Background/Purpose:  The previous studies reported that intensive treatment-strategies, including biological agents and glucocorticoids, can improve the severity of early rheumatoid arthritis. However, there was no report on their efficacy in Korean patients with early rheumatoid arthritis. Hence, in this study, we investigated the clinical efficacy of intensive treatments in patients with early rheumatoid arthritis in Korea.

Methods:  A total of 135 patients with rheumatoid arthritis (RA), who had not receive disease modifying anti-rheumatic drugs (DMARDs) and who had presented with joint symptoms within 1 year, were prospectively enrolled. Clinical outcome measurements and laboratory tests were performed monthly during one-year study period for adjusting treatment in order to achieve remission (Disease Activity Score in 28 joints, DAS28 (ESR) <2.6). All patients were randomly distributed to four treatment groups. Treatment groups were as followings: group1 = a step-up regimen starting with initial methotrexate (MTX) monotherapy and subsequent addition of sulfasalazine (SSZ) and hydroxychloroquine (HCQ); group 2 = initial triple therapy (MTX/SSZ/HCQ); group 3= initial high dose prednisolone with rapid-tapering schedule, combined with MTX; group 4 = initial tumor necrosis factor (TNF)-α blockades combined with MTX. At 12 months, functional ability (Health Assessment Questionnaire (HAQ)), mean differences in the DAS28 (ESR) score, proportion of patients meeting the American College of Rheumatology criteria for 50% improvement (ACR50) and DAS28 (ESR) remission were evaluated. Radiological progression was assessed by the modified Sharp scores after 12 months.

Results: Patients in group 3 and 4 had significantly lower HAQ score than those in group 1 or 2 at 6 months (0.06 and 0.14 vs 0.39 and 0.36, respectively, p=0.008). Furthermore, HAQ scores were still low in patients in group 3 and 4, compared to those in group 1 and 2 after 12 months, but they did not significantly differ (0.07 and 0.10 vs 0.27 and 0.23, respectively, p=0.056). Mean differences in DAS28 (ESR) scores between initial and final assessments were significantly greater in patients in group 3 and 4 than those in group 1 and 2 (–3.6 and –3.3 vs –2.3 and–2.9, respectively, p=0.029). Also ACR50 proportion of group 3 or 4 was significantly higher than that of group 1 or 2 (85 or 95% vs 54 or 76%, respectively, p=0.013). The percentages of patients fulfilling DAS28 (ESR) remission criteria or radiologic progression among study groups showed no significant differences.

Conclusion:  In Korean patients with early RA, intensive initial therapy of either high dose prednisolone or TNF-α blockades exhibited rapid functional improvement and excellent disease control at 1 year, compared to a step-up regimen starting with initial MTX monotherapy or parallel triple therapy. Also the efficacy of prednisolone combination therapy was comparable to that of TNF-α blockades combination therapy. Further clinical studies are needed to evaluate whether the initial clinical efficacies of combination therapy including either high dose prednisolone or a TNF-α blockades could be maintained during the long-term follow-up of patients with early rheumatoid arthritis.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/comparison-of-four-different-intensive-treatment-strategies-in-patients-with-early-rheumatoid-arthritis-in-korea/