PowerPoint Presentation


Efficacy of Ixekizumab in Patients Previously Treated with IL-17 Inhibitors

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

BACKGROUND
 Previous use of biologics may detrimentally impact 

the efficacy of subsequent biologic therapies1,2
 Ixekizumab is a high-affinity monoclonal antibody 

that selectively targets IL-17A3
− Is approved for treating moderate-to-severe 

plaque psoriasis

OBJECTIVE
 To evaluate the impact of previous use of 

biologics, particularly those targeting the IL-17 
pathway (brodalumab [IL-17RA antagonist] or 
secukinumab [IL-17A antagonist]), on the 
52-week efficacy of ixekizumab (IL-17A antagonist) 
in patients with moderate-to-severe psoriasis

METHODS

PASI 75 Response at Week 52 by Previous IL-17 
Inhibitor Exposure
NRI, Blinded Treatment Dosing Period, ITT Population 

CONCLUSIONS
 Previous exposure to biologics, including those 

targeting the IL-17 pathway (brodalumab or 
secukinumab), did not impact the 52-week 
efficacy of ixekizumab

KEY RESULTS

References
1. Ruiz Salas V, et al. J Eur Acad Dermatol Venereol. 

2012;26:508-513.
2. Mazzotta A, et al. Am J Clin Dermatol. 

2009; 10:319-324.
3. Liu L, et al. J Inflamm Res. 2016;9:39-50.

Baseline Demographics and Disease Characteristics by Previous IL-17 
Inhibitor Exposure 

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Disclosures
 K. A. Papp has served as a speaker, advisor, and/or 

received grant/research support from: 3M, 
Abbott/AbbVie, Akesis, Akros, Allergan, Alza, Amgen, 
Anacor, Applied Molecular Evolution, Astellas, Baxter, 
Bayer, Boehringer Ingelheim, Celgene, Celtic, 
Centocor, Cipher, Coherus, Dermira, Dow Pharma, Eli 
Lilly and Company, Forward Pharma, Funxional
Therapeutics, Galderma, Genentech, 
GlaxoSmithKline, Isotechnika, Janssen, Janssen 
Biotech (Centocor), Johnson & Johnson, Kyowa Hakko 
Kirin, Leo Pharma, Lypanosys, MedImmune, Meiji 
Seika Pharma, Merck, Merck Serono, Mitsibushi
Pharma, Mylan, Novartis, PanGenetics, Pfizer, 
Regeneron Pharmaceuticals, Roche, Stiefel, Sosei, 
Takeda, UCB, Vertex, Wyeth, and Xoma
 This study was sponsored by Eli Lilly and Company. 

Medical writing assistance was provided by Luke 
Carey, PhD, of ProScribe – part of the Envision 
Pharma Group, and was funded by Eli Lilly and 
CompanySafety Overview by Previous IL-17 Inhibitor Exposure - Blinded Treatment Dosing Period, Safety Population 

Kim A. Papp,1 Andrew Blauvelt,2 John Sullivan,3 Paula Polzer,4 Lu Zhang,4 Chih-Ho Hong5
1Probity Medical Research, Waterloo, Canada; 2Oregon Medical Research Center, Portland, USA;

3Kingsway Dermatology & Aesthetics, Miranda, Australia; 4Eli Lilly and Company, Indianapolis, USA; 5Probity Medical Research, Surrey, Canada

IL-17=interleukin-17; IL-17RA=interleukin-17 receptor A

Study Design - IXORA-P

a Dose-adjustment (IXE Q4W to IXE Q2W) based on whether a patient achieved sPGA ≥2 at 2 
consecutive visits during Week 12 through Week 40; investigators were blinded to the predefined criteria 
and timing
IXE=ixekizumab; IXE Q4W=80 mg IXE every 4 weeks; IXE Q2W=80 mg IXE every 2 weeks; IXE 
Q4W/IXE Q2W dose adjustment=80 mg IXE every 4 weeks/every 2 weeks; R=randomization; 
sPGA=static Physician’s Global Assessment; W=Week

R

Blinded Treatment Dosing Period

IXE Q2W (N=611)

1227
patients 

randomized
2:1:1

160-mg IXE starting dose

W0 W16 W52W40W20 W24 W32W28 W36

Dose-adjustment Per Protocola
IXE Q4W/IXE Q2W (N=306)

IXE Q4W (N=310)

Follow upScreening

AE=adverse event; IL-17=interleukin-17; IXE Q2W=80 mg ixekizumab every 2 weeks; IXE Q4W=80 mg ixekizumab every 4 weeks; SAE=serious adverse event; TEAE=treatment-emergent adverse event

Data are mean (standard deviation) unless otherwise stated
BSA=body surface area; IL-17=interleukin-17; PASI=Psoriasis Area and Severity Index

IL-17 Inhibitor Naïve
(N=939)

IL-17 Inhibitor 
Experienced

(N=288)

Age, years 48.1 (13.6) 46.6 (13.1)
Male, n (%) 609 (64.9) 201 (59.8)
Weight, kg 91.1 (23.7) 89.9 (22.5)
Psoriasis duration, years 18.5 (12.5) 22.2 (12.9)
Percentage of BSA involved 26.1 (17.4) 27.5 (18.0)
Previous biologic therapy, n (%) 284 (30.2) 288 (100.0)

Used 1 186 (19.8) 197 (68.4)
Used 2 58 (6.2) 62 (21.5)
Used ≥3 40 (4.3) 29 (10.1)

Previous secukinumab therapy, n (%) 0 13 (4.5)
Previous brodalumab therapy, n (%) 0 277 (96.2)
PASI 20.1 (8.0) 21.2 (9.0)

*

* p<.05 vs. IXE Q4W (Fisher’s exact test)
CI=confidence interval; IL-17=interleukin-17; ITT=Intent-to-Treat; IXE 
Q2W=80 mg ixekizumab every 2 weeks; IXE Q4W=80 mg ixekizumab
every 4 weeks; NRI=non-responder imputation; PASI=Psoriasis Area 
and Severity Index

 Ixekizumab showed efficacy in patients regardless of previous exposure to an IL-17 inhibitor biologic

PASI 90 Response at Week 52 by Previous IL-17 
Inhibitor Exposure 
NRI, Blinded Treatment Dosing Period, ITT Population 

*
‡†

80

45 42
51 47

61 58

66 64
75 73

79
81

76
82

86 85 87

†
†

* p<.05 vs. IXE Q4W; † p<.01 vs. IXE Q4W; ‡ p<.001 vs. IXE 
Q4W (Fisher’s exact test)
CI=confidence interval; IL-17=interleukin-17; ITT=Intent-to-Treat; 
IXE Q2W=80 mg ixekizumab every 2 weeks; IXE Q4W=80 mg 
ixekizumab every 4 weeks; NRI=non-responder imputation; 
PASI=Psoriasis Area and Severity Index

 Ixekizumab showed efficacy in patients 
regardless of previous exposure to a biologic

PASI Responses at Week 52 by Previous Biologic 
Exposure 
NRI, Blinded Treatment Dosing Period, ITT Population 

* p<.05 vs. IXE Q4W; ‡ p<.001 vs. IXE Q4W (Fisher’s exact test)
CI=confidence interval; IL-17=interleukin-17; ITT=Intent-to-Treat; IXE 
Q2W=80 mg ixekizumab every 2 weeks; IXE Q4W=80 mg ixekizumab
every 4 weeks; NRI=non-responder imputation; PASI=Psoriasis Area 
and Severity Index

PASI 100 Response at Week 52 by Previous IL-17 Inhibitor Exposure 
NRI, Blinded Treatment Dosing Period, ITT Population 

* p<.05 vs. IXE Q4W; ‡ p<.001 vs. IXE Q4W (Fisher’s exact test)  
CI=confidence interval; IL-17=interleukin-17; ITT=Intent-to-Treat; IXE Q2W=80 mg ixekizumab every 2 weeks; IXE Q4W=80 mg ixekizumab
every 4 weeks; NRI=non-responder imputation; PASI=Psoriasis Area and Severity Index

n (%)
IXE Q4W IXE Q2W

Naïve
(n=243) 

Experienced
(n=67)

Naïve
(n=233)

Experienced
(n=73)

Naïve 
(n=461)

Experienced
(n=148)

≥1 TEAE 202 (83.1) 45 (67.2) 180 (77.3) 50 (68.5) 346 (75.1) 201 (69.8)
Death 1 (0.4) 0 0 0 2 (0.4) 0
≥1 SAE 13 (5.3) 3 (4.5) 12 (5.2) 4 (5.5) 25 (5.4) 7 (4.7)
Discontinuation due to AE 5 (2.1) 1 (1.5) 10 (4.3) 3 (4.1) 13 (3.0) 5 (3.4)
Infections 135 (55.6) 31 (46.3) 120 (51.5) 30 (41.1) 211 (45.8) 67 (45.3)
Injection-site reactions 27 (11.1) 4 (6.0) 15 (6.4) 3 (4.1) 66 (14.3) 12 (8.1)
Allergic reactions/hypersensitivities 24 (9.9) 4 (6.0) 22 (9.4) 3 (4.1) 53 (11.5) 6 (4.1)
Depressions 4 (1.6) 1 (1.5) 3 (1.3) 1 (1.4) 8 (1.7) 4 (2.7)
Cerebrocardiovascular events 2 (0.8) 1 (1.5) 2 (0.9) 0 9 (0.2) 0
Inflammatory bowel disease 1 (0.4) 0 1 (0.4) 0 3 (0.7) 1 (0.7)
Malignancies 2 (0.8) 0 5 (2.1) 1 (1.4) 0 2 (1.4)

IXE Q4W/ IXE Q2W


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