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Table 1 Published studies on the use of TNF-α blockers in IBD pregnancies

From: Safety of TNF-α inhibitors during IBD pregnancy: a systematic review

Author Year Anti-TNF Stage of pregnancy Study type Mode of delivery Outcome of pregnancies
James [25] 2001 IFX P(T2) Case report Unknown Normal, healthy, full term
Srinivasan [21] 2001 IFX PC/P(T1) Case report Unknown Premature, preterm, LBW. Adverse outcome: intracerebral and intrapulmonary bleeding followed by death 3 days later (metronidazole + azathioprine + 5-ASA was also administered in pregnancy for treatment of flare and fistulae)
Bank et al. [24] 2002 IFX P(T1-T2) Case report Unknown Normal, healthy, full term (correspondence with authors)
Burt et al. [27] 2003 IFX PC Case report C-section Normal, healthy, preterm (36 weeks)
Katz et al. [49] 2004 IFX 53/96 PC; 58/96 P(T1); 6/96 unknown Case series from Infliximab Safety Database (82 CD, one UC, 10 RA, 3 unknown); 96 women, 72 births Unknown 64/96 were live births (1 preterm death at 24 week, 1 full-term with tetralogy of Fallot, 1 perinatal sepsis, 1 intestinal malrotation, 1 developmental delay); 4 pregnancies ended with twins. 14/96 were miscarriages, 18/96 were therapeutic terminations
Mahadevan et al.[32] 2005 IFX 9/10 PC; 8/10 P(T2); 8/10 P(T3); 7/10 PP Case series (n = 10 women) 8/10 C-section, 2/10 Vaginal 3/10 were preterm, 1/10 were LBW, 2/10 were neonatal illnesses, which resolved. All normal at follow-up
Tursi [34] 2006 IFX PC/P(T1-T3)/PP Case report Unknown Normal, healthy, preterm (36 weeks)
Xirouchakis et al. [64] 2006 IFX PC/P(T1) Case report Vaginal Normal, healthy, full term
Vasiliauskas et al. [16] 2006 IFX (10 mg/kg body weight) PC/P(T1-T3) Case report Vaginal Normal, healthy, full term
Mahadevan et al. [28] 2007 IFX P(T1-T3) Case series (n = 5) 4 vaginal/1 C-section Normal, healthy, full term
Malgarinos et al. [29] 2007 IFX PC/P(T1-T3) Case report Unknown Normal, healthy, preterm
Angelucci et al. [26] 2008 IFX P(T1) Case report C-section Normal, healthy, full term
Palmer et al. [20] 2008 IFX P(T2-T3) Case report Unknown Intra-uterine fetal death due to placental abruption or intra-uterine infection
Stengel et al. [33] 2008 IFX PC/P(T1-T3) Case report C-section Normal, healthy, full term
Kane et al. [68] 2009 IFX 2 PC/P(T1-T3), 1 P(T2) Case series (3 women) 2 vaginal, 1 C-section 3 normal, healthy, full term
Hou et al. [14] 2009 IFX PC/p(T1-T3) Case report Vaginal Normal, healthy, full term
Arai et al. [23] 2010 IFX P(T2-T3) Case report Unknown Normal, healthy, full term
Epping et al. [66] 2010 IFX PC/P(T1-T3) Case report Unknown Normal, healthy, full term
Angelucci et al. [65] 2010 IFX PC/P(T1) Case report C-section Normal, healthy, preterm (31 weeks)
Correia et al. [30] 2010 IFX PC/P(T1-T3) 2 case reports C-section Normal, healthy; 1 preterm (31 weeks)
Molnár et al. [47] 2010 IFX PC/P(T1-T3) Case report Unknown Normal, healthy, full term
Cheent et al. [63] 2010 IFX (10 mg/kg body weight) PC/P(T1-T3) Case report Vaginal Healthy, full term, no malformations
Aratari et al. [44] 2011 IFX P(T2) Case report C-section Healthy, preterm (37 weeks)
Abdul Wahab et al. [40] 2011 IFX P(T2-T3) Case report Unknown Normal, healthy, full term
Kozeluhova [41] 2011 IFX PC/P(T1-T3) Case report Unknown Normal, healthy, full term
Chaparro et al. [45] 2011 IFX PC/P(T1-T3) Case report C-section Normal, healthy, full term
Naganuma et al. [67] 2011 IFX PC/P(T1-3) Case series (3 women) Unknown All healthy, full term, 1 low birth weight, no malformations
Steenholdt et al. [22] 2012 IFX PC/P(T1-T2) Case report Unknown Normal, healthy, full term
Arguelles-Arias et al. [42] 2012 IFX PC/P(T1-T3) Case series (12 women) 8 vaginal, 4 C-sections 12 healthy children
Lichtenstein et al. [36] 2012 IFX 142 reported pregnancies Case series (analysis of data from TREAT registry) Unknown The vast majority of babies (92.4%) were healthy with no defects or other adverse events
Snoeckx et al. [38] 2013 IFX PC/P(T1-T3) Case series (556 pregnancies) Unknown There were 58 miscarriages, 38 elective abortions, 7 stillbirths, and 453 live births
Vesga et al. [80] 2005 ADA PC/P(T1-T3)/PP Case report C-section Normal, healthy, full term
Coburn et al. [77] 2006 ADA P(T2; T3) Case report Unknown Normal, healthy, full term
Mishkin et al. [79] 2006 ADA PC/P(T1-T3) Case report Vaginal Normal, healthy, full term
Chambers et al. [75] 2006 ADA PC/P(T1) Case series (5 women) Unknown All full-term live births. No malformations
Bosworth et al. [71] 2007 ADA PC/P(T1-T3) Case report C-section Normal, healthy, full term
Johnson et al. [72] 2009 ADA PC/P(T1-T3) Case-controlled study 34 women and 45 controls (OTIS) Unknown 29 live-born (1 with undescended testicle + 1 with microencephaly); 5 spontaneous abortions. Two major structural defects in control group
Jürgens et al. [78] 2010 ADA PC/P(T1) Case report Vaginal Healthy, full term
Ben-Horin et al. [74] 2010 ADA PC/P(T1-3) Case report Vaginal Healthy, full term
Abdul Wahab et al. [73] 2011 ADA PC/P(T1-T3) Case report C-section Twins, normal, healthy, full term
Mahadevan et al. [76] 2011 ADA PC/P(T1-T3) Case series (5 women) 2 vaginal 3 C-sections Healthy (one infant developed pulmonary edema, but recovered fully)
Kane et al. [31] 2009 CZP Unknown (UCB data on file) Case series (16 women) Unknown 4 healthy, full term; 1 small for gestational age; and 2 lost to follow-up. 8 induced abortions amd 1 spontaneous abortion
Mahadevan et al. [85] 2009 CZP P(T2; T3)/PP Case report Unknown Healthy, full term, no malformations
Oussalah et al. [86] 2009 CZP PC/P(T1; T3) Case report Vaginal Normal, healthy, full term. Adverse outcome in 1 case: bleeding 7 days post-partum, secondary to cotyledon retention
Steinberg et al. [84] 2010 CZP P(T2-T3) Case report C-section Healthy, full term, no malformations
Mahadevan et al. [87] 2012 CZP PC/P(T1-T3) Case series (139 pregnancies including 17 with rheumatoid arthritis) Unknown 21 miscarriages, 15 elective abortions, and 103 live births (2 with congenital abnormalities: 1 with mild unilateral hydronephrosis and 1 with vesicouretic reflux)
Slama et al. [19] 2010 IFX/ADA PC/P(T1-T3) Case series (289 pregnancies including other diseases than IBD) Unknown No increased risk of adverse pregnancy outcome compared with unexposed IBD pregnancies
Dunne et al. [46] 2011 IFX/ADA PC/P(T1-T3) 15 case series (15 women) Unknown 9 terminated pregnancies at study end. All live births were healthy, with two sets of twins
Schnitzler et al. [54] 2011 IFX/ADA PC and/or P(T1) and/or P(T2) Case-controlled study (35 women with 42 pregnancies (35 IFX + 7 ADA) versus 101 pregnancies before IBD/treatment and 56 matched pregnancies in healthy controls) Unknown 10 abortions (1 trisomy 18, 1 elective), 1 stillbirth (umbilical strangulation), 32 live births: 8/32 premature, 6/32 low birth weight. All children were born healthy but one child with necrotizing enterocolitis died at 13 days of age (mother required treatment for severe asthma and CD during T3)
Machková et al. [43] 2012 IFX/ADA PC/P(T1-T3) Case series (33 pregnancies in 31 women) Unknown 5/33 pregnancies ongoing. 24/28 healthy children (4/24 preterm), 3/24 spontaneous abortions, and 1/24 provoked abortion
Habal et al. [37] 2013 IFX/ADA PC/P(T1-T3) Case series (29 pregnancies in 21 women) Unknown 27 normal, healthy, full term; 2 miscarriages
Traussnigg et al. [39] 2013 IFX/ADA PC/P(T1-T3) Case series (14 pregnancies in 13 women) Unknown 13 normal, healthy, full term; 1 miscarriage
Zelinkova Z et al. [12] 2013 IFX/ADA PC/P(T1-T3) (T1-T2 ADA only) Case series (31 pregnancies in 28 women) Unknown 28 live births (27 normal, healthy, full term; 1 child born to a mother treated with concomitant methotrexate periconceptually had polydactyly); 3 miscarriages
Casanova et al. [48] 2011 IFX/ADA/CZP PC/P(T1-T3) Case-controlled retrospective study (30 pregnancies in treated mothers versus 110 unexposed IBD pregnancies) Unknown Prevalence of unfavorable delivery outcome (spontaneous abortion, preterm delivery, low birth weight and malformations) were higher in the control group
Seirafi et al. [52] 2011 IFX/ADA/CZP PC/P(T1-T3) Case series (85 women) Unknown 6/85 were miscarriages, 47/85 were live births (30/85 ongoing), 8/49 were preterm, 3/49 were deaths (two in utero/one very premature),7/46 live births had neonatal complications (1 infection, 3 respiratory distress syndrome, 6 LBW <2500 g, 1 HELLP syndrome
Mahadevan et al. [51] 2012 IFX/ADA/CZP PC/P(T1-T3) Case-controlled study (291 women without, and 79 with immunomodulators) Unknown No increased risk apart from higher risk of spontaneous abortion and C-section in group treated with biologics alone, and higher risk of preterm birth and infections int offspring at 12 months in combined thiopurine group verus biologics-alone group or unexposed IBD pregnancies
Casanova et al. [35] 2013 IFX/ADA/CZP PC/P(T1-T3) Case series (66 pregnancies) Unknown 55 normal, healthy full term;, 4 preterm; 6 miscarriages; 1 congenital abnormality (several cardiac malformations)
Mahadevan et al. [17] 2013 IFX/ADA/CZP PC/P(T1-T3) Case series (31 women) 15 vaginal, 16 C-section All 33 children (2 sets of twins) were normal, healthy, full term
  1. Abbreviations: 5- ASA 5-aminosalicylic acid, ADA adalimumab; C-section cesarean section, CZP certolizumab pegol, HELLP a syndrome characterized by hemolysis, elevated liver enzymes, and low platelet count (that is, a variant/complication of pre-eclampsia), IBD inflammatory bowel disease, IFX infliximab, LBW low birth weight, PC periconceptual (that is, use within 90 days before conception), PP post-partum, P(T1-T3) (pregnancy with trimester where biologics were reported to be administered), MTX methotrexate, TNF tumor necrosis factor, TREAT Therapy Resource Evaluation Assessment Tool.