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Taltz ® (ixekizumab) injection
80 mg/mLThis 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
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
- 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 The median time to relapse was 164 days.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 Induction (UNCOVER-1, -2, -3) and Maintenance (UNCOVER-1, -2) Dosing Period Study Designs.
- 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
Enclosed Prescribing Information
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
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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