria and to better clarify causal pathways.Publication Metadata only Omalizumab in pediatric chronic spontaneous urticaria: A systematic review and meta-analysis of efficacy and safety(WILEY, 2025) Alomari, Omar; Ozceker, Deniz; Mokresh, Muhammed Edib; Topcak, Asli Berivan; Ertan, Sinem Nur; Sahin, Merve Karaca; Caliskan, Nilay; Karadag, Sefika Ilknur Kokcu; Erbay, Muhammed Fatih; Yildirim, Guler; Bologur, Hamit; Gungor, Hilal; Kaplan, Ozlem; Tunc, Hasan Sarman; Goncu, Emek Kocaturk; University of Health Sciences Turkey; University of Health Sciences Turkey; Free University of Berlin; Humboldt University of Berlin; Charite Universitatsmedizin Berlin; Free University of Berlin; Humboldt University of Berlin; Bahcesehir UniversityChronic spontaneous urticaria significantly impairs quality of life in children, with limited treatment options beyond antihistamines. Omalizumab, an anti-IgE antibody, has shown promise in adults but data on its use in children, especially those under 12, are scarce. This systematic review and meta-analysis aim to evaluate the efficacy and safety of omalizumab in pediatric chronic spontaneous urticaria, providing insights to inform clinical practice and future guidelines. PubMed, Scopus, Embase, Cochrane, and Web of Science databases have been searched for relevant studies. The R software has been utilized to analyze the response and relapse rates, changes in urticaria scores, and adverse event rates. Subgroup analyses were also done based on response rate. The assessment of heterogeneity utilized the I2 and chi-squared tests, applying the random effect model. This systematic review included 36 studies met the inclusion criteria. The pooled response rate for omalizumab was 88.0% (95% CI: 80.7%-95.2%, I-2 = 61.0%, p = .001), with a complete response rate of 51.0% (95% CI: 32.7%-69.2%, I2 = 90.0%, p < .001). Good or well-controlled response rates were 50.5% (95% CI: 33.9%-67.1%, I-2 = 54.2%, p = .068), while poor or partial responses were 20.1% (95% CI: 14.3%-27.3%, I-2 = 0.0%, p = .787). Relapse rate were 24.3% (95% CI: 8.1%-40.6%, I-2 = 66.6%, p = .006). The Urticaria Activity Score showed a significant mean reduction in symptoms (SMD = -3.08, 95% CI: -5.45 to -0.71, I-2 = 89.1%, p < .001). Adverse events occurred in 3.4% of patients, with specific events including urticaria, angioedema, headaches, fatigue, flu-like symptoms, and mild joint pain. In pediatric patients under 12 years, 18 out of 21 achieved complete response, with a median age of 8 years and follow-up durations between 4 and 18 months. Adverse events in this group included serum sickness in one patient. Omalizumab appears to be an effective treatment option for chronic spontaneous urticaria, demonstrating effectiveness in improving symptoms and providing significant relief. The treatment is generally well-tolerated, with adverse events being rare and manageable. Overall, omalizumab contributing to better disease management and quality of life.