Mortality over 14 years in MTX-refractory patients randomized to a strategy of addition of infliximab or sulfasalazine and hydroxychloroquine
(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.
(Less)
- author
- Miller, Heather ; Wallman, Johan K. LU ; Petersson, Ingemar F. LU ; Saevarsdottir, Saedis ; Söderling, Jonas ; Ernestam, Sofia ; Askling, Johan ; Van Vollenhoven, Ronald and Neovius, Martin
- organization
- publishing date
- 2021-05-01
- 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
-
- pmid:33179071
- scopus:85107083684
- 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
- 2024-08-08 16:02:59
@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 <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}}, }