FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE RA, IN COMBINATION WITH MTX

TREATMENT WITH SIMPONI ARIA® RESULTED IN IMPROVEMENT IN PHYSICAL AND MENTAL COMPONENT SUMMARY SCORES OF SF-36¹

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

Mean change from baseline for patients receiving SIMPONI ARIA® + MTX vs patients receiving
placebo + MTX³

SF-36 PCS scores were not adjusted for multiplicity. Therefore, statistical significance has not been established.

In the GO-FURTHER™ study, a change from baseline in SF-36 score, including PCS and MCS, of ≥5 points was considered clinically meaningful.

Mean change from baseline for patients receiving SIMPONI ARIA® + MTX vs patients receiving
placebo + MTX³

SF-36 MCS scores were not adjusted for multiplicity. Therefore, statistical significance has not been established.

In the GO-FURTHER™ study, a change from baseline in SF-36 score, including PCS and MCS, of ≥5 points was considered clinically meaningful.

The 8 multi-item domains of the SF-36 instrument are³:

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 q8w 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 q8w 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 q8w in a blinded manner. All patients continued to receive MTX. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.³

CCP=cyclic citrullinated peptide; CRP=C-reactive protein; FACIT-F=Functional Assessment of Chronic Illness Therapy–fatigue; ITT=intention-to-treat; IV=intravenous; q8w=every 8 weeks; RA=rheumatoid arthritis; RF=rheumatoid factor; TNF=tumor necrosis factor.