what’s new in the treatment k, et al. eadv 2017, d3t01.1h sponsored by merck & co., inc. 84 81...

What’s New in the Treatment

of Psoriasis

Mark Lebwohl, MD Waldman Professor

And Chairman

Kimberly and Eric J. Waldman Department of Dermatology

Icahn School of Medicine at Mount Sinai

Mark Lebwohl is an employee of Mount Sinai which receives

research funds from: Abbvie, Amgen, Boehringer Ingelheim,

Celgene, Eli Lilly, Janssen / Johnson & Johnson, Kadmon,

Medimmune/Astra Zeneca, Novartis, Pfizer and ViDac.

Dr. Lebwohl is also a consultant for Allergan, Leopharma,

and Promius.

• Tildrakizumab

• Guselkumab – Tremfya ®

• Brodalumab – Siliq ®

• Ixekizumab – Taltz ®

• Secukinumab – Cosentyx ®

• Ustekinumab –Stelara ®

• Adalimumab – Humira®

• Etanercept –Enbrel ®

• Apremilast – Otezla ®

• Certolizumab - Cimzia ®

• Tofacitinib – Xeljanz ®

• Bimekizumab

• Risankizumab/Mirikizumab

PASI 75 Response Over Time

*P<0.001 vs PBO; †P<0.05 vs ETN; §P<0.001 vs ETN; P-values unadjusted for multiplicity.

P-values were calculated using the Cochran-Mantel-Haenszel (CMH) test stratified by body weight (≤90kg, >90kg) and prior exposure to biologic therapy for psoriasis.

Modified intention-to-treat population (ie, all randomized patients who received ≥1 dose of study medication).

The figure represents observed data only; data shown for Week 12 are based on missing data being imputed as non-responders.

PBO=placebo; TIL=tildrakizumab; ETN=etanercept.

0

0

20

40

60

80

100

Weeks

Res

pond

ers

(%)

TIL 100 mgTIL 200 mgPlacebo TIL 100 mgPlacebo TIL 200 mg

4 8 12 16 22 28

TIL 200: 62%*

PBO 3%

TIL 200: 82%

TIL 100: 64%*

PBO/TIL 100: 77%

PBO/TIL 200: 86%

TIL 100: 80%*

0

0

20

40

60

80

100

Weeks

Res

pond

ers

(%)

4 8 12 16 22 28

TIL 200: 66%*†

PBO: 6%

TIL 200: 74§

PBO/TIL 100: 58%

PBO/TIL 200: 74%TIL 100: 74§

TIL 100 mgTIL 200 mgPlacebo TIL 100 mgPlacebo TIL 200 mgETN

ETN: 48%ETN: 56%

TIL 100: 61%*†

reSURFACE 1 reSURFACE 2

TIL100 64%

TIL200 62%

PBO/TIL200 86%

TIL100 82%

TIL200 80%

PBO/TIL100 77%

reSURFACE 1 and 2: Overall efficacy after 2 years of treatment

FAS (full analysis set; subjects with ≥1 dose of extension treatment based on assigned treatment); as observed data

Patients entering OLE after 64 weeks (reSURFACE 1) or 52 weeks (reSURFACE 2) were at least partial responders (PASI ≥50).

For reSURFACE 1, patients had to have received active drug within 12 weeks of end of base study

Papp K, et al. EADV 2017, D3T01.1H Sponsored by Merck & Co., Inc.

84 81

88 84

52 54

66 61

22 23

34 33

58 55

66 67

0

10

20

30

40

50

60

70

80

90

100

TIL 100 mg(n=219)

TIL 200 mg(n=255)

TIL 100 mg(n=355)

TIL 200(n=333)

Patients

(%

)

PASI 75

PASI 90

PASI 100

PGA (0/1)

reSURFACE 1 – w.64 reSURFACE 2 – w.52

Voyage 1 Guselkumab PASI 75 Responders:

7

91.2

73.1

62.6

91.2

72.2

87.8

0

20

40

60

80

100

0 4 8 12 16 20 24 28 32 36 40 44 48

Perc

en

tag

e o

f P

ati

en

ts

Guselkumab (n=329) Placebo→Guselkumab (n=174) Adalimumab (n=334)

Weeks

2

Week 24

P<0.001 vs. ADA

Week 48

P<0.001 vs. ADA

Week 16

P<0.001 vs. ADA

A. Blauvelt, et al. FCD 2016.

Griffiths CEM, et al. EADV 2017, D3T01.I Sponsored by Janssen Research and Development LLC

VOYAGE1: PASI 90 & PASI 100 response with guselkumab through 2 years

PASI 90 PASI 100

n= 329 329 307 290

n= 174 165 161 158

n= 334 334 279 158

n= 329 329 307 290

n= 174 165 161 158

n= 334 334 279 158

0

20

0 12

Weeks

100

40

80

60

4 20 44 36 28 52 60 84 76 68 92 100

Pa

tie

nts

(%

)

24.0

46.6

50.5 55.1

51.6

49.0

0

20

0 12

Weeks

100

40

80

60

4 20 44 36 28 52 60 84 76 68 92 100

Pa

tie

nts

(%

)

50.5

78.9

80.1

82.3 82.1

81.1

NRI=72.3

NRI=43.2

GUS

Placebo → GUS

ADA → GUS

GUS

Placebo → GUS

ADA → GUS

ACR 20/50/70 Responses at Week 24

18.4

10.2

2.0

58.0

34.0

14.0

0

20

40

60

80

100

ACR20 ACR50 ACR70

% o

f P

ati

en

ts

Placebo (n=49) Guselkumab (n=100)

p<0.001

p=0.023 (post hoc) p=0.002

Primary Endpoint

RESULTS

Gottlieb A, et al. AAD 2017. P4454.

Percent of Patients with Resolution of Enthesitis at Week 24 in Patients with Enthesitis at Baseline

29.0

56.6

0

10

20

30

40

50

60

70

80

90

100%

of

Pa

tien

ts


p=0.012

Enthesitis assessed by Leeds Enthesitis Index (LEI)

Median % improvement in LEI at Week 24: 100% in guselkumab vs 33.3% in placebo (p=0.009)

RESULTS


Percent of Patients with Resolution of Dactylitis at Week 24 in Patients with Dactylitis at Baseline

17.4

55.2

0

10

20

30

40

50

60

70

80

90

100%

of

Pa

tien

ts


p=0.001


Presence and severity of dactylitis in hands/feet assessed by investigators using a 0-3 scale (none [0],

mild [1], moderate [2], severe [3])

Median % improvement in dactylitis at Week 24: 100% in guselkumab vs 33.3% in placebo (p<0.001)

RESULTS

62.9 62.4 52.3

60.3 60.2

43

27.4 22.4

23.5 19.8 17.1

18.7

0

10

20

30

40

50

60

70

80

90

100

12 48 96 168 240 264

Pa

tie

nts

(%

)

Week

sPGA 0 sPGA 1

95.4 94.6 91.7 93.7 92.1

85.7

94.5 95.5 92.4 93.4 92.8

88.2

0

10

20

30

40

50

60

70

80

90

100

12 48 96 168 240 264

Me

an

im

pro

ve

me

nt

(%)

Week

PASI BSA

n= 175 165 153 141 128 106

Pts off

treatmenta

aAt week 264, patients had been off treatment for ≥6 weeks

Papp K, et al. EADV 2017, P1798 Sponsored by LEO Pharma

Efficacy of brodalumab for moderate to severe psoriasis through 5 years

sPGA 0/1 response Improvement in PASI score and % BSA

Pts off

treatmenta

84.8

75.8 80.1

77.3

61.7

n= 175 165 153 141 128 107

aAt week 264, patients had been off treatment for ≥6 weeks. Error bars represent 95% CI

Papp K, et al. EADV 2017, P1798 Sponsored by LEO Pharma

PASI responses with brodalumab over 5 years

• “As observed” data

• Efficacy is maintained for up to 5 years

PASI 90

PASI 100

PASI 75

Patients off

treatmenta

n= 173 175 169 159 153 148 144 141 136 131 128 106

40

20

0

80

60

100

Week 8 72 96 192 216 264 24 48 240 168 144 120 36 16 2

Amendment (at Week 123):

17% of patients (30/181) had dose increased back to 210

mg due to inadequate response

Amendment (at Week 59):

65% of patients (118/181) had dose

decreased from 210 to 140 mg

Pa

tie

nts

(%

)

*P<0.05; †P<0.01; ‡P<0.001 vs IXE q4w aDose adjustment based on achievement of sPGA ≥2 at 2 consecutive visits during

Week 12 through Week 40; investigators were blinded to the predefined criteria and timing

Langley RG, et al. EADV 2017, OP04.03 Sponsored by Eli Lilly and Company

IXORA-P: Efficacy and safety of continuous 2-weekly dosing of ixekizumab over 52 weeks in patients with moderate to severe psoriasis

71 79

73 84 79

86

0

20

40

60

80

100

sPGA (0/1) PASI 75

sPGA (0/1) and PASI 75 responses at Week 52

(NRI)

Pa

tie

nts

(%

)

IXE q4w (n=310) IXE q4w/IXE q2w

(n=306)

IXE q2w (n=611)

PASI 90 and PASI 100 responses at Week 52

(NRI)

65

44

74

49

80

60

0

20

40

60

80

100

PASI 90 PASI 100

†

*

†

‡

‡

IXORA-P: study design

IXE q2w (n=611)

R

Blinded treatment dosing period Screening

Week 16

Follow-

up 0 20 24 40 52 28 32 36

N=1227

2:1:1

IXE q2w

IXE q4w/IXE q2w (n=306)

Dose adjustment per protocola

IXE q4w (n=310)

• IXE q2w is better at Week 52

Pa

tie

nts

(%

)

Ixekizumab, an interleukin-17A specific

monoclonal antibody, for the treatment of

biologic-naive patients with active psoriatic

arthritis: results from the 24-week randomised,

double-blind, placebo-controlled and active

(adalimumab)-controlled period of the phase

III trial SPIRIT-P1.

Mease PJ, et al

Ann Rheum Dis. 2017;76:79-87.

Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active

(adalimumab)-controlled period of the phase III trial SPIRIT-P1. Mease PJ, et al; Ann Rheum Dis. 2017;76:79-87.

0

20

40

60

80

100

0 2 4 6 8 10 12

PBO (N=74) IXE Q2W (N=75)

sPGA of Genitalia (0,1) NRI, Blinded Treatment Period, ITT Population

* p<.01 vs. PBO; † p<.001 vs. PBO ITT=Intent-to-Treat; IXE Q2W=80 mg ixekizumab every 2 weeks; NRI=non-responder imputation; PBO=placebo; sPGA=static Physician’s Global Assessment

Resp

on

se (

%) 73†

8

†

*

Week

†

†

♦ 7 out of 10 ixekizumab-treated patients achieved clear or almost clear genital skin at Week 12

♦ Percentage of patients achieving clear or almost clear genital skin was significantly greater for ixekizumab as early as Week 1

0

20

40

60

80

100

0 2 4 6 8 10 12


Gen-Itch NRS a NRI, Blinded Treatment Period, ITT Population With Baseline Gen-Itch NRS ≥3

† p<.001 vs. PBO a ≥3 point improvement in gen-itch NRS gen-itch NRS=genital itch numeric rating scale; ITT=Intent-to-Treat; IXE Q2W=80 mg ixekizumab every 2 weeks; NRI=non-responder imputation; PBO=placebo

♦ 6 out of 10 ixekizumab-treated patients had clinically meaningful improvementsa in genital itch at Week 12

♦ Percentage of patients achieving clinically meaningful improvement in genital itch was significantly greater for ixekizumab as early as Week 2

60†

8

† †

†

Resp

on

se (

%)

Week

♦ Proportion of patients achieving overall sPGA (0,1)

♦ Proportion of patients achieving a ≥3-point improvement in genital itch numeric rating scale (gen-itch NRS)

• Among patients with a baseline score of ≥3

♦ Proportion of patients whose frequency of sexual activity was never or rarely limited by genital psoriasis (SFQ Item 2 score 0 or 1)

• Among patients with a baseline score ≥2

SFQ Item 2 In the past week, how often

did your genital psoriasis

limit the frequency of your

sexual activity?

Never 0

Rarely 1

Sometimes 2

Often 3

Always 4

gen-itch NRS=genital itch numeric rating scale; SFQ=Sexual Frequency Questionnaire; sPGA=static Physician’s Global Assessment

Impact on frequency of sex! SFQ= Sexual Frequency Questionnaire

0

20

40

60

80

100

0 2 4 6 8 10 12


SFQ Item 2 Score (0,1) Response Rate NRI, Blinded Treatment Period, ITT Population With Baseline SFQ Item 2 Score ≥2

♦ Approximately 8 out of 10 ixekizumab-treated patients were no longer or rarely limited by the impact of genital psoriasis on frequency of sexual activity at Week 12

♦ Percentage of patients who were no longer or rarely limited by the impact of genital psoriasis on frequency of sexual activity was significantly greater for ixekizumab as early as Week 1

‡ p<.05 vs. PBO; * p<.01 vs. PBO; † p<.001 vs. PBO ITT=Intent-to-Treat; IXE Q2W=80 mg ixekizumab every 2 weeks; NRI=non-responder imputation; PBO=placebo; SFQ=Sexual Frequency Questionnaire

78†

21

†

*

‡

Resp

on

se (

%)

Week

0

10

20

30

40

50

60

70

80

90

100

Patients

(%

)

Bissonnette R, et al. EADV 2017, P2223 Sponsored by Novartis Pharma AG

SCULPTURE: Long-term skin improvement responses with secukinumab 300 mg fixed interval (q4w) through 5 years

As observed (AO)

Multiple imputation (MI, n=168 at each time point)

LOCF (n=168 at each time point)

Year 1

(n=162)

Year 2

(n=152)

Year 3

(n=139)

Year 4

(n=132)

Year 5

(n=122)

PASI 75

PASI 90

PASI 100

Δ=~8%

Δ=~7%

Δ=~5%

PASI 75 (%) PASI 90 (%) PASI 100 (%)

AO MI LOCF AO MI LOCF AO MI LOCF

Year 1 88.9 – – 68.5 – – 43.8 – –

Year 5 88.5 80.1 79.2 66.4 58.6 59.5 41.0 35.6 37.5

aRelapse: >50% loss of previous gain in PASI reduction

Lebwohl M, et al. EADV 2017, OP04.06 Sponsored by Novartis Pharma AG

ERASURE/FIXTURE extension study: Patients without relapse after withdrawal of secukinumab treatment

14

6

21

10

0

20

40

60

80

100

No relapse ≥12 months after SKB discontinuation

No relapse in 24 months afterSKB discontinuation

Patients

(%

) SKB 150 mg/placebo (n=100)

SKB 300 mg/placebo (n=120)

Proportion of patients without relapsea after withdrawal of SKB

Gottlieb AB, et al. EADV 2017, P0375 Sponsored by Novartis Pharma AG

FUTURE 2: Resolution of dactylitis and enthesitis through 2 years

• Similar responses with 300 mg and

150 mg, but 300 mg better in TNF

inhibitor-refractory patients

• Efficacy of the two doses should also

be compared in obese patients

74.3 78.0

54.3

61.8

76.1 79.9

58.8

71.5

0

20

40

60

80

100

1 2 3 4

Patients

(%

)



Week 52 Week 52 Week 104 Week 104

Dactylitis Enthesitis

Resolution of dactylitis and enthesitis

Ustekinumab in adolescent patients age

12 to 17 years with moderate-to-severe

plaque psoriasis: results of the

randomized phase 3 CADMUS study.

Landells I, et al.

J Am Acad Dermatol. 2015;73(4): 594-603.

Ustekinumab package insert

Business Use Only 25

Ustekinumab as therapy for psoriasis in a

2-year-old girl.

Min MS, et al.

J Eur Acad Dermatol Venereol.

2016;30(11):e109-10.

Adalimumab for nail psoriasis: Efficacy and safety

from the first 26 weeks of a phase 3, randomized,

placebo-controlled trial.

Elewski BE, Okun MM, Papp K, Baker CS,

Crowley JJ, Guillet G, Sundaram M,

Poulin Y, Gu Y, Geng Z, Williams DA, Rich PA.

J Am Acad Dermatol. 2018 Jan;78(1):90-99.

66.7

44.4

33.3

0

20

40

60

80

100

0D 1D 4D 8D 11D 16D 20D 28D 40D 52D

Long-term safety/efficacy of ADA for pediatric patients with chronic plaque psoriasis

Papp KA, et al. EADV 2015, FC02.04 Sponsored by AbbVie Inc.

86.1

72.2

47.2

0

20

40

60

80

100

0D 1D 4D 8D 11D 16D 20D 28D 40D 52D

Week

MTX PerA, n=37

ADA 0.8 PerD, n=36

ADA 0.8 PerA, n=39

ADA 0.8 PerD, n=36

ADA 0.4 PerA, n=38

ADA 0.4 PerD, n=36

32.4

57.9

43.6

Week 16A

21.6

28.9

30.8

Week 16A

Percentage achieving ≥PASI 75

Percentage achieving ≥PASI 90

Etanercept treatment for children and adolescents with plaque

psoriasis.

Paller AS, Siegfried EC, Langley RG, Gottlieb AB, Pariser D,

Landells I,Hebert AA, Eichenfield LF, Patel V, Creamer K,

Jahreis A; Etanercept PediatricPsoriasis Study Group.

N Engl J Med. 2008;358:241-51.

Long-term safety and efficacy of etanercept in children

and adolescents with plaque psoriasis.

Paller AS, Siegfried EC, Pariser DM, Rice KC, Trivedi M, Iles J,

Collier DH, Kricorian G, Langley RG

J Am Acad Dermatol. 2016;74:280-7.

5-year efficacy of ETN in children and adolescents with plaque psoriasis

Paller AS, et al. EADV 2015, FC02.05

PASI responses (as observed)

PASI 75 responses by BMI category (as observed)

• Largest and longest pediatric study with biologics in psoriasis reported to date

Strober B, et al. EADV 2017, FC02.08 Sponsored by Celgene Corporation

UNVEIL: 52-week efficacy and safety of apremilast in systemic- and biologic-naïve patients with moderate plaque psoriasis

• BSA involvement of 5% to 10%, naïve to

systemic and biologic therapy

• sPGA of 3 (moderate) based on a 0 to 5 scale

Screening Placebo-controlled

phase

0 Week 56

APR 30 mg bid (n=148)

16

Open-label treatment phase

R

1:2 Placebo (n=73)

52

Primary end point:

Mean % change in

PGA×BSA at Week 16

Safety observation

−5

APR 30 mg bid (n=64)

Placebo

(n=73)

Apremilast

(n=148)

Age (years) 51.1 ±13.7 48.6 ±15.4

Male 41 (56.2) 74 (50.0)

BMI (kg/m2) 30.8 ±6.5 30.5 ±7.4

Duration of psoriasis (years) 13.9 ±12.6 17.5 ±13.9

PGA×BSA score 21.6 ±5.9 21.8 ±5.3

% BSA 7.1 ±1.8 7.2 ±1.6

PASI score (0–72) 8.0 ±3.2 8.2 ±4.0

DLQI total score 11.1 ±6.5 11.0 ±6.5

Prior topical therapy 59 (80.8) 122 (82.4)

Data are mean ±SD or n (%)

At baseline, >80% of patients had received topical therapy before

enrollment

*P=0.0001 vs placebo from 2-sided Cochran-Mantel-Haenszel test stratified by site; LOCF was used to impute missing values. Error bars represent 95% CI

Strober B, et al. EADV 2017, FC02.08 Sponsored by Celgene Corporation

UNVEIL: PGA×BSA-75 and sPGA 0/1 response at Week 52 with apremilast in patients with moderate psoriasis

sPGA 0/1 response (LOCF) PGA×BSA-75 response at Week 52 (LOCF)

12.3

45.3

35.4 37.4

0

10

20

30

40

50

60

70

80

90

100

Patients

(%

)

*

Placeb

o

n=73

APR

n=147

Placebo/AP

R

n=64

APR/APR

n=147

Week 16 Week 52

9.6

35.9

30.4 29.1

0

10

20

30

40

50

60

70

80

90

100

Patients

(%

)

*

Placebo

n=73

APR

n=148

Placebo/AP

R

n=64

APR/APR

n=148

Week 16 Week 52

Jackson JM, et al. EADV 2017, P1946 Sponsored by Celgene Corporation

UNVEIL: Improvement in nails and scalp with apremilast at Week 52 in patients with moderate psoriasis

• Mild nail diseases – used target nail NAPSI – difficult to compare with other studies

• Caveat – scalp ScPGA had successes already in the baseline

• Increased attention to the moderate population is necessary as DLQI in some subsets is rather high

Characteristic Scalp psoriasisa (n=167) Nail psoriasisa (n=83)

Placebo (n=55)

APR (n=112)

Placebo (n=27)

APR (n=56)

% BSA 7.2 ±1.9 7.3 ±1.7 7.3 ±1.8 7.3 ±1.6

sPGA score=3 (moderate)b 53 (96.4) 110 (98.2) 26 (96.3) 55 (98.2)

PASI score (0–72) 8.1 ±3.2 8.2 ±4.3 8.0 ±2.8 8.1 ±2.9

DLQI total score 10.9 ±6.3 11.6 ±6.5 9.9 ±6.7 11.0 ±5.9

ScPGA score 0 (clear) 1 (minimal) 2 (mild) 3 (moderate) 4 (severe) 5 (very severe)

0 8 (14.5) 17 (30.9) 24 (43.6) 6 (10.9) 0

0 6 (5.4) 38 (33.9) 61 (54.5) 7 (6.3) 0

1 (3.7) 3 (11.1) 9 (33.3) 9 (33.3) 1 (3.7) 0

0 2 (3.6) 16 (28.6) 23 (41.1) 2 (3.6) 0

NAPSI total score 4.8 ±2.2 4.0 ±2.1 4.6 ±2.2 3.7 ±2.0

Data are mean ±SD or n (%) a65 patients had both scalp and nail psoriasis (22 placebo, 43 APR); b4 patients with sPGA=4 enrolled in error

-10.5 -28.9

-52.7 -51.9

-100

-80

-60

-40

-20

0

20

NAPSI scorec

Me

an

ch

an

ge

fro

m

ba

se

line (

%)

Week 16 Week 52

APR

(n=56)

Placebo

(n=27)

Placebo/APR

(n=23)

APR/APR

(n=48)

20.0

38.4

46.9 47.7

0

20

40

60

80

100

Pa

tie

nts

(%

)d

Week 16 Week 52

APR

(n=112)

Placebo

(n=55)

Placebo/APR

(n=49)

APR/APR

(n=88)

ScPGA 0/1 response

P=0.0178

cIncludes patients with baseline NAPSI score or ScPGA ≥1 dIncludes patients with baseline ScPGA score ≥1

Error bars represent 95% CIs

CIMPASI-1 and CIMPASI-2: Maintenance of response with certolizumab pegol during 32-week rerandomized maintenance period

*P<0.05, †P<0.0001 vs placebo, based on logistic regression model with factors for treatment, region and prior biologic exposure (yes/no). Week 16 PASI 50

nonresponders were imputed as nonresponders throughout maintenance period; all other missing data were imputed via multiple imputation (Markov chain

Monte Carlo [MCMC] method). CZP 200 mg q2w patients received loading dose of 400 mg at Weeks 0, 2 and 4

Reich K, et al. EADV 2017, P1973 Sponsored by Dermira Inc. in collaboration with UCB Pharma

PASI 75 (baseline to Week 48) PGA 0/1 (baseline to Week 48) PASI 90 (baseline to Week 48)

CIMPASI-1 CZP 200 mg q2w (n=95) CZP 400 mg q2w (n=88) Placebo (n=51)

20

0 48 2

40

60

100

80

12 24 16 0 28 20 4 8 32 40

60.2%

42.8%

0.4%

43.6%

†

†

* *

†

†

35.8%

Pa

tie

nts

(%

)

87.1%

20

0 48 2

40

60

100

80

12 24 16 0 28 20 4 8 32 40

67.2%

6.5%

75.8%

66.5%

†

† *

* * *

†

†

20

0 48 2

40

60

100

80

12 24 16 0 28 20 4 8 32 40

69.5%

52.7%

4.2%

†

†

†

* *

* *

*

57.9%

47.0%

CIMPASI-2

Pa

tie

nts

(%) 72.6%

66.6% 66.8%

Week

20

0 48 2

40

60

100

80

12 24 16 0 28 20 4 8 32 40

2.0%

† † †

*

*

†

†

71.6%

†

Week

20

0 48 2

40

60

100

80

12 24 16 0 28 20 4 8 32 40

78.7%

11.6%

†

†

†

†

*

81.3%

†

†

*

82.6%

81.4%

Week

20

0 48 2

40

60

100

80

12 24 16 0 28 20 4 8 32 40

62.0%

59.6%

4.5%

†

†

†

* *

*

55.4%

52.6%

CZP 200 mg q2w (n=91) CZP 400 mg q2w (n=87) Placebo (n=49)

CIMPACT: Maintenance of response with certolizumab pegol during 32-week rerandomized maintenance period

Missing data were imputed using NRI

Augustin M, et al. EADV 2017, P1969 Sponsored by Dermira Inc. in collaboration with UCB Pharma

Placebo q2w (n=22)

CZP 200 mg q2w (n=44)

CZP 400 mg q4w (n=44)

CZP 200 mg q2w

Placebo q2w (n=25)

CZP 200 mg q2w (n=50)

CZP 400 mg q2w (n=49)

CZP 400 mg q2w

PASI 75

89%

PGA 0/1

PASI 90

20

0 48 20

40

60

100

80

32 40 36 16 24 28 44

70%

61%

14% Pa

tie

nts

(%

)

20

0 48 20

40

60

100

80

32 40 36 16 24 28 44

88%

64%

12%

Pa

tie

nts

(%

)

20

0 48 20

40

60

100

80

32 40 36 16 24 28 44

Week

80%

46%

20

0 48 20

40

60

100

80

32 40 36 16 24 28 44

98%

80%

36%

Week

20

0 48 20

40

60

100

80

32 40 36 16 24 28 44

68%

61%

18%

Pa

tie

nts

(%

)

Week

20

0 48 20

40

60

100

80

32 40 36 16 24 28 44

88%

60%

12%

Week

89%

a2/16 infant samples excluded from per protocol analysis set (1 missing data at birth, 1 due to implausible PK data [ie, data not consistent with pediatric CZP

PK model, based on expected range of clearance, volume of distribution, and subsequent elimination t½]); b2 samples not collected; c1 umbilical cord excluded

due to missing data; dUmbilical cords were collected within 1 h of delivery. BLQ, below limits of quantitation of the assay; LLOQ, lower limit of quantitation

Kimball A, et al. EADV 2017, FC04.03 Sponsored by UCB Pharma

CRIB: Maternal and infant plasma and umbilical cord levels of certolizumab pegol

Plasma CZP levels (n=14 mother–infant

pairsa)

CZ

P c

on

ce

ntr

atio

n (

g/m

L)

10

100

0.1

1

BLQ

Delivery

(±24 hours)

Week 4

(±7 days)b

Week 8

(±7 days)

LLOQ = 0.032 g/mL

Mothers Infants

1 infant had minimal CZP level of

0.042 μg/mL, mother’s level was

49.4 μg/mL (infant/mother ratio:

0.0009)

Plasma CZP levels in umbilical cord

(n=15c)

CZ

P c

on

ce

ntr

atio

n (

g/m

L)

10

100

0.1

1

BLQ

Delivery

(±24 hours)

Umbilical

cordsd

LLOQ = 0.032 g/mL

Mothers Infants

The infant with a CZP level at birth

of 0.042 μg/mL had a CZP level of

0.040 μg/mL in the umbilical cord

Umbilical cord

Tofacitinib or Adalimumab versus Placebo for

Psoriatic Arthritis.

Mease P, Hall S, FitzGerald O, van der Heijde D,

Merola JF, Avila-Zapata F, Cieślak D, Graham D,

Wang C, Menon S, Hendrikx T, Kanik KS.

N Engl J Med. 2017 19;377:1537-1550.

First-in-human randomized study of bimekizumab, a

humanized monoclonal antibody and selective dual

inhibitor of IL-17A and IL-17F, in mild

psoriasis. Glatt S, Helmer E, Haier B, Strimenopoulou

F, Price G, Vajjah P, Harari OA, Lambert J,

Shaw S.

Br J Clin Pharmacol. 2017;83(5):991-1001.

RISANKIZUMAB

P0456 Safety, efficacy and PK of a p19-directed IL-23 antibody (LY3074828) in patients with plaque psoriasis and healthy subjects MIRIKIZUMAB • Phase 1, placebo-controlled, 40 patients, 5 healthy volunteers, 12

weeks; 4% BSA, PASI 6.6

Tuttle J, et al. EADV 2016, P0456 Sponsored by Eli Lilly and Company 45

• Another a p19-directed IL-23 antibody effective in phase 1

what’s new in the treatment k, et al. eadv 2017, d3t01.1h sponsored by merck & co., inc. 84 81...

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