Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose
The use of anti-rheumatic drugs in pregnancy is often complicated by concerns over their potential for adverse effects. Given that rheumatic diseases often affect women of childbearing age and may flare during pregnancy, the safety (or otherwise) of anti-rheumatic drugs and immunosuppressant’s are of particular importance. Practice has relied on information based mainly on experimental and animal studies. Human data is limited to inadvertent exposure described in case reports/series and population registries. Previous systematic reviews have identified risks with various anti-rheumatic drugs and biologics. This systematic review is an update on the consensus papers on anti-rheumatic drugs, biological agents and reproduction published in 2006/8.
Methods
A systematic search from 2006-2013 of PubMed, Embase, Cochrane, Lactmed and the UK Tetarology Information Services was carried out using MESH and free terms for drug, rheumatic disease and pregnancy. Review articles and non-English language papers were excluded.
Results
The search strategy identified 352 papers with original pregnancy outcome data.
Table 1. illustrates pregnancy outcomes for the immunosuppressant and biologic therapies.
Table 1 Pregnancy outcomes for rheumatological drugs
|
Drug |
No. of pregnancies exposed to drug |
Live births related to exposed drug (min)* |
Spontaneous 1st trimester loss (min) |
Spontaneous 2nd/3rd trimester loss (min) |
Major Malformations (min) §
|
Minor malformations (min) §
|
Level of evidence |
|
Prednisolone |
771 |
565 |
23 |
35 |
39 |
3 |
C |
|
Methotrexate |
12 |
10 |
2 |
0 |
4 |
5 |
D |
|
Leflunomide |
77 |
78 |
0 |
0 |
7 |
63# |
D |
|
Sulphasalazine |
12 |
12 |
1 |
0 |
2 |
0 |
D |
|
Azathioprine |
320 |
269 |
32 |
7 |
12 |
5 |
C |
|
HCQ |
212 |
230 |
15 |
0 |
29 |
7 |
B |
| MMF |
17 |
18 |
0 |
0 |
19 |
5 |
D |
|
Ciclosporin |
136 |
135 |
1 |
1 |
6 |
0 |
D |
|
Cyclophosphamide |
10 |
7 |
2 |
1 |
1 |
0 |
D |
|
Adalimumab |
122 |
110 |
6 |
1 |
5 |
1 |
D |
|
Etanercept |
19 |
16 |
1 |
1 |
1 |
0 |
D |
|
Infliximab |
130 |
120 |
11 |
2 |
1 |
2 |
D |
|
Group aTNFiΔ |
215 |
160 |
39 |
5 |
1 |
4 |
D |
|
Abatacept |
3 |
1 |
1 |
0 |
0 |
0 |
D |
|
Certolizumab |
10 |
12 |
0 |
0 |
0 |
0 |
D |
|
ΔCombination antiTNFi (infliximab, etanercept, adalimumab, certolizumab)*Includes twin pregnancies. #No increased risk of minor malformations compared to control group §Major & minor malformations meet the EUROCAT criteria for congenital anomalies |
|||||||
Conclusion
Evidence from this systematic review supports the compatibility of hydroxychloroquine, azathioprine, sulphasalazine and steroids in pregnancy. Increasing evidence of compatibility was found from pregnancies exposed (mostly at conception or during the first trimester) to anti-TNF alpha drugs that do not show an appreciable increase in the number of spontaneous miscarriages and congenital malformations. Further registry data is required for biologic drugs, before the safe use of these drugs can be advocated throughout pregnancy.
Disclosure:
S. Panchal,
None;
J. Flint,
None;
M. van de Venne,
None;
M. Piper,
None;
A. Hurrel,
None;
J. Cunningham,
None;
M. Gayed,
None;
K. Schreiber,
None;
S. Anthanari,
None;
M. Nisar,
None;
D. Williams,
None;
M. Khamashta,
None;
C. Gordon,
None;
I. Giles,
None.
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