Purpose: Anakinra is a recombinant human interleukin-1 receptor antagonist primarily administered by subcutaneous injection for the treatment of autoinflammatory conditions. Intravenous use of anakinra is only sparsely described in the literature. The aim of this study was to assess the safety of intravenous use of anakinra in a cohort of pediatric patients. Methods: This is a multicenter, retrospective cohort study. All patients who received intravenous anakinra from January 1st, 2017, to February 29th 2024 were enrolled. Collected data comprised: demographic characteristics, underlying clinical conditions, infusion-related data, anakinra-related adverse events and clinical response. Results: The case series included 113 patients: 64 (56.6%) with underlying rheumatologic diseases, 27 (23.9%) with onco-hematologic diseases, 22 (19.5%) with severe systemic infections. Fifty-nine patients (52.2%) were admitted to intensive care units. The intravenous anakinra dose ranged from 2 to 20 mg/kg/day, and treatment duration ranged from 1 to 80 days. Adverse events were observed in 10 of 113 treated children (8.8%). The most common events were transient elevation of liver or pancreatic enzymes in seven patients (6.2%) and maculopapular rash in two patients (1.2%). One patient (0.9%) experienced an anaphylactoid reaction immediately after the infusion. Sixteen patients (14.2%) died. Among those who died, ten were receiving ongoing anakinra treatment, with a median treatment duration of 27 days (range 2–42), while six patients had discontinued the drug several days earlier. Conclusion: Intravenous administration of anakinra appears to be safe and not associated with severe adverse events. Reported side effects were transient, not life-threatening, and resolved either with specific treatment or after drug discontinuation. Intravenous anakinra may therefore be considered a safe therapeutic option for selected life-threatening acute clinical conditions.
Safety of intravenous use of anakinra in pediatric inflammatory conditions: a retrospective multicenter study / Klanjscek, Marta; Trevisan, Matteo; Pastore, Serena; Pardeo, Manuela; Tommasini, Alberto; Caorsi, Roberta; Dell'Orso, Gianluca; Rumeileh, Sarah Abu; Conti, Chiara; D'Ippolito, Carmelita; Cortesi, Manuela; Maximova, Natasha; Cattalini, Marco; Simonini, Gabriele; Gattorno, Marco; De Benedetti, Fabrizio; Taddio, Andrea; Bracaglia, Claudia. - In: PEDIATRIC RHEUMATOLOGY ONLINE JOURNAL. - ISSN 1546-0096. - ELETTRONICO. - 24:(2026), pp. 0-0. [10.1186/s12969-026-01199-3]
Safety of intravenous use of anakinra in pediatric inflammatory conditions: a retrospective multicenter study
Rumeileh, Sarah Abu;Cattalini, Marco;Simonini, Gabriele;
2026
Abstract
Purpose: Anakinra is a recombinant human interleukin-1 receptor antagonist primarily administered by subcutaneous injection for the treatment of autoinflammatory conditions. Intravenous use of anakinra is only sparsely described in the literature. The aim of this study was to assess the safety of intravenous use of anakinra in a cohort of pediatric patients. Methods: This is a multicenter, retrospective cohort study. All patients who received intravenous anakinra from January 1st, 2017, to February 29th 2024 were enrolled. Collected data comprised: demographic characteristics, underlying clinical conditions, infusion-related data, anakinra-related adverse events and clinical response. Results: The case series included 113 patients: 64 (56.6%) with underlying rheumatologic diseases, 27 (23.9%) with onco-hematologic diseases, 22 (19.5%) with severe systemic infections. Fifty-nine patients (52.2%) were admitted to intensive care units. The intravenous anakinra dose ranged from 2 to 20 mg/kg/day, and treatment duration ranged from 1 to 80 days. Adverse events were observed in 10 of 113 treated children (8.8%). The most common events were transient elevation of liver or pancreatic enzymes in seven patients (6.2%) and maculopapular rash in two patients (1.2%). One patient (0.9%) experienced an anaphylactoid reaction immediately after the infusion. Sixteen patients (14.2%) died. Among those who died, ten were receiving ongoing anakinra treatment, with a median treatment duration of 27 days (range 2–42), while six patients had discontinued the drug several days earlier. Conclusion: Intravenous administration of anakinra appears to be safe and not associated with severe adverse events. Reported side effects were transient, not life-threatening, and resolved either with specific treatment or after drug discontinuation. Intravenous anakinra may therefore be considered a safe therapeutic option for selected life-threatening acute clinical conditions.
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