WorksheetsGastro Jan
Total questions: 35
Worksheet time: 23mins
UC is characterized by rectal sparing
Yes
NO, both CD & UC
No, CD only
Anal involvement is characteristic for CD
Yes
No, UC only
No, Both Cd & UC
STARDUST week 16 primary EP was
CDAI 70
CDAI 100
Clinical response
Clinical remission
STARDUST data was better than UST registrational trials
Yes
No, lower
No, The same
UST was approved in UC in
2018
2019
2017
2016
STARDUST population included bio failure
Yes, any biofailure
No, all bio naïve
Yes, but only 1 previous biologic
Primary EP in UNITI induction was
clinical remission, week 8
clinical response, week 8
Clinical remission, W16
clinical response, week 16
…..% of primary non responders were late responders to Ustekinumab
20
30
40
50
60
Ustekinumab infusion IV concentration is …….mg in ………ml, while SC is ……mg (Select all that apply)
130mg in 20ml, 90
130mg in 26ml, 90
5mg in 5ml, 90
5mg in ml, 90
Mayo score of 11 may be (Select all)
Moderate Proctitis
Sever Proctitis
Sever pancolitis
Moderate pancolitis
UNIFI program is
1 induction, 1 maintenance
2 induction, 1 maintenance
2 induction, 2 maintenance
1 induction, 2 maintenance
UST q12w versus q8w in UC naïve patients in UNIFI maintenance was
better response
lower response
same response
sig, better response
UST can be given concomitantly with dead vaccines
Yes
No, contraindicated
No. live vaccines only
What happened to the patients who were randomised to either placebo or ustekinumab q12w and who experienced loss of response between Weeks 8 and 32 in IM-UNITI?
They underwent dose adjustment to ustekinumab q8w
They underwent dose adjustment to ustekinumab q12w
They were removed from the maintenance study
They continued with treatment to which they were randomised
What were the major secondary endpoints at Week 44 in the IM-UNITI study?
Clinical response, maintenance of remission, glucocorticoid-free remission, and remission in patients with non-response or unacceptable side effects with an anti-TNF
CDAI ≤150, glucocorticoid-free remission and clinical response
≥200-point CDAI decrease from induction or clinical remission, CDAI ≤100, maintenance of remission and glucocorticoid-free remission
Clinical response and CDAI ≤150
You have been approached by a gastroenterologist who has heard of the UNITI-1 and UNITI-2 studies. He is interested in the potential of ustekinumab as a maintenance therapy. What key information from IM-UNITI would you share to give a balanced view of the study?
(Select all that apply)
Ustekinumab offers maintenance therapy potential, as significantly more patients were in remission or had demonstrated a clinical response with either dose over 44 weeks compared with placebo
The most common AEs with ustekinumab were infection, arthralgia, headache, and a Crohn’s disease event
The AE rate seen with ustekinumab was higher than with placebo over 44 weeks, with no apparent relationship between ustekinumab dose and safety
In the UNITI-1 induction study, patients were required to have an inadequate response/intolerance to ≥1 anti-TNF. What was required of patients in the UNITI-2 induction study?
Treatment failure to ≥2 immunosuppressants
Treatment intolerance to anti-TNFs and glucocorticoids
Inadequate response/intolerance to ≥2 anti-TNF therapies
Treatment failure or intolerance to immunosuppressants or glucocorticoids
What were the key features of both the UNITI-1 and UNITI-2 induction studies? (Select all that apply)
Patients were treated with ustekinumab ~6 mg/kg or 130 mg, versus placebo over an 8-week period
Patients were treated with ustekinumab ~6 mg/kg or 130 mg, versus adalimumab over a 12-week period
Patients treated with ustekinumab ~6 mg/kg were in bodyweight tiers of ≤55 kg, >55 and ≤85 kg, and >85 kg
They included patients with Crohn’s disease and a CDAI between 220 and 450
For which endpoints (primary and secondary) were ustekinumab 130 mg and ~6 mg/kg superior to placebo in UNITI-2?
(Select all that apply)
Clinical response at Week 6
Clinical remission at Week 8
Clinical response at Week 8
Clinical remission at Week 6
CDAI-70 response at Weeks 3 and 6
How did AE and SAE rates compare between UNITI-1 and UNITI-2?
(Select all that apply)
Similar 1-hour infusion AEs between ustekinumab and placebo in UNITI-1 only
Unfavourable difference in AE and SAE rates with ustekinumab versus placebo in both studies
Similar AE and SAE rates between all treatment groups in both studies
Similar 1-hour ustekinumab infusion AEs in both studies
Which of these was NOT used to evaluate the effect of HRQoL in the UNITI studies?
IBDQ
SF-36 MCS
SC-36 PCS
HADS
According to the Sandborn et al. Aliment Pharmacol Ther 2018 interim report from the IM-UNITI extension study, what proportion of patients were in remission at Week 92?
Approximately half
Nearly two-thirds
Nearly three-quarters
You are preparing a comparison of ustekinumab i.v. induction dosing for Crohn's disease at ~6 mg/kg versus 130 mg. What differences would you list as expected in a patient receiving ~6 mg/kg versus a fixed dose of 130 mg, based on the Adedokun et al. Gastroenterology 2018 combined analysis of UNITI-1 and -2?
(Select all that apply)
Higher serum ustekinumab levels
Better clinical outcomes
A higher rate of AEs
A higher rate of SAEs
Effects would depend on prior anti-TNF experience
Who can administer ustekinumab induction therapy?
Select any that apply
Healthcare professional only
Healthcare professional or patient self-administration
Patient self-administration
Family members or healthcare professional
Which sites can ustekinumab be injected into? (Select all that apply)
Upper thigh
Lower abdomen
Within 5 cm of the navel
Upper arm
What is the ustekinumab maintenance dose for a patient with CD weighing 100 kg?
260 mg i.v.
90 mg s.c.
290 mg s.c.
520 mg s.c.
Ustekinumab prevents downstream signaling mediated by
IL-6
IL-12 and IL-23
TNF
IL-32
UST can be given to IBD patient with NYHA type 3
Yes
No, Type 1 and 2 only
No, contraindicated for all types
…..% were in clinical response in randomized population at the start of IMUNITI while ….% were in clinical remission
60,100
100, 60
50,50
100,100
Dose optimization was allowed in UNIFI maintenance
yes, q12w to q8w only
yes, q8w to q4w only
Yes, q12w to q8w & q8w to q4w
was not allowed
Clinical remission in the sub population failing VDZ and TNFi was non significant in UNIFI maintenance
True
False
.......% of patients in clinical remission in UNIFI maintenance was Steroid free
50
70
80
97
.....% of patients that have more than 25% improvement in SES-CD score
58
48
33
11
STARDUST used...............as a decision for the maintenance dose
CDAI 70
Clinical response
Clinical remission
SES-CD change
....% of ADA at end of IM-UNITI while it was........% at end of UNIFI maintenance
5.7 & 2.3
2.3 & 5.7
4 & 5
4.6 & 5.7
