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Taltz ® (ixekizumab) injection80 mg/mL
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TALTZ® (ixekizumab): Maintenance of Response in Psoriasis
Long-term efficacy results in moderate-to-severe plaque psoriasis for ixekizumab treatment from UNCOVER-1 and -3 are included in this response.
UNCOVER-1 and -2: Efficacy Through Week 264
illustrates PASI and sPGA response rates in UNCOVER-1 and -2 through 264 weeks of treatment for patients receiving the recommended ixekizumab dosing regimen for moderate-to-severe plaque psoriasis. For the modified NRI method, missing data were considered nonresponders if patients discontinued treatment due to lack of efficacy, inadequate response, or AEs and imputed using multiple imputation in all other cases.3
Through 5 years of treatment in UNCOVER-1 and -2, the authors concluded that
- high-efficacy responses with the ixekizumab-approved dosing regimen were maintained with long-term treatment in patients with moderate-to-severe plaque psoriasis, and
- the safety profile of ixekizumab remained consistent with previous data.3
UNCOVER-3: Efficacy Through Week 60
In UNCOVER-3, patients who completed the 12-week randomized induction period were able to continue to the open-label, long-term extension and received ixekizumab Q4W from weeks 12 to 60.1
High rates of response observed at week 12 were generally maintained over the long-term extension period to week 60 (). At week 60, the percentage of patients treated with the recommended dosing of ixekizumab Q2W for the first 12 weeks, followed by Q4W thereafter, attaining or maintaining sPGA (0,1) was 75%.1
UNCOVER-3: Efficacy Through Week 264
UNCOVER-3 efficacy and safety data through 108 weeks, 156 weeks, and 204 weeks have been previously reported.4-6 presents the UNCOVER-3 PASI response rates through 264 weeks for patients receiving the approved ixekizumab dosing regimen. Missing data were imputed using multiple imputation, where the missing data were handled by estimating what the observations would have been if the patient continued with the hypothetical treatment, and the modified NRI method, where missing data were considered nonresponders if patients discontinued treatment due to AEs, lack of efficacy, or relapse and imputed using multiple imputation in all other cases.7
Through 5 years of treatment in UNCOVER-3, the authors concluded that ixekizumab demonstrated sustained efficacy and a consistent safety profile in patients receiving the approved dosing regimen.7
Enclosed Prescribing Information
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Gordon 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
2Griffiths CEM, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015;386(9993):541-551. http://dx.doi.org/10.1016/S0140-6736(15)60125-8
3Leonardi C, Reich K, Foley P, et al. Efficacy and safety of ixekizumab through 5 years in moderate-to-severe psoriasis: long-term results from the UNCOVER-1 and UNCOVER-2 phase 3 randomized controlled trials. Dermatol Ther (Heidelb). 2020;10(3):431-447. http://dx.doi.org/10.1007/s13555-020-00367-x
4Blauvelt A, Gooderham M, Iversen L, et al. Efficacy and safety of ixekizumab for the treatment of moderate-to-severe plaque psoriasis: results through 108 weeks of a randomized, controlled phase 3 clinical trial (UNCOVER-3). J Am Acad Dermatol. 2017;77(5):855-862. http://dx.doi.org/10.1016/j.jaad.2017.06.153
5Leonardi C, Maari C, Philipp S, et al. Maintenance of skin clearance with ixekizumab treatment of psoriasis: three-year results from the uncover-3 study. J Am Acad Dermatol. 2018;79(5):824-830.e2. http://dx.doi.org/10.1016/j.jaad.2018.05.032
6Lebwohl MG, Gordon KB, Gallo G, et al. Ixekizumab sustains high level of efficacy and favorable safety profile over 4 years in patients with moderate psoriasis: results from UNCOVER-3 study. 2020;34(2):301-309. J Eur Acad Dermatol Venereol. http://dx.doi.org/10.1111/jdv.15921
7Blauvelt A, Lebwohl MG, Mabuchi T, et al. Long-term efficacy and safety of ixekizumab: 5-year analysis of the UNCOVER-3 randomized controlled trial. J Am Acad Dermatol. Published online November 28, 2020. http://dx.doi.org/10.1016/j.jaad.2020.11.022
8Data on file, Eli Lilly and Company and/or one of its subsidiaries.
AE = adverse event
NRI = nonresponder imputation
PASI = Psoriasis Area and Severity Index
Q2W = every 2 weeks
Q4W = every 4 weeks
sPGA = static Physician Global Assessment
Date of Last Review: December 03, 2020