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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.
How do you restart Taltz® (ixekizumab) treatment following discontinuation in patients with psoriasis?
Once patients relapsed in the randomized withdrawal period of UNCOVER-1 and -2, they were retreated with ixekizumab 80 mg every 4 weeks without repeating the 160-mg starting dose.
Dosing to Restart Ixekizumab Following Treatment Discontinuation
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 as follows), response (both initial and regained response) was defined as a static Physician Global Assessment (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 UNCOVER-2), patients who were originally randomized to receive ixekizumab and who responded to treatment at week 12 were rerandomized to receive an additional 48 weeks of ixekizumab 80 mg every 4 weeks (Q4W), ixekizumab 80 mg every 12 weeks, or placebo.2
In those week 12 responders to ixekizumab who were rerandomized to treatment withdrawal (ie, placebo), 7% maintained their clinical response at week 60.2 The median time to relapse was 164 days in the integrated trials.1 Once patients relapsed, they were retreated with ixekizumab 80 mg Q4W without repeating the 160-mg starting dose.3 Induction (UNCOVER-1, -2, -3) and Maintenance (UNCOVER-1, -2) Dosing Period Study Designs illustrates the clinical trial design of UNCOVER-1 and -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
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; 2021.
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. https://doi.org/10.1111/jdv.14163
Appendix: Brief Description of the UNCOVER Clinical Trials
Figure 1 description: Patients were randomized to 12 weeks of treatment with placebo, etanercept 50 mg twice weekly, or ixekizumab 80 mg every 2 weeks or every 4 weeks following a 160-mg starting dose. After week 12, responders were rerandomized to placebo or ixekizumab 80 mg every 4 weeks or every 12 weeks and nonresponders received ixekizumab 80 mg every 4 weeks.
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 rerandomized to receive IXE Q4W, IXE Q12W, or PBO.
Nonresponders 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.
Nonresponders 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.
Date of Last Review: January 26, 2022