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THU0502 Efficacy and safety of canakinumab in patients with still's disease: a pooled analysis of sjia data by age groups
  1. E Feist1,
  2. P Quartier2,
  3. B Fautrel3,
  4. R Schneider4,
  5. P Sfriso5,
  6. P Efthimiou6,
  7. L Cantarini7,
  8. K Lheritier8,
  9. K Leon9,
  10. C Karyekar9,
  11. A Speziale8
  1. 1Charite-Universitätsmedizin, Berlin, Germany
  2. 2Necker-Enfants Malades Hospital
  3. 3Pitie Salpetriere Hospital, Paris, France
  4. 4PRCSG, Cincinnati, United States
  5. 5University of Padova, Padova, Italy
  6. 6Weill Cornell Medical College, New York, United States
  7. 7University of Siena, Siena, Italy
  8. 8Novartis Pharma AG, Basel, Switzerland
  9. 9Novartis Pharmaceuticals Corporation, East Hanover, United States

Abstract

Background Still's disease presents in paediatric and adult patients (pts) as a disease continuum with similar symptoms and pathophysiology.1,2

Objectives To evaluate the efficacy and safety of canakinumab (CAN), a selective human anti-IL1 β monoclonal antibody, in SJIA pts from pooled data across 3 age groups (grps): children, adolescent and adults (the latter representing adult-onset Still's disease [AOSD] population).

Methods Data of CAN treated pts were pooled from 4 SJIA studies (NCT00426218, NCT00886769, NCT00889863, NCT00891046). CAN was administered at 4 mg/kg every 4 weeks (wk). Efficacy parameters (adapted ACR [aACR] paediatric responses, juvenile idiopathic arthritis [JIA] ACR responses, pts with inactive disease), CRP levels over 12 wk and safety were assessed by age grp. One study [NCT00426218] was excluded for efficacy outcomes.

Results 216 children (2–<12 years [y]), 56 adolescents (12–<16 y) and 29 adults (≥16 y) were analysed for efficacy outcomes. The efficacy parameters across the 3 age grps were largely comparable (Table 1). The safety profile of CAN was similar across age grps (Table 2). One death was reported (adolescents grp). Clinical, laboratory and immunogenicity data showed no notable differences between the age grps.

Table 1.

Responses by age grp and time point

Conclusions Pooled analyses indicate similar efficacy of CAN across all the age grps of children, adolescents and adult SJIA pts. There were no meaningful differences in safety profiles across the different age grp. These analyses suggest similar efficacy of CAN in AOSD pts as observed in the SJIA pts.

References

  1. Jamilloux. Immunol Res 2015;61:53–62.

  2. Nirmala. Pediatric Rheumatol 2015;13:50.

References

Disclosure of Interest E. Feist Grant/research support from: Novartis, Consultant for: Novartis, P. Quartier Grant/research support from: Abbvie, Novartis, Pfizer, Chugai-Roche, Consultant for: Abbvie, Novartis, Pfizer, Sobi, Roche, Speakers bureau: Abbvie, Novartis, Sobi, Roche, B. Fautrel Grant/research support from: AbbVIe, MSD, Pfizer, Consultant for: AbbVie, Biogen, BMS, Celgène, Hospira, Janssen, Lilly, MSD, NORDIC Pharma, Pfizer, Roche, SOBI, UCB, R. Schneider Grant/research support from: Novartis, Consultant for: Novartis, P. Sfriso Consultant for: Novartis, P. Efthimiou: None declared, L. Cantarini Consultant for: Sobi, Novartis, Abbvie, K. Lheritier Employee of: Novartis, K. Leon Employee of: Novartis, C. Karyekar Employee of: Novartis, A. Speziale Employee of: Novartis

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