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WorksheetsRISA knowledge test
Total questions: 73
Worksheet time: 36mins
What are cytokines?
Molecules that act as chemoattractants and that draw monocytes and neutrophils into infected tissue
Proteins that are released by immune system cells and that act as intercellular mediators in an immune response
Monocytes that protect internal surfaces of body against pathogens
Molecules that recognize and kill abnormal cells such as tumors or infected cells
Which of the following statements is TRUE about autoimmunity?
Immune-mediated inflammatory diseases share some common inflammatory pathways as part of their pathogenesis
All immune disorders are considered autoimmune diseases
Autoimmunity is nonspecific and not stimulated by specific antigens
Autoimmunity is the immune system host reacting against nonself antigens
Which of the following is FALSE about the IL-23 cytokine?
It binds its cellular receptor that triggers a signaling pathway to release pro-inflammatory cytokines
It is composed of 2 subunits, p19 and p40
It is released by dendritic cells
It is activated by the JAK-STAT signaling pathway
Which of the following is TRUE about immune systems?
The innate and adaptive immune systems do not interact with each other
The adaptive immune system has a memory component to improve response
The innate immune system responds to specific antigens
All of the above
Which of the following describes a step in phagocytosis?
Plasma membrane surrounds the microbe, forming an extension around it to internalize the microbe
Monocytes migrate into tissues to become macrophages
Antibodies bind to bacterial toxins, neutralizing the toxins
Mast cells trigger of the cAMP and PDE4 signaling pathway
Which of these cells are categorized as lymphocytes?
Eosinophils, basophils, and neutrophils
Macrophages, dendritic cells, and mast cells
T cells, NK cells, and B cells
Dendritic cells, NK cells, and B cells
Which of the following statements is TRUE in regard to chronic inflammation?
Chronic inflammation dissipates once a foreign substance is removed from the tissue
Chronic inflammation involves only the skin
Chronic inflammation is a protective and self-limiting process
Chronic inflammation develops when an inflammatory agent persists in the injured tissue
Which of the following characterizes T cells?
Generate in the thymus
Remain dormant in lymphoid tissue until activated by antigens
Do not undergo clonal deletion
Produce antibodies when activated
Which of the following is TRUE about IL-17?
Produces local and systemic responses to infection through endothelial cells
Is secreted exclusively by TH17 cells
Both IL-17A and IL-17F bind to IL-17 receptors
Is composed of 2 subunits, p19 and p35
TNF-alpha induces which of the following
Increased migration of leukocytes, fluid, and protein
Increased vascular permeability
Increased blood flow
All of the above
What are the risk factors for psoriasis?
Family history of the disease, skin trauma, infection
Emotional stress, hormonal changes, exposure to sunlight
Smoking, certain medications, AIDS
All of the above
True or False: Patients with psoriasis plus comorbidities (associated diseases) have higher mortality rates than those without comorbidities.
True
False
What percentage of body surface area (BSA) must be affected to qualify as severe psoriasis?
<3%
3% to 10%
>10%
30%
What are the two key mechanisms involved in the pathogenesis of psoriasis?
Hyperproliferation of keratinocytes and inflammatory immune response
Innate immunity and adaptive immunity
Hypoproliferation of keratinocytes and inactive immune response
The JAK pathway and cAMP PDE4 pathway
Which of the following are effector cytokines rather than regulatory cytokines?
IL-23 and IL-17
TNF-alpha and IL-17
IL-12 and IL-23
PDE-4 and IL-6
Which of these are NOT types of psoriasis?
Dermatitis, eczema
Inverse, pustular
Erythrodermic, guttate
None of the above
Which of these is NOT considered an associated comorbidity of psoriasis?
Cardiovascular disease
Diabetes
Weight loss
Depression
Nail changes occur in approximately what percentage of people with psoriasis?
12%
30%
50%
75%
Which of the following is true about psoriatic arthritis?
The first signs of psoriatic arthritis typically occur at the same time as symptoms of psoriasis
Approximately 30% of patients with psoriasis develop psoriatic arthritis
Psoriatic arthritis often occurs in patients who are between 18 and 25 years old
Nail changes are not a common symptom of psoriatic arthritis
True or False: Severity of psoriatic arthritis in patients does NOT correlate with the severity of psoriasis.
True
False
Which of the following are clinical presentations of plaque psoriasis? [select all that apply]
Intense burning, itching, and pain
Plaques that crack and bleed
Plaques of varying sizes, from pinpoints to large plaques
Symmetrical distribution
Which of the following is TRUE about psoriasis epidemiology?
It is less common in women than in men
It is more common in eastern Asian populations
Its prevalence in different countries varies between 0.09% and 11.4%
The average age of onset for psoriasis is 15 years
What percentage of patients with psoriasis has at least 1 comorbidity?
35%
40%
45%
50%
Which of the following identifies the correct order of the 3 layers of the skin from outermost to innermost layers?
Dermis, basal layer, epidermis
Epidermis, dermis, hypodermis
Basal layer, granular layer, horny layer
Hypodermis, epidermis, dermis
Select the response that correctly fills in the blanks in this statement: In normal skin, it takes _____ for new keratinocytes to reach the surface layer of the skin, whereas in skin with psoriasis, it takes ____.
3 to 5 days; 3 to 5 hours
10 to 15 days; 5 to 7 days
30 to 60 days; 3 to 5 days
30 to 60 days; 15 to 20 days
Select the response that correctly fills in the blanks in this statement: In patients with psoriasis, keratinocyte proliferation in the basal layer ____ dramatically. When proliferation is ______ the shedding of cells from the surface, keratinocytes accumulate and form scaly plaque on the surface of the skin.
Increases; lower than
Increases; faster than
Decreases; faster than
Decreases; slower than
Risankizumab selectively binds with high affinity
to the ___ subunit of human ___ cytokine and inhibits its
interaction with the ___ receptor complex.
p40; IL-12; IL-12/23
p19; IL-23; IL-23
p40; IL-12; IL-12
p19; IL-12/23; IL-23
The proposed indication of risankizumab is for
the treatment of ________________________ in adults who are
candidates for ______________________.
Mild to severe plaque psoriasis; systemic therapy
Moderate to severe plaque psoriasis; systemic therapy
Severe plaque psoriasis; phototherapy
Moderate pustular psoriasis; biologic therapy
The recommended dose of risankizumab is ___ administered by
___ subcutaneous injection(s) at ___, ___, and every ___ thereafter
100 mg; 1; Week 0; Week 8; 16 weeks
100 mg; 2; Week 2; Week 4; 8 weeks
150 mg; 2; Week 0; Week 4; 12 weeks
150 mg; 1; Week 4; Week 8; 16 wee
What was the most frequently reported adverse reaction in
risankizumab clinical studies?
Injection-site reactions
Headaches
Nausea
Upper respiratory infections
The efficacy and safety of risankizumab was
assessed in ___ subjects included in ____ multicentre,
randomized, double-blind studies.
450; 3
1003; 4
2109; 4
4240; 5
Across all risankizumab studies, ___ of patients
had received prior biologic therapy for the treatment of
psoriasis.
7.6%
21.6%
42.1%
78.1%
In pooled data from risankizumab clinical trials, serious adverse events occurred in ___ of patients for the risankizumab group compared to 4.0% and 5.0% for the placebo and ustekinumab groups, respectively.
1.1%
2.4%
12.6%
19.1%
Which 52-week risankizumab Phase 3 clinical trial(s) was/were designed to assess the efficacy and safety of risankizumab compared with placebo and ustekinumab in patients with moderate to severe plaque psoriasis?
UltIMMa-1 and UltIMMa-2
IMMvent
IMMhance
IMMskin
Which 104-week risankizumab Phase 3 clinical trial(s) was/were designed to assess the efficacy and safety of risankizumab compared with placebo in patients with moderate to severe plaque psoriasis, as well as randomized withdrawal and retreatment?
UltIMMa-1 and UltIMMa-2
IMMvent
IMMhance
IMMskin
Which 44-week risankizumab Phase 3 clinical trial(s) was/were designed to assess the efficacy and safety of risankizumab compared with adalimumab in patients with moderate to severe plaque psoriasis?
UltIMMa-1 and UltIMMa-2
IMMvent
IMMhance
IMMskin
TRUE or FALSE: Risankizumab is contraindicated only in patients with hypersensitivity to its active substance or to any of its excipients, or in patients with clinically important active infections (eg, tuberculosis).
True
False
In an integrated analysis of patients receiving
risankizumab in UltIMMa-1 and UltIMMa-2, for PASI 90 responders at Week 16, ___ of patients who continued on risankizumab maintained the response at Week 52.
46.2%
88.4%
60.1%
26.9%
No dose adjustment of risankizumab is required among patients who are elderly (aged 65 years and over), or who have renal or hepatic impairment
True
False
Examination of age, gender, race, body weight,
baseline PASI score, concurrent psoriatic arthritis, previous nonbiologic systemic treatment, previous biologic treatment, and previous failure of a biologic did not identify differences in response to risankizumab among these subgroups.
True
False
Which of the following is NOT among key inclusion criteria for UltIMMa-1 and UltIMMa-2?
Adult patients (>=18 years)
Chronic plaque psoriasis for >=6 months
Non-plaque psoriasis (incl. guttate, erythrodermic, or
pustular) for >=6 months
Candidate for treatment with ustekinumab
In UltIMMa-1, what percent of the risankizumab and placebo groups achieved PASI 90 at Week 16?
26.5% vs. 8.7%
45.9% vs. 9.1%
75.3% vs. 4.9%
94.6% vs. 10.9%
In UltIMMa-1, what percent of the risankizumab and placebo groups achieved sPGA 0/1 at Week 16?
33.3% vs. 5.8%
73.6% vs. 9.0%
68.4% vs. 4.8%
87.8% vs. 7.8%
Which of the following ranked secondary endpoints of UltIMMa-1were significantly improved with risankizumab compared to ustekinumab at Week 52?
sPGA 0, PASI 90, and PASI 100, but not DLQI 0/1
DLQI 0/1 and PASI 90, but not sPGA 0 and PASI 100
PASI 90 only
sPGA 0, PASI 90, PASI 100, and DLQI 0/1
In UltIMMa-1, ___ of the risankizumab group and ___ of the ustekinumab group achieved PASI 100 at Week 52.
42.0%; 54.6%
56.3%; 21.0%
35.9%; 12.0%
76.5%; 75.9%
Which of the following statements about UltIMMa-1 is TRUE?
Risankizumab was consistently superior to placebo
Risankizumab was consistently superior to ustekinumab
There were no unexpected safety findings
All the statements are true
In UltIMMa-1 and UltIMMa-2, patients were stratified at randomization by what 2 baseline characteristics?
Age and sPG
Weight and prior TNF inhibitor exposure
Sex and PASI
BMI and prior biologic therapy exposure
In UltIMMa-2, ___ of the risankizumab group achieved PASI 90 and ___ achieved sPGA 0/1 at Week 16.
74.8%; 83.7%
83.5%; 60.0%
57.8%; 81.4%
55.3%; 50.4%
Which of the following statements about UltIMMa-2 is TRUE?
Risankizumab was consistently superior to placebo, but not
ustekinumab
The placebo group (who had switched to risankizumab at
Week 16) had similar efficacy endpoints compared to the
risankizumab group at Week 52
PASI 90 responses for risankizumab were not maintained
through Week 5
No non-treatment-emergent deaths occurred in the
risankizumab group
In UltIMMa-2, approximately what portion of the risankizumab group achieved clear skin (PASI 100, sPGA 0) at Week 16?
One-tenth (PASI 100 = 10.4%; sPGA 0 = 11.1%)
One-third (PASI 100 = 34.3%; sPGA 0 = 29.8%)
One-half (PASI 100 = 50.7%; sPGA 0 = 51.0%)
Three-quarters (PASI 100 = 74.7%; sPGA 0 = 75.6%)
In UltIMMa-2, approximately ___ of patients in the risankizumab group achieved PASI 100 at Week 52 compared to ___ for ustekinumab.
60%; 30%
40%; 20%
20%; 10%
10%; 5%
Which of the following statements about UltIMMa-2 safety findings is TRUE?
The proportions of patients with treatment-emergent
adverse events were similar across treatment groups
throughout the study duration
No malignancies occurred among each of the
risankizumab, ustekinumab, and placebo groups
No serious infections were reported in the risankizumab
group
No non-treatment-related major adverse cardiovascular
events were reported in the risankizumab group
In UltIMMa-1 and UltIMMa-2, respectively, approximately ___ and ___ of the risankizumab group achieved PASI 90 at Week 52, compared with approximately 44% and 51%
of the ustekinumab group.
98%; 91%
82%; 81%
60%; 45%
24%; 23%
Which of the following statements about the IMMhance study design are TRUE?
Patients were randomized to risankizumab 150 mg
or placebo
Patients originally randomized to risankizumab
who achieved sPGA 0/1 at Week 28 were rerandomized
to risankizumab (maintenance) or
placebo (withdrawal) at Weeks 28 to 104
It was designed as a 104-week study with 3 periods
All the statements are true
In IMMhance, what percent of the risankizumab and
placebo groups achieved PASI 90 at Week 16?
24.5% vs. 10.6%
57.7% vs. 5.5%
73.2% vs. 2.0%
91.5% vs. 8.8%
In IMMhance, what percent of the risankizumab and
placebo groups achieved sPGA 0/1 at Week 16?
40.0% vs. 5.7%
26.2% vs. 5.8%
83.5% vs. 7.0%
90.2% vs. 7.5%
What percent of patients in both treatment groups
remained in the IMMhance study by Week 16?
>=78%
>=89%
>=91%
>=97%
In IMMhance, a significant portion of the risankizumab group had clear (PASI 100, sPGA 0) or almost clear skin (PASI 90, sPGA 0/1) as early as ___, compared to placebo.
Week 4
Week 6
Week 8
Week 12
Which of the following statements about IMMhance at
Week 16 is TRUE?
The proportions of patients with treatmentemergent
adverse events were similar across
treatment groups throughout the study duration
No serious infections were reported in the
risankizumab group
No major adverse cardiovascular events were
reported in the risankizumab group
All the statements are true
In IMMhance, patients in the risankizumab arm were
rerandomized at Week 28 to risankizumab or placebo if
they met what criteria?
Patients who were initially randomized to placebo
and achieved PASI 90
Patients who were initially randomized to
risankizumab and achieved sPGA of 0/1
Patients who were initially randomized to placebo
and achieved sPGA of 0/1
Patients who were initially randomized to
risankizumab and did not achieve PASI 90
In IMMhance, ___ of the risankizumab
group achieved PASI 90 and ___ achieved sPGA 0/1 at Week 52.
65.8%; 68.4%
81.5%; 82.1%
61.3%; 52.4%
87.4%; 85.6%
In IMMhance, when was the last dose distributed?
Week 104
Week 100
Week 88
Week 94
In IMMhance, of the 31patients with
latent tuberculosis who did not receive prophylaxis during the study, ____ developed active TB during the mean follow-up of 55 weeks on risankizumab.
None
20
15
31
Which of the following statements about IMMhance is
TRUE?
The last dose of risankizumab was given at Week
100
67% of risankizumab patients achieved PASI 100 at
Week 100
Continuous risankizumab treatment was superior
to randomized withdrawal
sPGA 0/1 at Week 94 is a secondary endpoint
In IMMhance, approximately what portion of the
risankizumab group achieved clear skin (PASI 100) at
Week 94?
83%
72%
53%
68%
What percent of patients in the risankizumab group
achieved PASI 100 by Week 52?
53%
30%
75%
64%
Which of the following are TRUE about the study design of
IMMvent?
44-week study consisting of 2 parts
Patients originally randomized to adalimumab were
switched to risankizumab or continued adalimumab
at Week 16 if they achieved PASI 50 to <PASI 90
Enrolled adult patients with chronic plaque psoriasis
for >=6 months
All the statements are true
What percent of patients in the risankizumab group
remained in IMMvent by Week 16?
Over 96%
Over 85%
Over 80%
Over 74%
In IMMvent, ___ of the risankizumab group and ___ of the adalimumab group achieved PASI 90 at Week 16.
55.7%; 45.1%
46.7%; 60.2%
81.9%; 80.7%
72.4%; 47.4%
In IMMvent, what percent of the risankizumab and
adalimumab groups achieved sPGA 0/1 at Week 16?
39.1% vs. 40.0%
66.6% vs. 19.1%
83.7% vs. 60.2%
93.5% vs. 89.1%
In IMMvent, ___ of the risankizumab group and ___ of the adalimumab group achieved clear skin, ie,
PASI 100, at Week 16.
11.2%; 15.0%
21.5%; 20.0%
39.9%; 23.0%
67.5%; 55.7%
TRUE or FALSE: In IMMvent, the treatment-emergent
adverse event rates were similar across treatment groups
and in the 2 study phases.
True
False
What was the most frequently reported treatment-emergentadverse event in IMMvent?
Headache
Diarrhea
Dyspnea
Viral upper respiratory tract infecti