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: Pediatric Rheumatology Symposium 2017

Keywords: canakinumab and juvenile idiopathic arthritis (JIA), IL-1

Session Information

Date: Thursday, May 18, 2017

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.^1,2However, 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.³Pts, 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 .

« Back to Pediatric Rheumatology Symposium 2017

ACR Meeting Abstracts - 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/