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Clinical Trial
. 2011 Apr;21(2):122-33.
doi: 10.1007/s10165-010-0366-7. Epub 2010 Oct 16.

Efficacy and tolerability of tocilizumab in rheumatoid arthritis patients seen in daily clinical practice in Japan: results from a retrospective study (REACTION study)

Hisashi Yamanaka  1 , Yoshiya Tanaka, Eisuke Inoue, Daisuke Hoshi, Shigeki Momohara, Kentaro Hanami, Naoki Yunoue, Kazuyoshi Saito, Kouichi Amano, Hideto Kameda, Tsutomu Takeuchi
Affiliations
Clinical Trial

Efficacy and tolerability of tocilizumab in rheumatoid arthritis patients seen in daily clinical practice in Japan: results from a retrospective study (REACTION study)

Hisashi Yamanaka et al. Mod Rheumatol. 2011 Apr.

Abstract

Tocilizumab, a humanized monoclonal antibody to the interleukin 6 (IL-6) receptor, was approved for use as rheumatoid arthritis (RA) therapy in Japan in 2008, but its efficacy and tolerability in daily practice has not yet been reported. We report the results of a multicenter retrospective study on the efficacy and safety of tocilizumab involving all patients (n = 229) who were started on tocilizumab therapy at three rheumatology institutes in Japan from April 2008 through to March 2009. Tocilizumab was infused every 4 weeks at a dose of 8 mg/kg according to the drug labeling. Among the 229 patients, 55% concomitantly received methotrexate (MTX) and 63% had previously received anti-tumor necrosis factor (TNF) therapy. Average disease activity score (DAS) 28 of all 229 patients significantly decreased from 5.70 to 3.25 after 24 weeks of therapy. A European League Against Rheumatism (EULAR) good response and DAS28 remission was achieved in 57.4 and 40.7% of the patients, respectively, at 24 weeks. White blood cell counts significantly decreased and liver enzymes and total cholesterol slightly but significantly increased; however, liver enzyme levels did not increase in patients without MTX. Tocilizumab was discontinued in 47 cases (20.5%) due to lack of efficacy (5.2%), adverse events (11.4%), and other reasons (3.9%). The overall retention rate at 24 weeks was 79.5%. Based on these results, we conclude that tocilizumab therapy in daily rheumatology practice appears to be highly efficacious and well tolerated among active RA patients, including the anti-TNF therapy-refractory population. Tocilizumab infusion is therefore applicable not only as an alternative approach for anti-TNF therapy-resistant patients, but also as primary biologic therapy for active RA patients.

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Figures

Fig. 1
Fig. 1
Efficacy of tocilizumab infusion in inhibiting the signs and symptoms of rheumatoid arthritis (RA) patients seen in daily clinical practice. Values of the Daily Activity Score based on 28 joints (DAS28; a) and its components [tender joint count (TJC; b), swollen joint count (SJC; c), good health (GH; d), and erythrocyte sedimentation rate (ESR; e)] together with C-reactive protein (CRP) levels (f) from baseline to 24 weeks after the initiation of tocilizumab therapy are shown. Data were analyzed by the last observations carried forward (LOCF) method. Values were significantly lower than baseline values at all time points after 4 weeks of treatment (P < 0.00001)
Fig. 2
Fig. 2
Efficacy of tocilizumab infusion in inhibiting the signs and symptoms of RA patients in daily clinical practice. Values of DAS28 (a–c) and HAQ-DI (d–f) from baseline to 24 weeks after initiation of tocilizumab therapy are shown: a, d all 229 cases, b, e patients who concomitantly received methotrexate (MTX; filled diamond, n = 127) or did not receive MTX (filled square, n = 102), c, f patients who previously received anti-tumor necrosis factor (TNF) therapy (filled diamond, n = 144) or did not previously receive anti-TNF therapy (filled square, n = 85). Data were analyzed by the LOCF method. a, d At all time points after 4 weeks, values are significantly decreased from baseline (P < 0.00001), b, e at all time points after 4 weeks, values of patients who concomitantly received MTX are significantly lower than those of patients who did not (P < 0.00001), c, f at all timepoints after 4 weeks, values did not differ between patients who did and did not previously receive anti-TNF therapy
Fig. 3
Fig. 3
Efficacy of tocilizumab infusion in inhibiting the signs and symptoms of RA patients seen in daily clinical practice. Disease activity as assessed by DAS28 values at baseline and after 24 weeks of tocilizumab therapy is shown: a all 229 cases, b patients who concomitantly received MTX (n = 127), c patients who did not concomitantly receive MTX (n = 102), d patients who previously received anti-TNF therapy (n = 144), e patients who did not previously receive anti-TNF therapy (n = 85). Disease activity was categorized as high (DAS28 > 5.1), moderate (3.2 ≤ DAS28 ≤ 5.1), low (2.6 ≤ DAS28 < 3.2) and remission (DAS28 < 2.6) from the top column. Data were analyzed by the LOCF method
Fig. 4
Fig. 4
Kaplan–Meier curve of the retention rate of tocilizumab therapy. a Tocilizumab retention rate in all 229 cases. b Tocilizumab retention rates by cause of discontinuation. c Tocilizumab retention rates in patients who did (n = 127) and did not (n = 102) receive concomitant MTX. d Tocilizumab retention rates in patients who did (n = 144) and did not (n = 85) previously receive anti-TNF therapy
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