Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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Taltz®▼ (ixekizumab): Effektivitet vid återinsättning för plackpsoriasis

Sextiosex procent av ixekizumab responders som slutade behandlingen och sedan återfallit fick kliniskt svar inom 12 veckor efter omstart med ixekizumab vid 80 mg Q4W.

Detailed Information

 Some of the dosing schedules mentioned in this document are not consistent with the approved dosing schedule for plaque psoriasis in the Taltz summary of product characteristics. Please refer to the Taltz summary of product characteristics for approved dosing.1

  • For the analyses summarized below, response was defined as a sPGA score of 0 (clear skin) or 1 (minimal) and relapse was defined as a sPGA score of >3.2

  • In 2 phase 3 clinical trials (UNCOVER-1 and -2), patients who were originally randomized to ixekizumab and who responded to treatment at week 12 were re-randomized to an additional 48 weeks of ixekizumab 80 mg Q4W, ixekizumab 80 mg Q12W, or placebo.2

  • In those week 12 responders to ixekizumab who were re-randomized to treatment withdrawal (ie, placebo), 7% maintained their clinical response at week 60.2 For sPGA (0,1) responders at Week 12 re-randomised to treatment withdrawal (i.e., placebo), the median time to relapse (sPGA ≥ 3) was 164 days in integrated UNCOVER-1 and UNCOVER-2 studies.1 Once patients relapsed, they were retreated with ixekizumab 80 mg Q4W without repeating the 160 mg starting dose.3 Clinical trial design is illustrated in Figure 3

  • Among the retreated patients, within 12 weeks of restarting treatment with ixekizumab 80 mg Q4W

    • 66% regained a response of sPGA (0,1), and

    • 80% regained PASI 75 (see Figure 1 below).3

  • Based on the results, the authors of the poster presentation concluded that if it is necessary to interrupt therapy during routine clinical practice, and should retreatment with ixekizumab become necessary, it is safe and effective to do so.4

Figure 1. Retreatment Results (sPGA and PASI) in Patients who Restarted on Ixekizumab Q4W after Previous Week 12 Response to Ixekizumab Q2W and Subsequent Discontinuation and Relapse3,4

Abbreviations: IXE Q2W = ixekizumab 80 mg every 2 weeks following 160 mg starting dose; IXE Q4W = ixekizumab 80 mg every 4 weeks; PASI = Psoriasis Area and Severity Index; PBO = placebo; sPGA = static Physician Global Assessment.

Disease Severity at Retreatment

  • As shown in Figure 2, patients with lower disease severity at the time of retreatment had numerically better responses to retreatment with ixekizumab 80 mg Q4W than patients with higher disease severity at the start of retreatment.5

Figure 2. PASI 90 and PASI 100 Responses After 24 Weeks of Retreatment by Disease Severity at Retreatment5

Abbreviations: PASI = Psoriasis Area and Severity Index.

References

1. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375:345-356. http://dx.doi.org/10.1056/NEJMoa1512711

3. Blauvelt A, Papp KA, Sofen H, et al. Continuous dosing versus interrupted therapy with ixekizumab: An integrated analysis of two phase 3 trials in psoriasis. J Eur Acad Dermatol Venereol. 2017;31(6):1004-1013. http://dx.doi.org/10.1111/jdv.14163

4. Yosipovitch G, Blauvelt A, Papp K, et al. Impact of ixekizumab treatment withdrawal and retreatment on skin symptoms: Results from UNCOVER-1 and UNCOVER-2, two randomized phase 3 trials. Presented at 25th Congress of the European Academy of Dermatology and Venereology, Vienna, Austria; Sep 29-Oct 2, 2016.

5. Leonardi C, Mrowietz U, See K, et al. The association between disease severity at time of retreatment and probability of recapture in psoriasis patients receiving ixekizumab. Poster presented at: 77th Annual Meeting of the Society for Investigative Dermatology; May 8-11, 2019; Chicago, IL.

Appendix A: Clinical Trial Design

Figure 3. Induction (UNCOVER-1, -2, -3) and Maintenance (UNCOVER-1, -2) Dosing Period Study Designs2

Abbreviations: ETN = etanercept; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; IXE Q12W = ixekizumab 80 mg every 12 weeks; PBO = placebo; R = randomization; sPGA = static Physician Global Assessment.

Notes:
ETN arm was not included in UNCOVER-1.

Responders (sPGA 0 or 1) to ixekizumab at week 12 were re-randomized to receive IXE Q4W, IXE Q12W, or PBO.

Non-responders to ETN at week 12 in UNCOVER-2 were switched to IXE Q4W (without a 160 mg starting dose) after a 4-week washout period.

Non-responders to PBO at week 12 received a 160 mg starting dose of ixekizumab followed by IXE Q4W.

(dotted line) = relapse (sPGA≥3).

UNCOVER-3 is not represented in maintenance period design as the extension period consisted of open-label treatment with IXE Q4W.

Glossary

PASI 75 = 75% improvement from baseline in Psoriasis Area and Severity Index

Q4W = every 4 weeks

Q12W = every 12 weeks

sPGA = static Physician Global Assessment

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 2019 M07 18


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