Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study

Table 2 Patients with adverse events reported during the short-term period up to Week 16 and cumulative period (all treated patients; N = 20)

Safety events	Short-term period (Week 16)	Cumulative period
Deaths^a	0	0
SAEs^b	2 (10)	4 (20)
Related SAEs	1 (5)	1 (5)
Discontinued study treatment due to AEs	0	0
AEs	20 (100)	20 (100)
Related AEs	5 (25)	6 (30)
AEs of special interest
Infections	16 (80)	20 (100)
Malignancies	0	0
Autoimmune disorders^c	1 (5.0)	0
Infusion reactions
Acute infusional	0	1 (5)
Peri-infusional^d	2 (10)	5 (25)
Other AEs within 24 h^e	4 (20)	12 (60)

The short-term period includes data up to 56 days after the last dose in the short-term period or start of the long-term period, whichever occurred first
The cumulative period includes data from the first dose in the short-term period up to 56 days post the last dose in the cumulative period
^aData include deaths reported during each period including those that occurred > 56 days after the last dose
^bSAEs include hospitalizations for elective surgical procedures
^cThis event was not new onset, but worsening of the underlying disease (JIA)
^dDefined as AEs that occurred during the first 24 hours after the start of abatacept infusion and are included in the pre-specified Medical Dictionary for Regulatory Activities list of peri-infusional events of interest
^eDefined as AEs that occurred after the start of abatacept infusion but are not included in the list of peri-infusional AEs of special interest
AE adverse event, JIA juvenile idiopathic arthritis, SAE serious adverse event

ISSN: 1546-0096