Impact of conflicting information on the use of antirheumatic drugs in pregnancy and breastfeeding: perspectives of healthcare providers from the global PRAISE survey

Karen Schreiber; Christine Graversgaard; Ioannis Parodis; Nancy Agmon-Levin; Silvia Aguilera; Aleksandra Antovic; George K Bertsias; Ilaria Bini; Anca Bobirca; Susana Capela; Ricard Cervera; Nathalie Costedoat-Chalumeau; Radboud Dolhain; Oseme Etomi; Julia Flint; Joao Eurico Fonseca; Ruth Fritsch-Stork; Frauke Förger; Ian Giles; Bethan Goulden; Carina Götestam Skorpen; Iva Gunnarsson; Latika Gupta; Hege Svean Koksvik; Louise Linde; Jacob Lykke; Yvette Meissner; Anna Molto; Louise Moore; Marta Mosca; Catherine Nelson-Piercy; Luis Fernando Perez-Garcia; Luigi Raio; Ane Lilleoere Rom; Amihai Rottenstreich; Muna Saleh; Savino Sciascia; Anja Strangfeld; Elisabet Svenungsson; Maria G Tektonidou; Angela Tincani; Anne Troldborg; Jelena Vojinovic; Anne Voss; Marianne Wallenius; Nuria Zuniga-Serrano; Laura Andreoli

doi:10.1177/1759720X251350087

Impact of conflicting information on the use of antirheumatic drugs in pregnancy and breastfeeding: perspectives of healthcare providers from the global PRAISE survey

Karen Schreiber^*, Christine Graversgaard, Ioannis Parodis, Nancy Agmon-Levin, Silvia Aguilera, Aleksandra Antovic, George K Bertsias, Ilaria Bini, Anca Bobirca, Susana Capela, Ricard Cervera, Nathalie Costedoat-Chalumeau, Radboud Dolhain, Oseme Etomi, Julia Flint, Joao Eurico Fonseca, Ruth Fritsch-Stork, Frauke Förger, Ian Giles, Bethan GouldenCarina Götestam Skorpen, Iva Gunnarsson, Latika Gupta, Hege Svean Koksvik, Louise Linde, Jacob Lykke, Yvette Meissner, Anna Molto, Louise Moore, Marta Mosca, Catherine Nelson-Piercy, Luis Fernando Perez-Garcia, Luigi Raio, Ane Lilleoere Rom, Amihai Rottenstreich, Muna Saleh, Savino Sciascia, Anja Strangfeld, Elisabet Svenungsson, Maria G Tektonidou, Angela Tincani, Anne Troldborg, Jelena Vojinovic, Anne Voss, Marianne Wallenius, Nuria Zuniga-Serrano, Laura Andreoli

^*Corresponding author for this work

3 Citations (Scopus)

Abstract

BACKGROUND: Treating rheumatic musculoskeletal diseases (RMDs) during pregnancy and breastfeeding presents significant complexities, mainly due to inconsistencies between the clinical guidance documents and the reference safety information, including the summary of product characteristics (SmPC) and the patient information leaflets (PIL).

OBJECTIVES: To assess healthcare professionals' (HCPs) prescribing behaviors, comfort levels, and challenges when advising patients, focusing on discrepancies between clinical guidance documents and SmPC/PIL.

DESIGN: Online survey entitled PRAISE (Perception of healthcare providers Regarding Antirheumatics in pregnancy and breastfeeding: advice, Information and patient perSpEctives) and disseminated through HCPs groups and social media.

METHODS: A cross-sectional survey was conducted among 414 HCPs globally. Respondents were divided into prescribers (n = 336) and non-prescribers (n = 78) based on their self-reported role in prescribing antirheumatic medications to pregnant or breastfeeding patients with RMDs. The survey covered demographics, clinical experience, confidence in prescribing, use of clinical guidelines, and experiences managing conflicting information between guidelines and SmPC/PIL.

RESULTS: Prescribers were more likely than non-prescribers to feel comfortable discussing medication safety during pregnancy. Most prescribers found clinical guidance documents useful, with 48% rating them as "very useful" and 38% as "extremely useful." In case of conflicting information between clinical guidance documents and SmPC/PIL, 58% of HCPs reported that it caused confusion and tension in patient-doctor relationships, and almost 20% of them are "likely" or "very likely" to discontinue ongoing treatment. Clear communication and shared decision-making were the most common strategies used to address patient concerns.

CONCLUSION: HCPs often face significant challenges when advising patients with RMDs on the use of medications during pregnancy and breastfeeding. Conflicting information between clinical guidance documents and SmPC/PIL can disrupt patient-doctor relationship and lead to treatment discontinuation, with potential consequences on maternal disease control. Improved alignment between clinical guidance documents and the SmPC/PIL could enhance patient care and prevent confusion among HCPs and patients.

Original language	English
Article number	1759720X251350087
Journal	Therapeutic Advances in Musculoskeletal Disease
Volume	17
Pages (from-to)	1759720X251350087
ISSN	1759-720X
DOIs	https://doi.org/10.1177/1759720X251350087
Publication status	Published - 2025

Keywords

antirheumatic medications
breastfeeding
lactation
patient information leaflet
pregnancy
summary of product characteristics

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10.1177/1759720X251350087Licence: CC BY-NC

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Schreiber, K., Graversgaard, C., Parodis, I., Agmon-Levin, N., Aguilera, S., Antovic, A., Bertsias, G. K., Bini, I., Bobirca, A., Capela, S., Cervera, R., Costedoat-Chalumeau, N., Dolhain, R., Etomi, O., Flint, J., Fonseca, J. E., Fritsch-Stork, R., Förger, F., Giles, I., ... Andreoli, L. (2025). Impact of conflicting information on the use of antirheumatic drugs in pregnancy and breastfeeding: perspectives of healthcare providers from the global PRAISE survey. Therapeutic Advances in Musculoskeletal Disease, 17, 1759720X251350087. Article 1759720X251350087. https://doi.org/10.1177/1759720X251350087

Impact of conflicting information on the use of antirheumatic drugs in pregnancy and breastfeeding: perspectives of healthcare providers from the global PRAISE survey. / Schreiber, Karen; Graversgaard, Christine; Parodis, Ioannis et al.
In: Therapeutic Advances in Musculoskeletal Disease, Vol. 17, 1759720X251350087, 2025, p. 1759720X251350087.

Research output: Contribution to journal › Journal article › Research › peer-review

Schreiber, K, Graversgaard, C, Parodis, I, Agmon-Levin, N, Aguilera, S, Antovic, A, Bertsias, GK, Bini, I, Bobirca, A, Capela, S, Cervera, R, Costedoat-Chalumeau, N, Dolhain, R, Etomi, O, Flint, J, Fonseca, JE, Fritsch-Stork, R, Förger, F, Giles, I, Goulden, B, Götestam Skorpen, C, Gunnarsson, I, Gupta, L, Koksvik, HS, Linde, L , Lykke, J, Meissner, Y, Molto, A, Moore, L, Mosca, M, Nelson-Piercy, C, Perez-Garcia, LF, Raio, L, Rom, AL, Rottenstreich, A, Saleh, M, Sciascia, S, Strangfeld, A, Svenungsson, E, Tektonidou, MG, Tincani, A, Troldborg, A, Vojinovic, J, Voss, A, Wallenius, M, Zuniga-Serrano, N & Andreoli, L 2025, 'Impact of conflicting information on the use of antirheumatic drugs in pregnancy and breastfeeding: perspectives of healthcare providers from the global PRAISE survey', Therapeutic Advances in Musculoskeletal Disease, vol. 17, 1759720X251350087, pp. 1759720X251350087. https://doi.org/10.1177/1759720X251350087

Schreiber K, Graversgaard C, Parodis I, Agmon-Levin N, Aguilera S, Antovic A et al. Impact of conflicting information on the use of antirheumatic drugs in pregnancy and breastfeeding: perspectives of healthcare providers from the global PRAISE survey. Therapeutic Advances in Musculoskeletal Disease. 2025;17:1759720X251350087. 1759720X251350087. doi: 10.1177/1759720X251350087

@article{e53cee0681de4dbf9cfe81074f7b258b,

title = "Impact of conflicting information on the use of antirheumatic drugs in pregnancy and breastfeeding: perspectives of healthcare providers from the global PRAISE survey",

abstract = "BACKGROUND: Treating rheumatic musculoskeletal diseases (RMDs) during pregnancy and breastfeeding presents significant complexities, mainly due to inconsistencies between the clinical guidance documents and the reference safety information, including the summary of product characteristics (SmPC) and the patient information leaflets (PIL).OBJECTIVES: To assess healthcare professionals' (HCPs) prescribing behaviors, comfort levels, and challenges when advising patients, focusing on discrepancies between clinical guidance documents and SmPC/PIL.DESIGN: Online survey entitled PRAISE (Perception of healthcare providers Regarding Antirheumatics in pregnancy and breastfeeding: advice, Information and patient perSpEctives) and disseminated through HCPs groups and social media.METHODS: A cross-sectional survey was conducted among 414 HCPs globally. Respondents were divided into prescribers (n = 336) and non-prescribers (n = 78) based on their self-reported role in prescribing antirheumatic medications to pregnant or breastfeeding patients with RMDs. The survey covered demographics, clinical experience, confidence in prescribing, use of clinical guidelines, and experiences managing conflicting information between guidelines and SmPC/PIL.RESULTS: Prescribers were more likely than non-prescribers to feel comfortable discussing medication safety during pregnancy. Most prescribers found clinical guidance documents useful, with 48\% rating them as {"}very useful{"} and 38\% as {"}extremely useful.{"} In case of conflicting information between clinical guidance documents and SmPC/PIL, 58\% of HCPs reported that it caused confusion and tension in patient-doctor relationships, and almost 20\% of them are {"}likely{"} or {"}very likely{"} to discontinue ongoing treatment. Clear communication and shared decision-making were the most common strategies used to address patient concerns.CONCLUSION: HCPs often face significant challenges when advising patients with RMDs on the use of medications during pregnancy and breastfeeding. Conflicting information between clinical guidance documents and SmPC/PIL can disrupt patient-doctor relationship and lead to treatment discontinuation, with potential consequences on maternal disease control. Improved alignment between clinical guidance documents and the SmPC/PIL could enhance patient care and prevent confusion among HCPs and patients.",

keywords = "antirheumatic medications, breastfeeding, lactation, patient information leaflet, pregnancy, summary of product characteristics",

author = "Karen Schreiber and Christine Graversgaard and Ioannis Parodis and Nancy Agmon-Levin and Silvia Aguilera and Aleksandra Antovic and Bertsias, \{George K\} and Ilaria Bini and Anca Bobirca and Susana Capela and Ricard Cervera and Nathalie Costedoat-Chalumeau and Radboud Dolhain and Oseme Etomi and Julia Flint and Fonseca, \{Joao Eurico\} and Ruth Fritsch-Stork and Frauke F{\"o}rger and Ian Giles and Bethan Goulden and \{G{\"o}testam Skorpen\}, Carina and Iva Gunnarsson and Latika Gupta and Koksvik, \{Hege Svean\} and Louise Linde and Jacob Lykke and Yvette Meissner and Anna Molto and Louise Moore and Marta Mosca and Catherine Nelson-Piercy and Perez-Garcia, \{Luis Fernando\} and Luigi Raio and Rom, \{Ane Lilleoere\} and Amihai Rottenstreich and Muna Saleh and Savino Sciascia and Anja Strangfeld and Elisabet Svenungsson and Tektonidou, \{Maria G\} and Angela Tincani and Anne Troldborg and Jelena Vojinovic and Anne Voss and Marianne Wallenius and Nuria Zuniga-Serrano and Laura Andreoli",

note = "{\textcopyright} The Author(s), 2025.",

year = "2025",

doi = "10.1177/1759720X251350087",

language = "English",

volume = "17",

pages = "1759720X251350087",

journal = "Therapeutic Advances in Musculoskeletal Disease",

issn = "1759-720X",

publisher = "SAGE Publications Inc.",

}

TY - JOUR

T1 - Impact of conflicting information on the use of antirheumatic drugs in pregnancy and breastfeeding

T2 - perspectives of healthcare providers from the global PRAISE survey

AU - Schreiber, Karen

AU - Graversgaard, Christine

AU - Parodis, Ioannis

AU - Agmon-Levin, Nancy

AU - Aguilera, Silvia

AU - Antovic, Aleksandra

AU - Bertsias, George K

AU - Bini, Ilaria

AU - Bobirca, Anca

AU - Capela, Susana

AU - Cervera, Ricard

AU - Costedoat-Chalumeau, Nathalie

AU - Dolhain, Radboud

AU - Etomi, Oseme

AU - Flint, Julia

AU - Fonseca, Joao Eurico

AU - Fritsch-Stork, Ruth

AU - Förger, Frauke

AU - Giles, Ian

AU - Goulden, Bethan

AU - Götestam Skorpen, Carina

AU - Gunnarsson, Iva

AU - Gupta, Latika

AU - Koksvik, Hege Svean

AU - Linde, Louise

AU - Lykke, Jacob

AU - Meissner, Yvette

AU - Molto, Anna

AU - Moore, Louise

AU - Mosca, Marta

AU - Nelson-Piercy, Catherine

AU - Perez-Garcia, Luis Fernando

AU - Raio, Luigi

AU - Rom, Ane Lilleoere

AU - Rottenstreich, Amihai

AU - Saleh, Muna

AU - Sciascia, Savino

AU - Strangfeld, Anja

AU - Svenungsson, Elisabet

AU - Tektonidou, Maria G

AU - Tincani, Angela

AU - Troldborg, Anne

AU - Vojinovic, Jelena

AU - Voss, Anne

AU - Wallenius, Marianne

AU - Zuniga-Serrano, Nuria

AU - Andreoli, Laura

PY - 2025

Y1 - 2025

N2 - BACKGROUND: Treating rheumatic musculoskeletal diseases (RMDs) during pregnancy and breastfeeding presents significant complexities, mainly due to inconsistencies between the clinical guidance documents and the reference safety information, including the summary of product characteristics (SmPC) and the patient information leaflets (PIL).OBJECTIVES: To assess healthcare professionals' (HCPs) prescribing behaviors, comfort levels, and challenges when advising patients, focusing on discrepancies between clinical guidance documents and SmPC/PIL.DESIGN: Online survey entitled PRAISE (Perception of healthcare providers Regarding Antirheumatics in pregnancy and breastfeeding: advice, Information and patient perSpEctives) and disseminated through HCPs groups and social media.METHODS: A cross-sectional survey was conducted among 414 HCPs globally. Respondents were divided into prescribers (n = 336) and non-prescribers (n = 78) based on their self-reported role in prescribing antirheumatic medications to pregnant or breastfeeding patients with RMDs. The survey covered demographics, clinical experience, confidence in prescribing, use of clinical guidelines, and experiences managing conflicting information between guidelines and SmPC/PIL.RESULTS: Prescribers were more likely than non-prescribers to feel comfortable discussing medication safety during pregnancy. Most prescribers found clinical guidance documents useful, with 48% rating them as "very useful" and 38% as "extremely useful." In case of conflicting information between clinical guidance documents and SmPC/PIL, 58% of HCPs reported that it caused confusion and tension in patient-doctor relationships, and almost 20% of them are "likely" or "very likely" to discontinue ongoing treatment. Clear communication and shared decision-making were the most common strategies used to address patient concerns.CONCLUSION: HCPs often face significant challenges when advising patients with RMDs on the use of medications during pregnancy and breastfeeding. Conflicting information between clinical guidance documents and SmPC/PIL can disrupt patient-doctor relationship and lead to treatment discontinuation, with potential consequences on maternal disease control. Improved alignment between clinical guidance documents and the SmPC/PIL could enhance patient care and prevent confusion among HCPs and patients.

AB - BACKGROUND: Treating rheumatic musculoskeletal diseases (RMDs) during pregnancy and breastfeeding presents significant complexities, mainly due to inconsistencies between the clinical guidance documents and the reference safety information, including the summary of product characteristics (SmPC) and the patient information leaflets (PIL).OBJECTIVES: To assess healthcare professionals' (HCPs) prescribing behaviors, comfort levels, and challenges when advising patients, focusing on discrepancies between clinical guidance documents and SmPC/PIL.DESIGN: Online survey entitled PRAISE (Perception of healthcare providers Regarding Antirheumatics in pregnancy and breastfeeding: advice, Information and patient perSpEctives) and disseminated through HCPs groups and social media.METHODS: A cross-sectional survey was conducted among 414 HCPs globally. Respondents were divided into prescribers (n = 336) and non-prescribers (n = 78) based on their self-reported role in prescribing antirheumatic medications to pregnant or breastfeeding patients with RMDs. The survey covered demographics, clinical experience, confidence in prescribing, use of clinical guidelines, and experiences managing conflicting information between guidelines and SmPC/PIL.RESULTS: Prescribers were more likely than non-prescribers to feel comfortable discussing medication safety during pregnancy. Most prescribers found clinical guidance documents useful, with 48% rating them as "very useful" and 38% as "extremely useful." In case of conflicting information between clinical guidance documents and SmPC/PIL, 58% of HCPs reported that it caused confusion and tension in patient-doctor relationships, and almost 20% of them are "likely" or "very likely" to discontinue ongoing treatment. Clear communication and shared decision-making were the most common strategies used to address patient concerns.CONCLUSION: HCPs often face significant challenges when advising patients with RMDs on the use of medications during pregnancy and breastfeeding. Conflicting information between clinical guidance documents and SmPC/PIL can disrupt patient-doctor relationship and lead to treatment discontinuation, with potential consequences on maternal disease control. Improved alignment between clinical guidance documents and the SmPC/PIL could enhance patient care and prevent confusion among HCPs and patients.

KW - antirheumatic medications

KW - breastfeeding

KW - lactation

KW - patient information leaflet

KW - pregnancy

KW - summary of product characteristics

UR - https://www.scopus.com/pages/publications/105014189778

U2 - 10.1177/1759720X251350087

DO - 10.1177/1759720X251350087

M3 - Journal article

C2 - 40678818

SN - 1759-720X

VL - 17

SP - 1759720X251350087

JO - Therapeutic Advances in Musculoskeletal Disease

JF - Therapeutic Advances in Musculoskeletal Disease

M1 - 1759720X251350087

ER -

Impact of conflicting information on the use of antirheumatic drugs in pregnancy and breastfeeding: perspectives of healthcare providers from the global PRAISE survey

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Keywords

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