y Endpoint: JIA ACR 30 response + absence of fever
Responders 85% 24%
Weighted difference
(95% CI) 62
(45, 78) -
JIA ACR Response Rates at Week 12
JIA ACR 30
Responders 91% 24%
Weighted difference*
(95% CI)† 67
(51, 83) -
JIA ACR 50
Responders 85% 11%
Weighted difference*
(95% CI) † 74
(58, 90) -
JIA ACR 70
Responders 71% 8%
Weighted difference*
(95% CI) † 63
(46, 80) -
The treatment effect of ACTEMRA was consistent across all components of the JIA ACR response core variables. JIA ACR scores and absence of fever responses in the open label extension were consistent with the controlled portion of the study (data available through 44 weeks).
Systemic Features
Of patients with fever or rash at baseline, those treated with ACTEMRA had fewer systemic features; 35 out of 41 (85%) became fever free (no temperature recording at or above 37.5°C in the preceding 14 days) compared to 5 out of 24 (21%) of placebo-treated patients, and 14 out of 22 (64%) became free of rash compared to 2 out of 18 (11%) of placebo-treated patients. Responses were consistent in the open label extension (data available through 44 weeks).
Corticosteroid Tapering
Of the patients receiving oral corticosteroids at baseline, 8 out of 31 (26%) placebo and 48 out of 70 (69%), ACTEMRA patients achieved a JIA ACR 70 response at week 6 or 8 enabling corticosteroid dose reduction. Seventeen (24%) ACTEMRA patients versus 1 (3%) placebo patient were able to reduce the dose of corticosteroid by at least 20% without experiencing a subsequent JIA ACR 30 flare or occurrence of systemic symptoms to week 12. In the open label portion of the study, by week 44, there were 44 out of 103 (43%) ACTEMRA patients off oral corticosteroids. Of these 44 patients 50% were off corticosteroids 18 weeks or more.
Health Related Outcomes
Physical function and disability were assessed using the Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI). Seventy-seven percent (58 out of 75) of patients in the ACTEMRA treatment group achieved a minimal clinically important improvement in CHAQ-DI (change from baseline of ≥ 0.13 units) at week 12 compared to 19% (7 out of 37) in the placebo treatment group.
16 HOW SUPPLIED/STORAGE AND HANDLING
For Intravenous Infusion
ACTEMRA (tocilizumab) is supplied in single-use vials as a preservative-free, sterile concentrate (20 mg per mL) solution for intravenous infusion. The following packaging configurations are available:
Individually packaged, single-use vials:
NDC 50242-135-01 providing 80 mg per 4 mL
NDC 50242-136-01 providing 200 mg per 10 mL
NDC 50242-137-01 providing 400 mg per 20 mL
For Subcutaneous Injection
ACTEMRA (tocilizumab) for subcutaneous administration is supplied as a sterile preservative-free liquid solution in a single-use prefilled syringe. The following packaging configurations are available:
NDC 50242-138-01 prefilled syringe providing 162 mg per 0.9mL
Storage and Stability: Do not use beyond expiration date on the container, package or prefilled syringe. ACTEMRA must be refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect the vials and syringes from light by storage in the original package until time of use, and keep syringes dry. Parenteral drug products should be inspected visually for parti |
