Pregnancy Outcome in Chinese Women with Rheumatic Disease Treated By Leflunomide (LEF)

Yan Zhao¹, lingxun shen², zongwen shuai³, Hengli Zhao⁴, Weinan Lai⁵, Xiaoling Lai⁶, Shaoying Zhang⁷, Xuequn Wang⁸, Shaoxian Hu⁹, Wenli Chen¹⁰, Wei Ji¹¹, Hua Wei¹², Qi Zhang¹³, Lixia Pang¹⁴, huaxiang Liu¹⁵, Qiang Shu¹⁵, Jun-li Zhang¹⁶, Yating Zhou¹⁷, Qiong Jiang¹⁸, Huaxiang Wu¹⁹, Jing Xue¹⁹, Ganping Bai²⁰, Li Zhang²¹ and Fei Xiao²¹, ¹Rheumatology, Peking Union Medical College Hospital, Beijing, China, ²Wuhan Union Hospital, wuhan, China, ³The First Affiliated Hospital of Anhui University, Hefei, China, ⁴Yantai Hospital of Traditional medicine University, Yantai, China, ⁵Nanfang Hospital, Guangzhou, China, ⁶Guangxi Hospital of Traditional Chinese Medicine, Nanning, China, ⁷Yiling Hospital, Yiling, China, ⁸The First Affiliated Hospital of Xinyang, Xinyang, China, ⁹Tongji hospital, wuhan, China, ¹⁰Wuhan Central Hospital, wuhan, China, ¹¹Jiangsu Province Hospital of TCM, Nanjing, China, ¹²Subei People's Hospital, Yangzhou, China, ¹³Dongying central hospital, Dongying, China, ¹⁴Dongying Hospital, Dongying, China, ¹⁵Qilu hospital of Shandong University, Jinan, China, ¹⁶Rheumatology, The Fifth Hospital of Xi’an City, Xi’an, China, ¹⁷Xian No5 Hospital, Shandong, China, ¹⁸Taizhou Hospital, Taizhou, China, ¹⁹The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China, ²⁰Chongqing Southwest Hospital, Chongqing, China, ²¹Gothic Internet Technology Corporation, Shanghai, China

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: DMARDs, outcomes and pregnancy

Session Information

Date: Monday, November 6, 2017

Title: Reproductive Issues in Rheumatic Disorders Poster

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose:

LEF is a first line DMARD. Due to the teratogenic effects in offspring of rats in preclinical study, the patients who plan to get pregnant are advised to withdraw the drug before pregnancy and take cholestyramine (CHL) simultaneously.

To evaluate the outcome of pregnancy of Chinese women with rheumatic disease treated by LEF in real world practice.

Methods: The patients with rheumatic disease treated by LEF who planed to get pregnant in the near future were included. The patients withdrew the LEF and were prescribed with CHL for drug clearance, 8 g, tid, for 11 days. The patients were followed up regularly. The medication and pregnancy outcome were recorded. The informed consent was obtained for all patients included.

Results:

66 patients cared by 43 doctors from 34 hospitals across China were enrolled. The mean age of patients were 31.54±4.63 (23-46) years old, including 39 (59.09%) patients with RA, 21 (31.82%) patients with SLE, 3(4.55%) patients with ctd, 1 (1.52%) patient with IgAN , 1 (1.52%) patient with takayasu arteritis, and 1 (1.52%) patient with Sjogren syndrome. The mean disease course was 6.72±2.87 (2-19) years. The mean medication time with Lef was 34.20±23.86 (2-94) months. The mean dose was 16.15±4.90 (10-20) mg. The drug combination during peripregnancy included glucocorticoid, CsA, HCQ ,FK506.

There were 36 patients who had live birth: 33 patients with singleton and 3 with twins; 31 patients used CHL and 5 did not; 33 planed to get pregnant (using CHL after withdrawal of LEF) and 3 had accidental pregnancy. The mean interval between withdrawal of LEF and being pregnant was 10.40±6.16 (-3-25) months; the mean interval between administration of CHL and being pregnant was 7.20±6.21 (-4-21) months. The children were healthy: mean age of 27.50±36.46 (1-228) months; 31 children of full-term birth, 5 of premature delivery, mean gestational age of 38.17±2.56 (28-40) weeks, 18% being low birth weight, mean birthweight of 2951.57±694.02 (1100-4200) g; Apgar score of 9.87±0.50 (8-10). The physical, mental and intellectual developments of offsprings are normal.

There were 9 (13.64%) patients who had abnormal pregnancy: 8 patients used CHL and 1 did not; all planed to get pregnant. The mean interval between withdrawal of LEF and being pregnant was 11.92±4.61 (6-18) months; the mean interval between administration of CHL and being pregnant was 8.86±5.692 (3-18) months. Among them, 5 had embryo (56%) development ceasing, 2 (22%) had spontaneous abortion, 1 (11%) had Down’s syndrome, and 1 (11%) had labor induction due to relapse.

Due to the relapse of rheumatic disease,12 (18.18%) patients resumed using immunosuppressive drugs including MTX and LEF, resulting in terminating the preparation of pregnancy.9 (13.64%) patients are successfully got pregnant and ongoing with good conditions so far.

Conclusion:

To our knowledge,this is the largest study about pregnancy outcomes with the treatment of lef. The teratogenic effects was not found, however, the spontaneous abortion and embryo development ceasing are worthy of attention. For the sake of safety, the patients who plan to get pregnant are encouraged to use CHL for drug clearance.

Disclosure: Y. Zhao, None; L. shen, None; Z. shuai, None; H. Zhao, None; W. Lai, None; X. Lai, None; S. Zhang, None; X. Wang, None; S. Hu, None; W. Chen, None; W. Ji, None; H. Wei, None; Q. Zhang, None; L. Pang, None; H. Liu, None; Q. Shu, None; J. L. Zhang, None; Y. Zhou, None; Q. Jiang, None; H. Wu, None; J. Xue, None; G. Bai, None; L. Zhang, None; F. Xiao, None.

To cite this abstract in AMA style:

Zhao Y, shen L, shuai Z, Zhao H, Lai W, Lai X, Zhang S, Wang X, Hu S, Chen W, Ji W, Wei H, Zhang Q, Pang L, Liu H, Shu Q, Zhang JL, Zhou Y, Jiang Q, Wu H, Xue J, Bai G, Zhang L, Xiao F. Pregnancy Outcome in Chinese Women with Rheumatic Disease Treated By Leflunomide (LEF) [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/pregnancy-outcome-in-chinese-women-with-rheumatic-disease-treated-by-leflunomide-lef/. Accessed .

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