Taltz® (Ixekizumab)

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Does the efficacy of ixekizumab vary based on psoriasis disease severity?

More severe psoriasis (baseline PASI score of at least 20) was not associated with reduced clinical response to ixekizumab.

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Efficacy of Ixekizumab by Baseline Psoriasis Disease Severity

This medical response may not completely match the information in the current local labeling for IXEKIZUMAB. Please see local labeling for approved label information.

UNCOVER-2 and -3: Integrated Week 12 Efficacy

The disease severity subgroup analysis summarized below used integrated data from UNCOVER-2 and -3 to compare the efficacy of the approved dosing regimen of ixekizumab in patients with plaque psoriasis (starting dose of 160 mg at week 0, followed by 80 mg every 2 weeks through week 12 then 80 mg every 4 weeks thereafter) in patients with baseline Psoriasis Area and Severity Index (PASI) <20 (N=475) and baseline PASI ≥20 (more severe psoriasis; N=261).1

At baseline, subjects in the integrated intent-to-treat population across all treatment groups had a median baseline PASI score of approximately 17 to 18.2

At week 12, baseline psoriasis severity had no meaningful effect on the efficacy of ixekizumab treatment, shown by similar numbers of patients achieving 75% improvement from baseline in PASI (PASI 75), 90% improvement from baseline in PASI (PASI 90), and 100% improvement from baseline in PASI (PASI 100) in both patients with baseline PASI <20 and baseline PASI ≥20 (UNCOVER-2 and -3 Integrated Data: PASI Response Rates at Week 12 by Baseline Disease Severity Subgroups, NRI Analysis). A significantly higher percentage of ixekizumab treated patients in both disease severity subgroups achieved PASI 75, PASI 90, and PASI 100 compared to etanercept treated patients (p<.001 for all comparisons between ixekizumab and etanercept).1

UNCOVER-2 and -3 Integrated Data: PASI Response Rates at Week 12 by Baseline Disease Severity Subgroups, NRI Analysis1

Abbreviations: ETN = etanercept 50 mg twice weekly; IXE Q2W = ixekizumab 80 mg every 2 weeks following 160-mg starting dose; NRI = nonresponder imputation; PASI = Psoriasis Area and Severity Index.

Note: p<.001 for all comparisons between ixekizumab and etanercept.

UNCOVER-3: Long-term Efficacy

A pooled analysis of UNCOVER-3 data determined that at week 52 of the open-label extension period, there was not a statistically significant difference in the percentage of patients reaching absolute PASI scores of ≤1, ≤2, ≤3, or ≤5 between patients with baseline PASI <20 and PASI ≥20 (UNCOVER-3: Absolute PASI Response Rates for IXE Q2W/IXE Q4W at Week 52 by Baseline PASI Score, NRI Analysis).3

UNCOVER-3: Absolute PASI Response Rates for IXE Q2W/IXE Q4W at Week 52 by Baseline PASI Score, NRI Analysis3

Abbreviations: IXE Q2W/IXE Q4W = After 160-mg starting dose of ixekizumab, patients received ixekizumab 80 mg every 2 weeks for 12 weeks, then received ixekizumab 80 mg every 4 weeks during the open-label extension period; NRI = nonresponder imputation; PASI = Psoriasis Area and Severity Index.

Results from UNCOVER-3 demonstrated that the high level of efficacy was maintained over 156 weeks of treatment with the approved dosing regimen of ixekizumab in both baseline psoriasis severity groups. At week 156, PASI 75 (by modified nonresponder imputation analysis) was attained by

  • 81.7% of patients with baseline PASI ≥20, and
  • 79.6% of patients with baseline PASI <20.1

UNCOVER Clinical Trial Program Overview

The pivotal randomized, double-blind, placebo-controlled phase 3 trials (UNCOVER-1, -2, and -3) studied ixekizumab in patients with moderate-to-severe plaque psoriasis, defined as a static Physician Global Assessment (sPGA) score of ≥3, PASI score ≥12, and body surface area of ≥10%.4 

The co-primary endpoints for these trials were the proportion of patients who achieved at least a PASI 75 and the proportion of patients who achieved a sPGA of 0 (clear) or 1 (minimal).4

References

1Kemeny L, Berggren L, Dossenbach M, et al. Efficacy and safety of ixekizumab in patients with plaque psoriasis across different degrees of disease severity: results from UNCOVER-2 and UNCOVER-3. J Dermatolog Treat. 2019;30(1):19-26. https://dx.doi.org/10.1080/09546634.2018.1473551

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3Mrowietz U, Carrascosa JM, Peñas PF, et al. Absolute and relative psoriasis area and severity indices over 1 year of treatment with ixekizumab: a descriptive analysis in patients with moderate-to-severe plaque psoriasis. Poster presented at: 75th Annual Meeting of the American Academy of Dermatology; March 3-7, 2017; Orlando, FL. Accessed August 6, 2021. https://server.aad.org/eposters/Submissions/getFile.aspx?id=4750&type=sub

4Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and UNCOVER-3 Study Groups. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711

Fecha de la última revisión: 2021 M08 05


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