FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE RA, IN COMBINATION WITH MTX
IMPROVEMENT IN SF-36 SCORES
ACR20 response at Week 14 (primary endpoint): 59% of patients receiving SIMPONI ARIA® + MTX achieved ACR20 response vs 25% of patients receiving placebo + MTX (P<0.001)1,2
HAQ-DI* score at Week 14: the mean improvement from baseline in HAQ-DI* score was 0.50 for patients receiving SIMPONI ARIA® + MTX (n=395) vs 0.19 for patients receiving placebo + MTX (n=197) (P<0.001)1,2
*HAQ-DI=Health Assessment Questionnaire Disability Index. A reduction in HAQ-DI score of ≥0.25 is clinically meaningful. The HAQ-DI is a validated questionnaire. It is scored from 0 (no disability) to 3 (completely disabled).
Mean change from baseline for patients receiving SIMPONI ARIA® + MTX (n=395) vs patients receiving placebo + MTX (n=197)3:
Patients receiving SIMPONI ARIA® + MTX demonstrated greater improvement from baseline compared with placebo and MTX in all areas of SF-36 at Weeks 12, 16, and 243
SF-36 is a 36-item short-form health survey for patients. This instrument yields an 8-domain profile of functional health and well-being scores as well as psychometrically based PCS and MCS scores.
The 8 multi-item domains of the SF-36 instrument are4:
Physical health domains
- Limitations in physical functioning due to health problems
- Limitations in usual role activities due to physical health problems
- Bodily pain
- General health perception
Mental health domains
- Limitations in social functioning due to physical or mental health problems
- Limitations in usual role activities due to personal or emotional problems
- Vitality (energy and fatigue)
- General mental health (psychological distress and well-being)
Study design: GO-FURTHER™ was a global, multicenter, randomized, double-blind, placebo-controlled study in 592 adult patients who had moderately to severely active RA despite a stable dose of MTX (15-25 mg/week) for ≥3 months and who had not been previously treated with an anti-TNF agent. Moderately to severely active RA was defined as ≥6 swollen joints (out of 66 total) and ≥6 tender joints (out of 68 total), RF positive and/or anti-CCP antibody positive, and CRP ≥1.0 mg/dL. Patients were randomized to receive SIMPONI ARIA® 2 mg/kg + MTX (n=395) or placebo + MTX (n=197) as a 30-minute IV infusion at Weeks 0 and 4, and then q8 weeks through Week 100. At Week 16, patients in the placebo + MTX group with <10% improvement from baseline in both swollen joint count and tender joint count began receiving SIMPONI ARIA® 2 mg/kg beginning with an induction regimen at Weeks 16 and 20, followed by maintenance infusions q8 weeks in a blinded manner. At Week 24, all patients remaining in the placebo + MTX group began receiving SIMPONI ARIA® 2 mg/kg beginning with an induction regimen at Weeks 24 and 28, followed by maintenance infusions q8 weeks in a blinded manner. All patients continued to receive MTX. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.