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The below information is provided in response to your request and may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above.
TALTZ® prescribing information does not contain recommendations for drug holidays in patients treated with ixekizumab. With consistent dosing, most patients maintained response at week 60 (Taltz Package Insert, 2017).
Data on stopping ixekizumab treatment after 12 weeks following clinical response, then re-starting after relapse, are described below. For these analyses, Response was defined as a static Physician Global Assessment (sPGA) score of 0 (clear) or 1(minimal) and Relapse was defined as a sPGA score of >3 (Taltz Package Insert, 2017).
Seventy-five percent of patients who responded ([sPGA] 0,1) to ixekizumab (every 2 weeks [Q2W]) at week 12 and were then re-randomized to an additional 48 weeks of ixekizumab 80 mg every 4 weeks (Q4W) consistently maintained their response at week 60 (Taltz Package Insert, 2017).
Conversely, for responders to ixekizumab Q2W at week 12 who were then re-randomized to treatment withdrawal (ie, placebo), the median time to relapse was about 5 months. Following relapse and then re-starting on ixekizumab 80mg Q4W, 66% regained their response within 12 weeks (Taltz Package Insert, 2017).
The analyses were conducted from UNCOVER-1 and UNCOVER-2 Phase 3 clinical trials. Details regarding the study designs for both the 12-week induction and 48-week maintenance periods of the phase 3 UNCOVER Clinical Trials are illustrated in Appendix A, Figure 1 (Taltz Package Insert, 2017).
Enclosed Prescribing Information
Taltz® [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
Date of Last Review: February 20, 2017