THU0090 MORTALITY OVER UP TO 14 YEARS FOLLOW-UP IN MTX-REFRACTORY PATIENTS RANDOMIZED TO A STRATEGY STARTING WITH ADDITION OF INFLIXIMAB OR ADDITION OF SULFASALAZINE AND HYDROXYCHLOROQUINE

Background: Longevity is the ultimate health outcome measure, incorporating treatment effectiveness as well as treatment safety. Randomized controlled trials tend to report data only on short term effects, while extended follow-up of long-term mortality data of treatment strategies are scarce. Objectives: To compare mortality risk over up to 14 years of follow-up in MTX-refractory patients with early RA, randomized to a strategy starting with addition of infliximab versus addition of sulfasalazine and hydroxychloroquine. Methods: We used data from a 2-arm, parallel, randomized, active-controlled, open-label trial (Swefot), in which patients with early RA (symptom duration <1y) were recruited from 15 rheumatology clinics in Sweden from 2002-2006. Patients who did not achieve low disease activity after 3-4 months of MTX were randomized to receive additional biological treatment with infliximab (n=128) or conventional combination treatment with sulfasalazine and hydroxychloroquine (n=130). By linking the trial database to the Swedish Total Population Register and Cause of Death Register, we collected complete data on all-cause mortality and emigration until August 31, 2017. Participants were followed until death, emigration, or end of follow-up, whichever came first. Analyses were by intention to treat. Results: Over a total 1477 and 1504 person-years of follow-up in the infliximab and the conventional combination treatment group there were 13 and 16 deaths, respectively (8.8 [95%CI 0.0-25.1] versus 10.6 [95%CI 0.0-28.4] deaths per 1000 person-years; mortality hazard ratio 1.2 [0.6-2.5]; P=0.62; Figure). After 5 years, approximately 50% of patients in the infliximab arm remained on biologic therapy and 50% in the conventional combination arm remained on synthetic DMARDs. Conclusion: No increased or decreased mortality risk could be observed over up to 14 years of follow-up in patients with MTX-refractory early RA, randomized to a strategy starting with addition of infliximab compared to patients randomized to a strategy starting with conventional combination treatment. At the end of the extended follow-up, a minority of patients remained on their assigned therapy, reflecting the treat to target paradigm. Disclosure of Interests: Heather Miller: None declared, Johan K Wallman Consultant for: Consultant for AbbVie, Celgene, Eli Lilly, Novartis, and UCB Pharma., Ingemar Petersson: None declared, Saedis Saevarsdottir Employee of: Part-time employee at deCODE Genetics/Amgen Inc, working on genetic research unrelated to this project., Jonas Söderling Consultant for: Abbvie, Merck, Novartis, Pfizer and Shire (unrelated to the present work), Sofia Ernestam: None declared, Johan Askling Grant/research support from: Karolinska Institutet (JA) has or has had research agreements with the following pharmaceutical companies, mainly in the context of the ATRIS national safety monitoring programme for rheumatology biologicals: Abbvie, BMS, MSD, Eli Lilly, Pfizer, Roche, Samsung Bioepis, and UCB., Consultant for: Karolinska Institutet has received remuneration for JA participating in ad boards arranged by Lilly, Novartis, and Pfizer., Ronald van Vollenhoven Grant/research support from: AbbVie, BMS, GSK, Pfizer, UCB, Consultant for: AbbVie, AstraZeneca, Biogen, Biotest, BMS, Celgene, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Lilly, Pfizer, UCB, Martin Neovius: None declared