Skip To Main Content
Lilly
Menu closed
Lilly
  • Account Login / Register
  • Medical Home
    • Medical Information
  • Medical Education
  • Science
Ask Lilly

We're here to help.

Chat
Chat with us Chat with us
Question Contact Us
Expand contact lilly
Lilly

You are now leaving the LillyMedical.com website

The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.
Click "Continue" to proceed or "Return" to return to LillyMedical.com.

  1. Medical Information Right
  2. Immunology Right
  3. Taltz (ixekizumab) injection Right
  4. TALTZ® (ixekizumab): Comparison With Ustekinumab in Plaque Psoriasis and Psoriatic Arthritis
Search Taltz (type in keywords)
Search Medical Information

If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)

Loading icon

Taltz ® (ixekizumab) injection

80 mg/mL

Full Prescribing Information

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

TALTZ® (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.

US_cFAQ_IXE303_COMPARISON_STELARA_PsO_PsA
US_cFAQ_IXE303_COMPARISON_STELARA_PsO_PsA
en-US

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

Treatment-Emergent Adverse Events Reported in IXORA-S After 52 Weeks of Treatment presents TEAEs reported through 52 weeks of IXORA-S.1

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 a humanized IgG4 mAb that selectively binds with the IL-17A cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine involved in normal inflammatory and immune responses. Ixekizumab inhibits the release of proinflammatory cytokines and chemokines.4

Ustekinumab is a human IgG1Ⱪ mAb 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

Enclosed Prescribing Information

TALTZ® (ixekizumab) injection, for subcutaneous administration, Lilly

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

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.

4Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.

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

Date of Last Review: February 09, 2021

Are you satisfied with this content?

Can't find what you're looking for? Contact us for answers to your medical questions.

  • Copyright
  • Terms of Use
  • Privacy Statement
  • Accessibility Statement
  • Sitemap

    This site is intended for US Healthcare Professionals only.

    4.0.17 02/2023 | GLOOTH00001 04/2015 | © Lilly USA, LLC 2023. All rights reserved.

    Product names listed above are trademarks or registered trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates

    facebook twitter linkedin
    visit www.phactmi.org
    Lilly