Article
In Children With Systemic Juvenile Idiopathic Arthritis With And Without Fever Canakinumab is Long Term Safe and Efficacious
Search Medline for
Authors
-
Gerd Horneff
- Asklepios Klinik Sankt Augustin, Zentrum für Allgemeine Pädiatrie und Neonatologie, St. Augustin
-
Nicola Ruperto
- Instituto G. Gaslini, Pediatria II and University of Genoa, Pediatric Rheumatology International Trials Organization (PRINTO), Genova, Italy
-
Hermine Brunner
- Cincinnati Children's Hospital Medical Center, UC Department of Pediatrics, Cincinnati, United States of America
-
Pierre Quartier
- Pitie-Salpetriere Hospital, Paris
-
Tamas Constantin
- Semmelweis University, Faculty of Medicine, Budapest, Hungary
-
Ekaterina Alexeeva
- Russian Academy of Medical Sciences, Rheumatology Department, Scientific Center for Children’s Health, Moskau, Russland
-
Isabelle Kone-Paut
- Hématologie et rhumatologie pédiatrique, Paris, France
-
Katherine Marzan
- Childrens Hospital Los Angeles, Los Angeles, USA
-
Nico Wulffraat
- University Medical Centre Utrecht, Wilhelmina Children's Hospital, Department of Pediatric Immunology, Utrecht, The Netherlands
-
Rayfel Schneider
- The Hospital for Sick Children Division of Rheumatology, Toronto
-
Shai Padeh
- Tel Aviv University Sackler School of Medicine, Chaim Sheba Medical Centre, Paediatric Department B, Tel Aviv, Israel
-
Vyacheslav Chasnyk
- Saint Petersburg State Pediatric Medical University, Hospital Pediatric Department, Saint Petersburg, Russia
-
Carine Wouters
- Katholieke Universiteit Leuven, Hospital Gasthuisberg, Leuven, Belgium
-
Jasmin Kümmerle-Deschner
- Universitätskinderklinik Tuebingen, Rheumatologie, Tübingen
-
Tilmann Kallinich
- Charité - Universitätsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie, Sektion Rheumatologie, Berlin
-
Bernard. R. Lauwerys
- Université Catholique de Louvain, Rheumatologie, Brüssel, Belgium
-
Elie Haddad
- CHU Saint-Justine, Montreal, Canada
-
Evgeny Nasonov
- Science Research Institute of Rheumatology, Moskau, Russia
-
Maria Trachana
- Aristotle University of Thessaloniki, Ippokration Hospital, Department of Pediatrics, Thessaloniki, Greece
-
Olga Vougiouka
- National and Kapodistrian University of Athens, 2nd Dept. Of Paediatrics of Athens University, Athen, Greece
-
Ken Abrams
- Novartis Pharmaceuticals Corporation, New Jersey, United States of America
-
Karolynn Leon
- Novartis Pharmaceuticals Corporation, New Jersey, I&D Development, Franchise 1, New Jersey, USA
-
Karine Lheritier
- Novartis Pharma AG, Basel, Switzerland
-
Alberto Martini
- Ospedale Gaslini Genova, Genova, Italy
-
Daniel J. Lovell
- Cincinnati Children's Hospital Medical Center, University of CIncinnati Department of Pediatrics, Cincinnati, United States of America
| Published: | September 1, 2015 |
|---|
Outline
Text
Introduction: Rapid and sustained efficacy of canakinumab (CAN) were previously demonstrated in patients with systemic juvenile idiopathic arthritis (SJIA)1. However, little is known about potential differences in response to CAN treatment between pts with vs. without SJIA associated fever. The objective is to evaluate the long-term efficacy and safety profile of CAN-naïve SJIA pts with and without SJIA associated fever.
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 wks. Every 3 months, response to CAN was measured 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: Data on 122/267 pts, 53 (43%) with and 69 (57%) without SJIA associated fever, were available for analysis with a median 94 wk study duration. At Wk4, ~75% of both subgroups had responded (≥aACR/JIA30), increasing to 90% at Wk12. At Wk2, ~21% of both subgroups had inactive disease; 44% at Wk8; 60% at Wk20 and then 60-70% for the remainder of the trial. CRM was achieved in about 29% of pts in both subgroups with ~22% maintaining it for ≥12 consecutive months. At baseline, the median JADAS score was 21.5 with 8 (7.5%) and 99 (92.5%) pts meeting the criteria for moderate (JADAS >3.8 and ≤10.5) and high disease activity (JADAS >10.5), respectively. At the last assessment, 53 (48%) pts had inactive disease (JADAS≤ 1); 10 (9%) with low active disease activity (JADAS >1 and ≤3.8); while 14 (13%) had moderate and 31 (28%) with high disease activity. Infection (0.56 infections/100 PT-days), typically involving upper respiratory tract was the most common type of adverse event. Fifteen pts discontinued due to an AE and 40 had >1 SAE (mostly infections, macrophage activation syndrome [MAS], or flare-associated) and no deaths.
Conclusion: Canakinumab provides similar efficacy in SJIA pts with and without SJIA associated fever at treatment onset. The long-term safety profile was acceptable and similar to the pivotal program in SJIA children with fever at enrollment.
