PMID- 36511097 OWN - NLM STAT- MEDLINE DCOM- 20221223 LR - 20221223 IS - 1365-2710 (Electronic) IS - 0269-4727 (Linking) VI - 47 IP - 12 DP - 2022 Dec TI - Tumour necrosis factor inhibitor combined with intravenous immunoglobulin and heparin for treatment of recurrent spontaneous abortion: A two-centre, retrospective, cohort study. PG - 2320-2324 LID - 10.1111/jcpt.13771 [doi] AB - 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. CI - (c) 2022 John Wiley & Sons Ltd. FAU - Jiang, Yi AU - Jiang Y AD - Department of Rheumatology and Immunology, The First Hospital Affiliated to Army Medical University, Chongqing, China. FAU - Zou, Qinghua AU - Zou Q AD - Department of Rheumatology and Immunology, The First Hospital Affiliated to Army Medical University, Chongqing, China. FAU - Zhang, Nian AU - Zhang N AUID- ORCID: 0000-0002-0474-2656 AD - Department of Traditional Chinese Medicine, The Second Hospital Affiliated to Army Medical University, Chongqing, China. FAU - Chen, Jingjing AU - Chen J AD - Department of Rheumatology and Immunology, The First Hospital Affiliated to Army Medical University, Chongqing, China. FAU - Chen, Xuemeng AU - Chen X AD - Department of Rheumatology and Immunology, The First Hospital Affiliated to Army Medical University, Chongqing, China. FAU - You, Qingxia AU - You Q AD - Department of Rheumatology and Immunology, The First Hospital Affiliated to Army Medical University, Chongqing, China. FAU - Wu, Hong AU - Wu H AD - Department of Rheumatology and Immunology, The First Hospital Affiliated to Army Medical University, Chongqing, China. LA - eng PT - Journal Article DEP - 20221213 PL - England TA - J Clin Pharm Ther JT - Journal of clinical pharmacy and therapeutics JID - 8704308 RN - 9005-49-6 (Heparin) RN - 0 (Immunoglobulins, Intravenous) RN - 0 (Tumor Necrosis Factor Inhibitors) RN - 0 (Enoxaparin) RN - 0 (Anticoagulants) SB - IM MH - Pregnancy MH - Female MH - Infant, Newborn MH - Humans MH - *Heparin/adverse effects MH - Immunoglobulins, Intravenous/adverse effects MH - Retrospective Studies MH - Tumor Necrosis Factor Inhibitors/therapeutic use MH - Cohort Studies MH - Enoxaparin/therapeutic use MH - Anticoagulants/adverse effects MH - *Abortion, Habitual/drug therapy OTO - NOTNLM OT - TNF inhibitor OT - intravenous immunoglobin and heparin OT - live birth rate OT - recurrent spontaneous abortion OT - safety profile EDAT- 2022/12/14 06:00 MHDA- 2022/12/24 06:00 CRDT- 2022/12/13 04:33 PHST- 2022/08/18 00:00 [revised] PHST- 2022/08/03 00:00 [received] PHST- 2022/08/24 00:00 [accepted] PHST- 2022/12/14 06:00 [pubmed] PHST- 2022/12/24 06:00 [medline] PHST- 2022/12/13 04:33 [entrez] AID - 10.1111/jcpt.13771 [doi] PST - ppublish SO - J Clin Pharm Ther. 2022 Dec;47(12):2320-2324. doi: 10.1111/jcpt.13771. Epub 2022 Dec 13.