ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 2422

Efficacy and Safety of Canakinumab in Children with Systemic Juvenile Idiopathic Arthritis: Results from the Phase 3 Extension Study

Hermine I. Brunner1, Nicolino Ruperto2, Pierre Quartier3, Tamas Constantin2, Ekaterina Alexeeva2, Isabelle Koné-Paut2, Katherine Marzan1, Nico Wulffraat2, Rayfel Schneider1, Shai Padeh2, Vyacheslav Chasnyk2, Carine Wouters2, Jasmin B. Kuemmerle-Deschner2, Tilmann Kallinich2, Bernard Lauwerys4, Elie Haddad1, Evgeny Nasonov2, Maria Trachana2, Olga Vougiouka2, Karolynn Leon5, Antonio Speziale6, Karine Lheritier6, Alberto Martini2, Daniel Lovell1,7 and on behalf of PRINTO/PRCSG, 1PRCSG, Cincinnati, OH, 2PRINTO-Istituto Gaslini, Genova, Italy, 3Necker-Enfants Malades Hospital, Paris, France, 4Cliniques Universitaires Saint-Luc and Université Catholique de Louvain, Brussels, Belgium, 5Novartis Pharmaceuticals Corporation, East Hanover, NJ, 6Novartis Pharma AG, Basel, Switzerland, 7Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Systemic JIA and interleukins (IL)

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print
Session Information

Date: Tuesday, November 10, 2015

Title: Pediatric Rheumatology - Clinical and Therapeutic Aspects Posters (ACR): Imaging and Novel Clinical Interventions

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose:
Systemic juvenile idiopathic
arthritis (SJIA) is a debilitating form of arthritis associated with systemic
symptoms such as anemia, rash, leukocytosis, elevated erythrocyte sedimentation
rate and acute-phase reactants. High and spiking fevers are also features of
the disease. Canakinumab (CAN) leads to improvement for patients (pts) with
SJIA exhibiting articular and systemic features at treatment onset.1 However,
little is known about the long-term safety and efficacy in CAN-naïve pts,
including those who may not exhibit systemic fever. Here we present the long-term efficacy and safety profile
of CAN in SJIA pts with and without fever at CAN initiation.

Methods:  Pts aged 2-20 years with SJIA with and without SJIA
associated fever at enrollment received open-label
CAN 4mg/kg s.c. every 4 weeks. Efficacy was assessed every 3 months by adapted JIA ACR
response criteria (aACR/JIA); juvenile arthritis disease activity score
[JADAS]; clinical inactive disease; clinical remission on medication [CRM, 6
months continuous clinical inactive disease]. Safety was assessed monthly.

Results: Of 123 pts, 70
(57%) with and 52 (42%) without SJIA associated fever, were available for
analysis with a median study duration of 96 weeks.  At Week 4, 73% and 81% of pts
with and without fever at study entry, respectively had ≥ aACR/JIA30,
increasing to 89% and 92% at Wk12.  At Week 2, 23.9% and 24.5% of pts with and
without fever at study entry, respectively, had inactive disease which
increased to 61.5% and 59.5%, respectively, at Week 32 and thereafter. CRM was
achieved in 42.3% of pts in the overall group with 26.8% maintaining it for 12
consecutive months. Median JADAS27-CRP and JADAS10-CRP scores were 6.0 (suggesting
moderate disease activity) at Day 15 and 1.5 (indicating low disease activity)
at the last assessment, respectively. The disease activity status at baseline
and end of study for JADAS10-CRP and JADAS27-CRP are presented in Table.  Adverse
events (AEs) were reported in 63 (90%) and 45 (86.5%) pts with and without
fever, respectively.  Serious AEs were reported in 24 (34.3%) and 16 (30.8%)
pts with and without fever, respectively. Overall, 8 events of MAS (pts with
fever, n=6; pts without fever, n=2) were reported in both the groups. No deaths
were reported during the study. No new safety signals were observed in the
subgroup.

Table . Disease
activity states based on JADAS27-CRP and JADAS10-CRP

 

Disease state, %

SJIA patients, N=123

Fever at baseline

Yes (n=70)

No (n=52)

Baseline

n=68

Last assessment

n=70

Baseline

n=52

Last assessment

n=51

JADAS10-CRP

ID

0

50

0

47.1

LDA

0

12.9

0

9.8

MDA

10.3

5.7

9.6

19.6

HDA

89.7

31.4

90.4

23.5

JADAS27-CRP

ID

0

50

0

47.1

LDA

0

12.9

0

9.8

MDA

8.8

2.9

7.7

15.7

HDA

91.2

34.3

92.3

27.5

Cut-off values for inactive disease (ID), low disease activity (LDA) , moderate disease activity (MDA), and high disease activity (HDA), respectively for JADAS10: ≤1, >1– ≤3.8, >3.8 – ≤10.5, and >10.5; and JADAS27: ≤1, >1 – ≤ 3.8, >3.8 – ≤8.5, and >8.5

Conclusion: Canakinumab provides similar long-term efficacy in
SJIA pts, irrespective of presence of systemic fever at treatment onset.  The
safety profile was acceptable and similar to the pivotal program in SJIA pts with
fever at enrollment.

Reference: 1. Ruperto et al. N Engl J Med. 2012; 367:
2396-406.

 


Disclosure: H. I. Brunner, Novartis, Roche, Pfizer, UCB, Celgene, Regeneron, Amgen, Astrazeneca, GSK, BMS, 5,Novartis, Roche, 8; N. Ruperto, Abbott, BMS, "Francesco Angelini", GlaxoSmithKline (GSK), Hoffman-La Roche, Italfarmaco, Janssen, Novartis, Pfizer, Sanofi Aventis, Schwarz Biosciences, Sobi, Xoma, Wyeth, 2,Abbott, AbbVie, Amgen, Biogenidec, Astellas, Alter, AstraZeneca, Boehringer, BMS, CD-Pharma,Celgene, CrescendoBio, EMD Serono,Hoffman-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, Sanofi Aventis, Servier, Takeda, Vertex, 8; P. Quartier, Abbvie, BMS, Chugai-Roche, Novartis, Pfizer, SOBI, 2,Abbvie, Novartis, Servier, SOBI, 5,Abbvie, BMS, Chugai-Roche, Medimmune, Novartis, Pfizer, SOBI, 8; T. Constantin, None; E. Alexeeva, Roche, Abbott, Novartis, Pfizer, Bristol-Myers Squibb, Centocor, 2,Roche, Novartis, Merck Sharp Dohme, aBristol-Myers Squibb, Medac, Pfizer, 8; I. Koné-Paut, Novartis, SOBI Biovitrum, Pfizer, Abbvie, Roche/Chugai, 5,Novartis, Pfizer, 9,Novartis, 9,To my institution: SOBI, Novartis, Roche, 2; K. Marzan, Novartis and Abbvie, 2; N. Wulffraat, Novartis, 2; R. Schneider, Novartis, Novimmune, Sobi, Innomar Strategies, 5; S. Padeh, None; V. Chasnyk, None; C. Wouters, GSK, Novartis, Roche, 2; J. B. Kuemmerle-Deschner, Novartis Pharmaceutical Corporation, 8,Novartis and Sobi, 5; T. Kallinich, None; B. Lauwerys, None; E. Haddad, None; E. Nasonov, None; M. Trachana, Novartis, Roche, Pfizer, 5,Novartis, Abbvie, Bristol Meyers, 2; O. Vougiouka, None; K. Leon, Novartis Pharmaceutical Corporation, 3; A. Speziale, Novartis, 3; K. Lheritier, Novartis, 1,Novartis, 3; A. Martini, Abbott, BMS, "Francesco Angelini", GlaxoSmithKline (GSK), Hoffman-La Roche, Italfarmaco, Janssen, Novartis, Pfizer, Sanofi Aventis, Schwarz Biosciences, Sobi, Xoma, Wyeth, 2,Abbott, Abbvie, Amgen, Biogenidecm Bristol MyersSquibb, Astellas, Behringer, Italfarmaco, Janssen, MedImmune, Novartis, NovoNordisk, Pfizer, Sanofi, Roche, Servier, Takeda., 8; D. Lovell, National Institutes of Health, 2,Astra-Zeneca, Bristol Meyers Squibb, AbbVee, Pfizer, Roche, Novartis, UBC, Forest Research Institute, Horizon, Johnson & Johnson, Biogen, Takeda, Genentech, Glaxo Smith Kline, Boehringer Ingelheim, Celgene, Jannsen, 5,Genentech, Roche, Novartis, 8.

To cite this abstract in AMA style:

Brunner HI, Ruperto N, Quartier P, Constantin T, Alexeeva E, Koné-Paut I, Marzan K, Wulffraat N, Schneider R, Padeh S, Chasnyk V, Wouters C, Kuemmerle-Deschner JB, Kallinich T, Lauwerys B, Haddad E, Nasonov E, Trachana M, Vougiouka O, Leon K, Speziale A, Lheritier K, Martini A, Lovell D. Efficacy and Safety of Canakinumab in Children with Systemic Juvenile Idiopathic Arthritis: Results from the Phase 3 Extension Study [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-canakinumab-in-children-with-systemic-juvenile-idiopathic-arthritis-results-from-the-phase-3-extension-study/. Accessed .
  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

« Back to 2015 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-and-safety-of-canakinumab-in-children-with-systemic-juvenile-idiopathic-arthritis-results-from-the-phase-3-extension-study/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology