Aldesleukin 18million unit powder for solution for injection vials

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by immune dysregulation, including impaired regulatory T cell (Treg) function. Low-dose interleukin-2 (Ld-IL-2) therapy has emerged as a promising approach to selectively expand Tregs and restore immune tolerance in SLE. This systematic review evaluates current evidence on the efficacy and safety of Ld-IL-2 therapy in patients with SLE. A comprehensive literature search was conducted across PubMed, Scopus, Web of Science, the Cochrane Library, and the Virtual Health Library for studies published up to April 10, 2025. Eligible studies included randomized controlled trials, cohort studies, and open-label trials that investigated Ld-IL-2 therapy in adult patients with SLE. Data were extracted on study design, patient demographics, intervention details, clinical and immunologic outcomes, adverse events, and predictive biomarkers. Risk of bias was assessed using the Modified Downs and Black checklist. Seven studies met the inclusion criteria, encompassing a total of 517 patients with active SLE. All studies reported significant expansion of Treg populations following Ld-IL-2 treatment. Clinical outcomes consistently showed reductions in disease activity scores, such as SLEDAI and BILAG, with SRI-4 response rates ranging from 43% to 65.5%. Ld-IL-2 therapy was well tolerated, with adverse events primarily limited to mild injection-site reactions and flu-like symptoms. No serious treatment-related infections or concerns about immunogenicity were observed. Several studies identified baseline biomarkers, including low complement C3 levels, elevated PD-1^hi^ Tregs, and reduced CD4+ T cell counts, as predictors of treatment response. Ld-IL-2 therapy appears to be a safe and effective immunomodulatory treatment for patients with SLE, capable of enhancing Treg function and reducing disease activity. While current evidence is encouraging, larger multicenter randomized trials are warranted to establish standardized treatment protocols and validate predictive biomarkers for optimized patient selection.

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BackgroundPatients undergoing gastrointestinal cancer surgery are often immunocompromised and susceptible to infectious complications. Recombinant Interleukin 2 activates effector immune cells and stimulates the expansion of regulatory T-cells, making it a promising intervention for prevention of inflammatory complications.ObjectiveOur objective was to investigate effects of different preoperative rIL2 dosages on postoperative outcome parameters.MethodsWe conducted a systematic literature review and meta-analysis and included RCTs that recruited adult patients undergoing gastrointestinal cancer surgery who received preoperative subcutaneous rIL2. We performed a systematic search of MEDLINE (via PubMed), Web of Science and the Cochrane Central Register of Controlled Trials (CENTRAL) from 1989 up to April 18th, 2024.ResultsOut of 2324 screened studies, we included 13 RCTs with a total of 504 patients. Lymphocyte counts [cells/mm3] at 1 week postoperative were higher in the intervention compared to the control group (MD 865 (95%CI: 26, 1705)). Surgical site infections and systemic infections were less likely to occur in the intervention group (OR 0.13 (95%CI: 0.03, 0.50); OR 0.25 (95%CI: 0.10, 0.66)). Severe side effects of rIL2 were not reported.ConclusionPreoperative rIL2-based immunomodulation prevents postoperative immunosuppression while the occurrence of severe side effects does not seem to be relevant.

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IntroductionInflammation plays a critical role in the pathogenesis of atherosclerosis, the leading cause of ischaemic heart disease (IHD). Studies in preclinical models have demonstrated that an increase in regulatory T cells (Tregs), which have a potent immune modulatory action, led to a regression of atherosclerosis. The Low-dose InterLeukin 2 (IL-2) in patients with stable ischaemic heart disease and Acute Coronary Syndromes (LILACS) study, established the safety of low-dose IL-2 and its biological efficacy in IHD. The IVORY trial is designed to assess the effects of low-dose IL-2 on vascular inflammation in patients with acute coronary syndromes (ACS).Methods and analysisIn this study, we hypothesise that low-dose IL-2 will reduce vascular inflammation in patients presenting with ACS. This is a double-blind, randomised, placebo-controlled, phase II clinical trial. Patients will be recruited across two centres, a district general hospital and a tertiary cardiac centre in Cambridge, UK. Sixty patients with ACS (unstable angina, non-ST elevation myocardial infarction or ST elevation myocardial infarction) with high-sensitivity C reactive protein (hsCRP) levels >2 mg/L will be randomised to receive either 1.5×106 IU of low-dose IL-2 or placebo (1:1). Dosing will commence within 14 days of admission. Dosing will comprise of an induction and a maintenance phase. 2-Deoxy-2-[fluorine-18] fluoro-D-glucose (18F-FDG) positron emission tomography/CT (PET/CT) scans will be performed before and after dosing. The primary endpoint is the change in mean maximum target to background ratios (TBRmax) in the index vessel between baseline and follow-up scans. Changes in circulating T-cell subsets will be measured as secondary endpoints of the study. The safety and tolerability of extended dosing with low-dose IL-2 in patients with ACS will be evaluated throughout the study.Ethics and disseminationThe Health Research Authority and Health and Care Research Wales, UK (19/YH/0171), approved the study. Written informed consent is required to participate in the trial. The results will be reported through peer-reviewed journals and conference presentations.Trial registration numberNCT04241601.

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