Sistema de Salut de Catalunya
Institut Català de la Salut
[Pluma A] Servei de Reumatologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Hamroun S] Department of Rheumatology, Pontoise Hospital, Pontoise, Paris, France. [Rüegg L] Department of Rheumatology and Immunology, Inselspital, Bern University Hospital, University of Bern, Switzerland. [Cecchi I] University Center of Excellence on Nephrologic, Rheumatologic and Rare Diseases (ERK-Net, ERNReconnect, and RITA-ERN Member) with Nephrology and Dialysis Unit, University of Turin, Turin, Italy. Center of ImmunoRheumatology and Rare Diseases (CMID), Coordinating Center of the Interregional Network for Rare Diseases of Piedmont and Aosta Valley, San Giovanni Bosco Hub Hospital, Turin, Italy. Department of Clinical and Biological Sciences, University of Turin, Turin, Italy. [Kramer M] Epidemiology and Health Services Research, German Rheumatology Research Center, Berlin, Germany. [Perez-Garcia LF] Department of Rheumatology, Erasmus University Medical Center, Rotterdam, Netherlands
Vall d'Hebron Barcelona Hospital Campus
2025-10-31T07:30:55Z
2025-10-31T07:30:55Z
2025-09
Fármacos antirreumáticos; Reproducción; Embarazo
Antirheumatic drugs; Reproduction; Pregnancy
Fàrmacs antireumàtics; Reproducció; Embaràs
Objectives This study aimed to summarise and update evidence to inform the 2024 update of the European Alliance of Associations for Rheumatology recommendations for the use of antirheumatic drugs in reproduction, pregnancy, and lactation. Methods A systematic literature review (SLR) was performed, including keywords on reproduction, adverse pregnancy outcomes (APOs), and lactation. Two appraised SLRs were the basis for the SLR on drug safety in men. If sufficient data were available, a meta-analysis was performed on maternal drug exposure and the risk of APOs. Results Of 6680 screened articles, 255 were included in the final analysis. In pregnancy, most evidence was available for biologic disease-modifying antirheumatic drugs (bDMARDs). Meta-analyses with adjusted risk estimates did not reveal APOs or serious infant infections to be associated with tumour necrosis factor inhibitor (TNFi) use. Data on non-TNFi bDMARDs did not raise concerns. In bDMARD-exposed infants, no serious adverse effects to rotavirus live vaccination were reported. Safety of Bacille Calmette–Guérin vaccination in TNFi-exposed infants could be a concern in the first 6 months of life. Regarding oral glucocorticoids, the SLR and meta-analysis using adjusted risk estimates found a dose-dependent association with an increased risk of preterm birth. Nonsteroidal anti-inflammatory drug use could reversibly reduce fecundability. Concerning lactation, available data on various bDMARDs was reassuring. In male patients, available evidence on methotrexate and most other drugs did not reveal adverse effects on sperm quality or birth outcomes. Cyclophosphamide remains the only drug that causes a dose-dependent irreversible infertility. Conclusions This SLR provides up-to-date evidence to guide the 2024 update of the European Alliance of Associations for Rheumatology recommendations for the use of antirheumatic drugs in reproduction, pregnancy, and lactation.
This work was supported by the European League Against Rheumatism as project QoC012.
Article
Published version
English
Embaràs; Alletament; Reumatisme - Tractament; Antireumàtics - Ús terapèutic; Reproducció; DISEASES::Musculoskeletal Diseases::Rheumatic Diseases; Other subheadings::Other subheadings::Other subheadings::/drug therapy; PHENOMENA AND PROCESSES::Reproductive and Urinary Physiological Phenomena::Reproductive Physiological Phenomena::Reproduction; PHENOMENA AND PROCESSES::Reproductive and Urinary Physiological Phenomena::Reproductive Physiological Phenomena::Reproduction::Pregnancy; PHENOMENA AND PROCESSES::Reproductive and Urinary Physiological Phenomena::Reproductive Physiological Phenomena::Lactation; CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antirheumatic Agents; ENFERMEDADES::enfermedades musculoesqueléticas::enfermedades reumáticas; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; FENÓMENOS Y PROCESOS::fenómenos fisiológicos reproductivos y urinarios::fenómenos fisiológicos de la reproducción::reproducción; FENÓMENOS Y PROCESOS::fenómenos fisiológicos reproductivos y urinarios::fenómenos fisiológicos de la reproducción::reproducción::embarazo; FENÓMENOS Y PROCESOS::fenómenos fisiológicos reproductivos y urinarios::fenómenos fisiológicos de la reproducción::lactancia; COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antirreumáticos
Elsevier
Annals of the Rheumatic Diseases;84(9)
https://doi.org/10.1016/j.ard.2025.02.021
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
Articles científics - HVH [3396]
