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IN ADULTS WITH MODERATE TO SEVERE PLAQUE PsO
Established safety profile through 5 years
Adverse events in the 16-week, placebo-controlled period of the VOYAGE 1 and VOYAGE 2 pooled clinical trials1,2
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)1,2*
PYs=patient-years.
*Safety summary includes all patients exposed to TREMFYA®.
Humira® is a registered trademark of Abbvie Biotechnology Ltd. Corporation.
References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.
IN ADULTS WITH ACTIVE PsA
Established safety profile through 2 years*
Combined safety across DISCOVER 1 and DISCOVER 2 through Week 24 and Year 11†
Adverse events reported in the placebo-controlled phase through Week 24 combined across DISCOVER 1 and DISCOVER 2
Adverse events reported through Year 1† combined across DISCOVER 1 and DISCOVER 2
Adverse events reported through Year 1† combined across DISCOVER 1 and DISCOVER 2
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 active 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)2:
- —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 end of study (112 weeks) in DISCOVER 21 only1
*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. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
IN MODERATE TO SEVERE PLAQUE PSORIASIS (PsO)
VISIBLE safety data were consistent with pivotal trials1,2
VISIBLE trial: Adverse events in the 16-week, placebo-controlled period (pooled data from Cohorts A and B)1*
No new safety signals were reported in VISIBLE through Week 48
PYs=patient-years.
*Study is blinded and currently ongoing.
†Patients received 100 mg TREMFYA® at Week 0, Week 4, and every 8 weeks thereafter.
References: 1. Data on file. Janssen Biotech, Inc. 2. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
IN ADULTS WITH MODERATE PLAQUE PSORIASIS
TREMFYA® safety profile
SPECTREM adverse events in the 16-week period1,2
No new safety concerns identified through Week 161†
PYs=patient-years.
*One event each of upper limb fracture, renal colic, and cerebrovascular accident.
†Study is blinded and currently ongoing.
References: 1. Data on file. Janssen Biotech, Inc. 2. Stein Gold L, Strober B, Armstrong AW, et al. SPECTREM: Guselkumab demonstrates consistent significant clearance at week 16 across the full range of low body surface area, moderate psoriasis with special site involvement. Poster presented at: 2024 Fall Clinical Dermatology Conference; October 24-27; Las Vegas, NV.
IN MODERATE TO SEVERE PLAQUE PsO AND ACTIVE PsA
Additional safety considerations
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, inflammatory bowel disease, or MACE1
No routine lab monitoring required during treatment of psoriatic disease1*†
Established safety profile
based on extensive patient experience
*As of March 2025.
†Psoriatic disease defined as moderate to severe plaque PsO or active psoriatic arthritis.
MACE=major adverse cardiovascular event (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke).
Reference: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
IN ADULTS WITH MODERATE TO SEVERE PLAQUE PsO
