Initial Treatment Strategy and the Long-Term
Outcome of Early Rheumatoid Arthritis
With special interest in the FIN-RACo trial and the current Finnish practice
Acta Universitatis Tamperensis No. 1737
By Vappu Rantalaiho
Tampere University Press
$87.50 Paper original
Background. The natural course of rheumatoid arthritis (RA) leads through joint inflammation to progressive joint damage and lost functional ability, elevated incidence of work disability and even increased mortality. Effective treatment with disease modifying antirheumatic drugs (DMARDs) has been shown to prevent or delay this progression. Thus, an early and aggressive treatment of RA is recommended internationally. In Finland, mainly due to beneficial 2- and 5-year results of a national multicenter study, the Finnish Rheumatoid Arthritis Combination Therapy Trial (FIN-RACo), a combination of 3 DMARDs and a small dose glucocorticoid (GC) is recommended as the initial treatment in active RA. In this study we aimed to elucidate the long-term effects and safety of such aggressive initial treatment by analysing the 11-year follow-up results of the FIN-RACo Trial. We also wanted to clarify how DMARDs are currently used in early RA in Finland and whether the possible change in treatments may have affected the incidence of work disability (WD) in early RA. Methods. In the FIN-RACo study 199 patients with early active RA were randomized to treatment with a combination of methotrexate (MTX), sulfasalazine (SASP), and hydroxychloroquine (HCQ) with prednisolone (FIN-RACo group) or treatment with a single DMARD (initially, SASP) with or without prednisolone (SINGLE group). The treatment in both groups aimed at remission. After 2 years, the treatment strategy became unrestricted. At 11 years, function was assessed with the Health Assessment Questionnaire (HAQ), and remission with the American College of Rheumatology (ACR) criteria (I). The radiographs of hands and feet, as well as of large joints were assessed and scored according to the Larsen method (II). In the second part of the study, data for all new Finnish RA patients was collected from a nationwide register maintained by the Social Insurance Institution (SII) from 1.1.2000 to 31.12.2007. Patient cohorts were analyzed in 2-year time periods (2000-01, 2002-03, 2004-05, 2006-07) and DMARDs purchased by them during the first year after the diagnosis were registered (III). For the patients available to labour force at the time of the diagnosis the incidence of continuous WD up to 31 Dec 2008 was clarified (IV).
Results. At 11 years, 138 patients were assessed (68 in the FIN-RACo group and 70 in the SINGLE group). The mean ± SD HAQ scores were 0.34 ± 0.54 in the FIN-RACo group and 0.38 ± 0.58 in the SINGLE group (p = 0.88). ACR remission was achieved by 37% (95% CI: 26 to 49) of the FIN-RACo group and by 19% (95% CI: 11 to 29) (p = 0.017) of the SINGLE group (I). The radiographs of hands and feet were available in 65 patients in each group at baseline and at 11 years. The mean change from baseline to 11 years in Larsen score was 17 (95 % CI: 12 to 26) in the FIN-RACo group and 27 (95 % CI: 22 to 33) in the SINGLE group (p = 0.037). Respectively 87% (95% CI: 74 to 94) and 72% (95% CI: 58 to 84) of the patients in the FIN-RACo and the SINGLE groups had no erosive changes in large joints at 11 years (II). From the SII database 14 878 (68.0% female, 62.6% RF-positive) patients with a new diagnosis of RA between 2000-07 were identified. In the first cohort single DMARD treatment (56.1%) was the most commonly used strategy during the first 3 months and SASP (63.0%) the most commonly used DMARD during the first year. In the last cohorts the respective treatments were combination DMARDs (55.3%) and methotrexate (69.0%). The change in treatment strategies and in DMARDs used was highly significant (p <0.001 for linearity) (III). From the same database, 7 831 (71% female, 61% RF-positive) not pensioned patients were identified. During the first 2 years the incidence of RA related continuous WD was 8.9 %, 9.4 %, 7.2 %, and 4.8 % (p < 0.001 for linearity) (IV).
Conclusions. Targeting remission with tight clinical controls results in good functional, clinical and radiographic outcomes in most RA patients. However, compared to initial single-DMARD therapy, initial combination DMARDs results in higher rates of patients achieving strict ACR remission and in lower radiographic progression even in the long term. During this millennium in Finland, increasingly active treatments have been adopted in the treatment of early RA and the incidence of continuous work disability has declined.
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