Tremfya Prescribing Information (PI) Flashcards
The results from these 3 multicenter, randomized, double-blind trials led to FDA approval of Tremfya in plaque psoriasis.
VOYAGE 1, VOYAGE 2, NAVIGATE
This study evaluated the efficacy, safety, and pharmacokinetics of TREMFYA with the One-Press patient-controlled injector.
ORION
FDA approval of Tremfya for active psoriatic arthritis is based on the results from these two randomized, double-blind, placebo-controlled trials.
DISCOVER 1 & DISCOVER 2
True or False: The dosage is the same for Tremfya in PsO and PsA.
True
What is the on-label dosing for Tremfya in both PsA and PsO?
100 mg subcutaneous injection given at Week 0, Week, 4, and then every 8 weeks thereafter.
Tremfya is administered IV or SubQ?
Subcutaneously
In addition to being available for injection as a single-dose, prefilled syringe, Tremfya is also available as a single-dose, patient-controlled injector called what?
One-Press
True or False: Tremfya is the first and only anti IL-23 with a patient-controlled, self-injection device.
True
For which patients is Tremfya contraindicated?
Those that have a history of serious hypersensitivity reaction to guselkumab of any of the excipients.
If a serious hypersensitivity reaction occurs in a patient taking Tremfya, initiate appropriate therapy only. True or False?
False, Tremfya should be discontinued and appropriate therapy initiated to treat the hypersensitivity reation.
What was the total number of patients participating in VOYAGE 1 and VOYAGE 2 when thinking about pooled safety information?
1441 patients
What was the adverse event rate for Tremfya patients in the 16-week, placebo-controlled period of VOYAGE 1 and VOYAGE 2 pooled clinical trials?
49% (330 events per 100 patient-years of follow-up)
What was the serious adverse event rate for Tremfya patients in the 16-week, placebo-controlled period of VOYAGE 1 and VOYAGE 2 pooled clinical trials?
1.9% (6.3 events per 100 patient-years of follow-up)
What adverse reactions occurred in less than 1% of the patients in the TREMFYA group and a higher rate than in the placebo group through week 16 in VOYAGE 1 and VOYAGE 2?
Migraine, candida infections, and urticaria
Infections occurred in __ of patients in the TREMFYA group compared to __ of patients in the placebo group.
23%, 21%
What were the most common infections (greater than or equal to 1%) with TREMFYA?
Upper respiratory tract infections, gastroenteritis, tinea infections, and herpes simplex infections. All cases were mild to moderate in severity and did not lead to discontinuation of TREMFYA.
Elevated liver enzymes were reported more frequently in the TREMFYA group (__%) than in the placebo group (__%). All cases except __ were mild to moderate in severity and did not result in discontinuation of TREMFYA.
2.6%, 1.9%, 1
The safety profile in patients with PsA who were treated with TREMFYA is similar to those patients with plaque psoriasis, with the addition of?
Bronchitis and neutrophil count decreased.
In the 24-week placebo-controlled period, combined across the two PsA studies, bronchitis occurred in __% of patients in the TREMFYA q8w group and __% of patients in the TREMFYA q4w group compared to __% of patients in the placebo group.
1.6%, 2.9%, 1.1%
Neutrophil count decreased occurred in __% of (PsA) patients in the Tremfya q8w and __% of patients in the Tremfya q4w group compared to __% of patients in the placebo group.
0.3%, 1.6%, 0%
Guselkumab is a ______ monoclonal Ig___ antibody
human; IgG1lambda
What is the mean half-life of guselkumab in patients with plaque psoriasis?
15 to 18 days
VOYAGE 1 and VOYAGE 2 are referred to as what in the PI?
PsO1 & PsO2
NAVIGATE is referred to as what in the PI?
PsO3
ORION trial is referred to as what in the PI?
PsO4
DISCOVER 1 & DISCOVER 2 are also referred to as what in the PI?
PsA1 & PsA2
What was the major difference in the patient population between DISCOVER 1 & 2?
DISCOVER 2 included only (all) patients that were considered to be biologic naive (bio-naive)
Primary endpoint of the DISCOVER trials?
ACR20
Which infections occurred more frequently with Tremfya when compared to placebo?
Upper respiratory tract infections, gastroenteritis, tinea infections, and herpes simplex infections
