TY - JOUR
T1 - Impact of Ixekizumab Treatment on Itch and Psoriasis Area and Severity Index in Patients with Moderate-to-Severe Plaque Psoriasis
T2 - An Integrated Analysis of Two Phase III Randomized Studies
AU - Yosipovitch, Gil
AU - Reich, Adam
AU - Steinhoff, Martin
AU - Beselin, Anke
AU - Kent, Toby
AU - Dossenbach, Martin
AU - Berggren, Lovisa
AU - Henneges, Carsten
AU - Luger, Thomas
N1 - Funding Information:
Funding. This exploratory study was funded by Eli Lilly and Company (Lilly), Indianapolis, Indiana. Lilly also funded the article processing charges. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and the accuracy of the data analysis.
Funding Information:
Medical Writing and Editorial Assis tance. The authors would like to thank Shannon E. Gardell and Angela Lorio of Syneos Health for providing writing and editorial support. This was funded by Lilly.
Funding Information:
Disclosures. Gil Yosipovitch has served as a consultant and advisory board member of Eli Lilly and Company, Pfizer, Menlo, Trevi, Sanofi, Galderma, Sienna, Opko, Galderma, and Novartis, and has received research grants from the Leo Foundation, Pfizer, GSK, and Allergan. Adam Reich has served as a consultant, advisory board member, and/or paid speaker for, and/or has received research grants and/or honoraries for consulting and/or scientific lectures from, and/or got travel expenses reimbursed and/or participated in clinical trials sponsored by Cel-gene, Almirall, Leo Pharma, Eli Lilly and Company, Novartis, Menlo Pharmaceuticals, Chema Elektromet, Sun-Farm, Bioderma, and Gal-derma. Martin Steinhoff has served as consultant, advisory board member and/or paid speaker for, and/or has received research grants and/or honoraries for consulting and/or scientific lectures from, and/or has got travel expenses reimbursed and/or has participated in clinical trials sponsored by AbbVie, Almirall, Bayer, BMS, Eli Lilly and Company, Galderma, Janssen, Leo, Novartis, Menlo Pharmaceuticals, Pfizer, Pierre-Fabre, Sanofi, and Zymogenetics. Anke Beselin is an employee and stockholder of Eli Lilly and Company. Carsten Henneges is an employee and stockholder of Eli Lilly and Company. Martin Dossenbach is an employee and stockholder of Eli Lilly and Company. Lovisa Berggren is a contractor for Eli Lilly and Company. Toby Kent was an employee of Eli Lilly and Company during the preparation of the manuscript. Thomas Luger conducted clinical trials or received honoraria for serving as a member of the scientific advisory boards of AbbVie, Biogen-IDEC, Celgene, CERIES, Gal-derma, Eli Lilly and Company, Janssen-Cilag, La Roche Posay, Maruho, Meda, MSD, Mundi-pharma, Novartis, Pfizer, Sandoz, Sanofi-Aven-tis, Symrise, and Wolff.
PY - 2018/12/1
Y1 - 2018/12/1
N2 - Introduction: We evaluated baseline itch and its impact on the efficacy of ixekizumab (IXE) in clearing psoriasis and improving quality-of-life measures, and we explored the relationship between itch and psoriatic skin improvement. Methods: Data were analyzed from two double-blind, randomized, controlled phase III studies (UNCOVER-2/3) comparing etanercept (ETN), IXE, and placebo (PBO) in patients with moderate-to-severe plaque psoriasis. Long-term analysis included UNCOVER-3 data from week 0 to week 156. Results: At week 12, a clinically meaningful improvement in itch [Itch Numeric Rating Scale (NRS) reduction ≥ 4] was seen in 70.0%, 88.6%, and 90.8% of the IXE-treated patients in the baseline Itch NRS 4–6, 7–8, and 9–10 groups, respectively (all itch severity groups p < 0.001 versus ETN and PBO). Also, 68.9%, 67.1%, and 73.6% of the IXE-treated patients in the baseline Itch NRS 4–6, 7–8, and 9–10 groups, respectively, showed an improvement of ≥ 90.0% in the Psoriatic Area and Severity Index (PASI) at week 12 as compared to the baseline (PASI 90) (all itch severity groups p < 0.001 versus ETN and PBO). For most patients, itch reduction preceded psoriatic plaque improvement. Sustained effects of IXE on itch and PASI were observed during 3 years of treatment. Conclusions: Regardless of baseline itch severity, IXE treatment provided a rapid improvement in itch followed by clinically meaningful improvements in psoriasis. Funding: Eli Lilly and Company. Trial registration: ClinicalTrials.gov identifiers, NCT01597245 and NCT01646177.
AB - Introduction: We evaluated baseline itch and its impact on the efficacy of ixekizumab (IXE) in clearing psoriasis and improving quality-of-life measures, and we explored the relationship between itch and psoriatic skin improvement. Methods: Data were analyzed from two double-blind, randomized, controlled phase III studies (UNCOVER-2/3) comparing etanercept (ETN), IXE, and placebo (PBO) in patients with moderate-to-severe plaque psoriasis. Long-term analysis included UNCOVER-3 data from week 0 to week 156. Results: At week 12, a clinically meaningful improvement in itch [Itch Numeric Rating Scale (NRS) reduction ≥ 4] was seen in 70.0%, 88.6%, and 90.8% of the IXE-treated patients in the baseline Itch NRS 4–6, 7–8, and 9–10 groups, respectively (all itch severity groups p < 0.001 versus ETN and PBO). Also, 68.9%, 67.1%, and 73.6% of the IXE-treated patients in the baseline Itch NRS 4–6, 7–8, and 9–10 groups, respectively, showed an improvement of ≥ 90.0% in the Psoriatic Area and Severity Index (PASI) at week 12 as compared to the baseline (PASI 90) (all itch severity groups p < 0.001 versus ETN and PBO). For most patients, itch reduction preceded psoriatic plaque improvement. Sustained effects of IXE on itch and PASI were observed during 3 years of treatment. Conclusions: Regardless of baseline itch severity, IXE treatment provided a rapid improvement in itch followed by clinically meaningful improvements in psoriasis. Funding: Eli Lilly and Company. Trial registration: ClinicalTrials.gov identifiers, NCT01597245 and NCT01646177.
KW - IL-17A
KW - Itch
KW - Ixekizumab
KW - Psoriasis
UR - http://www.scopus.com/inward/record.url?scp=85057288267&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85057288267&partnerID=8YFLogxK
U2 - 10.1007/s13555-018-0267-9
DO - 10.1007/s13555-018-0267-9
M3 - Article
AN - SCOPUS:85057288267
VL - 8
SP - 621
EP - 637
JO - Dermatology and Therapy
JF - Dermatology and Therapy
SN - 2190-9172
IS - 4
ER -