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Leniolisib is a selective phosphoinositide 3-kinase delta inhibitor approved to treat APDS in patients \u226512 years old. We report final results from a single-arm, open-label extension study in 37 patients with APDS (NCT02859727). Median leniolisib exposure was 4.3 years (range, 1.2\u20137.0 years). Adverse events (AE) were reported in 34 patients; 87% were grade 1. Serious AEs, reported in 10 patients, were deemed unrelated to leniolisib. Two patients discontinued treatment due to AEs: cardiac arrest and Hodgkin\u2019s lymphoma. There were significant reductions in annual infection (P = 0.0005) and respiratory infection (P = 0.0017) rates per year of treatment. Immunoglobulin replacement therapy (IRT) use significantly decreased per year of treatment (P = 0.0095). Clinically meaningful improvements in general health scores from the 36-Item Short Form Survey were observed. Overall, long-term use of leniolisib was generally well tolerated, and infections and IRT use reduced over time.<\/jats:p>","DOI":"10.70962\/jhi.20260040","type":"journal-article","created":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T06:21:51Z","timestamp":1789453311000},"update-policy":"https:\/\/doi.org\/10.70962\/jhi.crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Open-label extension study of leniolisib in activated PI3K\u03b4 syndrome: Long-term efficacy and safety"],"prefix":"10.70962","volume":"3","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7881-6902","authenticated-orcid":true,"given":"V. 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