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
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.
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).
Patient characteristics at starting TCZ were as follows: mean age was 8.5 years (2.220.2); mean disease duration of sJIA was 4.2 years (0.116.2 years); mean PSL dose was 0.5mg/kg/day (0.11.5).
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).
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.
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