Summary

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• This summary is based on the review of one randomized controlled trial. ^[1]
• Leniolisib significantly reduced the size of index lymph nodes compared to placebo, with an adjusted mean change of -0.25 (95% confidence interval (CI): -0.38 to -0.12; P = 0.0006; N = 26).
• Leniolisib led to a significant increase in the percentage of naive B cells in peripheral blood compared to placebo, with an adjusted mean change of 37.30 (95% CI: 24.06, 50.54; P = .0002; N = 13).
• Leniolisib also significantly reduced spleen volume, with an adjusted mean difference of -186 cm³ (95% CI: -297 to -76.2; P = .0020), indicating improvement in organ size.
• Leniolisib was well-tolerated, with 23.8% of patients reporting treatment-related adverse events (AES), primarily of mild severity (grades 1-2). This was lower than the 30.0% reported in the placebo group.
• No significant safety concerns or adverse effects related to specific population types or subgroups were highlighted in the abstract.
• The study focused on patients aged ≥12 years with activated phosphoinositide 3-kinase delta syndrome (APDS). There were no specific findings reported for subgroups beyond this population.