Clinical Trial Information - Tremfya - PsA

Question 1

Both DISCOVER 1 & 2 included a ___ -week screening period.

Answer 1

six

Question 2

In the DISCOVER trials, what was the dosing schedule for the placebo group patients starting at Week 0 (beginning of double-blind period)?

Answer 2

Placebo injections were given initially at Week 0 and then every 4 weeks

Question 3

There was a third group in the DISCOVER trials, what did this group receive as their intervention (medication) - this group generally not shown in images in slides because this dosing not FDA approved?

Answer 3

Tremfya 100 mg every 4 weeks

Question 4

The blinded placebo-controlled period for the DISCOVER trials was what?

Answer 4

Weeks 0-24

Question 5

At week __ in both DISCOVER trials, patients taking placebo crossed over to receive Tremfya 100 mg at Week __, __, then every __ weeks thereafter.

Answer 5

0, 4, 4

Question 6

In DISCOVER 1, the (open-label) active treatment phase was from Week __ to Week __

Answer 6

24; 52

Question 7

In DISCOVER 2, the (open-label) active treatment phase was from Week __ to Week __

Answer 7

24; 100

Question 8

In the DISCOVER trials, at Week __, subjects in all treatment groups who had less than __ percent improvement from baseline in both swollen and tender joint counts were considered as meeting early escape criteria.

Answer 8

16, five

Question 9

True or False? Those patients who met early escape criteria were allowed to initiate or increase the dose of one of the permitted concomitant medications (non-biologic DMARD, corticosteroids, and NSAIDs) up to the maximum dose allowed.

Answer 9

True

Question 10

In DISCOVER 1 & 2 patients had to have active PsA for at least 6 months; however, the swollen/tender joint counts and CRP levels were slightly different. What were they for each trial?

Answer 10

In Discover 1, patients had 3 or more swollen/tender joints and a CRP level of at least 0.3 mg/dL

In Discover 2, patients had 5 or more swollen/tender joints and a CRP level of at least 0.6 mg/dL

Question 11

True or False, DISCOVER 1 patients were all bio-naive?

Answer 11

False, this is true of the inclusion criteria for DISCOVER 2

Question 12

In DISCOVER 1, included patients could have biologic experience with ______ anti-TNFs

Answer 12

Less than or equal to 2

Question 13

The primary endpoint in DISCOVER 1 and DISCOVER 2 was?

Answer 13

ACR20 response at Week 24

Question 14

In DISCOVER 2, speaking to the primary endpoint (ACR20 @ 24 weeks), ___% of patients achieved an ACR20 response in the Tremfya group vs. __% of patients achieved an ACR20 response in the placebo group

Answer 14

64% vs. 33%

Question 15

In DISCOVER 1, speaking to the primary endpoint (ACR20 @ 24 weeks), ___% of patients achieved an ACR20 response in the Tremfya group vs. __% of patients achieved an ACR20 response in the placebo group

Answer 15

52% vs. 22%

Question 16

What percentage of patients who received Tremfya every 8 weeks reported adverse events through 1 year combined across DISCOVER 1 and DISCOVER 2?

Answer 16

64.5%

Question 17

In the 24-week placebo-controlled period, combined across DISCOVER 1 and DISCOVER 2, bronchitis occurred in ___ of patients in the Tremfya every 8 weeks group and ___ of patients in the placebo group.

Answer 17

1.6%; 1.1%

Question 18

In the 24-week placebo-controlled period, combined across DISCOVER 1 and DISCOVER 2, neutrophil count decrease occurred in ___ of patients in the Tremfya every 8 weeks group and ___ of patients in the placebo group.

Answer 18

0.3%; 0%

Question 19

In DISCOVER 1, what percent of patients had previously received 1 or 2 TNF inhibitors?

Answer 19

31%

Question 20

In Discover 2 what were the baseline differences between groups seen in?

Answer 20

% of men, PASI severity, presence of dactylitis and enthesitis