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Mortality over 14 years in MTX-refractory patients randomized to a strategy of addition of infliximab or sulfasalazine and hydroxychloroquine

Miller, Heather ; Wallman, Johan K. LU ; Petersson, Ingemar F. LU ; Saevarsdottir, Saedis ; Söderling, Jonas ; Ernestam, Sofia ; Askling, Johan ; Van Vollenhoven, Ronald and Neovius, Martin (2021) In Rheumatology (United Kingdom) 60(5). p.2217-2222
Abstract

Objective: To compare mortality risk over up to 14 years of follow-up in methotrexate-refractory patients with early RA randomized to a strategy starting with addition of infliximab vs addition of SSZ and HCQ. Methods: Data was from the two-arm, parallel, randomized, active-controlled, open-label Swefot trial in which patients with early RA (symptom duration <1 y) were recruited from 15 rheumatology clinics in Sweden (2002-2005). Patients who did not achieve low disease activity after 3-4 months of MTX were randomized to addition of infliximab (n = 128) or SSZ and HCQ (n = 130). Participants were followed until death, emigration, or end of follow-up, whichever came first. Analyses were by intention-to-treat. Results: Over an average... (More)

Objective: To compare mortality risk over up to 14 years of follow-up in methotrexate-refractory patients with early RA randomized to a strategy starting with addition of infliximab vs addition of SSZ and HCQ. Methods: Data was from the two-arm, parallel, randomized, active-controlled, open-label Swefot trial in which patients with early RA (symptom duration <1 y) were recruited from 15 rheumatology clinics in Sweden (2002-2005). Patients who did not achieve low disease activity after 3-4 months of MTX were randomized to addition of infliximab (n = 128) or SSZ and HCQ (n = 130). Participants were followed until death, emigration, or end of follow-up, whichever came first. Analyses were by intention-to-treat. Results: Over an average follow-up of 13 years, there were 13 and 16 deaths, respectively [8.8 vs 10.6 deaths per 1000 person-years; mortality hazard ratio 1.2 (95% CI: 0.6, 2.5); P =0.62]. The 1-year mortality was 0.8% in both treatment arms, the 5-year mortality was 2.3% for the infliximab arm compared with 1.5% for the conventional combination treatment arm, while the 10-year mortality was 7.8% and 7.7%, respectively. After 5 years, ∼50% of patients in the conventional combination therapy arm had switched to biologic treatment, and 50% in the biologic arm had discontinued treatment with a biologic DMARD. Conclusion: No difference in mortality risk could be observed over up to 14 years of follow-up between treatment strategy groups. At 5 years (3 years after trial cessation), 50% of patients remained on their assigned therapy, reflecting that DMARD combination is an adequate treatment strategy in 50% of patients.

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author
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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
mortality, randomized controlled trial, register, rheumatoid arthritis
in
Rheumatology (United Kingdom)
volume
60
issue
5
pages
6 pages
publisher
Oxford University Press
external identifiers
  • scopus:85107083684
  • pmid:33179071
ISSN
1462-0324
DOI
10.1093/rheumatology/keaa553
language
English
LU publication?
yes
id
a11a8d7f-00c6-4005-8af4-754eba1dea5f
date added to LUP
2022-02-22 13:12:47
date last changed
2024-03-21 06:03:25
@article{a11a8d7f-00c6-4005-8af4-754eba1dea5f,
  abstract     = {{<p>Objective: To compare mortality risk over up to 14 years of follow-up in methotrexate-refractory patients with early RA randomized to a strategy starting with addition of infliximab vs addition of SSZ and HCQ. Methods: Data was from the two-arm, parallel, randomized, active-controlled, open-label Swefot trial in which patients with early RA (symptom duration &lt;1 y) were recruited from 15 rheumatology clinics in Sweden (2002-2005). Patients who did not achieve low disease activity after 3-4 months of MTX were randomized to addition of infliximab (n = 128) or SSZ and HCQ (n = 130). Participants were followed until death, emigration, or end of follow-up, whichever came first. Analyses were by intention-to-treat. Results: Over an average follow-up of 13 years, there were 13 and 16 deaths, respectively [8.8 vs 10.6 deaths per 1000 person-years; mortality hazard ratio 1.2 (95% CI: 0.6, 2.5); P =0.62]. The 1-year mortality was 0.8% in both treatment arms, the 5-year mortality was 2.3% for the infliximab arm compared with 1.5% for the conventional combination treatment arm, while the 10-year mortality was 7.8% and 7.7%, respectively. After 5 years, ∼50% of patients in the conventional combination therapy arm had switched to biologic treatment, and 50% in the biologic arm had discontinued treatment with a biologic DMARD. Conclusion: No difference in mortality risk could be observed over up to 14 years of follow-up between treatment strategy groups. At 5 years (3 years after trial cessation), 50% of patients remained on their assigned therapy, reflecting that DMARD combination is an adequate treatment strategy in 50% of patients. </p>}},
  author       = {{Miller, Heather and Wallman, Johan K. and Petersson, Ingemar F. and Saevarsdottir, Saedis and Söderling, Jonas and Ernestam, Sofia and Askling, Johan and Van Vollenhoven, Ronald and Neovius, Martin}},
  issn         = {{1462-0324}},
  keywords     = {{mortality; randomized controlled trial; register; rheumatoid arthritis}},
  language     = {{eng}},
  month        = {{05}},
  number       = {{5}},
  pages        = {{2217--2222}},
  publisher    = {{Oxford University Press}},
  series       = {{Rheumatology (United Kingdom)}},
  title        = {{Mortality over 14 years in MTX-refractory patients randomized to a strategy of addition of infliximab or sulfasalazine and hydroxychloroquine}},
  url          = {{http://dx.doi.org/10.1093/rheumatology/keaa553}},
  doi          = {{10.1093/rheumatology/keaa553}},
  volume       = {{60}},
  year         = {{2021}},
}