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Taltz ® (ixekizumab) injektion
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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 sPGA score of ≥3, PASI score ≥12, and BSA of ≥10%. The co-primary endpoints for these trials were the proportion of subjects who achieved at least PASI75 and the proportion who achieved a sPGA of 0 (clear) or 1 (minimal).1
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 Q2W through week 12 then Q4W thereafter) in patients with baseline PASI <20 (N=475) and baseline PASI ≥20 (more severe psoriasis; N=261).2 At baseline, subjects in the integrated intent-to-treat population across all treatment groups had a median baseline PASI score of approximately 17 to 18.3
At 12 weeks, baseline psoriasis severity had no meaningful impact on the efficacy of ixekizumab treatment, shown by similar numbers of patients achieving PASI75, 90, and 100 in both patients with baseline PASI <20 and baseline PASI ≥20 (see Figure 1below). A significantly higher percentage of ixekizumab treated patients in both disease severity subgroups achieved PASI75, 90, and 100 compared to etanercept treated patients (p<.001 for all comparisons between ixekizumab and etanercept).2
Figure 1. PASI Response Rates at Week 12 by Baseline Disease Severity Subgroups: UNCOVER-2 and -3 Integrated Data, NRI Analysis2
Abbreviations: ETN = etanercept 50 mg twice weekly; IXE Q2W = ixekizumab 80 mg every 2 weeks following 160 mg starting dose; NRI = non-responder imputation; PASI = psoriasis area and severity index.
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 (see Figure 2 below).
Figure 2. UNCOVER-3: Absolute PASI Response Rates for IXE Q2W/IXE Q4W at Week 52 by Baseline PASI Score, NRI Analysis4
Abbreviations: IXE Q2W/IXE Q4W = After 160 mg starting dose, 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 = non-responder imputation; PASI = psoriasis area and severity index.
Results from UNCOVER-3 demonstrated a 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, PASI75 (by modified NRI analysis) was attained by
81.7% of patients with baseline PASI ≥20, and
79.6% of patients with baseline PASI <20.2
Ixekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.5
1. Gordon KB, Blauvelt A, Papp KA, et al. 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
2. Kemeny L, Berggren L, Dossenbach M, Dutronc Y, 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. 2018;[Epub ahead of print].1-8. http://dx.doi.org/10.1080/09546634.2018.1473551
4. Mrowietz 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. Presented at 75th Annual Meeting of the American Academy of Dermatology, Orlando, FL; March 3-7, 2017.
BSA = body surface area
NRI = nonresponder imputation
PASI = Psoriasis Area and Severity Index
PASI75 = 75% improvement from baseline in Psoriasis Area and Severity Index
PASI90 = 90% improvement from baseline in Psoriasis Area and Severity Index
PASI100 = 100% improvement from baseline in Psoriasis Area and Severity Index
Q2W = every 2 weeks
Q4W = every 4 weeks
sPGA = static Physician Global Assessment
Datum fӧr senaste ӧversyn 2018 M11 16