The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation

Skorpen, Carina Götestam; Hoeltzenbein, Maria; Tincani, Anǵela; Fischer‐Betz, Rebecca; Eléfant, Élisabeth; Chambers, Christina D.; Silva, José António Pereira da; Nelson‐Piercy, Catherine; Cetin, Irene; Costédoat-Chalumeau, Nathalie; Dolhain, Radboud J E M; Förger, Frauke; Khamashta, Munther A.; Ruiz‐Irastorza, Guillermo; Zink, Angela; Vencovský, Jiří; Cutolo, Maurizio; Caeyers, N.; Zumbühl, Claudia; Østensen, Monika

doi:10.1136/annrheumdis-2015-208840

Cited by 781 publications

(778 citation statements)

References 67 publications

Supporting

Mentioning

617

Contrasting

Unclassified

152

Order By: Relevance

“…Exposure in late pregnancy and the resulting potential risk of postnatal infections 17 are associated with active placental drug transfer from mother to infant, mediated by binding of the Fc region to the neonatal Fc receptor (FcRn) 42. In contrast to other anti‐TNF agents, the CZP molecule lacks the Fc moiety, preventing binding to placental FcRn, thus limiting placental transport 43.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Pregnancy Outcomes After Exposure to Certolizumab Pegol

Clowse

Scheuerle

Chambers

et al. 2018

Arthritis & Rheumatology

Self Cite

129

View full text Add to dashboard Cite

ObjectiveAnti–tumor necrosis factor (anti‐TNF) medications are effective in controlling chronic inflammatory diseases, but information about their use and safety in pregnancy is limited. Consequently, anti‐TNF agents are often discontinued early in gestation. Certolizumab pegol (CZP), a PEGylated, Fc‐free anti‐TNF agent approved for the treatment of rheumatic diseases and/or Crohn's disease, has minimal to no active placental transfer. This analysis was undertaken to evaluate pregnancy outcomes in women receiving CZP, especially those exposed during early pregnancy.MethodsProspective and retrospective data on maternal CZP exposure were extracted from the UCB Pharma safety database through March 6, 2017. Analysis was limited to prospective reports to avoid potential bias associated with retrospective submissions. The numbers of live births, miscarriages, elective abortions, stillbirths, and major congenital malformations were ascertained.ResultsOf 1,137 prospectively reported pregnancies with maternal exposure to CZP, 528 (including 10 twin pregnancies) had 538 known outcomes: 459 live births (85.3%), 47 miscarriages (8.7%), 27 elective abortions (5.0%), and 5 stillbirths (0.9%). There were 8 major congenital malformations (1.7%) among the 459 infants. First trimester exposure occurred in 367 (81.2%) of 452 pregnancies resulting in 459 live births. Exposure during all 3 trimesters occurred in 201 (44.5%) of 452 pregnancies.ConclusionThis analysis represents the largest cohort of pregnant women exposed to an anti‐TNF agent for management of chronic inflammatory diseases. Analysis of pregnancy outcomes does not indicate a teratogenic effect of CZP, compared to the general population, nor an increased risk of fetal death. The data are reassuring for women of childbearing age considering treatment with CZP.

show abstract

Section: Discussionmentioning

confidence: 99%

“…Therefore, evidence generated through pharmacovigilance reporting and pregnancy registries is extremely important to help physicians and patients make informed decisions regarding anti–tumor necrosis factor (anti‐TNF) treatment for rheumatic diseases and CD during pregnancy 15, 17.…”

mentioning

confidence: 99%

Pregnancy Outcomes After Exposure to Certolizumab Pegol

Clowse

Scheuerle

Chambers

et al. 2018

Arthritis & Rheumatology

Self Cite

129

View full text Add to dashboard Cite

show abstract

“…A EULAR task force has published points to consider for the use of antirheumatic drugs in these situations [1]. Among the recommendations for the use of biologics, etanercept and certolizumab pegol may be considered for use throughout pregnancy, whereas the use of other anti-TNFa agents is limited to the first trimester; there is a paucity of data on safe use of biologics with other methods of action during pregnancy.…”

Section: Crib and Cradle: Minimal Transfer Of Certolizumab Pegol Durimentioning

confidence: 99%

Annual European Congress of Rheumatology

McNab¹

2017

Pediatr Drugs

View full text Add to dashboard Cite

The Annual European Congress of Rheumatology is one of the largest rheumatology congresses in the world, and the 18th Annual Congress coincided with the 70th anniversary of EULAR (the European League Against Rheumatism), attracting over 14,000 delegates from more than 120 countries. There were 180 sessions and poster tours across the spectrum of rheumatic and musculoskeletal diseases. There was a significant focus on biologics for pediatric rheumatology conditions, and this is reflected in this Meeting Report, which provides a brief summary of some of the new research and drug developments for pediatric rheumatology that were presented at the meeting.1 CRIB and CRADLE: minimal transfer of certolizumab pegol during pregnancy and lactationGood management of active chronic inflammatory conditions before/during pregnancy and lactation is crucial to ensure the best fetal and maternal outcomes. A EULAR task force has published points to consider for the use of antirheumatic drugs in these situations [1]. Among the recommendations for the use of biologics, etanercept and certolizumab pegol may be considered for use throughout pregnancy, whereas the use of other anti-TNFa agents is limited to the first trimester; there is a paucity of data on safe use of biologics with other methods of action during pregnancy.Biologics are usually derived from IgG, which permits the active transport of those molecules with an IgG1 Fc portion across the placenta, mediated by the fetal Fc receptor. Transfer is low during the first trimester but increases thereafter. Certolizumab pegol lacks the Fc portion and has no active placental transfer. The results of the CRIB study (NCT02019602), presented by Prof. Xavier Mariette (University Hospitals of Paris-Sud, France), confirmed this in 16 pregnant women with chronic inflammatory diseases [11 with rheumatoid arthritis (RA), three with Crohn's disease (CD) and one each with psoriatic arthritis (PsA) or axial spondyloarthritis (AS)] using a highly-sensitive certolizumab-specific electrochemiluminescence immunoassay with tenfold greater sensitivity than the assay used in prior studies [2]. In the CRIB pharmacokinetic (PK) study, the women (C30 weeks' gestation) were receiving a maintenance dose of certolizumab pegol, with the last dose given within 35 days of delivery. Drug concentrations were determined in blood samples collected from the mothers, umbilical cords, and infants at delivery and from infants at 4 and 8 weeks post-delivery. Median gestational age at birth was 39.9 weeks (range 37.7-41.7) and median weight was 3.3 kg (range 2.6-4.0). Maternal certolizumab pegol levels at delivery were within the expected therapeutic range. Data were available for 14 infants at delivery; 13 had no quantifiable drug (\0.032 lg/ ml, the lower limit of quantitation) whereas one had 0.042 lg/ml (infant:mother plasma ratio 0.09%). Certolizumab pegol was not detected in any infant at weeks 4 or 8. Of the evaluable placentas, three had quantifiable drug levels (max. 0.048 lg/ml). Infants of treated mothers h...

show abstract

“…De acordo com o consenso de 2016 da European League Against Rheumatism (EULAR), a prednisolona/prednisona podem ser administradas durante a gravidez na menor dose eficaz possível. 5 O uso de corticosteróides por longos períodos deve ser limitado a doses ≤7,5 mg/dia de prednisolona/prednisona e devem evitar-se doses superiores a 20mg/dia, mesmo por períodos curtos. 6,7 Não há evidência de efeitos adversos em recém-nascidos amamentados por mulheres medicadas com corticosteróides sistémicos, embora a maioria destes estudos reflitam dados com doses entre 5-10mg/dia.…”

Section: Corticosteróides Sistémicos (Categoria De Risco C Pela Food unclassified

“…[37][38][39] Contudo, de acordo com o consenso da EULAR, a toma de anti-inflamatórios não esteróides não seletivos pode ser continuada durante o primeiro e segundo trimestres da gestação, enquanto os inibidores seletivos da COX-2 devem ser evitados. 5 A toma de anti-inflamatórios não-esteróides não seletivos e do celecoxib é compatível com a amamentação mas os restantes inibidores seletivos da COX-2 não devem ser administrados neste contexto. …”

Section: Retinóides Sistémicos (Categoria De Risco X Pela Fda)unclassified

Gravidez, Aleitamento e Fármacos em Dermatologia - Tratamento Sistémico

Cesar

Azevedo

Mota

2016

SPDV

View full text Add to dashboard Cite

RESUMO -O crescente número de fármacos empregues na prática dermatológica e venereológica exige do dermatologista um conhecimento atualizado relativo à sua segurança. No caso particular de mulheres grávidas ou que amamentem, a decisão sobre se se deve ou não tratar com um determinado fármaco deve basear-se numa avaliação ponderada dos benefícios para a saúde materna e dos riscos potenciais para o bem-estar fetal ou do lactente. Quando estas doentes necessitam terapêuticas tópicas ou sistémicas, a maioria pode ser adequadamente tratada com opções consideradas seguras e eficazes. Na primeira parte deste artigo são abordados os dados mais recentes relativos à segurança de alguns dos medicamentos sisté-micos mais comummente usados em contexto dermatológico, na mulher em idade fértil. PALAVRAS-CHAVE -Agentes Dermatológicos/uso terapêutico; Aleitamento/efeito dos medicamentos; Complicações na Gravidez/quimioterapia; Doenças da Pele/quimioterapia; Doenças de Pele/tratamento; Gravidez. Pregnancy, Lactation and Drugs in DermatologySystemic Therapy ABSTRACT -The increasing number of drugs used in dermatological a venereological practice demands from the dermatologist INTRODUÇÃOAo tratar doentes grávidas ou durante o período de aleitamento é fundamental um conhecimento dos potenciais efeitos adversos dos medicamentos sobre o desenvolvimento do feto ou do lactente. O risco de teratogenicidade e a capacidade de cada fármaco ser excretado no leite materno permite, na maioria das ocasiões, optar por alternativas seguras no tratamento de doenças do foro dermatológico em mulheres durante o período gestacional e durante a amamentação.Este artigo de revisão tem por objetivo abordar os dados disponíveis referentes à segurança (ou falta dela) de alguns dos fármacos mais comummente prescritos em contexto dermatológico e venereológico nas mulheres em idade fér-til. A primeira parte deste artigo aborda os fármacos administrados por via sistémica e a segunda parte irá abordar os fármacos de aplicação local. Corticosteróides sistémicos (categoria de risco C pela Food Drug Administration -FDA)A dexametasona e a betametasona não sofrem metabolização placentária significativa, passando inalterados através da placenta.1 Já a prednisolona sofre conversão em metabolitos inativos pela placenta humana, o que limita a sua passagem para o embrião/feto, pelo que é a opção

show abstract

The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation

Cited by 781 publications

References 67 publications

Pregnancy Outcomes After Exposure to Certolizumab Pegol

Pregnancy Outcomes After Exposure to Certolizumab Pegol

Annual European Congress of Rheumatology

Gravidez, Aleitamento e Fármacos em Dermatologia - Tratamento Sistémico

Contact Info

Product

Resources

About