Background Adalimumab (ADA) treatment in combination with methotrexate (MTX) is one of the established effective treatments for patients with rheumatoid arthritis (RA). However, the treatment with biologic disease-modifying anti-rheumatic drugs (bDMARDs) has unresolved risks such as infection or malignancy. Furthermore, the treatment with bDMARDs is accompanied with a financial burden. To extend the interval of ADA administration with maintaining efficacy might be useful option from the point of view of safety and economic aspect.
Objectives The aim of this study was to investigate the possibility for extension of the interval of ADA administration after the achievement of low disease activity (LDA) in patients with RA.
Methods This study was based on the KABUKI (keeping cartilaginous quality by adlimumab in patient with RA in Kansai area) study, an open-label, randomized trial. Sixty-eight patients who started ADA every other week treatment from July 2010 to October 2013 were included in this prospective randomized study. Patients archived LDA (DAS28-ESR3.2) at week 24 were randomly assigned to two groups receiving ADA 40mg every 2 or 4 weeks during next 24 weeks. Patients above LDA (DAS28-ESR >3.2) at week 24 were randomly assigned to groups receiving ADA 40mg plus increased dose of methotrexate (MTX) or switching ADA to other bDMARDs. Clinical, laboratory, ultrasonographic (US) and radiographic assessments were performed until week 48.
Results Of 68 patients, 61 patients continued ADA 40 mg every other week until week 24. In these 61 patients, 29 patients achieved LDA at week 24. After week 24, the disease activity increased in only one patient of ADA 40 mg every 4 weeks group (n=13). However, others had kept LDA as well as patients receiving ADA 40 mg every other week. The increase of power Doppler signal in US assessment was not detected in patients with ADA 40 mg every 4 weeks. There was no difference in radiographic joint damage between ADA 40 mg every 4 and 2 weeks groups. Patients who could not achieve LDA at week 24 did not show siginificant difference in disease activity even after changing to different protocol with increasing MTX dosage or stwitching bDMARDs.
Conclusions Treatment with ADA 40 mg every 4 weeks might be effective as well as ADA 40 mg every other week in patients with RA after the achievement of LDA at 24 weeks. The extension of the interval of ADA administration after the achievement of LDA in patients with RA may be a feasible treatment option.
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Disclosure of Interest T. Okano: None declared, K. Inui: None declared, M. Tada: None declared, Y. Sugioka: None declared, K. Mamoto: None declared, T. Koike Grant/research support from: Takeda Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Abbvie GK, Teijin Pharma Ltd., MSD K.K. and Ono Pharmaceutical Co., Ltd., H. Nakamura: None declared