Pregnancy outcome after TNF-α inhibitor therapy during the first trimester: a prospective multicentre cohort study
Identifieur interne : 002978 ( Main/Exploration ); précédent : 002977; suivant : 002979Pregnancy outcome after TNF-α inhibitor therapy during the first trimester: a prospective multicentre cohort study
Auteurs : Corinna Weber-Schoendorfer [Allemagne] ; Marc Oppermann [Allemagne] ; Evelin Wacker [Allemagne] ; Nathalie Bernard [France] ; Delphine Beghin ; Benedikte Cuppers-Maarschalkerweerd ; Jonathan L. Richardson [Royaume-Uni] ; Laura E. Rothuizen [Suisse] ; Alessandra Pistelli [Italie] ; Heli Malm [Finlande] ; Georgios Eleftheriou [Italie] ; Debra Kennedy [Australie] ; Mine Kadioglu Duman [Turquie] ; Reinhard Meister [Allemagne] ; Christof Schaefer [Allemagne]Source :
- British Journal of Clinical Pharmacology [ 0306-5251 ] ; 2015.
Descripteurs français
- KwdFr :
- Adalimumab (effets indésirables), Anticorps monoclonaux (effets indésirables), Avortement spontané (épidémiologie), Certolizumab pégol (effets indésirables), Europe (épidémiologie), Facteur de nécrose tumorale alpha (antagonistes et inhibiteurs), Femelle, Grossesse, Humains, Infliximab (effets indésirables), Issue de la grossesse (épidémiologie), Malformations dues aux médicaments et aux drogues (épidémiologie), Naissance prématurée (épidémiologie), Poids de naissance (), Premier trimestre de grossesse, Étanercept (effets indésirables), Études cas-témoins, Études prospectives.
- MESH :
- antagonistes et inhibiteurs : Facteur de nécrose tumorale alpha.
- effets indésirables : Adalimumab, Anticorps monoclonaux, Certolizumab pégol, Infliximab, Étanercept.
- épidémiologie : Avortement spontané, Europe, Issue de la grossesse, Malformations dues aux médicaments et aux drogues, Naissance prématurée.
- Femelle, Grossesse, Humains, Poids de naissance, Premier trimestre de grossesse, Études cas-témoins, Études prospectives.
English descriptors
- KwdEn :
- Abnormalities, Drug-Induced (epidemiology), Abortion, Spontaneous (epidemiology), Adalimumab (adverse effects), Antibodies, Monoclonal (adverse effects), Birth Weight (drug effects), Case-Control Studies, Certolizumab Pegol (adverse effects), Etanercept (adverse effects), Europe (epidemiology), Female, Humans, Infliximab (adverse effects), Pregnancy, Pregnancy Outcome (epidemiology), Pregnancy Trimester, First, Premature Birth (epidemiology), Prospective Studies, Tumor Necrosis Factor-alpha (antagonists & inhibitors).
- MESH :
- chemical , adverse effects : Adalimumab, Antibodies, Monoclonal, Certolizumab Pegol, Etanercept, Infliximab.
- chemical , antagonists & inhibitors : Tumor Necrosis Factor-alpha.
- drug effects : Birth Weight.
- epidemiology : Abnormalities, Drug-Induced, Abortion, Spontaneous, Europe, Pregnancy Outcome, Premature Birth.
- Case-Control Studies, Female, Humans, Pregnancy, Pregnancy Trimester, First, Prospective Studies.
Abstract
TNF-α inhibitors are considered relatively safe in pregnancy but experience is still limited. The aim of this study was to evaluate the risk of major birth defects, spontaneous abortion, preterm birth and reduced birth weight after first trimester exposure to TNF-α inhibitors.
Pregnancy outcomes of women on adalimumab, infliximab, etanercept, certolizumab pegol or golimumab were evaluated in a prospective observational cohort study and compared with outcomes of a non-exposed random sample. The samples were drawn from pregnancies identified by institutes collaborating in the European Network of Teratology Information Services.
In total, 495 exposed and 1532 comparison pregnancies were contributed from nine countries. The risk of major birth defects was increased in the exposed (5.0%) compared with the non-exposed group (1.5%; adjusted odds ratio (ORadj) 2.2, 95% CI 1.0, 4.8). The risk of preterm birth was increased (17.6%; ORadj 1.69, 95% CI 1.1, 2.5), but not the risk of spontaneous abortion (16.2%; adjusted hazard ratio [HRadj] 1.06, 95% CI 0.7, 1.7). Birth weights adjusted for gestational age and sex were significantly lower in the exposed group compared to the non-exposed cohort (
TNF-α inhibitors may carry a risk of adverse pregnancy outcome of moderate clinical relevance. Considering the impact of insufficiently controlled autoimmune disease on the mother and the unborn child, TNF-α inhibitors may nevertheless be a treatment option in women with severe disease refractory to established immunomodulatory drugs.
Url:
DOI: 10.1111/bcp.12642
PubMed: 25808588
PubMed Central: 4594709
Affiliations:
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’s-Hertogenbosch</institution><addr-line>Netherlands</addr-line></nlm:aff></affiliation></author><author><name sortKey="Richardson, Jonathan L" sort="Richardson, Jonathan L" uniqKey="Richardson J" first="Jonathan L" last="Richardson">Jonathan L. Richardson</name><affiliation wicri:level="1"><nlm:aff id="au5"><institution>UK Teratology Information Service, Newcastle upon Tyne Hospitals NHS Foundation Trust & Newcastle University</institution><addr-line>Newcastle upon Tyne, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Newcastle upon Tyne</wicri:regionArea></affiliation></author><author><name sortKey="Rothuizen, Laura E" sort="Rothuizen, Laura E" uniqKey="Rothuizen L" first="Laura E" last="Rothuizen">Laura E. Rothuizen</name><affiliation wicri:level="1"><nlm:aff id="au6"><institution>Swiss Teratogen Information Service (STIS) and Division of Clinical Pharmacology, University Hospital</institution><addr-line>Lausanne, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Lausanne</wicri:regionArea></affiliation></author><author><name sortKey="Pistelli, Alessandra" sort="Pistelli, Alessandra" uniqKey="Pistelli A" first="Alessandra" last="Pistelli">Alessandra Pistelli</name><affiliation wicri:level="1"><nlm:aff id="au7"><institution>Centro di Riferimento Regionale di Tossicologia Perinatale, Azienda Ospedaliero Universitaria Careggi</institution><addr-line>Firenze, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Firenze</wicri:regionArea></affiliation></author><author><name sortKey="Malm, Heli" sort="Malm, Heli" uniqKey="Malm H" first="Heli" last="Malm">Heli Malm</name><affiliation wicri:level="1"><nlm:aff id="au8"><institution>Teratology Information Service, HUSLAB and Helsinki University Central Hospital</institution><addr-line>Helsinki, Finland</addr-line></nlm:aff><country xml:lang="fr">Finlande</country><wicri:regionArea>Helsinki</wicri:regionArea></affiliation></author><author><name sortKey="Eleftheriou, Georgios" sort="Eleftheriou, Georgios" uniqKey="Eleftheriou G" first="Georgios" last="Eleftheriou">Georgios Eleftheriou</name><affiliation wicri:level="1"><nlm:aff id="au9"><institution>Poison Control Centre and Teratology Information Service, Hospital Papa Giovanni XXIII</institution><addr-line>Bergamo, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Bergamo</wicri:regionArea></affiliation></author><author><name sortKey="Kennedy, Debra" sort="Kennedy, Debra" uniqKey="Kennedy D" first="Debra" last="Kennedy">Debra Kennedy</name><affiliation wicri:level="1"><nlm:aff id="au10"><institution>Mothersafe, Royal Hospital for Women</institution><addr-line>Randwick, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Randwick</wicri:regionArea></affiliation></author><author><name sortKey="Kadioglu Duman, Mine" sort="Kadioglu Duman, Mine" uniqKey="Kadioglu Duman M" first="Mine" last="Kadioglu Duman">Mine Kadioglu Duman</name><affiliation wicri:level="1"><nlm:aff id="au11"><institution>Department of Pharmacology, Karadeniz Technical University</institution><addr-line>Trabzon, Turkey</addr-line></nlm:aff><country xml:lang="fr">Turquie</country><wicri:regionArea>Trabzon</wicri:regionArea></affiliation></author><author><name sortKey="Meister, Reinhard" sort="Meister, Reinhard" uniqKey="Meister R" first="Reinhard" last="Meister">Reinhard Meister</name><affiliation wicri:level="1"><nlm:aff id="au12"><institution>Department of Mathematics, Beuth Hochschule für Technik Berlin (University of Applied Sciences)</institution><addr-line>Berlin, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Schaefer, Christof" sort="Schaefer, Christof" uniqKey="Schaefer C" first="Christof" last="Schaefer">Christof Schaefer</name><affiliation wicri:level="1"><nlm:aff id="au1"><institution>Pharmakovigilanzzentrum Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Charité Universitätsmedizin Berlin</institution><addr-line>Berlin, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Berlin</wicri:regionArea></affiliation></author></analytic><series><title level="j">British Journal of Clinical Pharmacology</title><idno type="ISSN">0306-5251</idno><idno type="eISSN">1365-2125</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Abnormalities, Drug-Induced (epidemiology)</term><term>Abortion, Spontaneous (epidemiology)</term><term>Adalimumab (adverse effects)</term><term>Antibodies, Monoclonal (adverse effects)</term><term>Birth Weight (drug effects)</term><term>Case-Control Studies</term><term>Certolizumab Pegol (adverse effects)</term><term>Etanercept (adverse effects)</term><term>Europe (epidemiology)</term><term>Female</term><term>Humans</term><term>Infliximab (adverse effects)</term><term>Pregnancy</term><term>Pregnancy Outcome (epidemiology)</term><term>Pregnancy Trimester, First</term><term>Premature Birth (epidemiology)</term><term>Prospective Studies</term><term>Tumor Necrosis Factor-alpha (antagonists & inhibitors)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adalimumab (effets indésirables)</term><term>Anticorps monoclonaux (effets indésirables)</term><term>Avortement spontané (épidémiologie)</term><term>Certolizumab pégol (effets indésirables)</term><term>Europe (épidémiologie)</term><term>Facteur de nécrose tumorale alpha (antagonistes et inhibiteurs)</term><term>Femelle</term><term>Grossesse</term><term>Humains</term><term>Infliximab (effets indésirables)</term><term>Issue de la grossesse (épidémiologie)</term><term>Malformations dues aux médicaments et aux drogues (épidémiologie)</term><term>Naissance prématurée (épidémiologie)</term><term>Poids de naissance ()</term><term>Premier trimestre de grossesse</term><term>Étanercept (effets indésirables)</term><term>Études cas-témoins</term><term>Études prospectives</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Adalimumab</term><term>Antibodies, Monoclonal</term><term>Certolizumab Pegol</term><term>Etanercept</term><term>Infliximab</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Tumor Necrosis Factor-alpha</term></keywords><keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Facteur de nécrose tumorale alpha</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Birth Weight</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Adalimumab</term><term>Anticorps monoclonaux</term><term>Certolizumab pégol</term><term>Infliximab</term><term>Étanercept</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Abnormalities, Drug-Induced</term><term>Abortion, Spontaneous</term><term>Europe</term><term>Pregnancy Outcome</term><term>Premature Birth</term></keywords><keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Avortement spontané</term><term>Europe</term><term>Issue de la grossesse</term><term>Malformations dues aux médicaments et aux drogues</term><term>Naissance prématurée</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Case-Control Studies</term><term>Female</term><term>Humans</term><term>Pregnancy</term><term>Pregnancy Trimester, First</term><term>Prospective Studies</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Femelle</term><term>Grossesse</term><term>Humains</term><term>Poids de naissance</term><term>Premier trimestre de grossesse</term><term>Études cas-témoins</term><term>Études prospectives</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Aims</title><p>TNF-α inhibitors are considered relatively safe in pregnancy but experience is still limited. The aim of this study was to evaluate the risk of major birth defects, spontaneous abortion, preterm birth and reduced birth weight after first trimester exposure to TNF-α inhibitors.</p></sec><sec><title>Methods</title><p>Pregnancy outcomes of women on adalimumab, infliximab, etanercept, certolizumab pegol or golimumab were evaluated in a prospective observational cohort study and compared with outcomes of a non-exposed random sample. The samples were drawn from pregnancies identified by institutes collaborating in the European Network of Teratology Information Services.</p></sec><sec><title>Results</title><p>In total, 495 exposed and 1532 comparison pregnancies were contributed from nine countries. The risk of major birth defects was increased in the exposed (5.0%) compared with the non-exposed group (1.5%; adjusted odds ratio (OR<sub>adj</sub>) 2.2, 95% CI 1.0, 4.8). The risk of preterm birth was increased (17.6%; OR<sub>adj</sub> 1.69, 95% CI 1.1, 2.5), but not the risk of spontaneous abortion (16.2%; adjusted hazard ratio [HR<sub>adj</sub>] 1.06, 95% CI 0.7, 1.7). Birth weights adjusted for gestational age and sex were significantly lower in the exposed group compared to the non-exposed cohort (<italic>P</italic> = 0.02). As a diseased comparison group was not possible to ascertain, the influence of disease and treatment on birth weight and preterm birth could not be differentiated.</p></sec><sec><title>Conclusions</title><p>TNF-α inhibitors may carry a risk of adverse pregnancy outcome of moderate clinical relevance. Considering the impact of insufficiently controlled autoimmune disease on the mother and the unborn child, TNF-α inhibitors may nevertheless be a treatment option in women with severe disease refractory to established immunomodulatory drugs.</p></sec></div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Finlande</li><li>France</li><li>Italie</li><li>Royaume-Uni</li><li>Suisse</li><li>Turquie</li></country></list><tree><noCountry><name sortKey="Beghin, Delphine" sort="Beghin, Delphine" uniqKey="Beghin D" first="Delphine" last="Beghin">Delphine Beghin</name><name sortKey="Cuppers Maarschalkerweerd, Benedikte" sort="Cuppers Maarschalkerweerd, Benedikte" uniqKey="Cuppers Maarschalkerweerd B" first="Benedikte" last="Cuppers-Maarschalkerweerd">Benedikte Cuppers-Maarschalkerweerd</name></noCountry><country name="Allemagne"><noRegion><name sortKey="Weber Schoendorfer, Corinna" sort="Weber Schoendorfer, Corinna" uniqKey="Weber Schoendorfer C" first="Corinna" last="Weber-Schoendorfer">Corinna Weber-Schoendorfer</name></noRegion><name sortKey="Meister, Reinhard" sort="Meister, Reinhard" uniqKey="Meister R" first="Reinhard" last="Meister">Reinhard Meister</name><name sortKey="Oppermann, Marc" sort="Oppermann, Marc" uniqKey="Oppermann M" first="Marc" last="Oppermann">Marc Oppermann</name><name sortKey="Schaefer, Christof" sort="Schaefer, Christof" uniqKey="Schaefer C" first="Christof" last="Schaefer">Christof Schaefer</name><name sortKey="Wacker, Evelin" sort="Wacker, Evelin" uniqKey="Wacker E" first="Evelin" last="Wacker">Evelin Wacker</name></country><country name="France"><noRegion><name sortKey="Bernard, Nathalie" sort="Bernard, Nathalie" uniqKey="Bernard N" first="Nathalie" last="Bernard">Nathalie Bernard</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Richardson, Jonathan L" sort="Richardson, Jonathan L" uniqKey="Richardson J" first="Jonathan L" last="Richardson">Jonathan L. Richardson</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Rothuizen, Laura E" sort="Rothuizen, Laura E" uniqKey="Rothuizen L" first="Laura E" last="Rothuizen">Laura E. Rothuizen</name></noRegion></country><country name="Italie"><noRegion><name sortKey="Pistelli, Alessandra" sort="Pistelli, Alessandra" uniqKey="Pistelli A" first="Alessandra" last="Pistelli">Alessandra Pistelli</name></noRegion><name sortKey="Eleftheriou, Georgios" sort="Eleftheriou, Georgios" uniqKey="Eleftheriou G" first="Georgios" last="Eleftheriou">Georgios Eleftheriou</name></country><country name="Finlande"><noRegion><name sortKey="Malm, Heli" sort="Malm, Heli" uniqKey="Malm H" first="Heli" last="Malm">Heli Malm</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Kennedy, Debra" sort="Kennedy, Debra" uniqKey="Kennedy D" first="Debra" last="Kennedy">Debra Kennedy</name></noRegion></country><country name="Turquie"><noRegion><name sortKey="Kadioglu Duman, Mine" sort="Kadioglu Duman, Mine" uniqKey="Kadioglu Duman M" first="Mine" last="Kadioglu Duman">Mine Kadioglu Duman</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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