Taltz® (Ixekizumab)

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Ixekizumab: Comparison With Ustekinumab in Plaque Psoriasis and Psoriatic Arthritis

In a head-to-head study, ixekizumab was superior to ustekinumab in achievement of the primary endpoint of PASI 90 at week 12. No head-to-head study of ixekizumab and ustekinumab has been conducted in psoriatic arthritis.

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Ixekizumab and Ustekinumab Head-to-Head Study in Plaque Psoriasis

Trial Overview

  • IXORA-S was a 52-week, head-to-head trial that compared the efficacy and safety of ixekizumab and ustekinumab in patients with moderate-to-severe plaque psoriasis. The primary objective was achieved demonstrating noninferiority and superiority of ixekizumab to ustekinumab, as measured by the proportion of patients achieving PASI 90 at week 12.1

Efficacy

PASI 90 Response Rates Through Week 52, ITT Population, NRI shows a significantly greater percentage of patients treated with ixekizumab achieved PASI 90, compared with those treated with ustekinumab, as early as week 4 and at all subsequent time points, including the primary endpoint of week 12.1

PASI 75 and PASI 100 Response Rates Through Week 52, ITT Population, NRI includes results for PASI 75 and PASI 100 through week 52 in the ixekizumab and ustekinumab treatment groups, respectively.1

Analyses at time points other than week 12, and the NAPSI analyses included in this response, were not adjusted for multiplicity.

PASI 90 Response Rates Through Week 52, ITT Population, NRI1

Abbreviations: ITT = intent-to-treat; IXE = ixekizumab 160-mg starting dose followed by 80 mg every 2 weeks for the first 12 weeks and every 4 weeks through week 52; NRI = nonresponder imputation; PASI 90 = 90% improvement from baseline in Psoriasis Area and Severity Index; UST = 45 mg ustekinumab given as subcutaneous injection for participants with body weight ≤100 kg and 90 mg subcutaneous injection for participants with body weight >100 kg at weeks 0, 4, 16, 28, and 40.

† p<.01 vs UST; ‡ p<.001 vs UST based on Fisher’s exact test.

PASI 75 and PASI 100 Response Rates Through Week 52, ITT Population, NRI1

Abbreviations: ITT = intent-to-treat; IXE = ixekizumab 160-mg starting dose followed by 80 mg every 2 weeks for the first 12 weeks and every 4 weeks through week 52; NRI = nonresponder imputation; PASI = Psoriasis Area and Severity Index; UST = 45 mg ustekinumab given as subcutaneous injection for participants ≤100 kg and 90 mg subcutaneous injection for participants >100 kg at weeks 0, 4, 16, 28, and 40.

* p<.05 vs UST; † p<.01 vs UST; ‡ p<.001 vs UST based on Fisher’s exact test.

Efficacy in Nail Involvement

Patients in IXORA-S with baseline fingernail involvement (NAPSI >0) were assessed for improvements in NAPSI scores across 52 weeks of treatment. Each fingernail was scored for bed and matrix psoriasis; then scores were added to obtain total NAPSI fingernail scores ranging from 0 (no nail psoriasis) to 80 (severe nail psoriasis).2

Progressive improvement in NAPSI scores was observed in both groups, with complete resolution of nail psoriasis occurring in a significantly greater percentage of patients treated with ixekizumab compared with ustekinumab at week 16 (p=.02) and through week 52 (p<.001) as shown in Efficacy in Nail Lesions at Weeks 16 and 52 in Patients With Baseline Fingernail Psoriasis.2

Efficacy in Nail Lesions at Weeks 16 and 52 in Patients With Baseline Fingernail Psoriasis2,3

 

Ustekinumab

Ixekizumab

Patients with NAPSI >0, n (%) 

105 (63.3) 

84 (61.8) 

Baseline NAPSI total score, mean (SD) 

24.8 (20.0) 

28.3 (19.9) 

Week 16 NAPSI = 0 by NRI, n (%)

17 (16.2)

26 (31.0)a

Week 52 NAPSI = 0 by NRI, n (%)

30 (28.6)

52 (61.9)b

NAPSI change from baseline at week 52 by mBOCF, LSM (95% CI)

-15.6 (-17.8, -13.4)

-22.4 (-24.8, -20.0)b

Abbreviations: LSM = least squares mean; mBOCF = modified baseline observation carried forward; NAPSI = nail psoriasis severity index; NRI = nonresponder imputation; UST = ustekinumab.

ap=.02 vs UST.

bp<.001 vs UST.

Safety

Through 52 weeks of treatment, no deaths were reported in either treatment group.1

Treatment-Emergent Adverse Events Reported in IXORA-S After 52 Weeks of Treatment1

 

Ustekinumab

(N=166)

n (%)

Ixekizumab

(N=135)a

n (%)

P Value

TEAEs

139 (83.7)

117 (86.7)

0.519

SAEs

14 (8.4)

10 (7.4)

0.832

AEs leading to discontinuation

2 (1.2)b

3 (2.2)c

0.660

Abbreviations: AE = adverse event; IXE = ixekizumab; SAE = serious adverse event; TEAE = treatment-emergent adverse event.

aOne patient was randomized to the IXE group in error but not treated, as the patient was found to meet one of the exclusion criteria.

bPulmonary mass (n=1), transaminase increased (n=1).

cDepression (n=1), exposure during pregnancy (n=1), injection-site hypersensitivity (n=1).

Ixekizumab and Ustekinumab in Psoriatic Arthritis: Lack of Head-to-Head Data

Lilly has not completed studies to compare the safety and efficacy of ixekizumab to that of ustekinumab in patients with PsA.

Since clinical trials are conducted under widely varying and controlled conditions, efficacy outcomes and adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Additional Information

Ixekizumab is an IgG4 mAb that binds with high affinity (<3pM) and specificity to IL-17A, a proinflammatory cytokine. Elevated levels of IL-17A have been implicated in the pathogenesis of a variety of autoimmune disease. In psoriasis, the IL-17A ligand plays a major role in driving excess keratinocyte proliferation and activation. Neutralization of IL-17A by ixekizumab inhibits these actions. Ixekizumab does not bind to ligands IL-17B, IL-17C, IL-17D, IL-17E or IL-17F.4

Ustekinumab is a human IgG1mAb that binds with specificity to the p40 protein, a subunit of both the IL-12 and IL-23 cytokines. Interleukin-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as NK cell activation.5

References

1Reich K, Pinter A, Lacour JP, et al; IXORA-S Investigators. Comparison of ixekizumab with ustekinumab in moderate-to-severe psoriasis: 24-week results from IXORA-S, a phase III study. Br J Dermatol. 2017;177(4):1014-1023. https://doi.org/10.1111/bjd.15666

2Wasel N, Thaçi D, French LE, et al. Ixekizumab and ustekinumab efficacy in nail psoriasis in patients with moderate-to-severe psoriasis: 52-week results from a phase 3, head-to-head study (IXORA-S). Dermatol Ther (Heidelb). 2020;10(4):663-670. https://doi.org/10.1007/s13555-020-00383-x

3Wasel N, Dutronc Y, Schinzel B, Lacour JP. 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. Abstract presented at: 27th Congress of the European Academy of Dermatology and Venereology (EADV); September 12-16, 2018; Paris, France.

4Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5Ustekinumab. Micromedex Health Solutions. Accessed November 6, 2017. http://www.micromedexsolutions.com/

Glossary

IgG1 = immunoglobulin G subclass 1

IgG4 = immunoglobulin G subclass 4

IL = interleukin

Lilly = Eli Lilly and Company

mAb(s) = monoclonal antibody

NAPSI = Nail Psoriasis Severity Index

NK = natural killer

PASI 90 = 90% improvement from baseline in Psoriasis Area and Severity Index

PsA = psoriatic arthritis

Q2W = every 2 weeks

Q4W = every 4 weeks

TEAE = treatment-emergent adverse event

Fecha de la última revisión: 2021 M02 09


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