Efficacy of anakinra in reducing progression to organ dysfunction in patients with pneumonia (INSPIRE): a randomised, double-blind, placebo-controlled, phase IIa trial
Abstract
Summary Background Early recognition of risk of death in pneumonia and start of precision immunotherapy to improve outcomes is an unmet need. We hypothesized that a precision strategy approach combining early recognition of interleukin (IL)-1 activation coupled with Anakinra treatment may improve pneumonia outcome. Methods INSPIRE is a prospective, double-blind randomized placebo-controlled trial which recruited hospitalized adults with community-acquired or hospital-acquired pneumonia, with qSOFA (quick sequential organ failure assessment) equal to 1 and plasma presepsin (soluble CD14) more than 350 pg/ml. Patients were 1:1 randomised to standard-of-care medication plus either subcutaneous placebo or subcutaneous Anakinra 100 mg once daily for 10 days. The primary endpoint was progression into organ dysfunction defined as meeting at least one of the following two conditions; (i) at least 2-point increase of the baseline SOFA score by day 7 and/or (ii) death by day 90. This was analyzed in the intention-to-treat (ITT) population. This trial is registered with the EU Clinical Trials Register (2022-002390-28) and ClinicalTrials.gov (NCT05785442). Findings Patients were enrolled between March 2023 and June 2024; 30 patients in the placebo arm and 30 patients in the Anakinra arm were the ITT population. The primary endpoint was met in 50·0% (15 patients) of placebo-treated and in 20·0% (6 patients) of Anakinra-treated patients (difference 30·0% [5·9 to 49%]; p: 0·011). 90-day…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 30 participants or records.
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