Journal of Clinical and Aesthetic Dermatology

MAY 2018

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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34 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY May 2018 • Volume 11 • Number 5 O R I G I N A L R E S E A R C H psoriasis spanning six months or longer. Patients were candidates for phototherapy and/or systemic therapy. Inclusion criteria also required that patients had at least a 10-percent body sur face area (BSA) involvement, a PASI score of at least 12, a sPGA score of at least 3 (6-point scale), and a PatGA score of at least 3 at baseline. Patients were excluded if they were unwilling or unable to commit to the photography schedule for the study duration, if they had a form of psoriasis other than plaque psoriasis, if they had a serious disorder or illness other than psoriasis, if they had a serious infection within three months prior to baseline, if there was evidence or suspicion of active or latent tuberculosis, or if they were women who were pregnant or lactating. Patients were also excluded if they had previously received IL-17 or IL-23 antagonists, as both agents affect similar cytokines and signaling pathways and prior exposure could potentially confound interpretation of study results. All enrolled patients provided written informed consent prior to undergoing study related procedures. For this 48-week, randomized, single- center, open-label study, patients were randomized at a ratio of 1:1 to receive 80mg of ixekizumab either ever y two (Q2W) or four (Q4W) weeks during the induction dosing period (0–12 weeks) following an initial 160mg dose of ixekizumab. All patients received 80mg ixekizumab Q4W during the maintenance dosing period (12–48 weeks), with the final dose of ixekizumab administered at Week 44. PatGA and Itch NRS were repor ted daily by patients using an electronic diar y between Weeks 0 and 2, then twice a week from Weeks 2 to 4, once a week from Weeks 4 to 12, once per month from Weeks 12 to 24, and once ever y three months from Weeks 24 to 48. Clinicians assessed sPGA and PASI during each visit at Weeks 0, 1, 2, 3, 4, 8, 12, 24, 36, and 48. The study protocol was approved by the site's institutional review board and the study was per formed in accordance with the ethical standards of the Declaration of Helsinki. Informed consent was obtained from all individual par ticipants included in the study prior to undergoing study related procedures. identifier: NCT02387801. FIGURE 1. Rapid onset of clinical response to ixekizumab—Response rates are presented as the percentage of patients achieving the indicated treatment outcomes at each visit. PASI 50 (blue circles), PASI 75 (red squares), PASI 90 (purple triangles), PASI 100 (inverted green triangles, dotted line), sPGA 0/1 (orange diamonds), and sPGA 0 (open black squares) response rates are shown for patients receiving A) 80mg IXE Q2W/Q4W (N=6) or B) 80mg IXE Q4W/Q4W (N=6) treatment regimens; C) Response rates for patients achieving an itch NRS improvement of at least 4 points from baseline (for patients with a baseline score of ≥4) are shown for both the IXE Q2W/Q4W (N=6, blue circles) and IXE Q4W/Q4W (N=5, red squares) treatment regimens. Because of a decreased frequency of patient visits between Weeks 12 and 48, the x-axis scale is condensed after Week 12. Missing values were imputed as nonresponse. All patients achieved PASI 50 and 75 by Weeks 2 and 4, respectively. IXE: ixekizumab; NRS: numeric rating scale; PASI: Psoriasis Area and Severity Index; Q2W: every 2 weeks; Q2W/Q4W, 80mg IXE Q2W during the induction dosing period and Q4W during the maintenance dosing period; Q4W: every 4 weeks; Q4W/Q4W, 80mg IXE Q4W during both the induction and maintenance dosing periods; sPGA: static Physician's Global Assessment

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