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

SIMPONI ARIA^® IS THE FIRST AND ONLY ANTI-TNFα BIOLOGIC WITH FACIT-F IN THE LABEL

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

FACIT-Fatigue (FACIT-F) measures a patient's level of fatigue and tiredness
over the last 7 days through a questionnaire consisting of 13 questions.²

Treatment with SIMPONI ARIA^® resulted in improvement in fatigue as measured by
FACIT-F³

The FACIT-F endpoint was not adjusted for multiplicity. Therefore, statistical significance has not been established.

Patients with a ≥4-point improvement in fatigue as measured by FACIT-F

Facit FRA

The FACIT-F endpoint was not adjusted for multiplicity. Therefore, statistical significance has not been established.

The threshold for clinically meaningful improvement when assessing fatigue using FACIT-F in clinical trials was based on literature in RA that supports a change of ≥4-point improvement.

FACIT-F=Functional Assessment of Chronic Illness Therapy-Fatigue.

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

^†The same patients may not have responded at each time point.

^‡Although not developed for patients with RA, FACIT-Fatigue has been used to assess fatigue in rheumatology, and its properties have been evaluated for the RA population.

^§In rheumatology, a change of ≥4 points is considered meaningful and has been used as response definition in the RA population.

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

NEXT: View Safety Profile in RA: Placebo-Controlled Phase »

INFUSION EXPERIENCE

LEARN MORE

DOSING CALCULATOR

GET STARTED

ACCESS AND AFFORDABILITY