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To assess the efficacy and safety of canakinumab in Japanese patients with systemic juvenile idiopathic arthritis (sJIA). This was an open-label, single-arm active treatment study. sJIA patients, aged ≥2 to

Shu Hashimoto,1 Hisataro Ikeuchi,2 Shujiro Murata,2 Tetsuji Kitawaki,2 Kimitoshi Ikeda,2 Donald Banerji3 1Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan; 2Novartis Pharma KK, Minato-ku, Tokyo, Japan; 3Novartis Pharmaceuticals Corporation, EastHanover, NJ, USA Background: COPD-related deaths are increasing in Japan, with ~5.3 million people at risk.Methods: The SHINE was a 26-week, multicenter, randomized, double-blind, parallel-group study that evaluated safety and efficacy of indacaterol (IND)/glycopyrronium (GLY) 110/50µg once daily (od) compared with GLY 50µg od, IND 150µg od, open-label tiotropium (TIO) 18µg od, and placebo. The primary end point was trough forced expiratory volume in 1second (FEV1) at Week 26. Other key end points included peak FEV1, area under the curve for FEV1 from 5minutes to 4hours (FEV1 AUC5min–4h), Transition Dyspnea Index focal score, St George’s Respiratory Questionnaire total score, and safety. Here, we present efficacy and safety of IND/GLY in the Japanese subgroup.Results: Of 2,144 patients from the SHINE study, 182 (8.5%) were Japanese and randomized to IND/GLY (n=42), IND (n=41), GLY (n=40), TIO (n=40), or placebo (n=19). Improvement in trough FEV1 from baseline was 190mL with IND/GLY and treatment differences versus IND (90mL), GLY (100mL), TIO (90mL), and placebo (280mL) along with a rapid onset of action at Week 26. IND/GLY showed an improvement in FEV1 AUC5min–4h versus all comparators (all P

Background Systemic juvenile idiopathic arthritis (SJIA) is a distinct form of juvenile idiopathic arthritis (JIA), accounting for approximately 4% to 17% of JIA1. In Japan, a higher frequency of SJIA, 41.7% of JIA2 has been reported compared to Europe and United States. Tocilizumab (TCZ) is the only approved biologic for SJIA treatment in Japan. However, some patients (pts) demonstrate persistently high disease activity and/or drug intolerabiliy. Therefore, new treatment options are required. Here, we evaluated the efficacy and safety of canakinumab (CAN), a human anti-interleukin-1s monoclonal antibody, in Japanese SJIA pts. Objectives To report the results of a 28 week (Wk) interim whole analysis of Phase III data (NCT02396212) of CAN, and the subgroup analysis of pts with or without prior use of TCZ. Methods Patients (age ≥2- Results The trial enrolled 19 pts who had insufficient response to prior treatment; the majority (15/19, 78.9%) had received TCZ (table 1). Of the 19 pts, 3 discontinued CAN due to lack of efficacy or adverse events (AE) by Wk28 and 16 completed the assessment of Wk28. All pts (19/19) achieved aACR 30/50/70 at Wk8 (figure 1). Overall, 73.7% (14/19) pts achieved corticosteroid tapering at Wk28 and 2 pts (10.5%) achieved ”steroid free”. Of 15 pts with prior use of TCZ, 12 pts (80.0%) achieved aACR 100 at Wk8 and 11 pts (73.7%) achieved corticosteroid tapering (26.3%, 5/19). Serious AE (SAE) was seen in 41.1% (8/19) pts, and the most frequent SAE was JIA (flare or worsening of SJIA, 21.1%, 4/19). One macrophage activation syndrome (MAS) but no death was reported. Conclusions CAN 4 mg/kg q4w s.c. provided improvement in disease activity and a redution of oral steroid dose in Japanese SJIA pts, including those who were not well-controlled with TCZ. No new safety concerns were reported. References [1] Ravelli A, Martini. Lancet2007; 369(9563):767–78. [2] Takei S, et al. Annual Report on children with chronic refractory diseases from the Japanese Ministry of Health, Labor and Welfare2008;102–13. Disclosure of Interest None declared

Background To better evaluate the efficacy and safety of the indacaterol/glycopyrronium (IND/GLY) fixed-dose combination versus tiotropium in Japanese patients, a pooled data analysis was conducted from the SHINE and ARISE studies, which were part of the IND/GLY clinical trial program. Methods Japanese patients with moderate-to-severe COPD were included in the analysis. Efficacy in terms of pre-dose forced expiratory volume in one second (FEV 1 ) at Week 12 and Week 24/26 (ARISE/SHINE) and FEV 1 at 30min and 60min post-dose at Day 1, Week 12, and Week 24/26 was evaluated. Health status using the St. George׳s Respiratory Questionnaire (SGRQ) score, rescue medication use (number of puffs/day), safety, and tolerability were also assessed. Results In total, 340 patients (IND/GLY, n =161; IND, n =41; GLY, n =40; tiotropium, n =79; and placebo, n =19) were included in the analysis that focused on comparing IND/GLY versus tiotropium since they were included in both studies. At Week 12 and Week 24/26, pre-dose FEV 1 was significantly improved with IND/GLY compared with tiotropium (treatment differences=70mL and 80mL, respectively; both P ≤0.001). FEV 1 at 30min and 60min post-dose, the SGRQ total score, and rescue medication use were more statistically significant with IND/GLY than with tiotropium for all assessed time-points. The overall incidence of adverse events (AEs) and serious AEs was similar between the IND/GLY- and tiotropium-treated groups. Conclusions Compared to tiotropium, IND/GLY provided significant improvements in lung function, health status, and rescue medication use, while having a good safety profile in Japanese patients with moderate-to-severe COPD.

SummaryIntroductionThis post hoc analysis evaluated the efficacy of indacaterol, a novel inhaled once-daily long-acting β2-agonist, by disease severity (GOLD 2005) in patients with moderate-to-severe COPD from six Asian countries/areas (Hong Kong, India, Japan, Korea, Singapore, Taiwan).MethodsData from a 12-week, double-blind, placebo-controlled, parallel-group study in patients randomized to indacaterol 150 μg, indacaterol 300 μg or placebo once daily were analyzed based on baseline disease severity (moderate or severe). Endpoints were: trough FEV1 (average of 23 h 10 min and 23 h 45 min post-dose values), transition dyspnoea index (TDI) and St George's Respiratory Questionnaire (SGRQ) at Week 12. Safety data were collected.ResultsOf 347 patients randomized, 59.7% had moderate, and 40.3% had severe COPD. Least squares means (LSMs) indacaterol–placebo differences in trough FEV1 at Week 12 exceeded the pre-specified minimal clinically important difference (MCID) of 0.12L and were statistically superior (p