Pregnancy and foetal outcomes following anti-tumor necrosis factor alpha therapy: A prospective multicentre study

Objective As many inflammatory rheumatic diseases affect patients in childbearing age, some concern has been expressed about the safety of biologic drugs during pregnancy. This study evaluated the effects of anti-tumor necrosis factor alpha (TNF\u3b1) agents on pregnancy/foetal outcomes. Methods Thirty-eight pregnancies were followed prospectively from November 2008 to February 2015. Information about the patients\u2019 exposure to anti-TNF\u3b1, disease activity, DMARD therapy, pregnancy/foetal outcomes were registered. Results Twenty-four/38 (71.1%) pregnancies were exposed to anti-TNF\u3b1 at conception/I trimester, 11/38 (28.9%) prior to conception and 3 (11.1%) following paternal exposure. There were two congenital malformations: one infant (4.2%) was diagnosed with congenital diaphragmatic hernia and obstructive megaureter; the mother was exposed to adalimumab at conception/I trimester. While one foetus (9.1%) showed a trisomy 16, the mother 38 year-old had suspended etanercept 4 weeks before conception. There was no significant difference in pregnancy/foetal outcome between the two groups. Nor were there any significant differences in pregnancy/foetal outcomes in the various groups being treated with different anti-TNF\u3b1 antagonists. No congenital malformations were found in connection to paternal exposure. Conclusion Study results suggest that anti-TNF\u3b1 drugs could be safe when administered during conception/I trimester and following paternal exposure

Long-term Outcome of Children Born to Women with Autoimmune Rheumatic Diseases: A Multicentre, Nationwide Study on 299 Randomly Selected Individuals

The concern about the offspring's health is one of the reasons for a reduced family size of women with rheumatic diseases (RD). Increased risk of autoimmune diseases (AD) and neurodevelopmental disorders (ND) has been reported in children born to patients with RD. Within a nationwide survey about reproductive issues of women with RD, we aimed at exploring the long-term outcome of their children. By surveying 398 patients who received their diagnosis of RD during childbearing age (before the age of 45), information about the offspring were obtained from 230 women who declared to have had children. A total of 148 (64.3%) patients were affected by connective tissue diseases (CTD) and 82 (35.7%) by chronic arthritis. Data on 299 children (156 males, 52.1%; mean age at the time of interview 17.1\ub19.7years) were collected. Twelve children (4.0%), who were born to patients with CTD in 75% of the cases, were affected by AD (8 cases of celiac disease). Eleven children had a certified diagnosis of ND (3.6%; 6 cases of learning disabilities); 9 of them were born to mothers with CTD (5 after maternal diagnosis). No association was found between ND and prenatal exposure to either maternal autoantibodies or anti-rheumatic drugs. Absolute numbers of offspring affected by AD and ND were low in a multicentre cohort of Italian women with RD. This information can be helpful for the counselling about reproductive issues, as the health outcomes of the offspring might not be an issue which discourage women with RD from having children

Was ist Unternehmenskultur?

Objective To assess fetal and maternal outcomes in women with systemic sclerosis (SSc). Methods Prospectively collected data on 99 women with SSc from 25 Italian centers were analyzed retrospectively. Women with SSc were observed during 109 pregnancies (from 2000 to 2011), and outcomes were compared to those in the general obstetric population (total of 3,939 deliveries). The maternal age at conception was a mean +/- SD 31.8 +/- 5.3 years, and the median disease duration at conception was 60 months (range 2193 months). Results SSc patients, compared to the general obstetric population, had a significantly increased frequency of preterm deliveries (25% versus 12%) and severe preterm deliveries (<34 weeks of gestation) (10% versus 5%), intrauterine growth restriction (6% versus 1%), and babies with very-low birth weight (5% versus 1%). Results of multivariable analysis showed that corticosteroid use was associated with preterm deliveries (odds ratio [OR] 3.63, 95% confidence interval [95% CI] 1.1211.78), whereas the use of folic acid (OR 0.30, 95% CI 0.100.91) and presence of antiScl-70 antibodies (OR 0.26, 95% CI 0.080.85) were protective. The disease remained stable in most SSc patients, but there were 4 cases of progression of disease within 1 year from delivery, all in antiScl-70 antibodypositive women, 3 of whom had a disease duration of <3 years. Conclusion Women with SSc can have successful pregnancies, but they have a higher-than-normal risk of preterm delivery, intrauterine growth restriction, and babies with very-low birth weight. Progression of the disease during or after pregnancy is rare, but possible. High-risk multidisciplinary management should be standard for these patients, and pregnancy should be avoided in women with severe organ damage and postponed in women with SSc of recent onset, particularly if the patient is positive for antiScl-70 antibodies

Long-term follow-up of 320 children born to mothers with systemic autoimmune diseases: a multicentre italian survey from 24 rheumatology centres

Background/Purpose: Rheumatic Diseases (RD) frequently affect women during reproductive age, therefore counseling on family planning is crucial for their quality of life. Children’s outcome is a major topic, but no large studies are available. This study aimed at assessing the long-term health conditions of children born to women with RD. Methods: 24 Italian Rheumatology Centers distributed the questionnaire (65 multiple-choice and 12 open-answer questions) to consecutive patients (aged 18-55) during September 2015. Data were analyzed subdividing children upon maternal diagnosis: Chronic Arthritides (CA) and Connective Tissue Diseases (CTD). Results: Data were collected for 320 children (166 males, 52%) born to 184 mothers (63 CA and 121 CTD). At the time of interview, children had a mean age of 17.1±9.6 years. Pre-term delivery (<37 w) was observed in 72 cases (22.5%), including 13 (4%) cases born <34 w. The occurrence of an autoimmune/inflammatory disease (AIID) and/or neurodevelopmental disorders (ND)/learning disabilities (LD) is reported in Table 1. Twelve children (3.7%) were diagnosed with an AIID, mostly coeliac disease (8/12, 67%). Eleven children (3.4%) were diagnosed as having a ND and/or LD by a Pediatric Neuropsychiatrist. To rule out the possible effects of in utero exposure to maternal autoantibodies and/or anti-rheumatic drugs in the pathogenesis of ND, data on such exposures were retrieved for 280 children (87.5%) and a comparison was performed between affected (n=11) and not-affected children (n=258) as reported in Table 2. Conclusion: The long-term follow-up of children born to mothers with RD in this large, multicenter study of randomly interviewed women did not raise particular concerns in terms of relevant health problems. In particular, each AIID did not display a significantly increased frequency as compared to the literature (e.g. 2.5% coeliac disease as compared to 1-2% in the general pediatric population, GPP). Children with ND/LD had a tendency to cluster in the group of mothers with CTD, especially after maternal diagnosis, with a higher frequency as compared to GPP (7.9% vs 3%). No particular association with the in utero exposure to either autoantibodies or drugs was found. Therefore, our data suggest that the development of ND/LD in children of patients with RD cannot be linked exclusively to maternal disease. The results of this study can be reassuring for patients with RD about problems in the offspring possibly related to their disease