{"doi":"10.1111/all.70181","title":"Long‐Term Efficacy and Safety of Ligelizumab as Re‐Treatment in Patients With Chronic Spontaneous Urticaria","abstract":"BACKGROUND: Chronic spontaneous urticaria (CSU) is a debilitating skin condition affecting approximately 1% of the global population, characterized by recurrent wheals, angioedema, or both for over 6 weeks without identifiable external triggers. METHODS: This Phase 3b multicentre, double-blinded followed by open-label extension study evaluated the long-term efficacy and safety of ligelizumab re-treatment in patients with CSU who rolled over from previous studies. Patients from the PEARL-1 or PEARL-2 Phase 3 trials (re-treatment subpopulation) received blinded re-treatment with ligelizumab 72 mg or 120 mg every 4 weeks for 12 weeks, followed by open-label ligelizumab 120 mg up to Week 104. Patients from a Phase 3 open-label Japanese study or a Phase 2 pediatric study received open-label ligelizumab 120 mg throughout. Primary and key secondary efficacy endpoints were assessed at Week 12 in the re-treatment subpopulation; safety was evaluated throughout. RESULTS: In the overall ligelizumab re-treatment subpopulation, 53.5% and 57.5% of patients treated with ligelizumab 72 mg and 120 mg, respectively, achieved weekly urticaria activity score (UAS7) of ≤ 6 at Week 12. Re-treatment efficacy was demonstrated in both treatment arms, across all secondary endpoints, maintained up to Week 52. Re-treatment efficacy in the overall trial population showed similar trends to those in the re-treatment subpopulation. The safety profile of ligelizumab showed no new or unexpected safety signals compared with the known safety profile of ligelizumab. CONCLUSION: Long-term and re-treatment with ligelizumab was well tolerated and efficacious in patients with CSU, aligning with the short-term outcomes observed in the Phase 3 PEARL studies.","journal":"Allergy","year":2025,"id":584498,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9551,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":251714,"name":"Marcus Maurer","orcid":"0000-0002-4121-481X","position":1,"is_corresponding":false},{"id":315033,"name":"Adam Reich","orcid":"0000-0002-5573-1754","position":2,"is_corresponding":false},{"id":1210126,"name":"Chia‐Yu Chu","orcid":"0000-0002-9370-3279","position":3,"is_corresponding":false},{"id":1497290,"name":"Diana Deleanu","orcid":"0000-0002-8431-8352","position":4,"is_corresponding":false},{"id":264675,"name":"Gordon Sussman","orcid":"0000-0002-2202-2513","position":5,"is_corresponding":false},{"id":909155,"name":"Jorge Sánchez","orcid":"0000-0001-6341-783X","position":6,"is_corresponding":false},{"id":28655,"name":"Knut Brockow","orcid":"0000-0002-2775-3681","position":7,"is_corresponding":false},{"id":1497291,"name":"Koremasa Hayama","orcid":"0000-0001-8651-2493","position":8,"is_corresponding":false},{"id":1386353,"name":"Michihiro Hide","orcid":null,"position":9,"is_corresponding":false},{"id":1497292,"name":"M. 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