Taltz® (Ixekizumab)

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Ixekizumab: Maintenance of Response in Plaque Psoriasis

Los resultados de eficacia a largo plazo en psoriasis en placas de moderada a grave para el tratamiento con ixekizumab del UNCOVER-1 y -3 se incluyen en esta respuesta.

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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: Efficacy Through Week 264

UNCOVER-1 and -2: Ixekizumab PASI and sPGA Response Rates Through 5 Years of Treatment, Approved Dosing Regimen Population, mNRI 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-1 and -2: Ixekizumab PASI and sPGA Response Rates Through 5 Years of Treatment, Approved Dosing Regimen Population, mNRI3

Abbreviations: IXE Q2W = ixekizumab every 2 weeks; IXE Q4W = ixekizumab every 4 weeks; mNRI = modified nonresponder imputation; PASI = Psoriasis Area and Severity Index; PASI 75 = 75% improvement from baseline in Psoriasis Area and Severity Index; PASI 90 = 90% improvement from baseline in Psoriasis Area and Severity Index; PASI 100 = 100% improvement from baseline in Psoriasis Area and Severity Index; sPGA = static Physician Global Assessment.

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 (UNCOVER-3: PASI Responses by Treatment Week, ITT Population, NRI). 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: PASI Responses by Treatment Week, ITT Population, NRI1

Abbreviations: ITT = intent to treat; IXE Q2W = ixekizumab every 2 weeks; IXE Q4W = ixekizumab every 4 weeks; NRI = nonresponder imputation; PASI = Psoriasis Area and Severity Index; PASI 75 = 75% improvement from baseline in Psoriasis Area and Severity Index; PASI 90 = 90% improvement from baseline in Psoriasis Area and Severity Index; PASI 100 = 100% improvement from baseline in Psoriasis Area and Severity Index.

UNCOVER-3: Efficacy Through Week 204

UNCOVER-3 efficacy and safety data through 108 weeks, 156 weeks, and 204 weeks have been previously reported.4-6 UNCOVER-3: PASI 75, PASI 90, and PASI 100 Response Rates Through Week 264, Approved Dosing Regimen Population, Observed Data, MI, and mNRI 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.4

UNCOVER-3: PASI 75, PASI 90, and PASI 100 Response Rates Through Week 264, Approved Dosing Regimen Population, Observed Data, MI, and mNRI7,8

Abbreviations: IXE = ixekizumab; MI = multiple imputation; mNRI = modified nonresponder imputation; PASI 75 = 75% improvement from baseline in Psoriasis Area and Severity Index; PASI 90 = 90% improvement from baseline in Psoriasis Area and Severity Index; PASI 100 = 100% improvement from baseline in Psoriasis Area and Severity Index; Q2W = every 2 weeks; Q4W = every 4 weeks.

References

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.

Glossary

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

Fecha de la última revisión: 2020 M12 03


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