IN ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
TREMFYA® SAFETY PROFILE
In clinical trials, 1823 patients with moderate to severe plaque psoriasis received TREMFYA®. Of these, 1393 were exposed to TREMFYA® for at least 6 months and 728 were exposed for at least 1 year.
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®
- Adverse reactions that occurred in <1% but >0.1% of the patients in the TREMFYA® group and at a higher rate than in the placebo group through Week 16 in VOYAGE 1 and VOYAGE 2 were migraine, candida infections, and urticaria
- Through Week 48, no new adverse reactions were identified with TREMFYA® use and the frequency of the adverse reactions was similar to the safety profile observed during the first 16 weeks of treatment1
*Data from 2 placebo- and active-controlled trials (VOYAGE 1 and VOYAGE 2) in 1441 patients (mean age 44 years; 70% males; 82% white) were pooled to evaluate the safety of TREMFYA® (100 mg administered subcutaneously at Weeks 0 and 4, followed by q8w). This safety information does not include data from NAVIGATE, ECLIPSE, ORION, DISCOVER 1 OR DISCOVER 2 studies.
†Includes nasopharyngitis, upper respiratory tract infection (URTI), pharyngitis, and viral URTI.
‡Includes headache and tension headache.
§Includes injection-site erythema, bruising, hematoma, hemorrhage, swelling, edema, pruritus, pain, discoloration, induration, inflammation, and urticaria.
kIncludes gastroenteritis and viral gastroenteritis.
¶Includes tinea pedis, tinea cruris, tinea infection, and tinea manuum infections.
#Includes oral herpes, herpes simplex, genital herpes, genital herpes simplex, and nasal herpes simplex.
IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)
SAFETY PROFILE IN ACTIVE PsA1
Safety profile in PsA across 2 clinical trials
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 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
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.