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Taltz ® (ixekizumab) injection
80 mg/mL
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.
Can Taltz® (ixekizumab) maintain long-term response in plaque psoriasis?
Long-term efficacy results in moderate-to-severe plaque psoriasis for ixekizumab treatment from UNCOVER-1 and -3 are included in this response.
Detailed Information
All 3 pivotal UNCOVER psoriasis clinical trials evaluated long-term efficacy of ixekizumab for up to a total of 5 years in patients who participated through the entire studies.1,2
UNCOVER-1 and -2: Efficacy Through Week 264
illustrates Psoriasis Area and Severity Index (PASI) and static Physician Global Assessment (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 nonresponder imputation (NRI) method, missing data were considered nonresponders if patients discontinued treatment because of lack of efficacy, inadequate response, or adverse events (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 every 4 weeks (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, among patients treated with the recommended dosing of ixekizumab every 2 weeks for the first 12 weeks, followed by Q4W thereafter, 75% attained or maintained sPGA (0,1).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 because of 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
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Gordon 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
2Griffiths CEM, Reich K, Lebwohl M, et al; UNCOVER-2, UNCOVER-3 Investigators. 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. https://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: a 5-year analysis of the UNCOVER-3 randomized controlled trial. J Am Acad Dermatol. 2020;85(2):360-368. https://doi.org/10.1016/j.jaad.2020.11.022
8Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: November 28, 2023