OFFER YOUR RA PATIENTS FLEXIBLE ADMINISTRATION OPTIONS WITH PROVEN EFFICACY 1,11
ACTEMRA SC delivered similar efficacy to ACTEMRA IV
Proven Efficacy at Week 24
- Design: Randomized, double-blind, double dummy, active-controlled, parallel-group, Phase III non-inferiority trial
- Patient population: DMARD-IR patients (N=1262)
- Study arms: Randomized 1:1 to evaluate the efficacy and safety of ACTEMRA 162 mg SC* QW + DMARD(s) (n=631) vs ACTEMRA 8 mg/kg IV† Q4W + DMARD(s) (n=631)
- Primary endpoint: Non-inferiority (12% non-inferiority margin) of ACTEMRA SC to ACTEMRA IV in proportion of patients achieving ACR20 at week 24
The primary endpoint of non-inferiority was met
- ACR20 was achieved in 69% of patients with ACTEMRA 162 mg SC* QW and 73% of patients with ACTEMRA 8 mg/kg IV† Q4W + DMARDs at week 24
IMPORTANT SAFETY INFORMATION
Events of gastrointestinal (GI) perforation have been reported in
clinical trials, primarily as complications of diverticulitis in RA
patients. Use ACTEMRA with caution in patients who may be at increased
risk for GI perforation. Promptly evaluate patients presenting with
new-onset abdominal symptoms for early identification of GI
Please see additional Important Safety Information below, and full
Prescribing Information, including
*The recommended starting dose of ACTEMRA SC for patients <100 kg is 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response. For patients ≥100 kg, the recommended dose of ACTEMRA SC is 162 mg administered subcutaneously every week.
†The recommended starting dose of ACTEMRA IV for adult patients is 4 mg/kg every 4 weeks followed by an increase to 8 mg/kg every 4 weeks based on clinical response.
ACR=American College of Rheumatology; DAS=disease activity score; DMARD=disease-modifying antirheumatic drug; DMARD-IR=inadequate response to DMARDs; Q4W=every-4-week dose; QW=every-week dose; RA=rheumatoid arthritis; SC=subcutaneous.