1. Safety Profile

PROVEN SAFETY PROFILE IN PSORIATIC DISEASE*

Proven safety across 4 pivotal clinical trials in moderate to severe plaque psoriasis and active PsA

SAFETY PROFILE IN MODERATE TO SEVERE PLAQUE PSORIASIS ACROSS 2 CLINICAL TRIALS1

In the 16-week, placebo-controlled period of the VOYAGE 1 and VOYAGE 2 pooled clinical trials:

  • In clinical trials, infections occurred in 23% of patients in the TREMFYA® group vs 21% of patients in the placebo group through 16 weeks of treatment. The rate of serious infections for the TREMFYA® group and the placebo group was <0.2%. A similar risk of infection was seen in the placebo-controlled trials in patients with psoriatic arthritis
  • The most common (>1%) infections were upper respiratory infections, gastroenteritis, tinea infections, and herpes simplex infections; all cases were mild to moderate in severity and did not lead to discontinuation of TREMFYA®

*Psoriatic disease is defined as moderate to severe plaque psoriasis and active PsA.

†US-licensed active comparator.

‡Safety summary includes all patients exposed to TREMFYA®.

§In the open-label extension, an event was included in Year 1 if it occurred within 52 weeks after the first TREMFYA® administration; in Year 2 if it occurred between 52 weeks and 104 weeks after the first TREMFYA® administration; in Year 3 if it occurred between 104 weeks and 156 weeks after the first TREMFYA® administration; in Year 4 if it occurred between 156 weeks and 208 weeks after the first TREMFYA® administration; in Year 5 if it occurred beyond 208 weeks after the first TREMFYA® administration.

Safety profile in active PsA across 2 clinical trials1

In the 24-week, placebo-controlled period of the combined DISCOVER 1 and DISCOVER 2 clinical trials:

  • The overall safety profile observed in patients with psoriatic arthritis treated with TREMFYA® is generally consistent with the safety 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 studies1:

    – 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 group 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

TREMFYA® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or any of its excipients. Warnings and precautions include infections, tuberculosis (TB), hypersensitivity, and immunizations.

No labeled warnings or precautions for malignancy or inflammatory bowel disease.1

Initially evaluate for TB and monitor patients for signs and symptoms of TB infection during and after treatment.

NO ROUTINE LAB MONITORING REQUIRED DURING TREATMENT.1

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