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

Heather Miller*, Johan K. Wallman, Ingemar F. Petersson, Sædís Sævarsdóttir, Jonas Söderling, Sofia Ernestam, Johan Askling, Ronald Van Vollenhoven, Martin Neovius

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


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.

TRIAL REGISTRATION:, identifier: NCT00764725.

Original languageEnglish
Pages (from-to)2217-2222
Number of pages6
JournalRheumatology (United Kingdom)
Issue number5
Early online date12 Nov 2020
Publication statusPublished - May 2021

Bibliographical note

© The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email:

Other keywords

  • Adult
  • Aged
  • Antirheumatic Agents/therapeutic use
  • Arthritis, Rheumatoid/drug therapy
  • Drug Therapy, Combination
  • Female
  • Humans
  • Hydroxychloroquine/therapeutic use
  • Infliximab/therapeutic use
  • Male
  • Methotrexate/therapeutic use
  • Middle Aged
  • Sulfasalazine/therapeutic use
  • Survival Rate
  • Treatment Outcome


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