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. 2025 Jul 16:17:1759720X251350087.
doi: 10.1177/1759720X251350087. eCollection 2025.

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  1   2   3 , Christine Graversgaard  4   5 , Ioannis Parodis  6   7 , Nancy Agmon-Levin  8 , Silvia Aguilera  7   9 , Aleksandra Antovic  6 , George K Bertsias  10   11 , Ilaria Bini  12 , Anca Bobirca  13 , Susana Capela  14   15 , Ricard Cervera  16 , Nathalie Costedoat-Chalumeau  17 , Radboud Dolhain  18 , Oseme Etomi  19 , Julia Flint  20 , Joao Eurico Fonseca  14   15 , Ruth Fritsch-Stork  21 , Frauke Förger  22   23 , Ian Giles  24 , Bethan Goulden  24 , Carina Götestam Skorpen  25   26 , Iva Gunnarsson  6 , Latika Gupta  27   28 , Hege Svean Koksvik  29 , Louise Linde  30 , Jacob Lykke  31 , Yvette Meissner  32   33 , Anna Molto  34 , Louise Moore  35 , Marta Mosca  36 , Catherine Nelson-Piercy  19 , Luis Fernando Perez-Garcia  18 , Luigi Raio  37 , Ane Lilleoere Rom  31   38 , Amihai Rottenstreich  39   40   41 , Muna Saleh  42 , Savino Sciascia  43 , Anja Strangfeld  32   44 , Elisabet Svenungsson  6 , Maria G Tektonidou  45 , Angela Tincani  46   47 , Anne Troldborg  5   48 , Jelena Vojinovic  49 , Anne Voss  50 , Marianne Wallenius  28   51 , Nuria Zuniga-Serrano  52 , Laura Andreoli  4   2   46   47
Affiliations

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 et al. Ther Adv Musculoskelet Dis. .

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.

Plain language summary

When the patient leaflet and the clinical guidelines say different things on the use of antirheumatic medications during pregnancy and breastfeeding: global health care providers say that conflicting information can cause confusion and tension in the patient-clinician relationship Background: When pregnant or breastfeeding, women with rheumatic musculoskeletal diseases (RMDs) face challenges in managing their condition due to conflicting information about medication safety. Healthcare providers (HCPs) often struggle with discrepancies between clinical guidelines and the safety information provided with medications, such as the Summary of Product Characteristics and Patient Information Leaflets. This discrepancy can lead to difficulties in advising patients about safe medication use during pregnancy and breastfeeding. HCPs might feel uncertain or uncomfortable discussing medication safety, which can affect the patient-doctor relationship and even lead to stopping necessary treatments. The PRAISE study: To understand these challenges better, the PRAISE study conducted an online survey among 414 HCPs worldwide. We aimed to assess how HCPs prescribe medications, their comfort levels in advising patients, and the challenges they face due to conflicting information. Our key findings include: Confidence in prescribing: HCPs who prescribe medications were more comfortable discussing medication safety during pregnancy than those who do not prescribe.Usefulness of guidelines: Most prescribers found clinical guidelines very useful in managing patient care.Conflicting information: Over half of the HCPs reported feeling confused or tense when dealing with conflicting information between guidelines and medication safety documents. This confusion can lead to discontinuing treatments, which might negatively impact disease control.Communication strategies: HCPs often use clear communication and shared decision-making to address patient concerns. In conclusion, PRAISE highlights the need for better alignment between clinical guidelines and medication safety information to improve patient care and reduce confusion. This could help ensure that pregnant and breastfeeding women with RMDs receive the best possible.

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Conflict of interest statement

K.S.: Speaker and/or consultancy fees from Eli Lilly, Thermo-Fisher, UCB. C.G.: No conflict of interest. I.P.: Research funding and/or honoraria from Amgen, AstraZeneca, Aurinia, BMS, Eli Lilly, Gilead, GSK, Janssen, Novartis, Otsuka, and Roche. N.A.-L.: No conflict of interest. S.A.: No conflict of interest. A.A.: No conflict of interest. G.K.B.: Honoraria and consultancy fees from Abbvie, AstraZeneca, GSK, Novartis, Otsuka, Pfizer. I.B.: No conflict of interest. A.B.: Speaker and/or consultancy fees from Astra Zeneca, Boehringer Ingelheim, Ewo Pharma, Sandoz, Stada, UCB. S.C.: No conflict of interest. R.C.: Speaker and/or consultancy fees from Alpine, AstraZeneca, BMS, Celgene, Eli Lilly, GSK, Janssen, Pfizer, Roche, Rubió, UCB. N.C.-C.: Consultancy fees from BMS; research grants from Roche and UCB paid to the institution. R.D.: Unrestricted research grants from Dutch Arthritis Association, Galapagos, UCB, ZonMw. Speaking fees from Abbvie, AstraZeneca, Eli Lilly, Genzyme, Novartis, Roche, UCB. O.E.: No conflict of interest. J.F.: Speaker and consultancy fees from UCB. J.E.F.: No conflict of interest. R.F.-S.: Speaker and/or consultancy fees from: GSK, Novartis, Pfizer, UCB. F.F.: Speaker and/or consultancy fees from GSK, Novartis, Otsuka, Roche, UCB. I.Giles: Research funding, speaker and consultancy fees from UCB. B.G.: Speaker fees from GSK. C.G.S.: No conflict of interest. I.Gunnarsson: Research collaboration with Annexon, speaker fees from Otsuka. L.G.: No conflict of interest. H.S.K.: No conflict of interest. L.L.: Research funding from Novartis was paid to the institution. J.L.: No conflict of interest. Y.M.: Speaker fees from Eli Lilly, Pfizer. A.M.: Speaker and/or consultancy fees from Abbvie, Biogen, BMS, Janssen, Novartis, Pfizer, UCB, Viatris. L.M.: Speaker fees from Janssen, UCB. M.M.: Speaker and consultancy fees from UCB. C.N.-P.: Speaker and consultancy fees from UCB. L.F.P.-G.: Speaker and/or consultancy fees from AlfaSigma, Galapagos, Pfizer. L.R.: No conflict of interest. A.L.R.: No conflict of interest. A.R.: No conflict of interest. M.S.: No conflict of interest. S.S.: No conflict of interest. A.S.: Speaker fees from AbbVie, Amgen, Eli Lilly, Galapagos/AlfaSigma, Janssen, MSD, Pfizer, Roche, Takeda, UCB. A.S. is the PI of the RABBIT register, which is funded through an institution with unrestricted grants from AbbVie, Amgen, BMS, Celltrion, Eli Lilly, Fresenius Kabi, Alfasigma, Hexal, MSD, Pfizer, Samsung Biogen, Sanofi, Biocon, UCB. E.S.: Research grant from Merck paid to the institution. M.G.T.: Research funding and/or honoraria from Abbvie, Boehringer Ingelheim, DEMO, Eli Lilly, Faran, GSK, UCB. A.T.: Speaker and consultancy fees from Galapagos, UCB. A.T.: Speaker fees from AstraZeneca, Boehringer Ingelheim, Otsuka, Vipor Pharmaceuticals. J.V.: No conflict of interest. A.V.: No conflict of interest. M.W.: No conflict of interest. N.Z.-S.: Speaker fees from GSK. L.A.: Speaker and/or consultancy fees from AlfaSigma, GSK, Janssen, Novartis, Pfizer, UCB, Werfen Group.

Figures

Figure 1.
Figure 1.
Question 1—Ease of discussion of a lack of data for the use of medications during pregnancy. The scores were subdivided into three categories: <30, 30–70, and >70. Percentages within the bars were calculated with reference to prescribers and non-prescribers as denominators.
Figure 2.
Figure 2.
Question 2—Likelihood of healthcare professionals discontinuing medications in the case of conflicting information. Percentages within the bars were calculated with reference to prescribers and non-prescribers.
Figure 3.
Figure 3.
Question 3—Likelihood of patients discontinuing medications in the case of conflicting information. The scores were subdivided into three categories: <30, 30–70, and >70. Percentages within the bars were calculated with reference to prescribers and non-prescribers as denominators.
Figure 4.
Figure 4.
Question 4—Likelihood of patients expressing concerns when informed about conflicting information. Percentages within the bars were calculated with reference to prescribers and non-prescribers.
Figure 5.
Figure 5.
Question 5—Impact of conflicting information on patient–physician relationship. Percentages within the bars were calculated with reference to prescribers and non-prescribers.
Figure 6.
Figure 6.
Question 6—Strategies to address patient concerns in the case of conflicting information. Percentages within the bars were calculated with reference to prescribers and non-prescribers.
Figure 7.
Figure 7.
Question 7—Impact of conflicting advice between different healthcare professionals on patient–physician relationship. Percentages within the bars were calculated with reference to prescribers and non-prescribers.
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