A total of 105 recurrent spontaneous abortion (RSA) patients who received tumour necrosis factor inhibitor (TNFi) + intravenous immunoglobin (IVIG) + Heparin (enoxaparin) (n = 48) or IVIG+Heparin (enoxaparin) (n = 57) were retrospectively included in this two-centre cohort study. Live birth rate was increased in the TNFi+IVIG+Heparin group compared to the IVIG+Heparin group (72.9% vs. 52.6%). After adjustment by the multivariate logistic regression model, TNFi+IVIG+Heparin was also superior to IVIG+Heparin regarding the increased live birth rate. However, other obstetric outcomes and adverse event incidence were of no difference between TNFi+IVIG+Heparin and IVIG+Heparin group. Interestingly, it was observed that younger age and less number of previous miscarriages related to a higher live birth rate in the TNFi+IVIG+Heparin group but not in the IVIG+Heparin group.
Abstract
What is known and objective
Immune disorder is a key trigger of recurrent spontaneous abortion (RSA); meanwhile, tumour necrosis factor inhibitor (TNFi) is a fundamental therapeutic for multiple immune and inflammatory diseases. Hence, this real-world study aimed to explore the efficacy and safety of TNFi combined with intravenous immunoglobin (IVIG) and heparin therapy in RSA patients.
Methods
A total of 105 RSA patients who received TNFi+IVIG+Heparin (enoxaparin) (n = 48) or IVIG+Heparin (enoxaparin) (n = 57) were retrospectively included in this two-centre cohort study.
Results and discussion
The live birth rate of RSA patients in the TNFi+IVIG+heparin group was 72.9% (95% confidence interval [CI]: 69.6%–85.9%). Besides, the live birth rate in the IVIG+heparin group was 52.6% (95% CI: 42.8%–62.4%). By comparison, the live birth rate was higher in the TNFi+IVIG+heparin group compared to the IVIG+heparin group (p = 0.033). After adjustment by the multivariate logistic regression model using the enter method, TNFi+IVIG+Heparin was also superior to IVIG+Heparin regarding increased live birth rate (odds ratio [OR] = 2.941, p = 0.015). Moreover, TNFi+IVIG+Heparin (vs. IVIG+Heparin) also served as an independent factor for increased live birth rate (OR = 2.423, p = 0.035) by the forward stepwise method in the multivariate analysis. Gestational weeks at delivery (38.3 ± 1.3 vs. 37.7 ± 2.0 weeks, p = 0.155), newborn weight (3123.9 ± 332.1 vs. 3056.6 ± 287.4 g, p = 0.390), Apgar score of newborns (9.8 ± 0.5 vs. 9.7 ± 0.7, p = 0.271) were of no difference between TNFi+IVIG+Heparin and IVIG+Heparin groups. In terms of safety profile, the adverse events were of no difference between the TNFi+IVIG+Heparin and the IVIG+Heparin groups (all p > 0.05), either.
What is new and conclusion
TNFi combined with IVIG and heparin therapy improves the live birth rate but does not elevate the adverse events compared to IVIG and heparin therapy in RSA patients.
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