Predictors of response in patients with active systemic JIA (SJIA) receiving canakinumab: an exploratory analysis of pooled 12-week data
نویسندگان
چکیده
Methods Data from 3 trials were pooled for this analysis. CANnaïve patients (pts; n=178) aged 2–19 years with active SJIA were enrolled and received sc CAN 4 mg/kg/month; Predictors of response (according to aACR* 30, 70, and Inactive Disease [ID]) at Days (D) 15, 29, 57 and 85 were explored using univariate and multivariate logistic regression analyses. The candidate predictors (categorical variables) of CAN-response considered were: Age group, Gender, Prior NSAIDS (no/yes), Prior MTX(no/yes), Steroids (0, >0 – ≤0.4;> 0.4), Number of Active Joints (≤10, 11-≤20, >20) and Joints with Limitation of Motion (≤10, 11-≤20,>20), CRP (elevated/normal) at baseline and at D15. All candidate predictors with p<0.1 in univariate analyses were included in the multivariate analysis. *ACR response plus absence of fever.
منابع مشابه
Use of the JADAS criteria to assess efficacy of canakinumab in patients with SJIA – an analysis of 12-week pooled data
Introduction The composite score JADAS 2 27-CRP (J27), 10-CRP (J10), and cut-off values for inactive (ID), low (LDA), moderate (MDA) and high disease activity (HDA) were designed to monitor the level of disease activity in all JIA subtypes. The efficacy of canakinumab (CAN), a selective, human, anti-IL-1b monoclonal antibody, was previously demonstrated in SJIA in phase III trials using aACR-JI...
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OBJECTIVES To describe the efficacy, safety, and exposure-response relationship of canakinumab in a subgroup of patients with systemic juvenile idiopathic arthritis (SJIA) aged ≥16 years, representative of adult-onset Still's disease (AOSD) patients, and to compare this subgroup with those of children and young adolescents with SJIA by pooling clinical data collected during the development prog...
متن کاملPReS-FINAL-2157: Efficacy of canakinumab in the treatment of systemic juvenile idiopathic arthritis: a 12-week pooled post-hoc analysis
Methods Data from the 3 trials done as part of the phase III program were pooled for this analysis. Pts aged 2-19 yrs with active SJIA were enrolled and received subcutaneous CAN 4 mg/kg or placebo. The post-hoc analysis presented here focuses on SJIA response to CAN therapy in the initial treatment period of a total of 178 CAN-naïve pts. Methodological factors precluded a comparator group, so ...
متن کاملEfficacy of canakinumab in biologic-naïve versus previously biologic-exposed SJIA patients: a 12 week pooled post-hoc analysis
Introduction Canakinumab (CAN), a selective, human anti-IL-1b monoclonal antibody is approved for SJIA in over 30 countries. Efficacy and safety of CAN over 12 weeks have been demonstrated in 2 phase III trials [1]. Out of these trials >60% of the pts received a previous biologic and were switched to CAN due to lack of efficacy or for safety reasons, and may be more refractory to another biolog...
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عنوان ژورنال:
دوره 12 شماره
صفحات -
تاریخ انتشار 2014