OP0147

TARGETED TREATMENT WITH COMBINATION DMARDS PRODUCES EXCELLENT CLINICAL AND RADIOGRAPHIC LONG-TERM OUTCOMES IN EARLY RHEUMATOID ARTHRITIS REGARDLESS OF INITIAL INFLIXIMAB. THE 5-YEAR FOLLOW-UP RESULTS OF THE NEO-RACO TRIAL.

V. Rantalaiho ^1,*M. Korpela ¹P. Hannonen ²O. Kaipiainen-Seppänen ³T. Möttönen ⁴M. Kauppi ⁵A. Karjalainen ⁶K. Laiho ⁵H. Kautiainen ³M. Leirisalo-Repo ⁷

¹Tampere University Hospital, Tampere, ²Central Finland Central Hospital, Jyväskylä, ³Kuopio University Hospital, Kuopio, ⁴Turku University Hospital, Turku, ⁵Päijät-Häme Central Hospital, Lahti, ⁶Oulu University Hospital, Oulu, ⁷Helsinki University Hospital, Helsinki, Finland

Background: The treatment of rheumatoid arthritis (RA) should aim at remission. A substantial part of the patients may achieve this target when an initial treatment with a combination of disease modifying anti-rheumatic drugs (DMARD) is used. Initial biologics may induce a faster response than traditional DMARDs, but their role on long-term outcomes is ambiguous [1].

Objectives: To study whether the addition of infliximab to aggressive, targeted initial combination-DMARD treatment produces extra benefit in the long-term outcomes in patients with early RA.

Methods: A total of 99 patients with early (< 1 year), DMARD-naïve RA were treated with a combination of methotrexate (max 25mg/week), sulfasalazine (max 2g/day), hydroxychloroquine (35mg/kg/week) and prednisolone (7.5mg), and randomized to blindly receive either infliximab (FIN-RACo+INFL) or placebo (FIN-RACo+PLA) infusions at weeks 4, 6, 10, 18, and 26. After 2 years the treatment strategies became unrestricted, but throughout the follow-up the treatment goal was strict ACR remission. At 5 years the clinical and radiographic outcomes, as well as the treatments used were assessed.

Results: A total of 94 patients (95%) were followed up for 5 years, 46 in the FIN-RACo+INFL and 48 in the FIN-RACo+PLA group. The proportion of patients in strict ACR remission was 59% (95% CI 43 to 73%) and 60% (95% CI 45 to 74%) (p=0.87), and in DAS28 remission 83% (95% CI 69 to 92%) and 88% (95% CI 75 to 95%) (p=0.51), in the FIN-RACo+INFL and FIN-RACo+PLA groups, respectively. The corresponding mean (SD) total Sharp/van der Heijde scores at 5 years were 5 (8), and 5 (7), while the mean changes in it from baseline to 5 years were 2 (95% CI 0 to 4) and 4 (95% CI 2 to 5) (p=0.13) . From 2 to 5 years, the median (IQR) cumulative prednisolone doses were 1.4 (0.7-4.1)  and 1.2 (0.8-3.3) mg/day in the FIN-RACo+INFL and  in the FIN-RACo+PLA groups (p=0.92), respectively, while during the total follow-up of 5 years, the respective median (IQR) numbers of intra-articular glucocorticoid injections were 4 (1-15) and 7 (3-12) (p=0.54). After 6 months any biologic drug was initiated to 4 (9%) and 8 patients (17%) (p=0.36), and the median (range) number of synthetic or biologic DMARDs used was 3 (3-10) and 3 (3-11), in the FIN-RACo+INFL and FIN-RACo+PLA groups, respectively.

Conclusions: In early RA, targeted treatment with a combination of DMARDs and prednisolone induces remission and minimises radiographic progression in most patients at 5 years; adding initial infliximab for 6 months does not improve these outcomes or reduce the need of consequent treatment.

References: [1] Klarenbeek et al. The impact of four dynamic, goal-steered treatment strategies on the 5-year outcomes of rheumatoid arthritis patients in the BeSt study. Ann Rheum Dis 2011;70:1039-46.

Disclosure of Interest: None Declared