FOR ADULTS WITH ACTIVE PsA
SIGNIFICANT IMPROVEMENT IN PHYSICAL FUNCTION
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)1-3
Through Week 14, patients receiving SIMPONI ARIA® achieved greater improvement from baseline in HAQ-DI score vs placebo1†‡§
At Week 14: Percentage of patients with HAQ-DI* response (≥0.3 improvement from baseline)
At Week 24: Percentage of patients with HAQ-DI* response (≥0.3 improvement from baseline)
Proportion of HAQ-DI responses were not adjusted for multiplicity. Therefore, statistical significance has not been established.
*HAQ-DI=Health Assessment Questionnaire Disability Index. A reduction in HAQ-DI score of ≥0.3 is clinically meaningful. The HAQ-DI is a validated questionnaire. It is scored from 0 (no disability) to 3 (completely disabled).
†The same patients may not have responded at each time point.
‡In this intention-to-treat (ITT) analysis, patients were considered to be nonresponders if they experienced any of the following: increased the dose of MTX or oral corticosteroids over baseline for PsA not as part of early escape; initiated treatment with DMARDs, systemic immunosuppressives, treatment with oral, intravenous (IV), or intramuscular (IM) corticosteroids, and/or biologics for PsA; met early escape criteria at Week 16 and started concomitant medication intervention; or discontinued treatment due to an unsatisfactory therapeutic effect. Treatment failure criteria were applied through Week 24 only. Last observation carried forward (LOCF) rules were applied to missing data.
§Change from baseline in HAQ-DI score is based on imputed data using LOCF for missing data.
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.