TY - CONF
T1 - Efficacy And Safety Of Canakinumab In Patients With Systemic Juvenile Idiopathic Arthritis
T2 - PReS Congress Sept. 2016 Genoa, Italy
AU - Ruperto, Nicolino
AU - Brunner, H.I.
AU - Quartier, Pierre
AU - Constantin, T.
AU - Alexeeva, Ekaterina
AU - Schneider, R.
AU - Kone-Paut, Isabelle
AU - Schikler, K.
AU - Marzan, K.
AU - Wulffraat, NM
AU - Padeh, S.
AU - Chasnyk, V.
AU - Wouters, C.
AU - Kuemmerle-Deschner, Jasmin B.
AU - Kallinich, Tilmann
AU - Lauwerys, B.
AU - Haddad, E.
AU - Nasonov, E.
AU - Trachana, M.
AU - Vougiouka, O.
AU - Leon, K.
AU - Speziale, A.
AU - Lheritier, K.
AU - Vritzali, E.
AU - Martini, A.
AU - Lovell, D.
PY - 2016/9/30
Y1 - 2016/9/30
N2 - Introduction: Canakinumab (CAN), a highly 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.
Objectives: To assess 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 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 paediatric 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 years median exposure in the study corresponding to 2.009 AEs/100 pt-days (733.6 AEs/100 pt-years) with infections (202.7 per 100 pt-years) 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-years) with the most common being JIA (14 pts) denoting disease flares or worsening of SJIA. Ten patients (6.8%) with a total of 12 MAS 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.
AB - Introduction: Canakinumab (CAN), a highly 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.
Objectives: To assess 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 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 paediatric 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 years median exposure in the study corresponding to 2.009 AEs/100 pt-days (733.6 AEs/100 pt-years) with infections (202.7 per 100 pt-years) 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-years) with the most common being JIA (14 pts) denoting disease flares or worsening of SJIA. Ten patients (6.8%) with a total of 12 MAS 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.
M3 - Poster
Y2 - 19 September 2016
ER -