Tremfya Prescribing Information (PI)

Question 1

The results from these 3 multicenter, randomized, double-blind trials led to FDA approval of Tremfya in plaque psoriasis.

Answer 1

VOYAGE 1, VOYAGE 2, NAVIGATE

Question 2

This study evaluated the efficacy, safety, and pharmacokinetics of TREMFYA with the One-Press patient-controlled injector.

Answer 2

ORION

Question 3

FDA approval of Tremfya for active psoriatic arthritis is based on the results from these two randomized, double-blind, placebo-controlled trials.

Answer 3

DISCOVER 1 & DISCOVER 2

Question 4

True or False: The dosage is the same for Tremfya in PsO and PsA.

Answer 4

True

Question 5

What is the on-label dosing for Tremfya in both PsA and PsO?

Answer 5

100 mg subcutaneous injection given at Week 0, Week, 4, and then every 8 weeks thereafter.

Question 6

Tremfya is administered IV or SubQ?

Answer 6

Subcutaneously

Question 7

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?

Answer 7

One-Press

Question 8

True or False: Tremfya is the first and only anti IL-23 with a patient-controlled, self-injection device.

Answer 8

True

Question 9

For which patients is Tremfya contraindicated?

Answer 9

Those that have a history of serious hypersensitivity reaction to guselkumab of any of the excipients.

Question 10

If a serious hypersensitivity reaction occurs in a patient taking Tremfya, initiate appropriate therapy only. True or False?

Answer 10

False, Tremfya should be discontinued and appropriate therapy initiated to treat the hypersensitivity reation.

Question 11

What was the total number of patients participating in VOYAGE 1 and VOYAGE 2 when thinking about pooled safety information?

Answer 11

1441 patients

Question 12

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?

Answer 12

49% (330 events per 100 patient-years of follow-up)

Question 13

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?

Answer 13

1.9% (6.3 events per 100 patient-years of follow-up)

Question 14

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?

Answer 14

Migraine, candida infections, and urticaria

Question 15

Infections occurred in __ of patients in the TREMFYA group compared to __ of patients in the placebo group.

Answer 15

23%, 21%

Question 16

What were the most common infections (greater than or equal to 1%) with TREMFYA?

Answer 16

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.

Question 17

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.

Answer 17

2.6%, 1.9%, 1

Question 18

The safety profile in patients with PsA who were treated with TREMFYA is similar to those patients with plaque psoriasis, with the addition of?

Answer 18

Bronchitis and neutrophil count decreased.

Question 19

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.

Answer 19

1.6%, 2.9%, 1.1%

Question 20

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.

Answer 20

0.3%, 1.6%, 0%

Question 21

Guselkumab is a ______ monoclonal Ig___ antibody

Answer 21

human; IgG1lambda

Question 22

What is the mean half-life of guselkumab in patients with plaque psoriasis?

Answer 22

15 to 18 days

Question 23

VOYAGE 1 and VOYAGE 2 are referred to as what in the PI?

Answer 23

PsO1 & PsO2

Question 24

NAVIGATE is referred to as what in the PI?

Answer 24

PsO3

Question 25

ORION trial is referred to as what in the PI?

Answer 25

PsO4

Question 26

DISCOVER 1 & DISCOVER 2 are also referred to as what in the PI?

Answer 26

PsA1 & PsA2

Question 27

What was the major difference in the patient population between DISCOVER 1 & 2?

Answer 27

DISCOVER 2 included only (all) patients that were considered to be biologic naive (bio-naive)

Question 28

Primary endpoint of the DISCOVER trials?

Answer 28

ACR20

Question 29

Which infections occurred more frequently with Tremfya when compared to placebo?

Answer 29

Upper respiratory tract infections, gastroenteritis, tinea infections, and herpes simplex infections