FOR ADULTS WITH ACTIVE PsA

IMPROVEMENT IN SF-36 SCORES

ACR20 Response at Week 14 (primary endpoint): 75% of patients receiving SIMPONI ARIA® +/- MTX achieved ACR20 response vs 22% of patients receiving placebo +/- MTX (P<0.001)1-3

Improvement in HAQ-DI score at Week 14 vs placebo: The mean improvement from baseline in HAQ‑DI* score was 0.60 for patients receiving SIMPONI ARIA® +/- MTX (n=241) vs 0.12 for patients receiving placebo +/- MTX (n=239) (P<0.001)1,2

*HAQ-DI=Health Assessment Questionnaire Disability Index. A reduction in HAQ-DI score of ≥0.3 is clinically meaningful. The HAQ 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 vs patients receiving placebo +/- MTX1:

PCS score at Week 24 was a prespecified endpoint that was not adjusted for multiplicity; P value is considered nominal.

MCS and PCS scores at Week 24 were prespecified endpoints that were not adjusted for multiplicity; P values are considered nominal.

Mean change from baseline in PCS scores and MCS scores is based on imputed data using LOCF for missing data.

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 are1:

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-VIBRANT was a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of SIMPONI ARIA® compared with placebo in 480 adult patients with active PsA. The target study population was biologic-naïve patients with active PsA for ≥6 months who met ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria at screening. Patients in this trial had a diagnosis of PsA for at least 6 months and had symptoms of active disease (≥5 swollen joints and  ≥5 tender joints and a CRP level of  ≥0.6 mg/dL). At Week 0, patients were randomized in a 1:1 ratio to 1 of 2 treatment groups. Patients were allowed to be treated with or without MTX. Patients in the placebo group (n=239) were randomized to receive IV placebo infusions at Weeks 0, 4, 12, and 20. Patients in the SIMPONI ARIA® group (n=241) were randomized to receive SIMPONI ARIA® 2 mg/kg infusions at Weeks 0, 4, and q8w thereafter through Week 52. Patients were to receive a placebo infusion at Week 24 to maintain the treatment blind. At Week 24, all patients switched to treatment with SIMPONI ARIA® 2 mg/kg and were to receive administrations at Weeks 24, 28, and q8w through Week 52. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.