Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Taltz® (ixekizumab): Underhåll av svar vid plackpsoriasis

Resultat av långsiktig effekt vid måttlig till svår plackpsoriasis för behandling med ixekizumab från UNCOVER-1 och -3 ingår i detta svar.

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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

Of 591 subjects who received ixekizumab Q2W during the Induction Period then Q4W afterward in study UNCOVER‑1, UNCOVER‑2, and UNCOVER‑3,

  • 427 subjects completed 5 years of ixekizumab treatment,
  • among those 101 patients required a dose escalation.3

Among the patients who completed the Week 264 assessment (N=427),

  • 295 patients (69%),
  • 289 patients (68%) and
  • 205 patients (48%)

were observed to have sPGA (0,1), PASI 90 and PASI 100 response, respectively, at Week 264.3

UNCOVER-1 and -2: 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.4

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.4
UNCOVER-1 and -2: Ixekizumab PASI and sPGA Response Rates Through 5 Years of Treatment, Approved Dosing Regimen Population, mNRI4

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 264

UNCOVER-3 efficacy and safety data through 108 weeks, 156 weeks, and 204 weeks have been previously reported.5-7

UNCOVER-3: PASI Responses by Treatment Week, ITT Population, NRI 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.8

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.8

UNCOVER-3: PASI 75, PASI 90, and PASI 100 Response Rates Through Week 264, Approved Dosing Regimen Population, Observed Data, MI, and mNRI8,9

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; 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

3Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland

4Leonardi 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

5Blauvelt 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

6Leonardi 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

7Lebwohl 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

8Blauvelt 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. Published online November 27, 2020. https://doi.org/10.1016/j.jaad.2020.11.022

9Data 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

Datum fӧr senaste ӧversyn 2020 M12 03


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