Background Although tocilizumab (TCZ), an antibody against interleukin-6 receptor, was proved to be effective in reducing signs and symptoms of rheumatoid arthritis (RA) patients in comparatively short time, the information of over 1-year TCZ treatment is lacking. TCZ monotherapy was more effective than adalimumab monotherapy and TCZ was recommended as first option of biologics monotherapy in EULAR recommendations. However, it is not well understood whether the concomitant drugs such as MTX and PSL can be reduced or stopped after good efficacy is achieved by TCZ treatment. It is also not well understood how the reduction of these drugs affects prevention of joint damage or quality of life (QOL).
Objectives This study investigated 2-year efficacy of TCZ in RA patients with focus on change of disease activity, change of QOL, prevention of joint damage and reduction of MTX and PSL.
Methods All RA patients (n=42) who initiated TCZ treatment in our institute were used for investigation of drug retention rate (Kaplan-Meier Method) and 2 years have passed in 22 cases. 19 cases in 22 cases continued 2-year TCZ therapy. These 19 cases were used for analysis of change of disease activity, change of QOL, prevention of joint damage and reduction of concomitant drugs (MTX and PSL). Disease activity (DAS28-CRP and CDAI), serum matrix metalloprotease-3 (MMP-3), modified health assessment questionnaire (mHAQ) and van der Heijde modified total Sharp score (mTSS) were evaluated at baseline, 1 year and 2 years.
Results 30 female and 12 male were included. Mean age was 58.0 years old. Mean RA duration was 8.9 years. A rate of bio-naive was 15.8%. MTX was concomitant in 28 patients (66.7%) at baseline (0-16mg/w). PSL was concomitant in 27 patients (64.3%) at baseline (0-15mg/d). Drug retention rate (n=42) was 81.6% at 1 year, 75.4% at 2 years, 70.7% at 3 years, 70.7% at 4 year and 64.3% at 5 years. Analysis using 19 cases was as follows. Mean DAS28 was 5.16 at baseline, 2.35 at 1 year and 1.90 at 2 years. Mean CDAI was 25.3 at baseline, 8.7 at 1 year and 5.8 at 2 years. In both DAS28-CRP and CDAI, there were significant differences not only between baseline and 1 year or 2 years but also between 1 year and 2 years. Mean MMP-3 (ng/ml) was 410.1 at baseline, 112.0 at 1 year and 92.3 at 2 years. There were significant differences between baseline and 1 year or 2 year. Mean mHAQ was 0.75 at baseline, 0.46 at 1 year and 0.35 at 2 years. Rates (%) of concomitant MTX and PSL at baseline, 1-year and 2-year were 73.7/47.4/26.3 and 68.4/63.2/31.6, respectively. There were significant differences not only between baseline and 1 year or 2 years but also between 1 year and 2 years. Mean delta (d) mTSS per year was 8.8 at baseline, 3.6 from baseline to 1 year and 1.2 from 1 to 2 years. There were significant differences in d-mTSS not only between baseline and 0-1 year or 1-2 years.
Conclusions Although concomitant MTX and PSL were decreased time after time, TCZ improved disease activity and QOL in RA patients not only from baseline to 1 year but also from 1 to 2 years. This study suggested that tapering of MTX and PSL was one of the recommended treatment strategies in RA patients who were treated with TCZ and achieved treat to target such as low disease activity or remission.
Disclosure of Interest Y. Hirano Speakers bureau: Abbott Japan Co. Ltd.; Eisai Co. Ltd.; Mitsubishi Tanabe Pharma Corporation; Pfizer Co. Ltd.; Chugai Pharmaceutical Co. Ltd.; and Bristol-Myers Squibb Co. Ltd., S. Hirabara: None declared, M. Isono: None declared, Y. Oishi: None declared, T. Kojima Speakers bureau: Abbott Japan Co. Ltd.; Eisai Co. Ltd.; Mitsubishi Tanabe Pharma Corporation; Pfizer Co. Ltd.; Chugai Pharmaceutical Co. Ltd.; and Bristol-Myers Squibb Co. Ltd., N. Ishiguro Speakers bureau: Abbott Japan Co. Ltd.; Eisai Co. Ltd.; Mitsubishi Tanabe Pharma Corporation; Pfizer Co. Ltd.; Chugai Pharmaceutical Co. Ltd.; and Bristol-Myers Squibb Co. Ltd.
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