TNF-alpha inhibitors

Table   Graphic     exposition period:

Congenital malformations
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROB
All congenital malformations (majors, minors, majors and minors, or unspecified)1.57 [1.16, 2.14]0%13 studies206971low ROB
Major congenital malformations1.67 [1.08, 2.58]0%9 studies64680not evaluable ROB
Respiratory system anomalies--0 study
Atrial septal defect--0 study
Atrioventricular septal defect--0 study
Cardiac septal defects--0 study
Ear, face and neck anomalies--0 study
Eye defects--0 study
Eye, ear, face and neck malformations--0 study
19 non statistically significant endpoints reported in only one study

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROB
Preterm (< 37 weeks)1.42 [1.21, 1.68]17%18 studies1,6192,529low ROB
Small for gestational age (weight)1.72 [0.83, 3.58]0%8 studies21311not evaluable ROB
Low birth weight (< 2500g)2.16 [0.94, 4.97]87%7 studies387952not evaluable ROB
Macrosomia (> 4000g)2.97 [0.24, 36.82]0%2 studies136not evaluable ROB

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROB
Caesarean2.56 [0.15, 42.43]95%2 studies59100not evaluable ROB
Maternal consequences (as a whole)1.66 [1.40, 1.95]0%3 studies41,125not evaluable ROB
Gestational diabete1.15 [0.88, 1.49]0%2 studies573394not evaluable ROB
Maternal infections1.42 [1.24, 1.63]0%2 studies191,849not evaluable ROB
Preeclampsia0.53 [0.03, 9.33]68%2 studies11109not evaluable ROB
Abruptio placentae--0 study
Assisted deliveries (forceps, vacuum, ...)--0 study
Placenta previa--0 study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROB
Neonatal infections0.90 [0.77, 1.04]0%7 studies961,064not evaluable ROB
Neonatal death (< 28 days of life)4.47 [0.37, 54.48]0%2 studies164not evaluable ROB
Neonatal medical care--0 study
Low Apgar score (< 7) (at 10 min)--0 study
Low Apgar score (< 7) (at 5 min)--0 study
3 non statistically significant endpoints reported in only one study

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROB
Child/Infant infections (> 1 year)--0 study

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROB
Early intrauterine death (< 22 weeks)1.01 [0.74, 1.37]54%9 studies1,2181,754not evaluable ROB
Elective/induced termination of pregnancy1.41 [0.96, 2.08]48%7 studies6961,509not evaluable ROB
Late intrauterine deaths (> 22 weeks)1.18 [0.61, 2.29]0%7 studies691,379not evaluable ROB
Ectopic pregnancy12.76 [1.31, 124.74]0%2 studies2104not evaluable ROB
Therapeutic terminations of pregnancy--0 study
1 non statistically significant endpoints reported in only one study

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROB
Neuro-developmental disorders (as a whole)0.83 [0.29, 2.40]0%2 studies1596not evaluable ROB
1 non statistically significant endpoints reported in only one study