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.

TALTZ® (ixekizumab):Dose when Re-starting Treatment for Plaque Psoriasis Following Prior Discontinuation

Data are available from Phase 3 clinical trials on re-starting Taltz (ixekizumab) following treatment discontinuation and subsequent relapse.

US_cFAQ_IXE302_DOSING_RESTART_FOLLOWING_DISCONTINUATION_PLAQUE_PSORIASIS
US_cFAQ_IXE302_DOSING_RESTART_FOLLOWING_DISCONTINUATION_PLAQUE_PSORIASIS
en-US

Detailed Information

  • Ixekizumab prescribing information does not include specific recommendations for reinitiating the dose when restarting ixekizumab following prior discontinuation or prolonged interruption of treatment.1
  • For the analyses summarized below, response (both initial and regained 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
  • Among the patients who relapsed and were retreated, within 12 weeks of restarting treatment with ixekizumab 80 mg Q4W, 66% regained a response of sPGA (0,1).1

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.

2Gordon 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

3Blauvelt 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

4Gordon 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

Appendix A: Brief Description of the UNCOVER Clinical Trials

Induction (UNCOVER-1, -2, -3) and Maintenance (UNCOVER-1, -2) Dosing Period Study Designs4

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

Q4W = every 4 weeks

Q12W = every 12 weeks

sPGA = static Physician Global Assessment

Date of Last Review: March 13, 2019


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