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SIMPONI ARIA® (golimumab) RA Clinical Trial: SF-36 Scores | HCP

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-36

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

*20% improvement in American College of Rheumatology criteria.

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).

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.

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

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 + MTX

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 randomized (intent-to-treat) population was used for these analyses.

§SF-36 is a validated questionnaire. The same patients may not have responded at each time point. Mean change from baseline in SF-36 score is based on imputed data using LOCF for missing data.

ǁAfter Week 24, patients and doctors knew that all patients were on SIMPONI ARIA® (blinded active treatment), which may have affected the results.

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 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.

PATIENT-REPORTED OUTCOMES

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

DOSING CALCULATOR

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

ACCESS AND AFFORDABILITY

View first-line coverage rates for SIMPONI ARIA®.