{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T18:14:27Z","timestamp":1792088067683,"version":"4.4.0"},"reference-count":60,"publisher":"American Society of Hematology","issue":"17","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2022,4,28]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Excessive intravascular release of lysed cellular contents from damaged red blood cells (RBCs) in patients with sickle cell anemia (SCA) can activate the inflammasome, a multiprotein oligomer promoting maturation and secretion of proinflammatory cytokines, including interleukin-1\u03b2 (IL-1\u03b2). We hypothesized that IL-1\u03b2 blockade by canakinumab in patients with SCA would reduce markers of inflammation and clinical disease activity. In this randomized, double-blind, multicenter phase 2a study, patients aged 8 to 20 years with SCA (HbSS or HbS\u03b20-thalassemia), history of acute pain episodes, and elevated high-sensitivity C-reactive protein &amp;gt;1.0 mg\/L at screening were randomized 1:1 to received 6 monthly treatments with 300 mg subcutaneous canakinumab or placebo. Measured outcomes at baseline and weeks 4, 8, 12, 16, 20, and 24 included electronic patient-reported outcomes, hospitalization rate, and adverse events (AEs) and serious AEs (SAEs). All but 1 of the 49 enrolled patients were receiving stable background hydroxyurea therapy. Although the primary objective (prespecified reduction of pain) was not met, compared with patients in the placebo arm, patients treated with canakinumab had reductions in markers of inflammation, occurrence of SCA-related AEs and SAEs, and number and duration of hospitalizations as well as trends for improvement in pain intensity, fatigue, and absences from school or work. Post hoc analysis revealed treatment effects on weight, restricted to pediatric patients. Canakinumab was well tolerated with no treatment-related SAEs and no new safety signal. These findings demonstrate that the inflammation associated with SCA can be reduced by selective IL-1\u03b2 blockade by canakinumab with potential for therapeutic benefits. This trial was registered at www.clinicaltrials.gov as #NCT02961218.<\/jats:p>","DOI":"10.1182\/blood.2021013674","type":"journal-article","created":{"date-parts":[[2022,2,28]],"date-time":"2022-02-28T22:03:00Z","timestamp":1646085780000},"page":"2642-2652","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":42,"title":["A randomized, placebo-controlled, double-blind trial of canakinumab in children and young adults with sickle cell anemia"],"prefix":"10.1182","volume":"139","author":[{"given":"David C.","family":"Rees","sequence":"first","affiliation":[{"name":"King's College London and King\u2019s College Hospital NHS Foundation Trust, London, United Kingdom;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yurdanur","family":"Kilinc","sequence":"additional","affiliation":[{"name":"Cukurova University Medical Faculty, Adana, Turkey;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Selma","family":"Unal","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology, Mersin University Medical Faculty, Mercin, Turkey;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7738-2620","authenticated-orcid":false,"given":"Carlton","family":"Dampier","sequence":"additional","affiliation":[{"name":"Children's Healthcare of Atlanta, Emory University School of Medicine, Atlanta, GA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Betty S.","family":"Pace","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Augusta University, Augusta, GA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Banu","family":"Kaya","sequence":"additional","affiliation":[{"name":"Barts Health NHS Trust, Royal London Hospital, London, United Kingdom;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7099-8449","authenticated-orcid":false,"given":"Sara","family":"Trompeter","sequence":"additional","affiliation":[{"name":"Cancer CT Unit, University College London Hospitals NHS Foundation Trust, and NHS Blood and Transplant, London, United Kingdom;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isaac","family":"Odame","sequence":"additional","affiliation":[{"name":"Hemoglobinopathy Program, The Hospital for Sick Children (SickKids), Toronto, ON, Canada;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5781-7669","authenticated-orcid":false,"given":"Johnny","family":"Mahlangu","sequence":"additional","affiliation":[{"name":"Haemophilia Comprehensive Care Centre, Faculty of Health Sciences, University of the Witwatersrand and NHLS, Johannesburg, Gauteng, South Africa;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sule","family":"Unal","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology, Hacettepe University, Ankara, Turkey;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Brent","sequence":"additional","affiliation":[{"name":"New Cross Hospital\/The Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Regine","family":"Grosse","sequence":"additional","affiliation":[{"name":"Clinic of Pediatric Hematology and Oncology, University Hospital Hamburg-Eppendorf, Hamburg, Germany;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beng R.","family":"Fuh","sequence":"additional","affiliation":[{"name":"Brody School of Medicine At East Carolina University, Greenville, NC;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2643-765X","authenticated-orcid":false,"given":"Baba P. 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