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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 (author)
Karolinska Institute
Wallman, Johan K. (author)
Lund University,Lunds universitet,Lund Arthritis Research Group (LARG),Forskargrupper vid Lunds universitet,Lund University Research Groups
Petersson, Ingemar F. (author)
Lund University,Lunds universitet,Lund OsteoArthritis Division - Clinical Epidemiology Unit,Forskargrupper vid Lunds universitet,Tillämpad epidemiologi,Lund University Research Groups,Applied epidemiology,Skåne University Hospital
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Saevarsdottir, Saedis (author)
Karolinska Institutet,Karolinska Institute,University of Iceland
Söderling, Jonas (author)
Karolinska Institute
Ernestam, Sofia (author)
Karolinska Institute,Akademiskt specialistcentrum, Stockholm
Askling, Johan (author)
Karolinska Institutet,Karolinska Institute
Van Vollenhoven, Ronald (author)
University of Amsterdam
Neovius, Martin (author)
Karolinska Institutet,Karolinska Institute
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 (creator_code:org_t)
2020-11-12
2021
English 6 s.
In: Rheumatology (United Kingdom). - : Oxford University Press (OUP). - 1462-0324 .- 1462-0332. ; 60:5, s. 2217-2222
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • 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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Reumatologi och inflammation (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Rheumatology and Autoimmunity (hsv//eng)

Keyword

mortality
randomized controlled trial
register
rheumatoid arthritis

Publication and Content Type

art (subject category)
ref (subject category)

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