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- Full Prescribing Information
REQUEST INFORMATION
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
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.
INFUSION EXPERIENCE
SIMPONI ARIA® offers an efficient 30-minute infusion.
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®.