(1) Background: The purpose of study was to compare the safety profile of glatiramer with natalizumab, alemtuzumab and ocrelizumab in pregnant and lactating women affected by multiple sclerosis (MS). (2) Methods: Individual case safety reports (ICSRs) were retrieved from the European spontaneous reporting system database (EudraVigilance). The reporting odds ratios (RORs) were computed to compare the reporting probability of events between natalizumab, alemtuzumab and ocrelizumab vs. glatiramer. (3) Results: A total of 1236 ICSRs reporting at least one DMT as a suspected drug were selected. More adverse drug reactions (ADRs) unrelated to pregnancy and breastfeeding (n = 1171; 32.6%) were reported than ADRs specific to pregnancy and breastfeeding (n = 1093; 30.4%). The most frequently reported unrelated ADR was MS relapse. Alemtuzumab and natalizumab seem to have a lower reporting probability of MS relapse compared to glatiramer (ROR 0.17, 95% CI 0.07-0.45 and ROR 0.34, 95% CI 0.20-0.57). Among pregnancy- and breastfeeding-related ADRs, the first most reported event was spontaneous abortion (n = 321; 8.9%). Natalizumab and ocrelizumab were associated with a higher reporting probability of spontaneous abortion compared to glatiramer (ROR 2.22, 95% CI 1.58-3.12; ROR 2.18, 95% CI 1.34-3.54, respectively), while alemtuzumab had a lower reporting frequency (ROR 0.32, 95% CI 0.17-0.60). (4) Conclusions: This study did not suggest any strong or new insights for DMTs in this special subpopulation. However, further studies need to be performed.
机构:
Japan Drug Informat Inst Pregnancy, Natl Ctr Child Hlth & Dev, Tokyo, Japan
Juntendo Univ, Grad Sch Med, Dept Clin Pharmacol & Regulatory Sci, Tokyo, Japan
Juntendo Univ, Grad Sch Med, Clin Pharmacol & Regulatory Sci, 2-1-1 Hongo,Bunkyo-ku, Tokyo, 1138421, JapanJapan Drug Informat Inst Pregnancy, Natl Ctr Child Hlth & Dev, Tokyo, Japan
Fujioka, Izumi
Ohtsu, Hiroshi
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Juntendo Univ, Grad Sch Med, Dept Clin Pharmacol & Regulatory Sci, Tokyo, Japan
Waseda Univ, Org Univ Res Initiat, Inst Med Regulatory Sci, Tokyo, Japan
Juntendo Univ, Dept Leading Ctr Dev & Res Canc Med, Tokyo, JapanJapan Drug Informat Inst Pregnancy, Natl Ctr Child Hlth & Dev, Tokyo, Japan
Ohtsu, Hiroshi
Yonemoto, Naohiro
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Natl Inst Mental Hlth, Natl Ctr Neurol & Psychiat, Tokyo, Japan
Juntendo Univ, Grad Sch Med, Dept Publ Hlth, Tokyo, JapanJapan Drug Informat Inst Pregnancy, Natl Ctr Child Hlth & Dev, Tokyo, Japan
Yonemoto, Naohiro
Sase, Kazuhiro
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Juntendo Univ, Grad Sch Med, Dept Clin Pharmacol & Regulatory Sci, Tokyo, Japan
Waseda Univ, Org Univ Res Initiat, Inst Med Regulatory Sci, Tokyo, JapanJapan Drug Informat Inst Pregnancy, Natl Ctr Child Hlth & Dev, Tokyo, Japan
Sase, Kazuhiro
Murashima, Atsuko
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Japan Drug Informat Inst Pregnancy, Natl Ctr Child Hlth & Dev, Tokyo, Japan
Natl Ctr Child Hlth & Dev, Ctr Maternal Fetal Neonatal & Reprod Med, Tokyo, JapanJapan Drug Informat Inst Pregnancy, Natl Ctr Child Hlth & Dev, Tokyo, Japan
机构:
Shaoxing Keqiao Women & Children ?s Hosp, Dept Pharm, Shaoxing, Zhejiang, Peoples R ChinaShaoxing Keqiao Women & Children ?s Hosp, Dept Pharm, Shaoxing, Zhejiang, Peoples R China
Li, Xiangyu
Yang, Fang
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Shaoxing Keqiao Women & Children ?s Hosp, Dept Pharm, Shaoxing, Zhejiang, Peoples R ChinaShaoxing Keqiao Women & Children ?s Hosp, Dept Pharm, Shaoxing, Zhejiang, Peoples R China
Yang, Fang
Zhou, Fuqun
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Shaoxing Keqiao Women & Childrens Hosp, Shaoxing, Zhejiang, Peoples R ChinaShaoxing Keqiao Women & Children ?s Hosp, Dept Pharm, Shaoxing, Zhejiang, Peoples R China
Zhou, Fuqun
Zhu, Shenghong
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Shaoxing Keqiao Women & Childrens Hosp, Dept Sci Educ, Shaoxing, Zhejiang, Peoples R ChinaShaoxing Keqiao Women & Children ?s Hosp, Dept Pharm, Shaoxing, Zhejiang, Peoples R China
Zhu, Shenghong
Yuan, Lingjing
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Shaoxing Second Hosp, Dept Sci Educ, Yanan Rd 123, Shaoxing 312000, Zhejiang, Peoples R ChinaShaoxing Keqiao Women & Children ?s Hosp, Dept Pharm, Shaoxing, Zhejiang, Peoples R China
Yuan, Lingjing
Ma, Li
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Shaoxing Keqiao Women & Children ?s Hosp, Dept Neurol, Keyan Ave 778, Shaoxing 312000, Zhejiang, Peoples R ChinaShaoxing Keqiao Women & Children ?s Hosp, Dept Pharm, Shaoxing, Zhejiang, Peoples R China
机构:
Sun Yat sen Univ, Affiliated Hosp 6, Dept Gastroenterol, Guangzhou 510000, Peoples R China
Sun Yat Sen Univ, Affiliated Hosp 6, Biomed Innovat Ctr, Guangzhou 510000, Peoples R ChinaSun Yat sen Univ, Affiliated Hosp 6, Dept Gastroenterol, Guangzhou 510000, Peoples R China
Tang, Jian
Li, Qing
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Sun Yat sen Univ, Affiliated Hosp 6, Dept Gastroenterol, Guangzhou 510000, Peoples R China
Sun Yat Sen Univ, Affiliated Hosp 6, Biomed Innovat Ctr, Guangzhou 510000, Peoples R ChinaSun Yat sen Univ, Affiliated Hosp 6, Dept Gastroenterol, Guangzhou 510000, Peoples R China
Li, Qing
Huang, Zhaopeng
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Sun Yat sen Univ, Affiliated Hosp 6, Dept Gastroenterol, Guangzhou 510000, Peoples R China
Sun Yat Sen Univ, Affiliated Hosp 6, Biomed Innovat Ctr, Guangzhou 510000, Peoples R ChinaSun Yat sen Univ, Affiliated Hosp 6, Dept Gastroenterol, Guangzhou 510000, Peoples R China
Huang, Zhaopeng
Shi, Lishuo
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Sun Yat sen Univ, Affiliated Hosp 6, Ctr Clin Res, Guangzhou 510000, Peoples R ChinaSun Yat sen Univ, Affiliated Hosp 6, Dept Gastroenterol, Guangzhou 510000, Peoples R China
Shi, Lishuo
Guo, Qin
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Sun Yat sen Univ, Affiliated Hosp 6, Dept Gastroenterol, Guangzhou 510000, Peoples R China
Sun Yat Sen Univ, Affiliated Hosp 6, Biomed Innovat Ctr, Guangzhou 510000, Peoples R ChinaSun Yat sen Univ, Affiliated Hosp 6, Dept Gastroenterol, Guangzhou 510000, Peoples R China
Guo, Qin
Li, Miao
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机构:
Sun Yat sen Univ, Affiliated Hosp 6, Dept Gastroenterol, Guangzhou 510000, Peoples R China
Sun Yat Sen Univ, Affiliated Hosp 6, Biomed Innovat Ctr, Guangzhou 510000, Peoples R ChinaSun Yat sen Univ, Affiliated Hosp 6, Dept Gastroenterol, Guangzhou 510000, Peoples R China
Li, Miao
Gao, Xiang
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机构:
Sun Yat sen Univ, Affiliated Hosp 6, Dept Gastroenterol, Guangzhou 510000, Peoples R China
Sun Yat Sen Univ, Affiliated Hosp 6, Biomed Innovat Ctr, Guangzhou 510000, Peoples R China
26 Yuancun Rd 2, Guangzhou 510000, Peoples R ChinaSun Yat sen Univ, Affiliated Hosp 6, Dept Gastroenterol, Guangzhou 510000, Peoples R China
Gao, Xiang
Chao, Kang
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机构:
Sun Yat sen Univ, Affiliated Hosp 6, Dept Gastroenterol, Guangzhou 510000, Peoples R China
Sun Yat Sen Univ, Affiliated Hosp 6, Biomed Innovat Ctr, Guangzhou 510000, Peoples R China
26 Yuancun Rd 2, Guangzhou 510000, Peoples R ChinaSun Yat sen Univ, Affiliated Hosp 6, Dept Gastroenterol, Guangzhou 510000, Peoples R China