Taltz ® (ixekizumab) injektion

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Taltz® ▼ (ixekizumab): Kliniska prövningar om påverkan på klåda vid psoriasisartrit

Medelförändringen från baslinjen i Itch NRS (numerisk skala för klåda) vid aktiv psoriasis i kliniska prövningar finns tillgänglig.

Itch Data from Psoriatic Arthritis Clinical Trials

The safety and efficacy of ixekizumab is being evaluated in 3 phase 3, multicenter, randomized studies to assess safety and efficacy compared with placebo in patients with active PsA.1,2 Brief descriptions of the pivotal clinical trials for active PsA are provided in  .

The change from baseline to week 12 in Itch NRS was a gated secondary endpoint in SPIRIT-P1. This outcome was not tested for statistical significance, as it did not meet the threshold for testing.3

The mean change in Itch NRS from baseline at week 12 and week 24 for patients who received ixekizumab Q4W and patients who received placebo during the 24-week double-blind placebo controlled treatment period of SPIRIT-P1 and SPIRIT-P2 is included below in Table 1. Integrated data (SPIRIT-P1 and SPIRIT-P2) is shown.4

Table 1. Change From Baseline to Week 12a and Week 24 in Itch Numeric Rating Scale in SPIRIT-P1 and SPIRIT-P2 (Integrated), MMRM4

 

IXE Q4W

PBO

12 Weeks

24 Weeks

12 Weeks

24 Weeks

N=141

N=141

N=134

N=134

LSM Change From Baseline in Itch NRS (SE)

-3.1 (0.19)

-3.1 (0.21)

-0.3 (0.20)

-0.7 (0.24)

Abbreviations: IXE Q4W = Ixekizumab 80 mg every 4 weeks following 160 mg starting dose; LEI = Leeds Enthesitis Index; LSM = least-squares mean; MMRM = mixed model for repeated measures; NRS = Numeric Rating Scale; PBO = Placebo; SE= standard error.

a Itch NRS change from baseline at week 12 was a major secondary objective of SPIRIT-P1. Per multiple testing procedure, this is considered not significant, as the preceding endpoint (change in LEI) was not significant.

References

1. Nash P, Kirkham B, Okada M, et al. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomized, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389(10086):2317-2327. http://dx.doi.org/10.1016/S0140-6736(17)31429-0

2. Mease PJ, Burmester G, Moriarty SR, et al. Safety of ixekizumab during 24 weeks of treatment in subjects with active psoriatic arthritis: Integrated safety analysis of two randomized, placebo controlled, phase 3 clinical trials. Poster presented at: 2017 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting; November 3-8, 2017; San Diego, CA.

3. Mease PJ, van der Heijde D, Ritchlin CT, et al. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017;76(1):79-87. http://dx.doi.org/10.1136/annrheumdis-2016-209709

4. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5. A long-term efficacy and safety study of ixekizumab (LY2439821) in participants with active psoriatic arthritis (SPIRIT P3). ClinicalTrials.gov identifier: NCT02584855. Updated November 6, 2018. Accessed March 13, 2019. https://www.clinicaltrials.gov/ct2/show/NCT02584855?term=SPIRIT-P3&rank=1.

Glossary

bDMARD = biologic disease-modifying antirheumatic drug

NRS = numeric rating scale

PsA = psoriatic arthritis

Q4W = every 4 weeks

TNF = tumor necrosis factor

Appendix: Clinical Trials Brief Descriptions

  • SPIRIT-P1 (N=417) is a phase 3, 24-week double-blind, placebo-controlled trial with an active reference arm in patients with active PsA who are naïve to bDMARDs with an extension period of up to 3 years.3

  • SPIRIT-P2 (N=363) is a phase 3, 24-week double-blind, placebo-controlled trial in patients with active PsA and an inadequate response or intolerance to TNF inhibitor, with an extension period of up to 3 years.1

  • SPIRIT-P3 (N=570) consists of a 36-week open-label period followed by a randomized double-blind withdrawal period from week 36 to week 104. This trial is being conducted in patients naïve to bDMARDs.5

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2020 M07 06


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