Impact of HbF inducers use on anti-cardiolipin and anti-beta2-glycoprotein I antibody levels in beta-thalassemia patients: a pilot study
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Abstract
Objective: To determine the levels of anti-cardiolipin (aCL) IgM/IgG and anti-β2-glycoprotein I (anti-β2-GPI) IgM/IgG antibodies in β-thalassemia patients receiving fetal hemoglobin (HbF) inducers.
Methods: This cross-sectional study was conducted from June-2024 to November-2025 at Peshawar General Hospital, Peshawar. Ethical approval was obtained from Institute of Pathology and Diagnostic Medicine, Khyber Medical University (Ref# KMU/IPDM/IEC/2024/21). Forty-two diagnosed β-thalassemia patients aged ≥1 year receiving HbF inducers (hydroxyurea 10–20 mg/kg and/or thalidomide 2–3 mg/kg) for at least six months were enrolled using convenient sampling. Patients with prior thromboembolic events, bleeding disorders, or acute illness were excluded. Serum aCL (IgM, IgG) and anti-β2-GPI (IgM, IgG) antibodies were measured using chemiluminescence immunoassay. Appropriate Statistical analysis was performed using GraphPad Prism 10.2.3, with p ≤0.05 considered statistically significant.
Results: Out of 42 β-thalassemia patients, 66.7% were male with a median age of 4.0 years (range 1.3–25). Majority (n=34) received combination HbF-inducing therapy, while four received thalidomide monotherapy and four received hydroxyurea monotherapy. Median antibody levels were as follows: anti-cardiolipin (aCL) IgM 2.22 U/mL and IgG 2.49 U/mL; anti-β2-glycoprotein I (anti-β2-GPI) IgM 2.23 U/mL and IgG 1.11 U/mL. All measured values were below the established positivity cut-off (≥20 AU/mL). No statistically significant differences were observed between males and females, and no correlation was found between antibody levels and age (p >0.05).
Conclusion: In β-thalassemia patients receiving HbF inducers, no detectable aCL or anti-β2-GPI antibodies were identified, and no association with age or gender was observed, suggesting no antibody elevation with hydroxyurea or thalidomide therapy.
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