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Taltz ® (ixekizumab) injection
80 mg/mL
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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.
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.
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.
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
|
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
|
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
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