Real-world safety data of first-line drugs for rheumatoid arthritis: insights from the Portuguese Reuma.pt database.
Objectives: To assess adverse events (AE) associated with first-line therapies for rheumatoid arthritis (RA) in a real-world setting. Material and Methods: Retrospective multicenter cohort study of patients fulfilling classification criteria for RA and followed up in 66 rheumatology centers from the...
| Publicado en: | ARP Rheumatology Vol. 4; no. 4; pp. 267 - 276 |
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| Autores principales: | , , , , , , , , , , , , , , , , , , , |
| Formato: | Artículo |
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Sociedade Portuguesa de Reumatologia
Oct-Dec2025
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| Materias: | |
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=lth&AN=190727923&site=ehost-live header: @attributes: shortDbName: lth uiTerm: 190727923 longDbName: MedicLatina uiTag: AN controlInfo: bkinfo: jinfo: jid: 27954552 N2OK jtl: ARP Rheumatology issn: 27954552 maglogo: N pubinfo: dt: Oct-Dec2025 vid: 4 iid: 4 pid: 38819 pub: Sociedade Portuguesa de Reumatologia artinfo: ui: 190727923 10.63032/XQFS6110 ppf: 267 ppct: 9 formats: fmt: @attributes: type: P size: 580KB tig: atl: Real-world safety data of first-line drugs for rheumatoid arthritis: insights from the Portuguese Reuma.pt database. aug: au: Ramos Rodrigues, J. Pires, L. Inês, L. Morgado, M. Pontes Ferreira, M. Cunha, A. Almeida, S. Santos, M. Moniz, A. C. Melim, D. Bernardes, M. Marques Gomes, C. Diz Lopes, M. Carvalho, D. Polido Pereira, J. Aguiar, J. Sopa, I. Duarte, C. Canhão, F. Palos, S. affil: Rheumatology Department, Unidade Local de Saúde da Cova da Beira, Portugal. FCS-UBI, Faculty of Health Sciences, University of Beira Interior, Covilhã, Portugal. Center for Research in Neuropsychology and Cognitive-Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences, University of Coimbra, Portugal. Rheumatology Department, Unidade Local de Saúde de Coimbra, Coimbra, Portugal. Faculty of Medicine, University of Coimbra, Coimbra, Portugal. Pharmaceutical Services, Unidade Local de Saúde da Cova da Beira, Alameda Pêro da Covilhã, Portugal. RISE-Health, Department of Medical Sciences, Faculty of Health Sciences, University of Beira Interior, Covilhã, Portugal. Rheumatology Department, Unidade Local de Saúde do Alto Minho, Ponte de Lima. Rheumatology department, ULS Lisboa Ocidental - Hospital Egas Moniz, Lisboa, Portugal. NOVA Medical School, Universidade Nova de Lisboa, Lisboa, Portugal. Rheumatology Department, Central Hospital of Funchal SESARAM EPE, Madeira, Portugal. Rheumatology Department, Unidade Local de Saúde de São João, Porto, Portugal. Department of Medicine, Faculty of Medicine, University of Porto, Porto, Portugal. Rheumatology Department, Local Health Unit of Santa Maria, Lisbon Academic Medical Centre. Faculty of Medicine, University of Lisbon, Lisbon, Portugal. Rheumatology Research Unit, Institute of Molecular Medicine, Faculty of Medicine, University of Lisbon, Lisbon Academic Medical Centre. su: Rheumatoid arthritis Methotrexate Medical records Termination of treatment Adverse health care events Safety Antirheumatic agents sug: subj: Rheumatoid arthritis Methotrexate Medical records Termination of treatment Adverse health care events Safety Antirheumatic agents keyword: Adverse Drug Reaction Reporting Systems Antirheumatic Agents Rheumatoid Arthritis Treatment Outcome ab: Objectives: To assess adverse events (AE) associated with first-line therapies for rheumatoid arthritis (RA) in a real-world setting. Material and Methods: Retrospective multicenter cohort study of patients fulfilling classification criteria for RA and followed up in 66 rheumatology centers from the Rheumatic Diseases Portuguese Registry (Reuma.pt). All AE reports associated with first-line disease-modifying antirheumatic drugs (DMARDs) up to November 2024 were included. Demographic and clinical data were analyzed, and AE characteristics were investigated. Categorical and continuous variables were compared using chi-square tests and Mann–Whitney U tests, respectively. Statistical significance was defined as p < 0.05. Results: Among 1 880 AE entries, 377 (20.1%) were attributed to first-line DMARDs, most commonly methotrexate (62.9%) although no information on drug dosage was available. The median age at AE occurrence was 58.6 years (IQR: 19.32), and 82% were female. A causality assessment was available in 317 reports, with 40.3% deemed "probable," 28.1% "possible," and 10.6% "definitive." Severe AE were reported in 13.2% of cases, with pulmonary involvement being the most common (20.8%). Overall, 46.7% of patients discontinued treatment for any reason. Male sex was significantly associated with severe AE (OR = 2.31; 95% CI: 1.17–4.55; p = .014), and older patients were more likely to experience severe AE (median age 65.7 vs. 57.9 years; p < .001). The most affected body organ systems were gastrointestinal (9.3%), skin (8.2%), and hematological (8.2%). The median time to AE onset from treatment initiation was 1.27 years (IQR: 2.63), and from disease onset was 8.56 years (IQR: 11.76). Conclusions: AE related to first-line RA therapies can lead to significant clinical consequences, including treatment discontinuation. Male sex and advanced age were associated with increased AE severity. The most affected systems appear consistent with known drug safety profiles, particularly that of methotrexate; however, the absence of information regarding drug dosage precludes more detailed conclusions. These findings emphasize the need for individualized monitoring strategies and improved pharmacovigilance to optimize long-term treatment safety and adherence in RA management. pubtype: Academic Journal doctype: Article src: R language: English refInfo: copyright: @attributes: flag: Y custom: Copyright of ARP Rheumatology is the property of Sociedade Portuguesa de Reumatologia and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. item: ARP Rheumatology holder: Sociedade Portuguesa de Reumatologia dt: @attributes: year: 2025 holdings: @attributes: islocal: N |
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