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Predictors of response in patients with active systemic JIA (SJIA) receiving canakinumab: an exploratory analysis of pooled 12-week data

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Introduction

Canakinumab (CAN), a selective, human, anti- interleukin-1β monoclonal antibody, has been shown to be efficacious in the treatment of SJIA (Ruperto et al. N Engl J Med 2012).

Objectives

To explore baseline demographics and clinical characteristics that are most predictive of response to CAN in CAN-naïve SJIA patients during the initial 12 weeks of therapy.

Methods

Data from 3 trials were pooled for this analysis. CAN-naïve 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.

Results

By week 2 there was substantial clinical benefit with 102 pts (57%) and 36 pts (20%) achieving aACR70 and ID, respectively; by week 12, 108 pts (61%) had aACR70 and 50 pts (28%) ID. The multivariate analysis indicated that normal CRP at D15 is the only predictor significant (all p < 0.05) for ID at all time-points (Table 1).

Table Inactive Disease - Multivariate logistic regression analysis on 12-week data

Conclusion

This exploratory analysis suggests that CAN-naïve patients with normal CRP (i.e. ≤10 mg/l) at Day 15, lower baseline steroid doses, low number of active joints, no prior anti-TNF or prior NSAID use are those most likely to achieve inactive disease up to 12 weeks.

Disclosure of interest

N. Ruperto Grant / Research Support from: To Gaslini Hospital: Abbott, Astrazeneca, BMS, Centocor Research & Development, Eli Lilly and Company, "Francesco Angelini", Glaxo Smith & Kline, Italfarmaco, Novartis, Pfizer Inc., Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, Wyeth Pharmaceuticals Inc., Speaker Bureau of: Astrazeneca, Bristol Myers and Squibb, Janssen Biologics B.V., Roche, Wyeth, Pfizer, H. Brunner Consultant for: Novartis, Genentech, Pfizer, UCB, AstraZeneca, Biogen, Boehringer-Ingelheim, Regeneron, Paid Instructor for: Novartis, Speaker Bureau of: Novartis, Genentech, I. Kone-Paut Grant / Research Support from: SOBI, Chugai, Consultant for: Pfizer, SOBI, Novartis, AbbVie, Cellgene, Chugai, B. Magnusson: None declared., S. Ozen Consultant for: Novartis (Turkey), Speaker Bureau of: Speaker’s fee from SOBI, F. Sztajnbok Grant / Research Support from: Institutional grant (UERJ) for participating in the canakinumab trial., Speaker Bureau of: Novartis-Brasil, J. Anton Consultant for: Novartis, Speaker Bureau of: Novartis, J. Barash Grant / Research Support from: Investigator in the Canakinumab study sponsored by Novartis, F. Corona: None declared., K. Lheritier Shareholder of: Novartis, Employee of: Novartis Pharma AG, C. Gaillez Employee of: Novartis Pharma AG, A. Martini Grant / Research Support from: Bristol Myers and Squibb, Centocor Research & Development,Glaxo Smith & Kline, Novartis, Pfizer Inc, Roche, Sanofi Aventis, Schwarz Biosciences GmbH, I declare that the Gaslini Hospital which is the public Hospital where I work as full time employee has received contributions to support the PRINTO research activities from the industries above mentioned. OLD: Francesco Angelini S.P.A., Janssen Biotech Inc, Abbott. , Consultant for: Bristol Myers and Squibb, Centocor Research & Development, Glaxo Smith & Kline, Novartis, Pfizer Inc, Roche, Sanofi Aventis, Schwarz Biosciences GmbH, I declare that the Gaslini Hospital which is the public Hospital where I work as full time employee has received contributions to support the PRINTO research activities from the industries above mentioned. , Speaker Bureau of: Abbott, Bristol Myers Squibb, Astellas, Boehringer, Italfarmaco, MedImmune, Novartis, NovoNordisk, Pfizer, Sanofi, Roche, Servier, D. Lovell Grant / Research Support from: National Institutes of Health- NIAMS , Consultant for: Astra-Zeneca, Centocor, Amgen, Bristol Meyers Squibb, Abbott, Pfizer, Regeneron, Roche, Novartis, UBC, Forest Research Institute, Horizon, Johnson & Johnson, Speaker Bureau of: Novartis, Roche.

Author information

Correspondence to N Ruperto.

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This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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Keywords

  • Multivariate Logistic Regression Analysis
  • Active Joint
  • Full Time Employee
  • Inactive Disease
  • Forest Research Institute