{"doi":"10.1016/j.jacig.2025.100498","title":"Treatment of indolent systemic mastocytosis with sarilumab is not supported in a randomized trial","abstract":"Background: . Serum levels of IL-6 correlate with severity of disease and risk of progression of systemic disease. Objective: We conducted a double-blind placebo-controlled study to assess safety and efficacy for the use of sarilumab in improving the quality of life for those with indolent systemic mastocytosis. ClinicalTrial.gov registration NCT03770273. Methods: A double-blind trial randomized 16 participants. The primary analysis compared the arms on the Mastocytosis Quality of Life Questionnaire (MC-QoL) index at 16 weeks, adjusting for the baseline MC-QoL. Mean baseline MC-QoL was 47.8. Results: = .40; 95% confidence interval, -8.9, 20.8), limiting a possible sarilumab advantage to at most 9 units of MC-QoL. Similar conclusions were observed for other quality-of-life indices. Conclusions: Results in this small trial did not support using sarilumab to treat this population and highlights the importance of double-blind randomized studies.","journal":"Journal of Allergy and Clinical Immunology Global","year":2025,"id":536189,"datarank":0.11706485716123521,"base_score":0.6931471805599453,"endowment":0.6931471805599453,"self_citation_contribution":0.10397207708399181,"citation_network_contribution":0.013092780077243411,"self_endowment_contribution":0.10397207708399181,"citer_contribution":0.013092780077243411,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":1,"citers_with_citation_signal":1,"citers_with_endowment":1,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9085,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT03770273"]},"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":266553,"name":"Jing Wang","orcid":"0000-0003-2410-5408","position":1,"is_corresponding":false},{"id":1421513,"name":"Robin A. Eisch","orcid":null,"position":2,"is_corresponding":false},{"id":517435,"name":"Linda M. Scott","orcid":"0000-0003-0334-1479","position":3,"is_corresponding":false},{"id":348690,"name":"Erica Brittain","orcid":"0000-0003-3370-6598","position":4,"is_corresponding":false},{"id":242067,"name":"Dean D. Metcalfe","orcid":"0000-0002-7781-8260","position":5,"is_corresponding":false},{"id":242063,"name":"Hirsh D. Komarow","orcid":"0000-0001-7012-9406","position":0,"is_corresponding":true}],"reference_count":21,"raw_metadata":null,"created_at":"2026-07-19T02:52:05.227140Z","pmid":"40529483","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}