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IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)
Treatment With TREMFYA® Resulted in Improvement in Fatigue as Measured by FACIT-F
DISCOVER 2: MEAN CHANGE FROM BASELINE IN FACIT-F SCORE AT WEEK 24 (NRI)*†‡
IN DISCOVER 1 AT WEEK 24
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.