Figure. Mean percent change from baseline PASI score (95% CI) by study week and week 28 PASI status category

Data are as observed; sample size at each study week is based on patients with non-missing data.
CI, confidence interval; LTE, long-term extension; PASI, Psoriasis Area and Severity Index; W28, week 28.

W28 PASI 100         W28 PASI 75–89        LTE start (reSURFACE 1)
W28 PASI 90–99        W28 PASI 50–75        LTE start (reSURFACE 2) 

-100.0
-90.0
-80.0
-70.0
-60.0
-50.0
-40.0
-30.0
-20.0
-10.0

0.0

M
ea

n 
pe

rc
en

t 
ch

an
ge

 f
ro

m
 

ba
se

lin
e 

P
A

S
I 

sc
or

e

Study week

W28 PASI 100 W28 PASI 90–99 LTE Start (reSURFACE2)
W28 PASI 75–89 W28 PASI 50–74 LTE Start (reSURFACE1)

Number of patients:
W28 PASI 100
W28 PASI 90–99
W28 PASI 75–89
W28 PASI 50–74

91
131
79
34

91
131
79
34

91
131
79
34

81
117
63
22

82
121
63
26

85
122
70
27

84
127
70
33

83
127
75
33

86
125
76
33

86
129
78
34

89
130
79
34

91
130
78
34

90
131
78
34

91
131
79
34

90
129
78
34

89
128
75
33

91
131
79
34

91
131
79
34

91
130
79
34

91
131
79
34

start (reSURFACE 2)
start (reSURFACE 1)

-100.0
-90.0
-80.0
-70.0
-60.0
-50.0
-40.0
-30.0
-20.0
-10.0

0.0

M
ea

n 
pe

rc
en

t 
ch

an
ge

 f
ro

m
 

ba
se

lin
e 

P
A

S
I 

sc
or

e

Study week

W28 PASI 100 W28 PASI 90–99 LTE Start (reSURFACE2)
W28 PASI 75–89 W28 PASI 50–74 LTE Start (reSURFACE1)

Number of patients:
W28 PASI 100
W28 PASI 90–99
W28 PASI 75–89
W28 PASI 50–74

91
131
79
34

91
131
79
34

91
131
79
34

81
117
63
22

82
121
63
26

85
122
70
27

84
127
70
33

83
127
75
33

86
125
76
33

86
129
78
34

89
130
79
34

91
130
78
34

90
131
78
34

91
131
79
34

90
129
78
34

89
128
75
33

91
131
79
34

91
131
79
34

91
130
79
34

91
131
79
34

start (reSURFACE 2)
start (reSURFACE 1)

-100.0
-90.0
-80.0
-70.0
-60.0
-50.0
-40.0
-30.0
-20.0
-10.0

0.0

M
ea

n 
pe

rc
en

t 
ch

an
ge

 f
ro

m
 

ba
se

lin
e 

P
A

S
I 

sc
or

e

Study week

W28 PASI 100 W28 PASI 90–99 LTE Start (reSURFACE2)
W28 PASI 75–89 W28 PASI 50–74 LTE Start (reSURFACE1)

Number of patients:
W28 PASI 100
W28 PASI 90–99
W28 PASI 75–89
W28 PASI 50–74

91
131
79
34

91
131
79
34

91
131
79
34

81
117
63
22

82
121
63
26

85
122
70
27

84
127
70
33

83
127
75
33

86
125
76
33

86
129
78
34

89
130
79
34

91
130
78
34

90
131
78
34

91
131
79
34

90
129
78
34

89
128
75
33

91
131
79
34

91
131
79
34

91
130
79
34

91
131
79
34

start (reSURFACE 2)
start (reSURFACE 1)

-100.0
-90.0
-80.0
-70.0
-60.0
-50.0
-40.0
-30.0
-20.0
-10.0

0.0

M
ea

n 
pe

rc
en

t 
ch

an
ge

 f
ro

m
 

ba
se

lin
e 

P
A

S
I 

sc
or

e

Study week

W28 PASI 100 W28 PASI 90–99 LTE Start (reSURFACE2)
W28 PASI 75–89 W28 PASI 50–74 LTE Start (reSURFACE1)

Number of patients:
W28 PASI 100
W28 PASI 90–99
W28 PASI 75–89
W28 PASI 50–74

91
131
79
34

91
131
79
34

91
131
79
34

81
117
63
22

82
121
63
26

85
122
70
27

84
127
70
33

83
127
75
33

86
125
76
33

86
129
78
34

89
130
79
34

91
130
78
34

90
131
78
34

91
131
79
34

90
129
78
34

89
128
75
33

91
131
79
34

91
131
79
34

91
130
79
34

91
131
79
34

start (reSURFACE 2)
start (reSURFACE 1)

-100.0
-90.0
-80.0
-70.0
-60.0
-50.0
-40.0
-30.0
-20.0
-10.0

0.0

M
ea

n 
pe

rc
en

t 
ch

an
ge

 f
ro

m
 

ba
se

lin
e 

P
A

S
I 

sc
or

e

Study week

W28 PASI 100 W28 PASI 90–99 LTE Start (reSURFACE2)
W28 PASI 75–89 W28 PASI 50–74 LTE Start (reSURFACE1)

Number of patients:
W28 PASI 100
W28 PASI 90–99
W28 PASI 75–89
W28 PASI 50–74

91
131
79
34

91
131
79
34

91
131
79
34

81
117
63
22

82
121
63
26

85
122
70
27

84
127
70
33

83
127
75
33

86
125
76
33

86
129
78
34

89
130
79
34

91
130
78
34

90
131
78
34

91
131
79
34

90
129
78
34

89
128
75
33

91
131
79
34

91
131
79
34

91
130
79
34

91
131
79
34

start (reSURFACE 2)
start (reSURFACE 1)

-100.0
-90.0
-80.0
-70.0
-60.0
-50.0
-40.0
-30.0
-20.0
-10.0

0.0

M
ea

n 
pe

rc
en

t 
ch

an
ge

 f
ro

m
 

ba
se

lin
e 

P
A

S
I 

sc
or

e

Study week

W28 PASI 100 W28 PASI 90–99 LTE Start (reSURFACE2)
W28 PASI 75–89 W28 PASI 50–74 LTE Start (reSURFACE1)

Number of patients:
W28 PASI 100
W28 PASI 90–99
W28 PASI 75–89
W28 PASI 50–74

91
131
79
34

91
131
79
34

91
131
79
34

81
117
63
22

82
121
63
26

85
122
70
27

84
127
70
33

83
127
75
33

86
125
76
33

86
129
78
34

89
130
79
34

91
130
78
34

90
131
78
34

91
131
79
34

90
129
78
34

89
128
75
33

91
131
79
34

91
131
79
34

91
130
79
34

91
131
79
34

start (reSURFACE 2)
start (reSURFACE 1)

-100.0

-90.0

-80.0

-70.0

-60.0

-50.0

-40.0

-30.0

-20.0

-10.0

0.0

M
ea

n 
pe

rc
en

t 
ch

an
ge

 f
ro

m
 b

as
el

in
e 

P
A

S
I 

sc
or

e

Study week
Number of patients:

W28 PASI 100
W28 PASI 90–99
W28 PASI 75–89
W28 PASI 50–74

91
131
79
34

91
131
79
34

91
131
79
34

81
117
63
22

82
121
63
26

85
122
70
27

84
127
70
33

83
127
75
33

86
125
76
33

86
129
78
34

89
130
79
34

91
130
78
34

90
131
78
34

91
131
79
34

90
129
78
34

89
128
75
33

91
131
79
34

91
131
79
34

91
130
79
34

91
131
79
34

Early and maintained response levels in psoriasis patients treated with tildrakizumab
Kim A Papp;1 Jensen Yeung;2 Neil Shear;3 Lorne Albrecht;4 Charles Lynde;5 Jingchuan Zhang;6 Yang Zhao;6 Jeff Parno;6 Alan M Mendelsohn;6 Melinda Gooderham7

1K. Papp Clinical Research, and Probity Medical Research, Waterloo, ON, CA; 2Women’s College Hospital and Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, CA; and Probity Medical Research, Waterloo, ON, CA; 3Division of Dermatology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, CA; 4Enverus Medical, Surrey, BC, Canada; 5Department of Medicine, University of Toronto, Toronto, ON, CA;
6Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA; 7Probity Medical Research, and SKiN Centre for Dermatology, Peterborough, ON, CA; and Queen’s University, Kingston, ON, CA

INTRODUCTION
• Tildrakizumab is an IgG1/κ monoclonal antibody that selectively inhibits the p19 subunit of interleukin-23 and is 

approved in the US, Europe, and Australia to treat adult patients with moderate to severe plaque psoriasis1
• The efficacy and safety of tildrakizumab has been demonstrated in two phase 3, double-blind, randomized, 

controlled trials (reSURFACE 1, NCT01722331; and reSURFACE 2, NCT01729754)2,3
• This post hoc analysis examined the long-term efficacy of tildrakizumab 100 mg up to week 148 among patients 

achieving various Psoriasis Area and Severity Index (PASI) responses at week 28 in reSURFACE 1 and 2

METHODS
• Both reSURFACE 1 and reSURFACE 2 used a three-part design:3

 — Part 1 (0–12 weeks): Patients were randomized (1:2:2) to blinded subcutaneous placebo or tildrakizumab 
100 or 200 mg at weeks 0 and 4

 — Part 2 (12–28 weeks): Patients previously receiving placebo were rerandomized to tildrakizumab 100 or 200 
mg at weeks 12 and 16 and every 12 weeks (Q12W) thereafter. Patients continuing tildrakizumab from Part 
1 received a placebo injection at week 12 to maintain the blind and a dose of tildrakizumab at weeks 16 and 
28. At week 28, tildrakizumab nonresponders (PASI <50) discontinued

 — Part 3 (reSURFACE 1: 28–64 weeks; reSURFACE 2: 28–52 weeks): Tildrakizumab responders (PASI 
≥75) were rerandomized to receive placebo every 2 weeks (reSURFACE 1) or tildrakizumab 100 or 200 
mg Q12W (reSURFACE 1 and 2). Responders who were rerandomized to placebo were retreated with the 
same tildrakizumab dose upon relapse (defined as reduction in maximum PASI response by 50%) 

• Patients who received tildrakizumab in Part 1 and achieved PASI ≥50 at the end of Part 3 were eligible to enter 
the long-term extension (LTE) study3

• Patients treated with tildrakizumab 100 mg in parts 1–3 (at weeks 0, 4, and every 12 weeks after) and who 
received ≥1 dose during the LTE were included in this analysis

• Percent PASI improvement from baseline to week 148 was examined for patients achieving PASI 50–74, 75–
89, 90–99, and 100 responses at week 28 using both observed data and imputed data with last observation 
carried forward (LOCF)

RESULTS
• A total of 335 patients were included in the analysis

Table. Baseline demographics and clinical characteristics by % PASI improvement from baseline to week 28

PASI 50–74 
(n = 34)

PASI 75–89 
(n = 79)

PASI 90–99 
(n = 131)

PASI 100 
(n = 91)

Age, years 46.9 (14.36) 45.9 (12.78) 45.2 (13.06) 42.4 (14.07)
Male, n (%) 26 (76.5) 53 (67.1) 94 (71.8) 62 (68.1)
Body surface area, % 34.5 (20.11) 31.1 (16.43) 33.7 (18.79) 29.0 (16.06)
Disease duration, years 13.9 (10.44) 18.0 (12.42) 16.9 (11.18) 14.5 (10.83)
PASI score 20.24 (8.80) 19.46 (6.44) 20.99 (8.03) 18.49 (5.82)
Comorbidities, n (%)

PsA 7 (20.6) 11 (13.9) 22 (16.8) 16 (17.6)
Diabetes 4 (11.8) 7 (8.9) 9 (6.9) 8 (8.8)
CVD 9 (26.5) 21 (26.6) 25 (19.1) 22 (24.2)

Prior biologics, n (%) 4 (11.8) 10 (12.7) 2 (19.8) 11 (12.1)
Data are mean (standard deviation) unless otherwise specified.
CVD, cardiovascular disease; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis.

• Patients had longstanding psoriasis (mean 16.1 years), but 85.2% had not previously been treated with a 
biologic (Table)

• Mean PASI improvements at week 4 were 27.1%, 36.6%, 44.7%, and 52.5% for week 28 PASI 50–74, 75–89, 
90–99, and 100 groups, respectively

• A greater mean PASI response at week 8 was indicative of a greater mean PASI response at week 28 (Figure)
• Responses were sustained through week 148 in patients achieving a week 28 mean PASI 75 response or higher

 — Responses were 85.3%, 92.4%, and 95.4% for  PASI 50–74, 75–89, 90–99, and 100, respectively
• Patients achieving week 28 PASI 50–74 had continuous mean PASI improvement from week 28 (64.4%) to week 52 (79.4%) and week 64 (82.2%); responses were further sustained through 148 weeks (81.4%)
• Results were similar when using either data as observed or imputed using LOCF

Presented at Fall Clinical Dermatology Conference for PAs & NPs 2020, April 3–5, Orlando, FL, USA

DISCUSSION
• Patients who received tildrakizumab and 

achieved PASI ≥90 at week 28 had rapid 
improvements as early as week 4

• Among patients achieving PASI ≥50 at week 
28, PASI improvements were improved or 
sustained through 148 weeks 

REFERENCES
1. Frampton JE. Am J Clin Dermatol. 2019;20(2):295–306.
2. Reich K, Papp KA, Blauvelt A, et al. Lancet. 

2017;390(10091):276–88.
3. Reich K, Warren RB, Iversen L, et al. Br J Dermatol. 

2020;182(3):605–17.

ACKNOWLEDGMENTS
Writing and editorial support was provided by Asclepius Analytics, 
LLC; and Kathleen Pieper, PhD, of AlphaBioCom, LLC; and was 
funded by Sun Pharmaceutical Industries, Inc.

DISCLOSURES
KAP has served as consultant and/or investigator and/or speaker 
for AbbVie, Akros, Allergan, Amgen, Anacor, Arcutis, Astellas, 
AstraZeneca, Baxalta, Baxter, Boehringer Ingelheim, Bristol-Myers 
Squibb, CanFite, Celgene, Coherus, Dermira, Dow Pharma, Eli 
Lilly, Forward Pharma, Galderma, Genentech, Gilead Sciences, 
GlaxoSmithKline, InflaRx GmbH, Janssen, Kyowa Hakko Kirin, 
LEO Pharma, MedImmune, Meiji Seika Pharma, Merck Sharp 
& Dohme, Merck-Serono, Mitsubishi Pharma, Moberg Pharma, 
Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-
Aventis/Genzyme, Takeda, UCB, and Valeant/Bausch Health; 
on a steering committee and/or advisory board for AbbVie, 
Amgen, Astellas, Baxter, Boehringer Ingelheim, Bristol-Myers 
Squibb, Celgene, Dow Pharma, Eli Lilly, Galderma, Janssen, 
Kyowa Hakko Kirin, Merck Sharp & Dohme, Merck-Serono, 
Novartis, Pfizer, Regeneron, Sanofi-Aventis/Genzyme, UCB, 
and Valeant/Bausch Health; and as scientific officer for Akros, 
Anacor, and Kyowa Hakko Kirin. LA has served as an advisor/
consultant for, has received grants/honoraria from, and has 
served as a speaker for AbbVie, Celgene, DS Biopharma, Eli Lilly, 
Galderma, Janssen, LEO Pharma, Novartis, Regeneron, Sanofi 
Genzyme, and Valeant. JY has been a speaker, consultant, and 
investigator for AbbVie, Allergan, Amgen, Astellas, Boehringer 
Ingelheim, Celgene, Centocor, Coherus, Dermira, Eli Lilly, Forward, 
Galderma, GlaxoSmithKline, Janssen, LEO Pharma, MedImmune, 
Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, 
Takeda, UCB, Valeant, and Xenon. NS has been a paid consultant 
for AbbVie; Actelion; Biogen; Celgene; Eli Lilly; Janssen; LEO 
Pharma; Novartis; Sanofi; and Sun Pharmaceutical Industries, 
Inc. CL has received funding from AbbVie, Amgen, Boehringer 
Ingelheim, Celgene, Coherus, Dermira, Eli Lilly, Galderma, 
Innovaderm, Janssen, LEO Pharma, Merck, Merck Sharp & 
Dohme , MedImmune, Novartis, Pfizer, Regeneron, and Xoma; 
and reimbursement of travel, accommodation, and hospitality 
expenses from AbbVie, Amgen, Boehringer Ingelheim, Celgene, 
Eli Lilly, Janssen, LEO Pharma, Merck, Merck Sharp & Dohme, 
Novartis, Pfizer, and Valeant. JZ and YZ were employees of Sun 
Pharmaceutical Industries, Inc., at the time of study conduct. 
JP has served as statistical consultant for Sun Pharmaceutical 
Industries, Inc.; and Kyowa Kirin Pharmaceutical Development, Inc. 
AMM is an employee of Sun Pharmaceutical Industries, Inc. MG 
has been an investigator, consultant, and/or speaker for AbbVie; 
Actelion; Akros; Amgen; Arcutis; Boehringer Ingelheim; Bristol-
Myers Squibb; Celgene; Dermira; Eli Lilly; Galderma; Glenmark; 
GlaxoSmithKline; Janssen; LEO Pharma; MedImmune; Merck; 
Novartis; Pfizer; Regeneron; Roche; Sanofi Genzyme; Sun 
Pharmaceutical Industries, Inc.; UCB; and Valeant; and has been 
on an advisory board for AbbVie; Amgen; Boehringer Ingelheim; 
Celgene; Eli Lilly; Galderma; Janssen; LEO Pharma; Novartis; 
Pfizer; Regeneron; Sanofi Genzyme; Sun Pharmaceutical 
Industries, Inc.; and Valeant.