Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.


Can Long-Term Use of Tocilizumab Induce Drug-Free Remission in Systemic Juvenile Idiopathic Arhtritis Refractory to Steroid Therapy?

Kubota1,  Tomohiro, Yamasaki1,  Yuichi, Yasumura2,  Junko, Kuwada3,  Naomi, Nonaka1,  Yukiko, Takezaki1,  Tomoko, Akaike1,  Harumi

Kagoshima University, Kagoshima City, Japan
Hiroshima University, Hiroshima City, Japan
Kumamoto University, Kumamoto City, Japan

Background/Purpose:

Tocilizumab (TCZ), a humanized anti-human interleukin-6 receptor monoclonal antibody developed in Japan, is firstly approved in Japan as a biologic agent for systemic juvenile idiopathic arthritis (sJIA) in the world1). Therefore, the purpose of this study is to investigate whether long-term TCZ therapy can induce drug-free remission in the sJIA patients refractory to conventional therapy.

Methods:

Cumulative incidence of patients who attained our serial treatment goal of 1st) decreased dose of steroid less than 0.2mg/kg/day of prednisolone (PSL), 2nd) prolongation of TCZ interval from every 2w to 3w, 3rd) discontinuation of PSL, and 4th) discontinuation of TCZ was evaluated by Kaplan-Meier method. 20 patients who were resistant to 3 times of consecutive weekly intravenous methyl-prednisolone pulse therapy (3 consecutive days) in active phase and/or were refractory to long-term oral steroid therapy for more than 6 months were recruited, and treated by 8 mg/kg of TCZ for more than 6 months (max 7 years).

Results:

Patient characteristics at starting TCZ were as follows: mean age was 8.5 years (2.2–20.2); mean disease duration of sJIA was 4.2 years (0.1–16.2 years); mean PSL dose was 0.5mg/kg/day (0.1–1.5).

Of 16 patients treated with more than 0.2mg/kg/day of PSL at the baseline, incidence of patient attained 1st endpoint of reduced PSL dose to <0.2mg/kg/day was 50% at 6 months and 75% at 1 year after initiating TCZ. The 2nd endpoint of prolongation of interval of TCZ administration from every 2 weeks to 3 weeks was attained in 57% of patients at 1year, in 73% at 3years, and in 91% at 5 years after starting TCZ.

Discontinuation of PSL, 3rd endpoint of this study, was attained in 12% of patients at 3years, in 20% at 5years, and in 50% at 6 years of TCZ therapy. Discontinuation of TCZ, the primary endpoint of this study, was attained in 23% of patients at 5yeras, and in 38% of patients at 6 years after TCZ induction. There were no patients who ceased TCZ therapy due to side effect during the study period (mean 4.5 years).

Conclusion:

TCZ was effective and well-tolerated in Japanese sJIA patients in the long-term clinical setting. TCZ can induce drug-free remission in sJIA patients refractory to conventional steroid therapy.

Reference

1.Yokota, S, et al. Lancet. 2008; 371: 998–1006

To cite this abstract, please use the following information:
Kubota, Tomohiro, Yamasaki, Yuichi, Yasumura, Junko, Kuwada, Naomi, Nonaka, Yukiko, Takezaki, Tomoko, et al; Can Long-Term Use of Tocilizumab Induce Drug-Free Remission in Systemic Juvenile Idiopathic Arhtritis Refractory to Steroid Therapy? [abstract]. Arthritis Rheum 2011;63 Suppl 10 :267
DOI:

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