Jashin J Wu, 1 Alexander Egeberg, 2 James A Solomon, 3,4,5 Olawale Osuntokun, 6 Orin Goldblum, 6 Susan R Moriarty, 6 Fangyi Zhao, 6 Neil Korman 7
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1 4662 Ixekizumab Treatment Shows a Neutral Impact on the Glucose and Lipid Profile of Patients with Moderate-to-Severe Psoriasis: Results from UNCOVER-1, -2, and -3 Jashin J Wu, 1 Alexander Egeberg, 2 James A Solomon, 3,4,5 Olawale Osuntokun, 6 Orin Goldblum, 6 Susan R Moriarty, 6 Fangyi Zhao, 6 Neil Korman 7 1 Kaiser Permanente Los Angeles Medical Center, Los Angeles, USA; 2 Gentofte Hospital, Hellerup, Denmark; 3 Ameriderm Research, Ormond Beach, USA; 4 University of Central Florida, College of Medicine, Orlando, USA; 5 University of Illinois, College of Medicine, Urbana, USA; 6 Eli Lilly and Company, Indianapolis, USA; 7 University Hospitals Case Medical Center, Cleveland, USA This study was sponsored by Eli Lilly and Company.
2 Disclosures J. J. Wu is a consultant for/received honoraria from: AbbVie, Amgen, Celgene, Dermira, Eli Lilly and Company, Pfizer, Regeneron, Sun Pharmaceutical, has other relevant conflicts with: AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Coherus Biosciences, Dermira, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Regeneron, Sandoz, Sun Pharmaceutical This study was sponsored by Eli Lilly and Company. Medical writing assistance was provided by John Bilbruck, PhD, CMPP of ProScribe Envision Pharma Group, and was funded by Eli Lilly and Company
3 Background and Objective Background Patients with psoriasis have a higher prevalence of cardiovascular (CV) risk factors than those without psoriasis 1 Both psoriasis and certain parameters associated with CV disease are linked to chronic inflammation 2 Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin- 17A, is highly efficacious in patients with moderate-to-severe psoriasis 3-7 Objective To examine CV-related parameters in patients with moderate-to-severe psoriasis treated with ixekizumab for up to 60 weeks and to compare these results to placebotreated patients 1. Menter A, et al. J Eur Acad Dermatol Venerol 2010;24: Davidovici BB, et al. J Inv Derm 2010;130: Liu L, et al. J Inflamm Res. 2016;9: Leonardi C, et al. N Eng J Med. 2012;366: Gordon KB, et al. J Am Acad Dermatol. 2014;71: Griffiths CE, et al. Lancet. 2015;386: Gordon KB, et al. N Eng J Med. 2016;375:
4 Study Design UNCOVER-1, -2, and -3 Screening Double-blind Induction Period a Double-blind Maintenance Period b 3,866 patients randomized R IXE-treated patients received 160-mg starting dose (N=1161) (N=1167) (N=791) spga (0,1) Responders at Week 12 R (N=416) (N=402) IXE Q12W (N=408) WEEK 60 (N=740) WEEK 0 WEEK 12 WEEK 60 : 80 mg IXE every 2 weeks : 80 mg IXE every 4 weeks : 50 mg twice weekly a : Placebo IXE Q12W: 80 mg IXE every 12 weeks a Patients from UNCOVER-1, -2, and -3 shown; only patients in UNCOVER-2 and -3 randomized to 50 mg twice weekly b Patients from UNCOVER-1, and -2 shown; patients in UNCOVER-1 and -2 also rerandomized to 80 mg IXE every 12 weeks (data not presented in these analyses) =etanercept; IXE=ixekizumab; R=randomization; spga=static Physician s Global Assessment
5 Methods Key Eligibility Criteria Inclusion criteria Psoriasis Area and Severity Index (PASI) score 12 at both screening and baseline visits 10% body surface area (BSA) involvement at both screening and baseline visits Static Physician s Global Assessment (spga) score 3 Exclusion criteria Prior exposure to etanercept (UNCOVER-2 and -3)
6 Methods Laboratory Measures The following CV-related parameters measured in serum at baseline and at Weeks 12 and 60: Fasting glucose Total cholesterol Low density lipoprotein (LDL) cholesterol High density lipoprotein (HDL) cholesterol Very low density lipoprotein (VLDL) cholesterol Triglycerides (TG) LDL-cholesterol/HDL-cholesterol Statistical Analyses Week 12 data = Integrated induction period data (UNCOVER-1, -2 and -3) Week 60 data = Integrated maintenance period data (UNCOVER-1 and -2)
7 Baseline Demographics and Disease Characteristics (N=791) (N=739) (N=1161) (N=1167) Age, years 46.2 (12.8) 45.5 (13.3) 45.4 (13.1) 45.1 (12.9) Male, n (%) 559 (70.7) 504 (68.2) 787 (67.8) 766 (65.6) Race, white, n (%) 725 (91.7) 681 (92.7) 1068 (92.3) 1091 (93.6) Weight, kg 91.6 (23.5) 92.5 (23.4) 92.1 (23.5) 90.8 (22.7) Body mass index, kg/m (7.2) 31.0 (7.4) 30.7 (7.2) 30.4 (7.1) Psoriasis duration a, years 19.1 (12.1) 18.5 (12.1) 18.9 (12.4) 18.8 (12.1) Values are mean (standard deviation) unless otherwise stated a From symptom onset =etanercept; =80 mg ixekizumab every 2 weeks; =80 mg ixekizumab every 4 weeks; =placebo
8 Change from Baseline in Laboratory Parameters at Weeks 12 and 60, LOCF Baseline, mg/dl Change from baseline, mg/dl (N=791) (N=739) Week 12 Week 60 (N=1161) (N=1167) (N=402) (N=416) Glucose 103 (32) 1.1 (27) 100 (29) 1.5 (25) 102 (31) 1.7 (23) 101 (29) 0.8 (22) 100 (21) 0.7 (14) 101 (26) 0.4 (21) Total cholesterol 200 (42) -1.6 (25) 199 (41) 0.7* (27) 198 (41) 3.4 (28) 197 (42) 3.7 (26) 200 (42) -2.0 (26) 201 (41) -1.0 (26) LDL cholesterol 117 (37) -1.0 (21) 116 (34) -0.2 (22) 115 (35) 1.8 (23) 115 (36) 2.5 (22) 116 (36) -0.0 (22) 117 (37) -1.0 (22) HDL cholesterol 52 (16) 0 (7.9) 53 (15) 0.1 (8.2) 53 (15) 0.1 (8.0) 52 (15) 0.5 (8.2) 55 (15) -0.3 (7.8) 53 (16) 0.1 (8.8) VLDL cholesterol 29 (15) -0.5 (11) 28 (14) 0.6 (12) 29 (15) 1.2 (11) 29 (14) 0.9* (12) 28 (15) 0.6 (12) 29 (14) 0.1 (12) Triglycerides 155 (99) -0.5 (77) 148 (97) 10.3* (92) 154 (97) 9.5* (82) 154 (98) 2.6 (79) 151 (98) 14 (88) 158 (97) 11 (92) Values are mean (standard deviation) *p<.05, p<.01, p<.001 vs =etanercept; HDL=high density lipoprotein; =80 mg ixekizumab every 2 weeks; =80 mg ixekizumab every 4 weeks; LDL=low density lipoprotein; LOCF=last observation carried forward; VLDL=very low density lipoprotein; =placebo
9 Mean LDL/HDL Ratio (mg/dl) Ixekizumab has a Neutral Effect on LDL/HDL Ratio at 60 Weeks, LOCF 6 Induction Period 6 Maintenance Period 5 X (N=791) 5 X (N=402) 4 (N=1161) (N=1167) 4 (N=416) Week Week Integrated induction period (Week 12, UNCOVER-1, -2, and -3); Integrated maintenance period (Week 60, UNCOVER-2, and -3) =80 mg ixekizumab every 2 weeks; =80 mg ixekizumab every 4 weeks; HDL=high-density lipoprotein; =80 mg ixekizumab every 2 weeks; =80 mg ixekizumab every 4 weeks; LDL=low-density lipoprotein; LOCF=last observation carried forward; =placebo
10 Ixekizumab Not Associated With Abnormal Glucose and Lipid Levels at 60 Weeks Patients with Abnormal High Values a (%) Patients with Abnormal High Values a (%) Patients with Abnormal High Values a (%) Fasting Glucose Total Cholesterol Week 12 Week 60 Week 12 Week 60 N N Triglycerides Week 12 Week 60 N a Definition of abnormal high values (at any time post baseline) varied according to age, gender, and race of patient. Ranges were: Glucose, mg/dl Total cholesterol, mg/dl Triglycerides, mg/dl. Integrated induction period (Week 12, UNCOVER-1, -2, and -3); Integrated maintenance period (Week 60, UNCOVER-2, and -3) =etanercept; =80 mg ixekizumab every 2 weeks; =80 mg ixekizumab every 4 weeks; =placebo
11 Conclusions Ixekizumab appears to have a neutral effect on glucose levels and the lipid profile after 60 weeks in patients with moderate-to-severe psoriasis Ixekizumab was not associated with clinically meaningful changes in glucose, total cholesterol, LDL, HDL, VLDL, TG, and LDL/HDL ratio in patients with moderate-tosevere plaque psoriasis
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