European network of pregnancy registers in rheumatology (EuNeP)

Concept

There is a high unmet need of robust data on the outcomes of pregnancies in women with inflammatory rheumatic diseases (IRD) and on the safety of a substantial number of drugs when used before or during pregnancy. The aim of our project is to combine existing data and to improve future pregnancy counseling by using better information on pregnancy outcomes and drug safety.

Therefore, experts from France, Germany, Norway and Switzerland who already run prospective pregnancy registers in women with IRD came together.

Facts and figures

Project Lead
R Fischer-Betz
Heinrich-Heine University

A Strangfeld
German Rheumatism Research Centre
rebecca.fischer@med.uni-duesseldorf.de
strangfeld@drfz.de
FOREUM research grant: € 298.000
2017–2021

Meet the team

R Fischer-Betz
Heinrich-Heine University
A Strangfeld
German Rheumatism Research Centre
N Costedoat-Chalumeau
Université Paris-Descartes
A Molto
Groupe Hospitalier Cochin-Saint Vincent de Paul
M Wallenius
University of Trondheim
F Förger
University Hospital and University of Bern
Y Meissner
German Rheumatism Research Centre

Objectives

  • To evaluate the nature and extent of existing data
  • To define a common core data set as primary outcome
  • To perform and publish a first joint data analysis on pregnancy outcomes as secondary outcome
  • To enable newly setup pregnancy registers to use the methods and approaches already developed

Patient voice

Patient participation is crucial to explore which questions regarding pregnancies are the most relevant for the patients. Two female patients (one with rheumatoid arthritis and one with systemic lupus erythematosus) are involved in identifying research questions of interest and in defining the core data set, with specific focus on the patient-reported outcomes.

Interim results

Data items and methods of data collection in the participating registers were evaluated and summarized. Patient perspectives regarding pregnancy registers and their needs for information were identified with a survey. The core data set was developed by a EULAR task force and was published as a EULAR recommendation. Currently, the joint data analysis is being performed with the aim to analyse adverse pregnancy outcomes in women with axial spondyloarthritis.

Publications

  • Meissner Y., Fischer-Betz R., Andreoli L., Costedoat-Chalumeau N., De Cock D., Dolhain RJEM, Forger F., Goll D., Molto A., Nelson-Piercy C., Ozdemir R., Raio L., Rodriguez-Garcia S. C., Sciascia S., Wallenius M., Zbinden A., Zink A. and Strangfeld A. EULAR recommendations for a core data set for pregnancy registries in rheumatology. Ann Rheum Dis 2021;80(1):49-56.
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  • Meissner Y., Strangfeld A., Costedoat-Chalumeau N., Forger F., Goll D., Molto A., Ozdemir R., Wallenius M. and Fischer-Betz R. European Network of Pregnancy Registers in Rheumatology (EuNeP)-an overview of procedures and data collection. Arthritis Res Ther 2019;21(1):241.
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EULAR Abstracts

2018

  • FRI0601: The nature and extent of data items collected across European pregnancy registers – first results of the European network of pregnancy registers in rheumatology (EUNEP)

2019

  • OP0326: Development of a standardized minimal core data set for pregnancy registers in rheumatology – results of a EULAR task force

2020

  • FRI0558: Pregnancy outcomes in patients with axial spondyloarthritis – a first joint analysis of a European collaboration of pregnancy registers
  • AB0804: Pregnancy and psoriatic arthritis: A systematic literature review of disease activity and adverse pregnancy outcomes

Go to EULAR Abstract Archive

ACR Abstracts

2018

  • AB2426: Defining a Standardized Core Data Set for Pregnancy Registers in Rheumatic Diseases – an European Approach Abstract 2426. Arthritis Rheumatol. 2018; 70 (suppl 10). Accessed March 28, 2019.
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Goals/Milestones

Year 1: Meetings of representatives from existing pregnancy registers in Europe; collection, evaluation and data analyses, definition of the first research question.
Year 2: Publication on structure and content of all registers, preparation of first data analysis, first steps for building up new pregnancy registers, preparation of a second publication, preparation of first joint data analysis.
Year 3: Publication of first joint data analysis, covering pregnancy outcomes under different exposures. Support of new registers, depending on the availability of funding for these registers in individual countries