Session Information
Date: Tuesday, November 10, 2015
Title: Reproductive Issues in Rheumatic Disorders: Basic and Clinical Aspects Poster Session
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: Anti-TNFalfa agents have been used to control disease activity of patients with Chronic Arthritides (Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis) during the wash-out period of teratogenic DMARDs and are usually discontinued at positive pregnancy index. Moderate to severe maternal disease activity during pregnancy can justify the use of the drugs in the 2nd-3rd trimester and in the postpartum period. This is a case-control study on the health and developmental conditions of children exposed in utero and/or during breastfeeding to anti-TNFalfa agents and non-exposed children born to women with the same disease.
Methods: An ad-hoc created questionnaire was submitted to women who were followed during pregnancy by a multidisciplinary team (rheumatologist, gynaecologist, neonatologist). Data on birth, lactation, weaning, growth parameters, developmental milestones, vaccinations and disease conditions were collected.
Results: The table reports the characteristics of 25 cases (9 male, 16 female) (21 exposed to etanercept, 3 to adalimumab, 1 to certolizumab) and 25 controls (12 M, 13 F). Eighteen children were exposed during the first trimester (discontinuation of anti-TNFalfa agent at positive pregnancy index), while 7 during the 2nd-3rd trimester (discontinuation at 34th-37th week, mean exposure of 13.3 weeks). Both cases and controls underwent vaccinations without any severe complications. Vaccinations were protective; only one child with periconception exposure to etanercept developed chicken-pox despite vaccination. Five children (3 cases and 2 controls) were breastfed during maternal anti-TNFalfa therapy (3 etanercept, 2 adalimumab).
Conclusion: No differences in birth parameters, congenital malformations and developmental steps in the first 24 months of life have been found between cases and controls. Growth parameters were within the curves of the general population. Cases received more vaccinations than controls: this may be due to the feeling by either parents or paediatricians that these children exposed to immunosuppressive agents could be more susceptible to infectious diseases. No relevant infectious diseases nor post-vaccine complications have been noted in the 6 children exposed to anti- TNFalfa during the 2nd-3rd trimester of gestation nor in the 5 exposed during lactation. Globally, the long-term follow-up of children supports the safety of use of anti-TNFalfa agents, either preconceptionally or during the 2nd-3rdtrimester of pregnancy. Data on use during breastfeeding are still anecdotal but can be helpful for counseling the patients who are strongly motivated to breastfeed.
|
|
Children exposed to anti- TNF alfa (CASES) n=25 |
Children not exposed to anti- TNF alfa (CONTROLS) n=25 |
|
Gestational week at birth |
38 (37-39) |
39 (38-40) |
|
Birth weight (g) |
3156 (2750-3520) a,b |
3260 (3030-3735)c |
|
Birth lenght (cm) |
49 (48-51) |
50 (48,5-51,6) |
|
Apgar index 1 min |
9 (9-9) |
9 (9-10) |
|
Apgar index 5 min |
10 (9-10) |
10 (9-10) |
|
Congenital malformations at birth |
1 female with Patent Foramen Ovale, pervius duct of Botallo, pulmonary hypertension; 1 female with Pierre Robin sequence + severe myopia; 1 male with cryptorchidms; 1 female with eversible metatarsal varus conditiond |
1 male with Ventricular Septal Defect, Patent Foramen Ovale, lumbar emivertebral fusion; 1 male with cardiac murmur due to 3 mild Ventricular Septal Defects; 1 male with right testicular hydrocele |
|
Perinatal complications |
1 female with emithoracical left angioma + jaundice |
1 male with jaundice; 1 male with iponatriema; 1 male with neonatal cyanosis with spontaneous resolution |
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Maternal breastfeeding (number of children) |
13 (54,2%)° |
16 (66,7%)*
|
|
Age at breastfeeding discontinuation (months) |
6 (3-7)
|
3 (2,75-7)
|
|
Weight: at 6 months (g) at 12 months (g) at 24 months (g) |
7500 (7150-7683) 9500 (9163-10663) n.16:12750 (10500-13620,5) |
7600 (7180-8108) 9700 (9090-10413) n.18: 12000 (11312,5-13150) |
|
Length: 6 months (cm) 12 months (cm) months (cm) |
66 (65-67) 75 (73,5-76,9) n.16: 85 (82,5-89,5) |
68 (64,6-69,3) 75,8 (73,8-76,6) n.18: 88 (85,8-90) |
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Age at seated position (months) |
6 (6-7)
|
6 (6-7)
|
|
Age at walking (months)
|
12 (11-13)
|
13 (11-14)
|
|
Age at speaking (months) |
16 (13-18) |
18 (12-20) |
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Age at June 2015 (months) |
43 (30-74)
|
50 (32-81)
|
a1 F SGA; b 1 M with macrosomia; c1 M with IUGR; d exposed to MTX in the periconception period *2 children not exposed to anti-TNFalfa in utero but during breastfeeding. ° 3 children exposed to anti-TNFalfa in utero and during breastfeeding. Data reported as median value, interquartile range.
To cite this abstract in AMA style:
Reggia R, Andreoli L, Bazzani C, Lazzaroni MG, Mazza G, Agosti M, Gorla R, Taglietti M, Lojacono A, Motta M, Tincani A. Longterm Follow-up of Children Born to Mothers with Chronic Arthritides and Exposed to Anti-TNF Alfa Agents during Pregancy and Breastfeeding: A Case-Control Study [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/longterm-follow-up-of-children-born-to-mothers-with-chronic-arthritides-and-exposed-to-anti-tnf-alfa-agents-during-pregancy-and-breastfeeding-a-case-control-study/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/longterm-follow-up-of-children-born-to-mothers-with-chronic-arthritides-and-exposed-to-anti-tnf-alfa-agents-during-pregancy-and-breastfeeding-a-case-control-study/