Poster abstracts
and disease severity using a post hoc analysis of patient-level
PASI data.
Methods: ReSURFACE 1 and 2 methods have been described pre-
viously [1]. Patients who participated in either TIL phase 3 study
received TIL 100 mg or TIL 200 mg at Week (W)0 and W4, and
every 12 weeks thereafter, or placebo (PBO) at W0 and W4 then
TIL 100 mg or 200 mg at W12 and W16. PASI score distributions
were analyzed using descriptive statistics.
Results: Numbers of patients and mean and median PASI scores
are shown in the Table. By W4 (1 dose), 55% of patients in both
TIL arms had PASI < 12, and would no longer meet clinical trial
entry criteria. The percentage of patients with PASI < 12 increased
during TIL treatment: 87% at W12, 93% at W28 (100 mg); 90%
at W12, 97% at W28 (200 mg). At W12, 32% (TIL 100 mg),
29% (TIL 200 mg), and 2% (PBO) of patients had PASI ≤ 1.0.
By W28, 48% (TIL 100 mg) and 52% (TIL 200 mg) of patients
had PASI ≤ 1.0. Median PASI scores at W28 were 2.0 (TIL 100
mg) and 1.0 (TIL 200 mg).
Conclusions: These results suggest that PASI scores may provide
additional information about disease severity, and resolution with
treatment, that might not otherwise be available using dichoto-
mous PASI assessments. Most TIL-treated patients had clinical
improvement by W4, and ≈50% had nominal disease severity
(PASI ≤ 1.0) by W28.
Reference:
1. Reich K, et al. Lancet. 2017;390:276–288.
Study sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck
& Co., Inc., Kenilworth, NJ, USA; analyses funded by Sun Pharmaceutical
Industries, Inc.
Table. PASI Scores
W0
Patients with PASI data, n
Mean (95% CI)
Median (range)
W4
Patients with PASI data, n
Mean (95% CI)
Median (range)
PASI < 12, n (%)
PASI ≤ 1.0, n (%)
W12
Patients with PASI data, n
Mean (95% CI)
Median (range)
PASI < 12, n (%)
PASI ≤ 1.0, n (%)
W28
Patients with PASI data, n
Mean (95% CI)
Median (range)
PASI < 12, n (%)
PASI ≤ 1.0, n (%)
TIL 100 mg
(n = 616) TIL 200 mg
(n = 622) PBO
(n = 309)
616
20.2 (19.6, 20.9)
18.0 (8.0–59.0) 622
20.3 (19.7, 20.9)
18.0 (5.0–66.0) 309
19.7 (18.8, 20.5)
18.0 (12.0–56.0)
610
12.1 (11.5, 12.8)
11.0 (0.0–53.0)
337 (55)
8 (1) 611
12.0 (11.4, 12.6)
11.0 (0.0–54.0)
335 (55)
11 (2) 302
18.0 (17.0, 19.0)
16.0 (2.0–59.0)
60 (20)
0 (0)
598
5.2 (4.7, 5.7)
3.0 (0.0–38.0)
521 (87)
189 (32) 602
4.6 (4.2, 5.1)
3.0 (0.0–36.0)
539 (90)
175 (29) 288
16.6 (15.6, 17.7)
15.5 (0.0–57.0)
73 (25)
5 (2)
575
3.4 (3.0, 3.8)
2.0 (0.0–26.0)
533 (93)
278 (48) 581
2.7 (2.4, 3.0)
1.0 (0.0–24.0)
561 (97)
303 (52) -
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P068
SUSTAINED AND IMPROVED EFFICACY OF
TILDRAKIZUMAB FROM WEEK 28 TO WEEK 52
IN TREATING MODERATE-TO-SEVERE PLAQUE
PSORIASIS
Boni Elewski 1 , Alan Menter 2 , Jeffrey Crowley 3 , Stephen Tyring 4 ,
Yang Zhao 5 , Simon Lowry 5 , Stephen Rozzo 5 , Alan Mendelsohn 5 ,
Jeffrey Parno 5 , Kenneth Gordon 6
Department of Dermatology, The University of Alabama at Birming-
ham, Birmingham, Alabama, 2 Division of Dermatology, Baylor University
Medical Center, Dallas, TX, 3 Bakersfield Dermatology, Bakersfield, CA,
4
Department of Dermatology, University of Texas Health Science Center,
Houston, TX, 5 Sun Pharmaceuticals, Princeton, NJ, 6 Medical College of
Wisconsin, Milwaukee, WI, USA
1
Introduction: Two phase-3, double-blind, randomized control-
led trials (reSURFACE 1: NCT01722331; reSURFACE 2:
NCT01729754) have demonstrated the efficacy and safety of tild-
rakizumab, a high affinity, humanized, IgG1 κ, anti-interleukin–23
31
monoclonal antibody, in the treatment of adult patients with
moderate-to-severe plaque psoriasis over 28 weeks1.
Objective:This analysis evaluated whether the efficacy is sustained
or improved from week 28 through week 52.
Methods: Both trials randomized adult patients with moderate-to-
severe plaque psoriasis to receive tildrakizumab 100 mg or 200
mg at weeks 0, 4, then every 12 weeks. At week 28, patients with
Psoriasis Area and Severity Index (PASI) response ≥50% were
re-randomized, based on their week-28 PASI response, to receive
the same, a higher or a lower dose of tildrakizumab or placebo
(randomized withdrawal in reSURFACE 1 per the trial designs).
The current analysis evaluated only patients treated with the same
dose of tildrakizumab (100 mg or 200 mg) throughout the first
52 weeks. Four mutually exclusive groups were created based
on week-28 PASI response: PASI 100, PASI 90–99, PASI 75–89
and PASI 50–74. PASI responses at week 52 (observed data) were
analyzed for each week-28 PASI-response group.
Results: This analysis included 352 patients on tildrakizumab 100
mg (male: 69.9%; mean baseline age: 44.9 years) and 313 on tild-
rakizumab 200 mg (male: 67.1%; mean baseline age: 46.4 years).
The proportions of patients achieving PASI 100, PASI 90–99, PASI
75–89 and PASI 50–74 at week 28 were 25.9%, 38.4%, 25.3%
and 10.5% respectively for those on the 100 mg dose, and 24.6%,
24.3%, 19.5% and 31.6% respectively for those on the 200 mg
dose. Among patients who achieved week-28 PASI≥90 with either
dose of tildrakizumab, 88.9–89.4% maintained PASI≥90 at week
52. Overall, 91.1% patients on the 100 mg dose and 93.9% on the
200 mg dose with week-28 PASI≥75 maintained PASI≥75 at week
52. In addition, 39.3–40.4% of patients with week-28 PASI 75–89
remained PASI 75–89 at week 52 and 33.7%-41.0% improved to
PASI≥90. Among patients with week-28 PASI 50–74, 20.2–29.7%
achieved PASI≥90 and 52.5–64.9% achieved PASI≥75 at week
52. Overall, only 2.6% of patients on the 100 mg (9 out of 352)
or 200 mg (8 out of 313) dose had week-52 PASI < 50.
Conclusions: Among patients with moderate-to-severe plaque
psoriasis treated with tildrakizumab 100 or 200 mg at weeks 0,
4, then every 12 weeks, those who achieved week-28 PASI≥50
and continued on the same dose had sustained or improved ef-
ficacy from week 28 through week 52. The majority patients who
achieved week-28 PASI≥75 or PASI≥90 maintained PASI≥75 or
PASI≥90 at week 52. More than half of partial responders (PASI
50–74) at week 28 eventually achieved PASI≥75 and at least 1 in
5 achieved PASI≥90 at week 52.
Reference:
1. Reich K, Papp KA, Blauvelt A, et al. Tildrakizumab versus placebo
or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSUR-
FACE 2): results from two randomised controlled, phase 3 trials. Lancet.
2017;390(10091):276-288.
This abstract was presented at 2018 Winter Clinical Dermatology
Conference-Hawaii.
P070
BETTER SKIN CLEARANCE IS ASSOCIATED WITH
IMPROVED QUALITY OF LIFE IN MODERATE-TO-
SEVERE PSORIASIS PATIENTS TREATED WITH
TILDRAKIZUMAB
Andrew Blauvelt 1 , Stephen Tyring 2 , Melinda Gooderham 3 , John
Koo 4 , Yang Zhao 5 , Simon Lowry 5 , Stephen Rozzo 5 , Alan Mendel-
sohn 5 , Jeffrey Parno 5 , Kristian Reich 6
1
Oregon Medical Research Center, Portland, OR, 2 Department of Der-
matology, University of Texas Health Science Center, Houston, TX, 3 Skin
Centre for Dermatology, Peterborough, ON, Canada, 4 Department of Der-
matology, University of California at San Francisco, CA, 5 Sun Pharmaceu-
ticals, Princeton, NJ, USA, 6 SCIderm Research Institute and Dermatologi-
kum Hamburg, Hamburg, Germany
Introduction: Tildrakizumab, a high affinity, humanized, IgG1 κ,
anti-interleukin–23 monoclonal antibody, has demonstrated effica-
Acta Derm Venereol 2018