FOR ADULTS WITH ACTIVE PsA

SIMPONI ARIA® IS THE FIRST  FULLY HUMAN ANTI‑TNFα BIOLOGIC WITH IMPROVEMENT IN BOTH PHYSICAL AND MENTAL COMPONENT SUMMARY SCORES OF SF-36 IN THE LABEL1,2

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)1,3,4

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 physical component summary (PCS) and
mental component summary (MCS) scores.4

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
physical component summary (PCS) and mental component summary (MCS) scores.4

Mean change from baseline for patients receiving SIMPONI ARIA® +/- MTX (n=233) vs patients receiving placebo +/- MTX (n=222)3-5

Sharp Scores Graph
Sharp Scores Graph

SF-36 PCS scores at Week 24 were not adjusted for multiplicity. Therefore, statistical significance has not been established.

In the GO-VIBRANT 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 (n=233) vs patients receiving placebo +/- MTX (n=222)3-5

Sharp Scores Graph
Sharp Scores Graph

SF-36 MCS scores at Week 24 were not adjusted for multiplicity. Therefore, statistical significance has not been established.

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

*  Mean change from baseline in PCS scores and MCS scores is based on imputed data using last observation carried forward for missing data.

†  No missing data imputation rule is applied.

‡  The P value is based on mixed-effect repeated measures model with treatment group, baseline MTX usage (Yes, No), baseline SF-36 PCS score, visit week, and an interaction of treatment and visit week as the terms in the model.

§  PCS and MCS scores at Week 14 were controlled endpoints that were tested sequentially among a list of other controlled endpoints only if the primary and major secondary endpoints achieved statistical significance.

||  SF-36 is a validated questionnaire. The same patients may not have responded at each timepoint.

#  After Week 24, selected sponsor personnel were unblinded to subject-level data, which may have affected results.

The 8 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-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 14.4

ACR20=20% improvement in American College of Rheumatology criteria; CRP=C-reactive protein; IV=intravenous; MTX=methotrexate; PsA=psoriatic arthritis; q8w=every 8 weeks; SF-36=36-item short-form survey; TNFα=tumor necrosis factor alpha.

NEXT:  View FACIT-F in PsA »

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PATIENT-REPORTED OUTCOMES (PROs) SIMPONI ARIA®

improvement in fatigue data as measured by FACIT-F in a clinical trial.

SEE RESULTS
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DOSING CALCULATOR

DOSING
CALCULATOR

Calculate an adult patient's dose of SIMPONI ARIA® based on weight.

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ACCESS AND AFFORDABILITY

View first-line coverage rates for SIMPONI ARIA®.

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References: 1. SIMPONI ARIA® (golimumab) [Prescribing Information]. Horsham, PA: Johnson & Johnson. 2. Humira® (adalimumab) [Prescribing Information]. North Chicago, IL: AbbVie Inc. 3. Kavanaugh A, Husni ME, Harrison DD, et al. Safety and efficacy of intravenous golimumab in patients with active psoriatic arthritis: results through week twenty-four of the GO-VIBRANT study. Arthritis Rheumatol. 2017;69(11):2151-2161. doi: 10.1002/art.40226. 4. Data on file. Johnson & Johnson. 5. Husni ME, Kavanaugh A, Murphy F, et al. Efficacy and safety of intravenous golimumab through one year in patients with active psoriatic arthritis. Arthrit Care Res. 2006;45(6):885-889.