IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)
DEMONSTRATED SAFETY PROFILE1
Safety profile in PsA across 2 clinical trials
*1 year defined as 60 weeks (through end of study) in DISCOVER 1 and 52 weeks in DISCOVER 2.
The overall safety profile observed in patients with psoriatic arthritis treated with TREMFYA® is generally consistent with the profile in patients with plaque psoriasis with the addition of bronchitis and neutrophil count decreased. In the 24-week, placebo-controlled period, combined across the 2 studies2:
– Bronchitis occurred in 1.6% of patients in the TREMFYA® q8w group and 1.1% of patients in the placebo group
– Neutrophil count decreased occurred in 0.3% of patients in the TREMFYA® q8w compared to 0% of patients in the placebo group. The majority of events of neutrophil count decreased were mild, transient, not associated with infection and did not lead to discontinuation
Initially evaluate for TB and monitor patients for signs and symptoms of TB infection during and after treatment.
NO ROUTINE LAB MONITORING REQUIRED DURING TREATMENT2.
References: 1. Data on file. Janssen Biotech, Inc. 2. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.