Patients’ quality of life in a Phase 4 real-world study of tildrakizumab in moderate-to-severe plaque psoriasis
Jayme Heim1, J Gabriel Vasquez1, Brad Schenkel2, Neal Bhatia3
1West Michigan Dermatology, Grandville, MI, USA; 2Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA; 3Therapeutics Clinical Research, San Diego, CA, USA

INTRODUCTION
• Psoriasis is a chronic, systemic, inflammatory disorder characterized by 

scaly, erythematous plaques on the skin that can significantly impact patients’ 
emotional and psychological well-being1 

• Tildrakizumab is an anti–interleukin-23 p19 monoclonal antibody approved for the 
treatment of adults with moderate-to-severe plaque psoriasis who are candidates 
for systemic therapy or phototherapy1,2 

• Efficacy of tildrakizumab for clinical improvement was associated with better skin-
related quality of life in the Phase 3 reSURFACE 1 and reSURFACE 2 trials,3  
but there is limited available real-world evidence regarding overall health-related 
quality of life (HRQoL) in patients with moderate-to-severe plaque psoriasis

OBJECTIVE
• To evaluate improvement in general and skin-specific HRQoL 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

Treatment

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

• Administered 
by a 
healthcare 
provider

HRQoL evaluation
(ITT population, n = 55)

Primary endpoint 
Change from baseline in:
• PGWBI total score at Weeks 28 

and 52

Secondary endpoints 
Change from baseline over time in:
• PGWBI total and subscaleb scores
• DLQI score

Proportion of patients with:
• DLQI score of 0 or 1
• DLQI score ≤5
• ≥5-point reduction in DLQI score

64

X

Time points (Weeks) shown in bold indicate when the primary efficacy endpoint was assessed (at Weeks 28 and 52) and the end of the 
study (at Week 64).
aBSA ≥3%. bSubscales of Anxiety, Depressed Mood, Positive Well-Being, Self-Control, General Health, and Vitality. 
BSA, body surface area; DLQI, Dermatology Life Quality Index; HRQoL, health-related quality of life; ITT, intention-to-treat; PGWBI, 
Psychological General Well-Being Index.

Assessments 
• Quality of life was evaluated using

 — The Psychological General Well-Being Index (PGWBI), administered at 
baseline and all postbaseline visits

 ○ Total score is the sum of 6 subscale scores
 ○ Higher PGWBI scores indicate improvement

 — The Dermatology Life Quality Index (DLQI), administered at baseline and all 
postbaseline visits

 ○ Higher DLQI scores indicate greater impairment

Statistical analysis 
• The intention-to-treat population was used for quality-of-life analyses and 

included all patients who enrolled and were assigned to receive tildrakizumab 
• Changes from baseline in PGWBI and DLQI scores 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. Demographics 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
PGWBI score, mean ± SD 
Total score 78.1 ± 14.1
Positive Well-Being 12.6 ± 3.3
General Health 9.9 ± 2.5
Anxiety 16.9 ± 4.0
Depressed Mood 12.5 ± 2.1
Self-Control 12.9 ± 2.1
Vitality 13.3 ± 3.2

DLQI score, mean ± SD 9.4 ± 5.2
ITT population.
Data shown as n (%) unless otherwise noted.
PGWBI, Psychological General Well-Being Index; DLQI, Dermatology Life Quality Index; ITT, intention-to-treat; SD, standard 
deviation.

Improvement in PGWBI 
• The total PGWBI score improved significantly from baseline to Week 64, with 

a mean ± SD change from baseline of 5.6 ± 14.1 (P = 0.01); the change from 
baseline was significant at both of the primary endpoint time points at Week 28  
(P = 0.033) and Week 52 (P <0.001; Figure 2)

Figure 2. Mean PGWBI total and subscale scores through 
Week 64

BL 4 8 12 16 28 40 52 64
0

10

20

30

40

50

60

70

80

90

100

Week

M
ea

n 
±

S
D

Positive Well-Being General Health Anxiety Depressed Mood Self-Control Vitality

78.1 (14.1)

82.3 (13.1)
P = 0.004

82.8 (13.2)
P = 0.016

82.7 (12.2)
P = 0.018

83.5 (13.3)
P = 0.005

82.2 (12.9)
P = 0.033

83.3 (11.1)
P = 0.003

85.2 (12.0)
P <0.001 83.2 (13.5)P = 0.011

n = 55 55 53 54 54 53 48 48 45

16.9 (4.0) 17.9 (4.1) 17.9 (4.3) 18.1 (3.8) 18.0 (4.2) 17.8 (3.8)
18.1 (3.7) 18.3 (3.5) 18.0 (3.9)

12.5 (2.1) 13.1 (1.9) 12.8 (2.0) 13.1 (1.7) 13.0 (1.9) 12.5 (2.3) 13.1 (1.6) 13.0 (1.6) 12.7 (1.9)

12.6 (3.3)
13.3 (3.3) 13.8 (3.2) 14.0 (3.1) 14.0 (2.6) 13.6 (3.0) 13.7 (2.9)

14.4 (3.2) 13.8 (3.2)

12.9 (2.1) 13.0 (1.9) 13.2 (1.8) 13.0 (1.8) 13.2 (1.9) 13.0 (2.0) 13.4 (1.4) 13.4 (1.4) 13.2 (1.8)

9.9 (2.5)
10.9 (2.1) 11.5 (2.1) 10.9 (2.4) 11.4 (2.4) 11.5 (2.0) 11.1 (2.3) 11.8 (2.3) 11.5 (2.2)

13.3 (3.2) 14.2 (3.1) 13.6 (3.2) 13.5 (3.1) 13.9 (3.3) 13.9 (3.2) 14.0 (2.8) 14.3 (3.1) 14.0 (3.5)

ITT population. Data labels report the mean (SD).
P-values are for change from baseline based on Student’s t-test.
BL, baseline; ITT, intention-to-treat; PGWBI, Psychological General Well-Being Index; SD, standard deviation.

• The PGWBI components with significant improvement from baseline to Week 64 
were Positive Well-Being (mean ± SD change, 1.4 ± 3.3; P = 0.008) and General 
Health (mean ± SD change, 1.7 ± 2.3; P <0.001) 

• The mean ± SD change from baseline to Week 64 for other PGWBI component 
scores was 1.1 ± 4.0 (P = 0.08) for Anxiety, 0.4 ± 2.5 (P = 0.3) for Depressed 
Mood, 0.2 ± 2.1 (P = 0.5) for Self-Control, and 0.9 ± 3.2 (P = 0.06) for Vitality

Improvement in DLQI 
• There were statistically significant improvements from baseline in DLQI score at all 

visits, beginning as early as Week 4 with sustained improvement through Week 64
• The DLQI score (mean ± SD) improved from 9.4 ± 5.2 at baseline to 2.0 ± 2.6 at 

Week 64 (P <0.001; Figure 3)

Figure 3. Mean DLQI score through Week 64

0

5

10

15

Week
4 8 12 16 40 64

3.3* 2.9*
2.6*

2.0*
1.8*

n = 55 52 52 54 48 45

2.2*
1.7*

28 52

4853

BL

55

5.5*

9.4

M
ea

n 
±

S
D

ITT population.
Error bars represent the SD.
*P <0.01. Statistically significant change from baseline based on Student’s t-test.
BL, baseline; DLQI, Dermatology Life Quality Index; ITT, intention-to-treat; SD, standard deviation.

• Proportions of patients meeting prespecified DLQI response thresholds at Week 64  
included

 — DLQI score of 0 or 1 signifying no negative impact on patients’ quality of life: 
62.2% of patients (95% confidence interval [CI], 46.5%−76.2%; Figure 4A)   

 — DLQI score ≤5: 93.3% of patients (95% CI, 81.7%−98.6%; Figure 4B) 
 — ≥5-point reduction in DLQI score: 78.9% of patients (95% CI, 62.7%−90.4%; 

Figure 4C)

Figure 4. Prespecified DLQI responses through Week 64
A BProportion of patients with 

DLQI score of 0 or 1
(no negative effect on patients’ 

quality of life)

BL 4 28 52 64
Week

0

20

40

60

80

100

1.8%

18.2%

52.8% 56.3%
62.2%

P
er

ce
nt

 ±
95

%
 C

I

n = 55 45485355

Proportion of patients with 
DLQI score ≤5

BL 4 28 52 64
Week

n = 55 45485355

13.0%

56.4%

94.3% 89.6% 93.3%

0

20

40

60

80

100

P
er

ce
nt

 ±
95

%
 C

I

Proportion of patients with 
≥5-point reduction in DLQI score

BL 4 28 52 64
Week

n = 45 42 384043

0%

44.4%

81.4% 82.5% 78.9%

0

20

40

60

80

100

P
er

ce
nt

 ±
95

%
 C

I

C

ITT population. Data are shown as percent ± 95% CI. 
BL, baseline; CI, confidence interval; DLQI, Dermatology Life Quality Index; ITT, intention-to-treat.

CONCLUSIONS
• Treatment with tildrakizumab in patients with moderate-to-severe plaque 

psoriasis in a real-world setting significantly improved HRQoL as measured by 
the PGWBI and DLQI

 
REFERENCES
1) Reich K, et al. Lancet. 2017;390(10091):276–88. 2) ILUMYA® (tildrakizumab-asmn) Injection 100 mg/mL. Full prescribing information. 
Cranbury, NJ; Sun Pharmaceutical Industries, Inc., 2022. 3) Blauvelt A, et al. J Eur Acad Dermatol Venereol. 2019;33(12):2305–12.

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 Elisabetta Lauretti, PhD, of AlphaBioCom, LLC, and funded by 
Sun Pharma.

DISCLOSURES
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. JGV reports nothing to 
disclose. BS is an employee of Sun Pharmaceutical Industries, Inc. 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.