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Safety of biological and targeted synthetic disease-modifying antirheumatic drugs for rheumatoid arthritis as used in clinical practice : Results from the ARTIS programme

Frisell, Thomas ; Bower, Hannah ; Morin, Matilda ; Baecklund, Eva ; Di Giuseppe, Daniela ; Delcoigne, Benedicte ; Feltelius, Nils ; Forsblad-D'Elia, Helena ; Lindqvist, Elisabet LU orcid and Lindström, Ulf , et al. (2023) In Annals of the Rheumatic Diseases 82(5). p.601-610
Abstract

Objective Longitudinal clinical registry-infrastructures such as Anti-Rheumatic Therapies in Sweden (ARTIS) allow simultaneous comparison of the safety of individual immunomodulatory drugs used in clinical practice, with consistent definitions of treatment cohorts, follow-up and outcomes. Our objective was to assess and compare incidence rates of key safety outcomes for individual targeted synthetic or biological disease-modifying antirheumatic drugs (b/ts DMARDs) in rheumatoid arthritis (RA), updating previous reports and including newer treatments including Janus Kinase inhibitors (JAKi). Methods Nationwide register-based cohort study including all patients with RA in Sweden registered as starting any b/tsDMARD 1 January 2010 through... (More)

Objective Longitudinal clinical registry-infrastructures such as Anti-Rheumatic Therapies in Sweden (ARTIS) allow simultaneous comparison of the safety of individual immunomodulatory drugs used in clinical practice, with consistent definitions of treatment cohorts, follow-up and outcomes. Our objective was to assess and compare incidence rates of key safety outcomes for individual targeted synthetic or biological disease-modifying antirheumatic drugs (b/ts DMARDs) in rheumatoid arthritis (RA), updating previous reports and including newer treatments including Janus Kinase inhibitors (JAKi). Methods Nationwide register-based cohort study including all patients with RA in Sweden registered as starting any b/tsDMARD 1 January 2010 through 31 December 2020, followed until 30 June 2021 (N=20 117). The incidence rates of selected outcomes, identified through national healthcare registers, were compared between individual b/tsDMARDs, adjusted for confounding by demographics, RA disease characteristics and comorbidity. Results There were marked differences in treatment discontinuations due to adverse events (rates per 1000 person-years ranged from 18 on rituximab to 57 on tofacitinib), but few significant differences were observed for the serious adverse events under study. Neither cardiovascular events nor general serious infections were more frequent on baricitinib or tofacitinib versus bDMARDs, but JAKi were associated with higher rates of hospital-treated herpes zoster (HR vs etanercept, 3.82 (95% CI 2.05 to 7.09) and 4.00 (1.59 to 10.06)). Low number of events limited some comparisons, in particular for sarilumab and tofacitinib. Conclusion Data from ARTIS supports that the b/tsDMARDs currently used to treat RA have acceptable and largely similar safety profiles, but differences exist in particular concerning tolerability and specific infection risks.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Antirheumatic Agents, Arthritis, Rheumatoid, Biological Therapy, Cardiovascular Diseases, Epidemiology
in
Annals of the Rheumatic Diseases
volume
82
issue
5
pages
10 pages
publisher
BMJ Publishing Group
external identifiers
  • pmid:36787994
  • scopus:85152484415
ISSN
0003-4967
DOI
10.1136/ard-2022-223762
language
English
LU publication?
yes
id
d02def7a-200f-4703-9c4f-c4e62e84c51a
date added to LUP
2023-06-20 12:23:59
date last changed
2024-04-19 22:59:45
@article{d02def7a-200f-4703-9c4f-c4e62e84c51a,
  abstract     = {{<p>Objective Longitudinal clinical registry-infrastructures such as Anti-Rheumatic Therapies in Sweden (ARTIS) allow simultaneous comparison of the safety of individual immunomodulatory drugs used in clinical practice, with consistent definitions of treatment cohorts, follow-up and outcomes. Our objective was to assess and compare incidence rates of key safety outcomes for individual targeted synthetic or biological disease-modifying antirheumatic drugs (b/ts DMARDs) in rheumatoid arthritis (RA), updating previous reports and including newer treatments including Janus Kinase inhibitors (JAKi). Methods Nationwide register-based cohort study including all patients with RA in Sweden registered as starting any b/tsDMARD 1 January 2010 through 31 December 2020, followed until 30 June 2021 (N=20 117). The incidence rates of selected outcomes, identified through national healthcare registers, were compared between individual b/tsDMARDs, adjusted for confounding by demographics, RA disease characteristics and comorbidity. Results There were marked differences in treatment discontinuations due to adverse events (rates per 1000 person-years ranged from 18 on rituximab to 57 on tofacitinib), but few significant differences were observed for the serious adverse events under study. Neither cardiovascular events nor general serious infections were more frequent on baricitinib or tofacitinib versus bDMARDs, but JAKi were associated with higher rates of hospital-treated herpes zoster (HR vs etanercept, 3.82 (95% CI 2.05 to 7.09) and 4.00 (1.59 to 10.06)). Low number of events limited some comparisons, in particular for sarilumab and tofacitinib. Conclusion Data from ARTIS supports that the b/tsDMARDs currently used to treat RA have acceptable and largely similar safety profiles, but differences exist in particular concerning tolerability and specific infection risks.</p>}},
  author       = {{Frisell, Thomas and Bower, Hannah and Morin, Matilda and Baecklund, Eva and Di Giuseppe, Daniela and Delcoigne, Benedicte and Feltelius, Nils and Forsblad-D'Elia, Helena and Lindqvist, Elisabet and Lindström, Ulf and Askling, Johan}},
  issn         = {{0003-4967}},
  keywords     = {{Antirheumatic Agents; Arthritis, Rheumatoid; Biological Therapy; Cardiovascular Diseases; Epidemiology}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{601--610}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{Annals of the Rheumatic Diseases}},
  title        = {{Safety of biological and targeted synthetic disease-modifying antirheumatic drugs for rheumatoid arthritis as used in clinical practice : Results from the ARTIS programme}},
  url          = {{http://dx.doi.org/10.1136/ard-2022-223762}},
  doi          = {{10.1136/ard-2022-223762}},
  volume       = {{82}},
  year         = {{2023}},
}