For US Healthcare Professionals
For US Healthcare Professionals
For US Healthcare Professionals
For US Healthcare Professionals
Safety Profile
IN ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
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.1
IN MODERATE TO SEVERE PLAQUE PSORIASIS
ADVERSE EVENTS IN THE 16-WEEK, PLACEBO-CONTROLLED PERIOD OF THE VOYAGE 1 AND VOYAGE 2 POOLED CLINICAL TRAILS1,2*
IN THE 16-WEEK, PLACEBO-CONTROLLED PERIOD OF THE VOYAGE 1 AND VOYAGE 2 POOLED CLINICAL TRIALS1:
IN MODERATE TO SEVERE PLAQUE PSORIASIS
ADVERSE REACTIONS OCCURRING IN ≥1% OF PATIENTS AND AT A HIGHER RATE THAN PLACEBO THROUGH WEEK 16 IN VOYAGE 1 AND VOYAGE 21*
IN MODERATE TO SEVERE PLAQUE PSORIASIS
ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, INFECTIONS, AND SERIOUS INFECTIONS PER 100 PATIENT-YEARS BY TREMFYA® EXPOSURE TIME PERIOD IN VOYAGE 1 AND VOYAGE 21*††‡‡
IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS
TREMFYA®: PROVEN SAFETY PROFILE IN PATIENTS WITH ACTIVE PsA2
†††1 year is defined as 60 weeks (through end of study) in DISCOVER 1 and 52 weeks in DISCOVER 2.
IN THE 24-WEEK, PLACEBO-CONTROLLED PERIOD OF THE COMBINED DISCOVER 1 AND DISCOVER 2 CLINICAL TRIALS:
DISCOVER 2: TREATMENT-EMERGENT ADVERSE EVENTS THROUGH END OF STUDY (112 WEEKS)2
Initially evaluate for tuberculosis (TB) and monitor patients for signs and symptoms of TB infection during and after treatment.1
NO ROUTINE LAB MONITORING REQUIRED DURING TREATMENT
TREMFYA® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients. Warnings and precautions include hypersensitivity, infections, TB, and immunizations.1
NO LABELED WARNINGS OR PRECAUTIONS FOR MALIGNANCY
NO LABELED WARNINGS OR PRECAUTIONS FOR INFLAMMATORY BOWEL DISEASE
Humira is a registered trademark of AbbVie Inc.
*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.
†US-licensed Humira®.
‡Includes nasopharyngitis, upper respiratory tract infection (URTI), pharyngitis, and viral URTI.
§Based on 1721 patients treated with TREMFYA® with 1662 patient-years of follow-up and a median patient-year of follow-up of 1.0 through Year 1.
||Includes injection-site erythema, bruising, hematoma, hemorrhage, swelling, edema, pruritus, pain, discoloration, induration, inflammation, and urticaria.
¶Includes 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.
††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.
§§Based on 1721 patients treated with TREMFYA® with 1662 patient-years of follow-up and a median patient-year of follow-up of 1.0 through Year 1.
||||Based on 1609 patients treated with TREMFYA® with 1570 patient-years of follow-up and a median patient-year of follow-up of 1.0 through Year 2.
¶¶Based on 1536 patients treated with TREMFYA® with 1497 patient-years of follow-up and a median patient-year of follow-up of 1.0 through Year 3.
##Based on 1470 patients treated with TREMFYA® with 1417 patient-years of follow-up and a median patient-year of follow-up of 1.0 through Year 4.
***Based on 1361 patients treated with TREMFYA® with 1020 patient-years of follow-up and a median patient-year of follow-up of 0.8 through Year 5.
References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.