FACIT-F Data: Active PsA | TREMFYA® (guselkumab) HCP

IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)

TREMFYA® IS THE FIRST IL-23 INHIBITOR TO INCLUDE FACIT-F IN THE LABEL FOR ACTIVE PsA 1,2

Treatment With TREMFYA® Resulted in Improvement in Fatigue as Measured by FACIT-F

FACIT-F

DISCOVER 2: MEAN CHANGE FROM BASELINE IN FACIT-F SCORE AT WEEK 24 (NRI)*†‡

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IN DISCOVER 1 AT WEEK 24

  • The mean change from baseline in FACIT-F score was 5.76 for patients receiving TREMFYA® q8w (n=127) vs 2.15 for patients receiving placebo (n=126)1*†‡

The FACIT-F endpoints in DISCOVER 1 and DISCOVER 2 were not adjusted for multiplicity. Therefore, statistical significance has not been established.

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. Lower scores reflect more severe fatigue.2

FACIT-F=Functional Assessment of Chronic Illness Therapy-Fatigue; NRI=nonresponder imputation.

*Through Week 24, patients were considered to have no improvement (change=0) after meeting treatment failure criteria: discontinued study agent for any reason, terminated study participation for any reason, initiated or increased the dose of disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids over baseline for PsA, or initiated protocol-prohibited medications/therapies for PsA. After Week 24, treatment failure rules were not applied.

Change from baseline, if missing, was considered to have no improvement (change=0) after patients discontinued study treatment due to any reason.

Patients with data missing were considered nonresponders.

References: 1. Data on file. Janssen Biotech, Inc. 2. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.