European journal of clinical pharmacology · 2025
Secukinumab improves pregnancy outcomes in recurrent spontaneous abortion with T helper 17 cells/T regulatory cells imbalance: a retrospective cohort study.
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Zhu Guihua, Wang Xue, Bi Shuqin, Liu Juan, Yuan Guiling, Li Ning, Fu Jinhua, Zhao Long
Аннотация
OBJECTIVE: This study aimed to evaluate the efficacy and safety of secukinumab, an Interleukin-17A (IL-17A) inhibitor, in patients with recurrent spontaneous abortion (RSA) associated with T helper 17 cells / T regulatory cells (Th17/Treg) imbalance.
METHODS: This retrospective cohort study evaluated 108 RSA patients with confirmed Th17/Treg imbalance (Th17/Treg ≥ 0.6 or IL-17A > 4.74 pg/mL) at a single center. Patients were divided into secukinumab (n = 54; 3 mg/kg subcutaneously plus standard therapy) and control (n = 54; standard therapy alone) groups. Primary outcomes included live birth rate and immunological parameters (Th17/Treg ratio, IL-17A levels), with secondary assessments of neonatal outcomes and safety.
RESULTS: The secukinumab group demonstrated significantly higher live birth rates (83.33% [45/54] vs 64.81% [35/54]; P = 0.047), with an odds ratio (OR) of 2.71 (95% Confidence Interval (CI): 1.10-6.73), and greater reductions in Th17/Treg ratios (P = 0.010) and IL-17A levels (P = 0.001) compared to controls. No congenital anomalies, maternal or neonatal infections, or treatment-related serious adverse events were observed in either group.
CONCLUSION: For RSA characterized by Th17/Treg imbalance, secukinumab demonstrates both clinical efficacy and an acceptable safety profile, suggesting its therapeutic utility.
METHODS: This retrospective cohort study evaluated 108 RSA patients with confirmed Th17/Treg imbalance (Th17/Treg ≥ 0.6 or IL-17A > 4.74 pg/mL) at a single center. Patients were divided into secukinumab (n = 54; 3 mg/kg subcutaneously plus standard therapy) and control (n = 54; standard therapy alone) groups. Primary outcomes included live birth rate and immunological parameters (Th17/Treg ratio, IL-17A levels), with secondary assessments of neonatal outcomes and safety.
RESULTS: The secukinumab group demonstrated significantly higher live birth rates (83.33% [45/54] vs 64.81% [35/54]; P = 0.047), with an odds ratio (OR) of 2.71 (95% Confidence Interval (CI): 1.10-6.73), and greater reductions in Th17/Treg ratios (P = 0.010) and IL-17A levels (P = 0.001) compared to controls. No congenital anomalies, maternal or neonatal infections, or treatment-related serious adverse events were observed in either group.
CONCLUSION: For RSA characterized by Th17/Treg imbalance, secukinumab demonstrates both clinical efficacy and an acceptable safety profile, suggesting its therapeutic utility.