WHAT IS THE IMPACT OF CONFLICTING INFORMATION ON THE USE OF ANTI-RHEUMATIC DRUGS IN PREGNANCY AND BREASTFEEDING? LIKELIHOOD FOR APPREHENSION AND MEDICATION CESSATION REPORTED BY HEALTH CARE PROVIDERS IN THE GLOBAL PRAISE SURVEY
Keywords: Pregnancy and reproduction, Safety, Interdisciplinary research, Patient information and education, Quality of care
K. Schreiber1,2,3, C. Graversgaard1,4, N. Agmon-Levin5, S. Aguilera6, A. Antovic7,8, G. K. Bertsias9,10, I. Bini11, A. Bobirca12, S. Capela13, R. Cervera14, N. Costedoat-Chalumeau15,16, O. Etomi17, J. Flint18, J. E. Fonseca19, R. Fritsch-Stork20, F. Förger21, I. Giles22, B. Goulden22, C. Götestam Skorpen23,24, I. Gunnarsson7,8, L. Gupta25,26, H. S. Koksvik27, L. Linde28, J. Lykke29, Y. Meissner30, A. Moltó31,32, L. Moore33, M. Mosca34, C. Nelson-Piercy17, L. F. Perez35, L. Raio36, A. L. Rom37,38, A. Rottenstreich39,40,41, M. Saleh42, S. Sciascia43,44, A. Strangfeld30, E. Svenungsson7,8, M. G. Tektonidou45, A. Tincani46,47, A. Troldborg48,49, J. Vojinovic50, A. Voss51, M. Wallenius23,27, A. Zbinden21, L. Andreoli46,47, on behalf of EULAR Study Group on Reproductive Health and Family Planning (ReHFaP)
1Danish Hospital for Rheumatic Diseases, Danish Center for Expertise in Rheumatology (CeViG), Sonderborg, Denmark
2Southern Danish University, Institute for Regional Health, Odense, Denmark
3Guy’s and St Thomas NHS Foundation Trust, Thrombosis and Haemostasis, London, United Kingdom
4Aarhus Universitetshospital, Rheumatology, Aarhus, Denmark
5Sheba Medical Center, The Zabludowicz Center for Autoimmune Diseases, Tel Hashomer, Israel
6Spanish Antiphospholipid Syndrome Association (SAF España), Elche, Spain
7Karolinska University Hospital, Division of Rheumatology, Stockholm, Sweden
8Karolinska Institutet, Department of Medicine, Division of Rheumatology, Stockholm, Sweden
9University of Crete School of Medicine, Rheumatology, Heraklion, Greece
10Institute of Molecular Biology and Biotechnology, Laboratory of Autoimmunity-Inflammation, Heraklion, Greece
11EULAR Young PARE, Avellino, Italy
12Dr. I. Cantacuzino Clinical Hospital, “Carol Davila” University of Medicine and Pharmacy, Department of Internal Medicine and Rheumatology, Bucharest, Romania
13Hospital de Santa Maria, Centro Hospitalar Lisboa Norte EPE, Faculty of Medicine, University of Lisbon, Lisbon Academic Medical Centre, Rheumatology, Lisbon, Portugal
14Hospital Clínic, University of Barcelona, Department of Autoimmune Diseases, Barcelona, Spain
15Hôpital Cochin, Centre de référence maladies auto-immunes et systémiques rares, Paris, France
16Université Paris Cité, Paris, France
17Guy’s & St Thomas’ Foundation Trust, Obstetric Medicine, London, United Kingdom
18Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, Rheumatology, Oswestry, United Kingdom
19Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa and Centro Hospitalar Universitário Lisboa Norte, Centro Académico de Medicina de Lisboa, Lisbon, Portugal
20Health Care Center Mariahilf, ÖGK and Rheumatology Department at the Sigmund Freud Private University, Vienna, Austria
21University Hospital of Bern, Department of Rheumatology, Immunology and Allergology, Bern, Switzerland
22UCL Division of Medicine, Centre for Rheumatology, London, United Kingdom
23Norwegian University of Science and Technology (NTNU), Department of Neuromedicine and Movement Science, Trondheim, Norway
24Ålesund Hospital, Department of Rheumatology, Ålesund, Norway
25Royal Wolverhampton Hospitals NHS Trust, Rheumatology, Wolverhampton, United Kingdom
26University of Manchester, Division of Musculoskeletal and Dermatological Sciences, Centre for Musculoskeletal Research, School of Biological Sciences, Manchester, United Kingdom
27St Olavs Hospital - Trondheim University Hospital, Norwegian National Advisory Unit on Pregnancy and Rheumatic Diseases, Dept of Rheumatology, Trondheim, Norway
28Copenhagen University Hospital, Rigshospitalet, Copenhagen Research Center for Autoimmune Connective Tissue Diseases (COPEACT), Lupus and Vasculitis Clinic, Copenhagen, Denmark
29Copenhagen University Hospital, Rigshospitalet, Department of Obstetrics, Copenhagen, Denmark
30German Rheumatism Research Centre, Epidemiology and Health Services Research, Berlin, Germany
31Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Rheumatology, Paris, France
32PRES Sorbonne Paris-Cité, INSERM (U1153), Paris, France
33Our Lady’s Hospice and Care Services, Harold’s Cross, Rheumatic and Musculoskeletal Disease Unit, Dublin, Ireland
34University of Pisa, Rheumatology Unit, Department of Clinical and Experimental Medicine, Pisa, Italy
35Erasmus MC, University Medical Center, Rheumatology, Rotterdam, Netherlands
36University Hospital of Bern, Obstetrics and Gynaecology, Bern, Switzerland
37Copenhagen University Hospital, Rigshospitalet, Department of Obstetrics, The Juliane Marie Centre, Copenhagen, Denmark
38University of Southern Denmark, Research Unit of Gynecology and Obstetrics, Department of Clinical Research, Odense, Denmark
39Zucker School of Medicine at Hofstra/Northwell, Division of Maternal- Fetal Medicine, Department of Obstetrics and Gynecology, New York, United States of America
40Rockefeller University, Laboratory of Blood and Vascular Biology, New York, United States of America
41Hadassah-Hebrew University Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Department of Obstetrics and Gynecology, Jerusalem, Israel
42Linköping University, Department of Biomedical and Clinical Sciences, Division of Inflammation and Infection/Rheumatology, Linköping, Sweden
43San Giovanni Hospital, Center of Research of Immunopathology and Rare Diseases, Turin, Italy
44University of Turin, Department of Clinical and Biological Sciences, Turin, Italy
45National and Kapodistrian University of Athens, First Department of Propaedeutic and Internal Medicine, Athens, Greece
46ASST Spedali Civili, Rheumatology and Clinical Immunology Unit - ERN ReCONNET, Brescia, Italy
47University of Brescia, Department of Clinical and Experimental Sciences, Brescia, Italy
48Aarhus University Hospital, Department of Rheumatology, Aarhus, Denmark
49Aarhus University, Department of Biomedicine and Department of Clinical Medicine, Aarhus, Denmark
50University of Nis, Faculty of Medicine, Clinic for Pediatrics, University Clinical Center Nis, Nis, Serbia
51Odense University Hospital, Department of Rheumatology, Odense, Denmark
Background: Rheumatic and musculoskeletal diseases (RMDs) frequently affect individuals of childbearing age. During pregnancy, disease control is vital, as disease activity leads to adverse outcomes for both the mother and the baby. Clinical guidance documents on the use of anti-rheumatics in pregnancy by the European Alliance of Associations in Rheumatology (EULAR), the British Society for Rheumatology (BSR), and the American College of Rheumatology (ACR), rely on systematic reviews of available data, but the recommendations are more liberal than the regulators reference safety information (RSI), creating inconsistent information. This misalignment challenges the shared decision-making process between healthcare providers (HCPs) and individuals with RMDs, potentially affecting their therapeutic choices during pregnancy. We hypothesize that such misalignment adversely affects the shared decision-making process and relationship between HCPs and individuals with RMDs.
Objectives: The PRAISE survey (Perception of health care providers Regarding Anti-rheumatics in pregnancy and breastfeeding: advice, Information and patient perSpEctives) was designed to explore the perspectives of HCPs on the shared decision-making process regarding the use of anti-rheumatics in pregnancy and breastfeeding, with particular focus on the scenario encompassing conflicting information.
Methods: We conducted a multinational, electronic survey among doctors, nurses and midwives in and outside of Europe from May and to December 2023. The survey was promoted by the EULAR Study Group on Reproductive Health & Family Planning (ReHFaP) and was distributed among networks of HCPs working with RMDs and pregnancy.
The survey consisted of 24 questions that explored how HCPs feel about prescribing and advising on anti-rheumatic drugs in pregnancy and breastfeeding and their use of clinical guidance documents in clinical practice. It also explored how HCPs perceive different clinical scenarios involving conflicting information between guidance documents and RSI.
Results: Responses on all questions were collected from 414 participants from 24 countries (19 EU countries and 5 non-EU countries), 70% of respondents were women (median age of 44 years). The majority were doctors (82%), practicing for >10 years (63.5%), with experience in prescription of anti-rheumatics for pregnant or lactating individuals. The majority of prescribers (88%) felt comfortable when prescribing anti-rheumatics in pregnancy, and 65% responded that they frequently or very frequently collaborate with other medical specialties (Figure 1).
The clinical guidance documents were used by 92% of respondents in daily practice, with 83% of respondents reporting them very or extremely useful. Twenty-five percent of the respondents were likely or very likely to discontinue an ongoing treatment if advice between the clinical guidance document and the RSI were conflicting, i.e. if the clinical guidance document supported the continuation of treatment and the RSI stated that the treatment was not compatible with use in pregnancy.
On a Visual Analogue Scale from 0-100 (with 100 being “extremely likely”), 60 was the average score reported when questioned about the likelihood that their patient will stop taking a medication if the RSI states that the drug has “a small increased risk of major malformations and should not be used during pregnancy unless your doctor considers the benefits outweigh the risk”. Most importantly, 58% reported that conflicting information causes confusion and tension in the patient-doctor relationship (Figure 2).
Conclusion: The PRAISE survey highlights the crucial role of clinical guidance documents in instructing HCPs in managing anti-rheumatic drugs during pregnancy in patients with RMDs.
However, the noteworthy finding that a quarter of respondents expressed readiness to cease medication use, when confronted with inconsistent advice, underscores the imperative of harmonizing recommendations between scientific societies and regulators.
This would safeguard the well-being of mother and child, address patient apprehension and strengthen the patient-doctor relationship.
REFERENCES: NIL.
Acknowledgements: Kirsten Frohlich (Danish Hospital for Rheumatic Diseases) is kindly acknowledged for her logistic support.
Disclosure of Interests: None declared.
DOI: 10.1136/annrheumdis-2024-eular.2182
Keywords: Pregnancy and reproduction, Safety, Interdisciplinary research, Patient information and education, Quality of care
Citation: , volume 83, supplement 1, year 2024, page 1140
