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Taltz ® (ixekizumab) injection
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 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
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
Date of Last Review: January 26, 2022