TREMFYA® (guselkumab) HCP

TREMFYA^® proven safety profile through 2 years*

Adverse events reported in the placebo-controlled phase through
Week 24 combined across DISCOVER 1 and DISCOVER 2¹

TREMFYA® (guselkumab) adverse events in DISCOVER 1 and DISCOVER 2study

PsA DISCOVER 1 and DISCOVER 2 adverse events table

In the 24-week, placebo-controlled period of the combined DISCOVER 1 and DISCOVER 2 clinical trials¹:

The overall safety profile observed in patients with PsA treated with TREMFYA^® is generally consistent with the profile in patients with plaque PsO, with the addition of bronchitis (occurred in 1.6% and 1.1% of patients in the TREMFYA^® q8w group and placebo group, respectively) and neutrophil count decreased (occurred in 0.3% and 0% of patients in the TREMFYA^® q8w group and placebo group, respectively)¹:

The majority of events of neutrophil count decreased were mild, transient, not associated with infection, and did not lead to discontinuation

Adverse events reported through 1 year combined across
DISCOVER 1 and DISCOVER 2^1†

TREMFYA® (guselkumab) adverse events in DISCOVER 1 and DISCOVER 2 study through Week 24

Adverse events reported through end of study (Week 112)
in DISCOVER 2 only^1,2

TREMFYA® (guselkumab) adverse events in DISCOVER 1 and DISCOVER 2 study through 1 year

PYs=patient-years.
*Through Week 112 in DISCOVER 2.

^†1 year is defined as 60 weeks (through end of study) in DISCOVER 1 and 52 weeks in DISCOVER 2.

References: 1. Data on file. Janssen Biotech, Inc. 2. McInnes IB, Rahman P, Gottlieb AB, et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through two years: results from a phase III, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Arthritis Rheumatol. 2022;74(3):475-485.

TREMFYA^® has an established safety profile through 5 years^1,2

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

TREMFYA® (guselkumab) adverse events in 16-week placebo VOYAGE 1 and VOYAGE 2 study

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

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*

TREMFYA® (guselkumab) adverse events in VOYAGE 1 and VOYAGE 2 study through 5 years

VOYAGE 1 and VOYAGE 2 adverse events data table

PYs=patient-years.

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

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

More than 230K patients treated with TREMFYA^®, and TREMFYA^® has been clinically studied for 15+ years¹*^†

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

No labeled warnings or precautions for malignancy, exacerbation of inflammatory bowel disease, candidiasis,^‡ or MACE.²

No routine lab monitoring required during treatment for psoriatic disease.^2§ǁ

^‡Candida infections as adverse reactions occurred in <1% but >0.1% of subjects in the TREMFYA^® group and at a higher rate than in the placebo group through Week 16 in VOYAGE 1 and VOYAGE 2.

MACE=major adverse cardiovascular event (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke).

*Based on phase 1 clinical trial of TREMFYA^® initiated in 2009.

^†More than 230,000 patients treated with TREMFYA^® in the United States from July 2017 to April 2024. Estimations are based on calculations using product-utilization data collected in the United States for TREMFYA^® to determine patient type, average dose per administration, total number of administrations, and patient persistency rates.

^§Psoriatic disease is defined as active PsA and moderate to severe plaque PsO.

^ǁAs of March 2025.

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