A 24-week multicentre, randomized, open-label, parallel-group study comparing the efficacy and safety of ixekizumab vs. fumaric acid esters and methotrexate in patients with moderate-to-severe plaque psoriasis naive to systemic treatment

K. Reich; M. Augustin; D. Thaçi; A. Pinter; A. Leutz; C. Henneges; E. Schneider; A. Schacht; M. Dossenbach; U. Mrowietz

doi:10.1111/bjd.18384

A 24-week multicentre, randomized, open-label, parallel-group study comparing the efficacy and safety of ixekizumab vs. fumaric acid esters and methotrexate in patients with moderate-to-severe plaque psoriasis naive to systemic treatment

K. Reich, M. Augustin^*, D. Thaçi, A. Pinter, A. Leutz, C. Henneges, E. Schneider, A. Schacht, M. Dossenbach, U. Mrowietz

^*Korrespondierende/r Autor/-in für diese Arbeit

Institut für Entzündungsmedizin

39 Zitate (Scopus)

Abstract

Background: Interleukin-17 antagonists have received a first-line label for moderate-to-severe plaque psoriasis. Objectives: We conducted the first head-to-head trial between the two most commonly used first-line therapies in Germany, fumaric acid esters (FAEs) and methotrexate, and the interleukin-17A antagonist, ixekizumab. Methods: Systemic-naive patients were randomized in this parallel-group, active-comparator, open-label, rater-blinded trial (each group n = 54). The primary outcome was the proportion of patients achieving ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) at 24 weeks. Key secondary outcomes included 24-week PASI 90 and 100, static Physician's Global Assessment (sPGA) score of 0 or 1, and Dermatology Life Quality Index (DLQI) score of 0 or 1. Safety events at week 24 were analysed using Fisher's exact test. Missing data were imputed using nonresponder imputation. The trial was registered at ClinicalTrials.gov (NCT02634801) and EudraCT (2015-002649-69). Results: At week 24, more ixekizumab-treated patients achieved PASI 75 [91% vs. 22% FAEs (P < 0·001) and 70% methotrexate (P = 0·014)], PASI 90 [80% vs. 9% FAEs (P < 0·001) and 39% methotrexate (P < 0·001)] and PASI 100 [41% vs. 4% FAEs (P < 0·001) and 13% methotrexate (P = 0·0041)], as well as sPGA (0,1) and DLQI (0,1). Conclusions: Ixekizumab was superior in inducing PASI 75/90/100, sPGA (0,1) and DLQI (0,1) responses at week 24 compared with methotrexate and FAEs. Safety profiles for all treatments were consistent with prior studies.

Originalsprache	Englisch
Zeitschrift	British Journal of Dermatology
Jahrgang	182
Ausgabenummer	4
Seiten (von - bis)	869-879
Seitenumfang	11
ISSN	0007-0963
DOIs	https://doi.org/10.1111/bjd.18384
Publikationsstatus	Veröffentlicht - 01.04.2020

Fördermittel

Conflicts of interest. K.R. has served as an advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Amgen, Biogen, Boehringer Ingelheim Pharma, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen‐Cilag, LEO Pharma, Eli Lilly and Company, Medac, Merck Sharp & Dohme, Novartis, Ocean Pharma, Pfizer, Regeneron, Sanofi, Takeda, UCB Pharma and Xenoport. M.A. has served as a consultant or paid speaker for clinical trials sponsored by AbbVie, Almirall, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly and Company, GSK, Hexal, Janssen, LEO Pharma, Medac, Merck, MSD, Novartis, Pfizer, UCB Pharma and Xenoport. D.T. has been an advisor for, received speaker's honoraria and grant support from, and participated in clinical trials for AbbVie, Almirall, Amgen, Biogen Idec, Bioskin, Boehringer Ingelheim, Celgene, Dignity, Dr Reddy's, Eli Lilly and Company, Galapagos, GlaxoSmithKline, LEO Pharma, Janssen‐Cilag, Kymab, Merck Sharp & Dohme, Mundipharma, Morphosis, Novartis, Pfizer, Regeneron, Samsung, Sanofi‐Genzyme, Sandoz and UCB Pharma. A.P. has worked as an investigator, speaker and/or advisor for AbbVie, Almirall‐Hermal, Amgen, Biogen Idec, Boehringer Ingelheim, Celgene, GSK, Eli Lilly and Company, Galderma, Hexal, Janssen, LEO Pharma, Medac, Merck Serono, Mitsubishi, MSD, Novartis, Pfizer, Regeneron, Roche, Sandoz Biopharmaceuticals, Schering‐Plough, Tigercat Pharma and UCB Pharma. U.M. has been an advisor for, received speakers honoraria and/or grants from, and/or participated in clinical trials for Abbott/AbbVie, Almirall‐Hermal, Amgen, Biogen Idec, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly and Company, Foamix, Forward Pharma, Janssen, LEO Pharma, Medac, Miltenyi Biotech, MSD, Novartis, Pfizer, VBL and Xenoport. A.L., C.H., E.S., A.S. and M.D. were employees of and minor stockholders in Eli Lilly and Company during the conduct of this study. 2

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Forschungsschwerpunkt: Infektion und Entzündung - Zentrum für Infektions- und Entzündungsforschung Lübeck (ZIEL)

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10.1111/bjd.18384

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Reich, K., Augustin, M., Thaçi, D., Pinter, A., Leutz, A., Henneges, C., Schneider, E., Schacht, A., Dossenbach, M., & Mrowietz, U. (2020). A 24-week multicentre, randomized, open-label, parallel-group study comparing the efficacy and safety of ixekizumab vs. fumaric acid esters and methotrexate in patients with moderate-to-severe plaque psoriasis naive to systemic treatment. British Journal of Dermatology, 182(4), 869-879. https://doi.org/10.1111/bjd.18384

@article{aadbae941c984ebf97a03b44d444310f,

title = "A 24-week multicentre, randomized, open-label, parallel-group study comparing the efficacy and safety of ixekizumab vs. fumaric acid esters and methotrexate in patients with moderate-to-severe plaque psoriasis naive to systemic treatment",

abstract = "Background: Interleukin-17 antagonists have received a first-line label for moderate-to-severe plaque psoriasis. Objectives: We conducted the first head-to-head trial between the two most commonly used first-line therapies in Germany, fumaric acid esters (FAEs) and methotrexate, and the interleukin-17A antagonist, ixekizumab. Methods: Systemic-naive patients were randomized in this parallel-group, active-comparator, open-label, rater-blinded trial (each group n = 54). The primary outcome was the proportion of patients achieving ≥ 75\% improvement in Psoriasis Area and Severity Index (PASI 75) at 24 weeks. Key secondary outcomes included 24-week PASI 90 and 100, static Physician's Global Assessment (sPGA) score of 0 or 1, and Dermatology Life Quality Index (DLQI) score of 0 or 1. Safety events at week 24 were analysed using Fisher's exact test. Missing data were imputed using nonresponder imputation. The trial was registered at ClinicalTrials.gov (NCT02634801) and EudraCT (2015-002649-69). Results: At week 24, more ixekizumab-treated patients achieved PASI 75 [91\% vs. 22\% FAEs (P < 0·001) and 70\% methotrexate (P = 0·014)], PASI 90 [80\% vs. 9\% FAEs (P < 0·001) and 39\% methotrexate (P < 0·001)] and PASI 100 [41\% vs. 4\% FAEs (P < 0·001) and 13\% methotrexate (P = 0·0041)], as well as sPGA (0,1) and DLQI (0,1). Conclusions: Ixekizumab was superior in inducing PASI 75/90/100, sPGA (0,1) and DLQI (0,1) responses at week 24 compared with methotrexate and FAEs. Safety profiles for all treatments were consistent with prior studies.",

author = "K. Reich and M. Augustin and D. Tha{\c c}i and A. Pinter and A. Leutz and C. Henneges and E. Schneider and A. Schacht and M. Dossenbach and U. Mrowietz",

note = "{\textcopyright} 2019 The Authors. British Journal of Dermatology published by John Wiley \& Sons Ltd on behalf of British Association of Dermatologists.",

year = "2020",

month = apr,

day = "1",

doi = "10.1111/bjd.18384",

language = "English",

volume = "182",

pages = "869--879",

journal = "British Journal of Dermatology",

issn = "0007-0963",

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Reich, K, Augustin, M, Thaçi, D, Pinter, A, Leutz, A, Henneges, C, Schneider, E, Schacht, A, Dossenbach, M & Mrowietz, U 2020, 'A 24-week multicentre, randomized, open-label, parallel-group study comparing the efficacy and safety of ixekizumab vs. fumaric acid esters and methotrexate in patients with moderate-to-severe plaque psoriasis naive to systemic treatment', British Journal of Dermatology, Jg. 182, Nr. 4, S. 869-879. https://doi.org/10.1111/bjd.18384

A 24-week multicentre, randomized, open-label, parallel-group study comparing the efficacy and safety of ixekizumab vs. fumaric acid esters and methotrexate in patients with moderate-to-severe plaque psoriasis naive to systemic treatment. / Reich, K.; Augustin, M.; Thaçi, D. et al.
in: British Journal of Dermatology, Jahrgang 182, Nr. 4, 01.04.2020, S. 869-879.

Publikation: Beiträge in Fachzeitschriften › Zeitschriftenaufsätze › Forschung › Begutachtung

TY - JOUR

T1 - A 24-week multicentre, randomized, open-label, parallel-group study comparing the efficacy and safety of ixekizumab vs. fumaric acid esters and methotrexate in patients with moderate-to-severe plaque psoriasis naive to systemic treatment

AU - Reich, K.

AU - Augustin, M.

AU - Thaçi, D.

AU - Pinter, A.

AU - Leutz, A.

AU - Henneges, C.

AU - Schneider, E.

AU - Schacht, A.

AU - Dossenbach, M.

AU - Mrowietz, U.

PY - 2020/4/1

Y1 - 2020/4/1

N2 - Background: Interleukin-17 antagonists have received a first-line label for moderate-to-severe plaque psoriasis. Objectives: We conducted the first head-to-head trial between the two most commonly used first-line therapies in Germany, fumaric acid esters (FAEs) and methotrexate, and the interleukin-17A antagonist, ixekizumab. Methods: Systemic-naive patients were randomized in this parallel-group, active-comparator, open-label, rater-blinded trial (each group n = 54). The primary outcome was the proportion of patients achieving ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) at 24 weeks. Key secondary outcomes included 24-week PASI 90 and 100, static Physician's Global Assessment (sPGA) score of 0 or 1, and Dermatology Life Quality Index (DLQI) score of 0 or 1. Safety events at week 24 were analysed using Fisher's exact test. Missing data were imputed using nonresponder imputation. The trial was registered at ClinicalTrials.gov (NCT02634801) and EudraCT (2015-002649-69). Results: At week 24, more ixekizumab-treated patients achieved PASI 75 [91% vs. 22% FAEs (P < 0·001) and 70% methotrexate (P = 0·014)], PASI 90 [80% vs. 9% FAEs (P < 0·001) and 39% methotrexate (P < 0·001)] and PASI 100 [41% vs. 4% FAEs (P < 0·001) and 13% methotrexate (P = 0·0041)], as well as sPGA (0,1) and DLQI (0,1). Conclusions: Ixekizumab was superior in inducing PASI 75/90/100, sPGA (0,1) and DLQI (0,1) responses at week 24 compared with methotrexate and FAEs. Safety profiles for all treatments were consistent with prior studies.

AB - Background: Interleukin-17 antagonists have received a first-line label for moderate-to-severe plaque psoriasis. Objectives: We conducted the first head-to-head trial between the two most commonly used first-line therapies in Germany, fumaric acid esters (FAEs) and methotrexate, and the interleukin-17A antagonist, ixekizumab. Methods: Systemic-naive patients were randomized in this parallel-group, active-comparator, open-label, rater-blinded trial (each group n = 54). The primary outcome was the proportion of patients achieving ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) at 24 weeks. Key secondary outcomes included 24-week PASI 90 and 100, static Physician's Global Assessment (sPGA) score of 0 or 1, and Dermatology Life Quality Index (DLQI) score of 0 or 1. Safety events at week 24 were analysed using Fisher's exact test. Missing data were imputed using nonresponder imputation. The trial was registered at ClinicalTrials.gov (NCT02634801) and EudraCT (2015-002649-69). Results: At week 24, more ixekizumab-treated patients achieved PASI 75 [91% vs. 22% FAEs (P < 0·001) and 70% methotrexate (P = 0·014)], PASI 90 [80% vs. 9% FAEs (P < 0·001) and 39% methotrexate (P < 0·001)] and PASI 100 [41% vs. 4% FAEs (P < 0·001) and 13% methotrexate (P = 0·0041)], as well as sPGA (0,1) and DLQI (0,1). Conclusions: Ixekizumab was superior in inducing PASI 75/90/100, sPGA (0,1) and DLQI (0,1) responses at week 24 compared with methotrexate and FAEs. Safety profiles for all treatments were consistent with prior studies.

UR - https://www.scopus.com/pages/publications/85075301844

UR - https://www.mendeley.com/catalogue/938f7089-bae7-3513-a958-20a15faa7738/

U2 - 10.1111/bjd.18384

DO - 10.1111/bjd.18384

M3 - Journal articles

C2 - 31376153

AN - SCOPUS:85075301844

SN - 0007-0963

VL - 182

SP - 869

EP - 879

JO - British Journal of Dermatology

JF - British Journal of Dermatology

IS - 4

ER -

Reich K, Augustin M, Thaçi D, Pinter A, Leutz A, Henneges C et al. A 24-week multicentre, randomized, open-label, parallel-group study comparing the efficacy and safety of ixekizumab vs. fumaric acid esters and methotrexate in patients with moderate-to-severe plaque psoriasis naive to systemic treatment. British Journal of Dermatology. 2020 Apr 1;182(4):869-879. doi: 10.1111/bjd.18384