Patient satisfaction with tildrakizumab treatment in a Phase 4 real-world study of tildrakizumab in patients with moderate-to-severe plaque psoriasis
Neal Bhatia1, J Gabriel Vasquez2, Brad Schenkel3, Jayme Heim2
1Therapeutics Clinical Research, San Diego, CA, USA; 2West Michigan Dermatology, Grandville, MI, USA; 3Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA

INTRODUCTION
• Psoriasis is a chronic, systemic, inflammatory disorder that significantly impairs 

patients’ physical and psychosocial well-being1 
• Treatment dissatisfaction among patients with moderate-to-severe psoriasis is a 

concern in clinical settings1,2 
• Tildrakizumab is an anti–interleukin-23 p19 monoclonal antibody approved for the 

treatment of moderate-to-severe plaque psoriasis in patients who are candidates 
for systemic therapy or phototherapy3 

• Limited data are available on patient satisfaction with tildrakizumab treatment in 
real-world settings

OBJECTIVE
• To report overall patient satisfaction with specific aspects of treatment in patients 

with moderate-to-severe plaque psoriasis after 64 weeks of treatment with 
tildrakizumab under real-world conditions

METHODS
Study design and population 
• This was a Phase 4, 64-week, uncontrolled, open-label, real-world study (Figure 1)

Figure 1. Study design

Uncontrolled, open-label, single-arm, multicenter study 
(NCT03718299)

Treatment and follow-up

Screening (N = 60)
Enrollment (N = 55)

Key criteria

Inclusion
• Male or female
• ≥18 years
• Moderate-to-severe plaque psoriasisa
• Candidates for phototherapy or 

systemic therapy
• No active or untreated latent 

tuberculosis

Exclusion
• Erythrodermic psoriasis
• Only pustular, guttate, or inverse 

psoriasis 
• Other skin conditions that could 

interfere with evaluation

Screening and 
enrollment

Study visit
Injection

Screening

X

Week: 0/baseline

X
X

4

X
X

8

X

12

X

16

X
X

20 24 28

X
X

32 36 40

X
X

44 48 52

X
X

64

Treatment

• Tildrakizumab 
100mg 
administered 
at Weeks 0 
(baseline), 4, 
16, 28, 40, 
and 52

• Administered 
by a 
healthcare 
provider

Patient Satisfaction 
Evaluation

(ITT population, N = 55)

TSQM
• Effectiveness
• Side Effects
• Convenience
• Global Satisfaction

Tildrakizumab Overall 
Satisfaction
• Improvement in Symptom
• Speed of Improvement
• Frequency of Dosing
• Side Effects

Happiness with Psoriasis Control

aBSA ≥3%.
BSA, body surface area; ITT, intention-to-treat; TSQM, Treatment Satisfaction Questionnaire for Medication. 

Assessments 
• Patient satisfaction was evaluated using 

 — The Treatment Satisfaction Questionnaire for Medication (TSQM),4 
administered at all postbaseline visits

 ○ The TSQM includes Effectiveness, Side Effects, Convenience, and Global 
Satisfaction domains

 — The Tildrakizumab Overall Satisfaction scale, administered at all 
postbaseline visits

 ○ This instrument includes Improvement in Symptoms, Speed of 
Improvement, Frequency of Dosing, and Side Effects domains

 — The Patient Happiness with Psoriasis Control instrument, administered at 
baseline and all postbaseline visits

 — For all measures, higher scores indicate greater satisfaction

Statistical analysis 
• The intention-to-treat population was used for patient satisfaction analysis and 

included all patients who enrolled and were assigned to receive tildrakizumab 
• Changes from baseline in Happiness with Psoriasis Control were analyzed using 

Student’s t-tests
 — Missing data were not imputed

RESULTS
Patient demographics 
• Of 55 patients enrolled, 45 were assessed at Week 64 (end of study) 
• The majority of patients were male (28/55; 50.9%) and White (52/55; 94.5%), 

with a mean ± standard deviation (SD) age of 48.6 ± 15.3 years (Table 1)

Table 1. Demographic and baseline characteristics

Characteristic Tildrakizumab(N = 55)

Sex

Female 27 (49.1)

Male 28 (50.9)

Race

White 52 (94.5)

Black or African American 2 (3.6)

Asian 1 (1.8)

Ethnicity

Hispanic or Latino 5 (9.1)

Not Hispanic or Latino 50 (90.9)

Age, years, mean ± SD 48.6 ± 15.3

Happiness with Psoriasis Control, mean ± SD 2.7 ± 2.3
ITT population.
Data shown as n (%) unless otherwise noted.
ITT, intention-to-treat; SD, standard deviation.

Figure 2. Mean TSQM domain scores through Week 64

Effectiveness Side Effects Convenience Global Satisfaction
0

25

50

75

100

125

150

79.5 79.2 82.2 81.978.7 77.1 85.2 81.776.5 81.3 85.1 80.559.5 70.8 83.3 72.7

M
ea

n 
±

S
D

 T
S

Q
M

 s
co

re

Week 4 Week 28 Week 52 Week 64

n = 55 53 48 45 6 3 3 3 55 53 48 45 55 53 48 45

ITT population.
Error bars represent the SD.
ITT, intention-to-treat; TSQM, Treatment Satisfaction Questionnaire for Medication; SD, standard deviation.

• The mean ± SD Tildrakizumab Overall Satisfaction domain scores increased 
from 6.0 ± 2.4 to 8.7 ± 2.0 for Improvement in Symptoms, 5.9 ± 2.4 to 8.3 ± 2.3 
for Speed of Improvement, 7.8 ± 2.1 to 9.1 ± 1.7 for Frequency of Dosing, and 
8.6 ± 2.1 to 9.6 ± 0.7 for Side Effects  (Figure 3)

Figure 3. Mean tildrakizumab Overall Satisfaction domain 
scores through Week 64

Improvement in 
Symptoms

Speed of
Improvement

Frequency of 
Dosing

Side Effects
0

5

10

15

8.7 8.3 9.1 9.68.4 7.9 8.6 9.58.0 7.8 8.3 9.16.0 5.9 7.8 8.6

n = 55 53 48 45 55 53 48 45 55 53 48 45 55 53 48 45

M
ea

n 
±

S
D

 O
ve

ra
ll 

S
at

is
fa

ct
io

n 
sc

or
e Week 4 Week 28 Week 52 Week 64

ITT population.
Error bars represent the SD.
ITT, intention-to-treat; SD, standard deviation.

Figure 4. Mean Happiness with Psoriasis Control score from 
baseline through Week 64

0

5

10

15

Week

8.5
8.48.2

6.4

2.7

4548535555n =

***
*

BL 4 28 52 64

M
ea

n 
±

S
D

 H
ap

pi
ne

ss
 w

ith
 P

so
ri

as
is

 
C

on
tr

ol
 s

co
re

ITT population.
Error bars represent the SD.
*P <0.01; statistically significant change from baseline based on Student’s t-test.
ITT, intention-to-treat; SD, standard deviation.

CONCLUSIONS
• Patients with moderate-to-severe plaque psoriasis treated with tildrakizumab in 

a real-world setting reported improvements in overall satisfaction and across all 
domains assessed

REFERENCES
1) Duffin KC, et al. Br J Dermatol. 2014;170(3):672–80.
2) Armstrong AW, et al. JAMA Dermatol. 2013;149(10):1180–85.
3) ILUMYA® (tildrakizumab-asmn) Injection 100 mg/mL. Full prescribing information. Cranbury, NJ; Sun Pharmaceutical 
Industries, Inc., 2022.
4) Atkinson MJ, et al. Health Qual Life Outcomes. 2004;2:12.

ACKNOWLEDGMENTS
We thank the patients for their participation and Dr. Stephen J Rozzo for contributions to the study. This study was 
funded by Sun Pharmaceutical Industries Limited. Medical writing support was provided by Nitish Chaudhari, PhD, of 
AlphaBioCom, LLC, and funded by Sun Pharma.

DISCLOSURES
NB is an advisor, consultant, and investigator for AbbVie, Almirall, Arcutis, Biofrontera, BMS, Brickell, Dermavant, EPI Health, 
Ferndale, Galderma, Genentech, InCyte, ISDIN, J&J, LaRoche-Posay, Leo, Lilly, Novartis, Ortho, Pfizer, P&G, Regeneron, 
Sanofi, Stemline, Sun Pharma, and Verrica. JGV reports nothing to disclose. BS is an employee of Sun Pharmaceutical 
Industries, Inc. JH is a speaker, advisor, and consultant for Amgen, AbbVie, Celgene, Eli Lilly, Janssen, and Novartis; an 
advisor for Galderma, Mayne, and Sanofi Regeneron; an advisor and consultant for Ortho Dermatologic; and a speaker and 
advisor for Sun Pharma.

• For the Happiness with Psoriasis Control instrument, the mean ± SD score 
increased from 2.7 ± 2.3 at baseline to 8.5 ± 2.5 at Week 64, corresponding to 
“extremely happy” (P <0.001 from Week 4 through Week 64; Figure 4)

Efficacy 
• From Week 4 to Week 64, the mean ± SD TSQM domain scores increased from 

59.5 ± 17.0 to 79.5 ± 20.1 for Effectiveness and 72.7 ± 18.6 to 81.9 ± 20.5 for 
Global Satisfaction, respectively. The Convenience score remained stable from 
Week 4 to Week 64 (83.3 ± 15.9 to 82.2 ± 16.4, respectively), and ≤6 patients 
reported side effects (Figure 2)