ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 3

Efficacy and Safety of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis: Results From an Open-Label, Long-Term Follow-up Study

Hermine Brunner1, Nicolino Ruperto2, Pierre Quartier3, Tamás Constantin2, Ekaterina Alexeeva2, Rayfel Schneider4, Isabelle Koné-Paut5, Kenneth N. Schikler6, Katherine Marzan4, Nico Wulffraat2, Shai Padeh7, Vyacheslav Chasnyk7, Carine Wouters7, Jasmin B. Kuemmerle-Deschner7, Tilmann Kallinich7, Bernard Lauwerys8, Elie Haddad4, Evgeny L Nasonov7, Maria Trachana7, Olga Vougiouka7, Karolynn Leon9, Antonio Speziale10, Karine Lheritier10, Eleni Vritzali11, Alberto Martini7 and Daniel Lovell4, 1Rheumatology, PRCSG, Cincinnati, OH, 2PRINTO-Istituto Gaslini, Genoa, Italy, 3Necker-Enfants Malades Hospital, Paris, France, 4PRCSG, Cincinnati, OH, 5Hôpital Kremlin Bicetre, University of Paris SUD, Paris, France, 6PRCSG, Cincinatti, OH, 7PRINTO-Istituto Gaslini, Genova, Italy, 8Cliniques Universitaires Saint-Luc and Université Catholique de Louvain, Brussels, Belgium, 9Novartis Pharmaceuticals Corporation, East Hanover, NJ, 10Novartis Pharma AG, Basel, Switzerland, 11Immunology and Dermatology Franchise, Novartis Pharma AG, Basel, Switzerland

Meeting: 2017 Pediatric Rheumatology Symposium

Keywords: ,

Session Information

Date: Thursday, May 18, 2017

Session Title: Plenary Abstract Session 1

Session Type: Abstract Submissions

Session Time: 2:00PM-3:00PM

Background/Purpose:  Canakinumab (CAN), a selective human anti-IL1 β monoclonal antibody, had demonstrated its efficacy and safety in patients (pts) with active systemic juvenile idiopathic arthritis (SJIA) in a comprehensive global clinical program consisting of one phase II and two phase III trials.1,2 However, limited data was available on long-term efficacy and safety of CAN in SJIA. The study objective was to assess the long-term efficacy and safety of CAN treated SJIA pts over a 5-year (yr) follow-up observational period.

Methods:  This was an open-label extension (OLE) study (NCT00891046) of SJIA pts participating in the global clinical trials of CAN.3 Pts, 2 to <20 yrs of age at the time of enrollment in study, received subcutaneous CAN 4 mg/kg every 4 weeks. Baseline was defined as the starting point of the extension trial. Efficacy assessments were done every 3 months, including adapted pediatric response criteria (aACR), clinical inactive disease, and clinical remission on medication (continuous 12 months of clinical inactive disease). Safety assessments included adverse events (AEs) and serious AEs (SAEs).

Results:  Overall, 147 pts to the OLE study had a median treatment duration of 3.2 yrs; total treatment exposure was approximately 365 pt-yrs. Of 147 pts, 100 (68%) completed 96 weeks of treatment, whereas 47 (32%) pts discontinued the study. Another 25 pts (17%) discontinued the study after Week 96. Of the 107 pts with an aACR 30 at entry to the OLE study, 61.7%, 79.4%, and 86.0% have had aACR 100, 90, and 70 responses, respectively at last assessment. At baseline, 32.7% of patients were with inactive disease which increased up to 60%–70% between Week 36 and Week 168. Clinical remission on medication was achieved in 43% pts. In total, 137 (93.2%) pts reported at least 1 AE during the 3.2 yrs median exposure in the study corresponding to 2.009 AEs/100 pt-days (733.6 AEs/100 pt-yrs) with infections (202.7 per 100 pt-yrs) being the most common AE. Overall, 47 (32.0%) pts had at least 1 SAE corresponding to 0.089 SAE/100 pt-days (32.6 SAE/100 pt-yrs) with the most common being JIA (14 pts) denoting disease flares or worsening of SJIA. Ten patients (6.8%) with a total of 12 macrophage activation syndrome events were reported as SAE and 7 patients among them discontinued the study. No deaths were reported.

Conclusion: In patients previously treated with CAN in pivotal trials, response to treatment was sustained or improved during long-term treatment in the OLE study. Safety profile of CAN was consistent with safety findings from previous studies.

References:

1. Ruperto N, et al. N Engl J Med. 2012;367(25):2396-406.
2. Ringold S, et al. Arthritis & Rheum. 2013;65 (10):2499-512.
3. Ruperto N, et al. Ann Rheum Dis. 2015;74(2):608.

Disclosure: H. Brunner, 5,8; N. Ruperto, 2,8; P. Quartier, 2,5,8; T. Constantin, None; E. Alexeeva, 2,8; R. Schneider, None; I. Koné-Paut, 2,5; K. N. Schikler, 5; K. Marzan, 2; N. Wulffraat, 2; S. Padeh, None; V. Chasnyk, None; C. Wouters, 2; J. B. Kuemmerle-Deschner, 2,5; T. Kallinich, 2,8; B. Lauwerys, None; E. Haddad, None; E. L. Nasonov, None; M. Trachana, 2,5; O. Vougiouka, None; K. Leon, 3; A. Speziale, 3; K. Lheritier, 1,3; E. Vritzali, 3; A. Martini, 2,8; D. Lovell, 2,8.

To cite this abstract in AMA style:

Brunner H, Ruperto N, Quartier P, Constantin T, Alexeeva E, Schneider R, Koné-Paut I, Schikler KN, Marzan K, Wulffraat N, Padeh S, Chasnyk V, Wouters C, Kuemmerle-Deschner JB, Kallinich T, Lauwerys B, Haddad E, Nasonov EL, Trachana M, Vougiouka O, Leon K, Speziale A, Lheritier K, Vritzali E, Martini A, Lovell D. Efficacy and Safety of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis: Results From an Open-Label, Long-Term Follow-up Study [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 4). https://acrabstracts.org/abstract/efficacy-and-safety-of-canakinumab-in-patients-with-systemic-juvenile-idiopathic-arthritis-results-from-an-open-label-long-term-follow-up-study-2/. Accessed February 23, 2019.

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