TREMFYA® (guselkumab) HCP

Safety profile in moderate to severe plaque psoriasis across
2 clinical trials^1,2

Adverse events in the 16-week, placebo-controlled period of the VOYAGE 1 and VOYAGE 2 pooled clinical trials^1,2

PsO VOYAGE 1 and VOYAGE 2 adverse events in 16 weeks table

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

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^®

Pooled safety data from VOYAGE 1 and VOYAGE 2 through 5 years (Week 264)²*

VOYAGE 1 and VOYAGE 2 adverse events data table

*Safety summary includes all patients exposed to TREMFYA^®.

Humira is a registered trademark of Abbvie Biotechnology Ltd. Corporation.

PYs=patient-years.

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

Safety profile in active PsA across 2 clinical trials^1,2

Combined safety across DISCOVER 1 and DISCOVER 2 at Week 24 and Year 1

Treatment-emergent adverse events reported in the placebo-controlled phase through Week 24: Combined across DISCOVER 1 and DISCOVER 2

PsA DISCOVER 1 and DISCOVER 2 adverse events table

Treatment-emergent adverse events through 1 year: Combined across DISCOVER 1 and DISCOVER 2*

DISCOVER 1 and DISCOVER 2 adverse events statistics

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

DISCOVER 2: Safety profile through Week 112

Treatment-emergent adverse events through end of study (112 weeks)²

PsA DISCOVER 2 adverse events chart through Week 112

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

Extensive clinical and patient experience

Extensive patient experience

years of
clinical studies*

ongoing and completed
clinical studies^†

~251K

patient-years
of experience^1‡

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

Most common (≥1%) adverse reactions associated with TREMFYA^® include upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

Established safety profile based on extensive patient experience

No labeled warnings or precautions for malignancy or inflammatory bowel disease, or MACE.²

No routine lab monitoring required during treatment across all approved indications.^2§

MACE=major adverse cardiovascular events (cardiovascular deaths, nonfatal myocardial infarctions, and nonfatal cerebrovascular events).

*Based on a phase 1 clinical trial that was initiated in June 2009.

^†Represents completed and ongoing PsO and PsA clinical studies.

^‡Based on worldwide estimated cumulative number of patient-years from launch in July 2017 through June 30, 2022. Patient exposure was estimated by calculation from distribution data.

^§As of August 2022.

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

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