PowerPoint Presentation


Comparison of Ixekizumab and Ustekinumab Efficacy in the Treatment of Nail Lesions of 
Patients With Moderate-to-Severe Plaque Psoriasis: 52-Week Data From the IXORA-S Trial

Fall Clinical Dermatology Conference - 37th Anniversary (FallCDC); Las Vegas, NV, USA; October 18-21, 2018 Study was sponsored by Eli Lilly and Company

BACKGROUND
 Psoriasis is a chronic inflammatory disorder potentially 

affecting the skin, scalp, and nails1 
 Up to 80% of patients with psoriasis have nail 

involvement1,2
 Nail psoriasis is persistent, slow to resolve, difficult to 

treat, and results can impair daily activities3-5
 IXORA-S is a Phase 3b, multicenter trial that compared 

the efficacy of ixekizumab with ustekinumab in patients 
with moderate-to-severe psoriasis
− Ixekizumab demonstrated superior efficacy to 

ustekinumab in improving skin lesions up to Week 
526 and nail psoriasis up to Week 247

OBJECTIVE
 To evaluate the comparative efficacy of ixekizumab and 

ustekinumab in the treatment of nail psoriasis in 
patients with moderate-to-severe psoriasis in the head-
to-head IXORA-S study at 52 weeks

METHODS
Figure 1. Study Design: IXORA-S CONCLUSIONS

 Improvement in nail psoriasis lesions was observed in 
both treatment groups
in IXORA-S
 Complete resolution of nail psoriasis was seen in 

significantly greater percentages of patients treated with 
ixekizumab compared with ustekinumab from Week 16 
through Week 52 of treatment
 Results suggest that ixekizumab provides significantly 

greater clearance of nail psoriasis than ustekinumab
 Longer periods of observation will be required to 

determine if nail lesions continue to improve beyond 
52 weeks of treatment

RESULTS
Significantly More Ixekizumab-treated Patients 
Achieved PASI 90 and PASI 100 Versus Ustekinumab
From Week 4 Through Week 52 (Primary Endpoint),1  
ITT Population, NRI 

 Inclusion criteria
⎼ ≥18-years-old
⎼ Chronic plaque psoriasis for ≥6 months prior to baseline 
⎼ Failure, contraindication, or intolerance to ≥1 systemic 

therapya
⎼ Psoriasis Area and Severity Index (PASI) score ≥10 at 

screening and baseline
 Exclusion criteria
⎼ Pattern of pustular, erythrodermic, and/or guttate forms 

of psoriasis
⎼ History of drug-induced psoriasis
⎼ Received systemic non-biologic therapy or 

phototherapy for psoriasis <4 weeks before baseline, or 
have had topical psoriasis treatment <2 weeks before 
baseline

⎼ Concurrent or recent useb of any biologic agent prior to 
baseline

References
1. Manhart R, Rich P. Clin Exp Rheumatol. 2015;33(Suppl.93):

S7-S13.
2. Bardazzi F, et al. J Eur Acad Dermatol Venereol. 2017;

31:843-846.
3. Reich A, Szepietowski JC. Am J Clin Dermatol. 

2011;12:313-320.
4. Gupta AK, Cooper EA. J Cutan Med Surg. 

2009;13(Suppl.2):S102-106.
5. Tan ES, et al. Am J Clin Dermatol. 2012;13:375-388.
6. Paul C, et al. J Am Acad Dermatol. 

2018;S0190-9622:32195-32199.
7. Ghislain P-D, et al. EADV 26th Congress. 2017;P1868.

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Disclosures
 N. Wasel has provided consultancy services for: Abbott 

Laboratories, Amgen, Astellas Pharma, Biogen Idec, EMD 
Serono, Isotechnika, Janssen-Ortho, Ortho Biotech, Schering-
Plough, and Wyeth, has performed contract research for: Abbott 
Laboratories, Amgen, Astellas Pharma, Biogen Idec, Celgene 
Corp, Centocor Ortho Biotech, Eli Lilly and Company, EMD 
Serono, Isotechnika, Leo Pharma, Merck Frosst, Novartis 
Pharmaceuticals, Pfizer, Takeda, and Wyeth; Y. Dutronc is a 
current employee and stockholder of Eli Lilly and Company; B. 
Schinzel worked as a freelancer for Clinipace Worldwide to 
conduct the analysis of this study; J-P Lacour has received grants 
from: AbbVie, Boehringer, Celgene, Eli Lilly and Company, 
Janssen, Leo Pharma, Novartis, and Roche, has been a 
consultant for: AbbVie, Celgene, Eli Lilly and Company, Leo 
Pharma, and Novartis
 Lovisa Berggren of Clinipace Worldwide provided statistical 

support for this presentation
 This study was sponsored by Eli Lilly and Company. Medical 

writing services were provided by Samantha Forster, PhD, of 
ProScribe – part of the Envision Pharma Group, and were funded 
by Eli Lilly and Company

Baseline Patient Demographics and Characteristics, ITT Population With Baseline Fingernail Psoriasis

Norman Wasel,1 Yves Dutronc,2 Birgit Schinzel,3 Jean-Philippe Lacour4
1Stratica Medical and Probity Medical Research, Edmonton, Canada; 2Eli Lilly and Company, Indianapolis, USA; 

3Clinipace Worldwide, Eschborn, Germany; 4University Hospital of Nice, France

IXE=ixekizumab; R=randomization; UST=ustekinumab

aIncluding cyclosporine, methotrexate, or phototherapy; bWithin the following washout periods: etanercept <28 
days; infliximab, adalimumab, or alefacept <60 days; golimumab <90 days; rituximab <12 months; or any other 
biologic agent <5 half-lives prior to baseline

Statistical Analyses
 Categorical data

− Logistic regression with terms for treatment, weight group 
(≤100 kg, >100 kg), and geographic region at Week 52

• Fisher’s exact test used as secondary analysis and at 
other visits

• Missing data imputed using non-responder imputation
 Continuous data

− Least squares mean change from baseline NAPSI and 
95% confidence intervals for each treatment group 
compared using analysis of covariance with treatment, 
weight group (≤100 kg, >100 kg), geographic region, and 
baseline NAPSI score as factors

• Missing data imputed using baseline observation for 
patients who discontinued due to adverse events

• Last non-missing post-baseline observation carried 
forward used for patients discontinuing for other reasons 
(modified baseline observation carried forward)

 Improvement of psoriasis was observed in both 
treatment groups

* p<.05 versus UST; † p≤.001 versus UST; ‡ p<.0001 versus UST based on Fisher’s exact test 
ITT=intent-to-treat; IXE Q2W/Q4W=ixekizumab 80 mg every 2 weeks to Week 12 followed by ixekizumab 80 
mg every 4 weeks; NRI=non-responder imputation; PASI 90/100=at least 90%/100% improvement in Psoriasis 
Area and Severity Index; UST=45 mg ustekinumab for patients ≤100 kg and 90 mg ustekinumab for patients 
>100 kg at Weeks 0 and 4 and every 12 weeks thereafter per label
1.     Paul C, et al. J Am Acad Dermatol. 2018;S0190-9622:32195-32199.

Assessment of Nail Psoriasis
 The Nail Psoriasis Severity Index (NAPSI) was used to 

assess fingernail psoriasis in patients with fingernail 
psoriasis at baseline

 84 ixekizumab-treated (61.8%) and 105 ustekinumab-treated patients (63.3%) presented with fingernail psoriasis 
 Baseline demographics and characteristics of patients were similar to those of patients in the ITT population1 

− No associations between treatment and age, gender, or weight found in patients with/without fingernail psoriasis
at baseline

ITT=Intent-to-Treat; IXE Q2W/Q4W=ixekizumab 80 mg every 2 weeks to Week 12 followed by ixekizumab 80 mg every 4 weeks; NAPSI=Nail Psoriasis Severity Index; UST=45 mg ustekinumab for patients ≤100 kg and 90 mg ustekinumab
for patients >100 kg at Weeks 0 and 4 and every 12 weeks thereafter per label
1. Reich K, et al. Br J Dermatol. 2017;177:1014-1023.

UST 
(N=105) IXE Q2W/Q4W (N=84)

Age, years 45.4 (12.7) 43.0 (12.0)
Male, n (%) 80 (76.2) 60 (71.4)
Weight, kg 91.3 (24.4) 87.5 (21.7)

≤100 kg, n (%) 71 (67.6) 62 (73.8)
>100 kg, n (%) 34 (32.4) 22 (26.2)

NAPSI total score
Median
1st quartile
3rd quartile

24.8 (20.0)
20.0
9.0

34.0

28.3 (19.9)
27.0
9.0

43.5

Data are mean (standard deviation) unless otherwise specified

Baseline NAPSI Score Was Not Correlated With 
Baseline PASI Score, ITT Population With Baseline 
Fingernail Psoriasis
 No relationship between baseline NAPSI score and 

baseline PASI score was identified in either treatment group

ITT=intent-to-treat; IXE Q2W/Q4W=ixekizumab 80 mg every 2 weeks to Week 12 followed by 
ixekizumab 80 mg every 4 weeks; NAPSI=Nail Psoriasis Severity Index; PASI=Psoriasis Area and 
Severity Index; UST=45 mg ustekinumab for patients ≤100 kg and 90 mg ustekinumab for patients 
>100 kg at Weeks 0 and 4 and every 12 weeks thereafter per label

NAPSI Total Score Was Significantly Improved as 
Early as Week 16 for Ixekizumab Versus Ustekinumab
and Was Sustained Through Week 52, ITT Population 
With Baseline Fingernail Psoriasis, Observed

* p<.05; † p≤.001; ‡ p<.0001 IXE versus UST based on ANOVA with treatment, weight, geographic region, and 
baseline NAPSI score as factors
ANOVA=analysis of covariance; ITT=Intent-to-Treat; IXE Q2W/Q4W=ixekizumab 80 mg every 2 weeks to Week 
12 followed by ixekizumab 80 mg every 4 weeks; NAPSI=Nail Psoriasis Severity Index; UST=45 mg 
ustekinumab for patients ≤100 kg and 90 mg ustekinumab for patients >100 kg at Weeks 0 and 4 and every 12 
weeks thereafter per label

 Improvement of nail psoriasis was observed in both 
treatment groups

Adjusted Change From Baseline in NAPSI Total Score 
Was Significantly Greater as Early as Week 8 for 
Ixekizumab Versus Ustekinumab and Was Sustained 
Through Week 52, ITT Population With Baseline 
Fingernail Psoriasis, mBOCF

* p<.05; ‡ p<.0001 IXE versus UST based on ANOVA with treatment, weight, geographic region, and 
baseline NAPSI score as factors
ANOVA=analysis of covariance; ITT=Intent-to-Treat; IXE Q2W/Q4W=ixekizumab 80 mg every 2 weeks to 
Week 12 followed by ixekizumab 80 mg every 4 weeks; LSM=least squares mean; mBOCF; modified 
baseline observation carried forward; NAPSI=Nail Psoriasis Severity Index; UST=45 mg ustekinumab for 
patients ≤100 kg and 90 mg ustekinumab for patients >100 kg at Weeks 0 and 4 and every 12 weeks 
thereafter per label

 Improvement from baseline of nail psoriasis was 
observed in both treatment groups

Significantly More Ixekizumab-treated Patients 
Achieved Complete Resolution of Nail Psoriasis 
Versus Ustekinumab From Week 16 Through Week 52, 
ITT Population With Baseline Fingernail Psoriasis, NRI 
 Progressively more patients achieved complete 

resolution (NAPSI = 0) of nail psoriasis in both 
treatment groups

* p<.05; † p≤.001; ‡ p<.0001 IXE versus UST based on Fisher's exact test for treatment comparison
ITT=Intent-to-Treat; IXE Q2W/Q4W=ixekizumab 80 mg every 2 weeks to Week 12 followed by 
ixekizumab 80 mg every 4 weeks; NAPSI=Nail Psoriasis Severity Index; NRI=non-responder imputation; 
UST=45 mg ustekinumab for patients ≤100 kg and 90 mg ustekinumab for patients >100 kg at Weeks 0 
and 4 and every 12 weeks thereafter per label

Patients Who Achieve Low PASI Scores at Week 52 May 
Still Experience Significant Nail Involvement at Week 52, 
ITT Population With Baseline Fingernail Psoriasis

ITT=intent-to-treat; IXE Q2W/Q4W=ixekizumab 80 mg every 2 weeks to Week 12 followed by 
ixekizumab 80 mg every 4 weeks; NAPSI=Nail Psoriasis Severity Index; PASI=Psoriasis Area 
and Severity Index; UST=45 mg ustekinumab for patients ≤100 kg and 90 mg ustekinumab for 
patients >100 kg at Weeks 0 and 4 and every 12 weeks thereafter per label

 Most patients who have experienced nail improvement at 
Week 52 have also obtained low PASI


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