REVIEW article
Front. Pharmacol.
Sec. Obstetric and Pediatric Pharmacology
Inconsistent medication recommendations for immune-mediated inflammatory diseases across pregnancy, lactation, and paternal preconception: a guideline-based review
Provisionally accepted
Elise Van den Broeck1
Sien Lenie2
Marc Ferrante3,4Ellen De Langhe5,6Barbara Neerinckx6,7
Tom Hillary8,9Kristel Van Calsteren10,5
Anne Smits11,12,7
Laure Sillis13,14,2Mette Julsgaard15,16
Veerle Foulon14,2
Michael Ceulemans13,14,2*- 1Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
- 2Pharmaceutical and Pharmacological Sciences, Katholieke Universiteit Leuven, Leuven, Belgium
- 3Chronic Diseases and Metabolism, Katholieke Universiteit Leuven, Leuven, Belgium
- 4Gastroenterology, UZ Leuven, Leuven, Belgium
- 5Development and Regeneration, Katholieke Universiteit Leuven, Leuven, Belgium
- 6Rheumatology, UZ Leuven, Leuven, Belgium
- 7Development and Regeneration, KU Leuven, Leuven, Belgium
- 8Dermatology, UZ Leuven, Leuven, Belgium
- 9Microbiology, Immunology and Transplantation, Katholieke Universiteit Leuven, Leuven, Belgium
- 10Gynecology and Obstetrics, UZ Leuven, Leuven, Belgium
- 11Child & Youth Institute, Katholieke Universiteit Leuven, Leuven, Belgium
- 12Neonatal Intensive Care Unit, UZ Leuven, Leuven, Belgium
- 13Fonds Wetenschappelijk Onderzoek Vlaanderen, Brussels, Belgium
- 14Child & Youth Institute, KU Leuven, Leuven, Belgium
- 15Hepatology and Gastroenterology, Aarhus Universitet, Aarhus, Denmark
- 16Clinical Medicine, Aalborg Universitet, Aalborg, Denmark
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Background: Immune-mediated inflammatory diseases (IMIDs) often affect women of childbearing age. Since active inflammatory disease is related with impaired reproductive outcomes, effective disease control is crucial. Clinical guidelines aim to support evidence-based shared decision-making. However, inconsistencies between guidelines across specialties may cause confusion, undermine adherence and lead to adverse health outcomes. This study aimed to assess consistency within and across perinatal IMID guidelines in gastroenterology, rheumatology and dermatology regarding medication use during pregnancy, lactation and among prospective fathers, and to identify medications with insufficient safety data. Methods: A review was conducted in August 2025 using most recent versions of leading international guidelines (N=11), published between and 2025. Guideline recommendations for IMID medications were categorized by two independent authors. Data-analysis examined the prevalence and type of consistency, trimester-specific consistency, most common recommendation per medication and the agreement on preconception discontinuation timing. Results: Within medical specialties, guideline consistency for individual medications was highest for gastroenterology (61/74, 82.4%), followed by rheumatology (165/220, 73.6%) and dermatology (57/94, 60.6%). Across specialties, agreement was greatest between gastroenterology and rheumatology (pregnancy 86.2%, lactation 81.2%, paternal 88.5%) and lowest between gastroenterology and dermatology (pregnancy 51.3%, lactation 40.6%, paternal 47.1%). Trimester-specific recommendations were consistent across guidelines in 33.3% (2/6) of the cases. Agreement on preconception discontinuation timing was 41.7% (5/12) for maternal cases and 66.7% (2/3) for paternal exposure. At least one inconsistency was found in 75.0% of within-guideline and 87.5% of across-guideline comparisons. At medication-class level, most inconsistencies stemmed from insufficient safety data reporting (59.5%), particularly for small molecules (28.6%), immunomodulators (26.1%) and interleukin inhibitors (34.1%). Conclusions: Inconsistencies between guidelines, both within and across specialties, were frequent and pose challenges for reproductive decision-making in IMID patients. The lack of safety data in reproductive contexts contributed to guideline inconsistencies and revealed the need to prioritize future research on recently marketed pharmacotherapeutic classes, such as small molecules (JAK-inhibitors, PDE4-modulators) and interleukin inhibitors. In the future, guidelines should be updated regularly, include explicit recommendations, integrate reproductive contexts, and adopt unambiguous language, standardized categories and uniform methodological frameworks.
Keywords: Clinical guidelines, Dermatology, Gastroenterology, Lactation, medication safety, Paternal Exposure, Pregnancy, Rheumatology
Received: 12 Nov 2025; Accepted: 10 Feb 2026.
Copyright: © 2026 Van den Broeck, Lenie, Ferrante, De Langhe, Neerinckx, Hillary, Van Calsteren, Smits, Sillis, Julsgaard, Foulon and Ceulemans. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Michael Ceulemans
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