Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance] (Enbrel-JIA)

Etanercept (genetical recombination)

All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).

의약품: Etanercept (genetical recombination)

All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis (restricted to the case of lack of effect by other treatment) during registered period (2.5 year).

다른 이름들:

• 엔브렐

Number of Participants With Treatment-Related Adverse Events of Etanercept

Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor.

Number of Participants With Serious Treatment-Related Adverse Events of Etanercept

Serious treatment-related adverse events are defined as any events that lead to death, life-thretening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anormaly/congenital deficiency, or other medically significant events or disorder.

Number of Unlisted Treatment-Related Adverse Events of Etanercept

Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. Unlisted treatment-related adverse events were confirmed with listed adverse drug reactions specified in Japanese package insert.

Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28

The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.

Percentage of Participants With Overall Improvement On Physician's Assessment.

Percentage of participants in whom the efficacy of etanercept was assessed as either markedly effective or effective.