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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.
Br J Dermatol. 2020 04; 182(4):869-879.BJ

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.

Links

Authors+Show Affiliations

Dermatologikum Berlin and SCIderm Research Institute, Hamburg, Germany.

Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.

Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.

Department of Dermatology, University Clinic of Frankfurt am Main, Frankfurt am Main, Germany.

Eli Lilly and Company and/or one of its subsidiaries, Indianapolis, IN, U.S.A.

Eli Lilly and Company and/or one of its subsidiaries, Indianapolis, IN, U.S.A.

Eli Lilly and Company and/or one of its subsidiaries, Indianapolis, IN, U.S.A.

Eli Lilly and Company and/or one of its subsidiaries, Indianapolis, IN, U.S.A.

Eli Lilly and Company and/or one of its subsidiaries, Indianapolis, IN, U.S.A.

Psoriasis Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.

MeSH

Antibodies, Monoclonal, HumanizedDouble-Blind MethodFumaratesGermanyHumansMethotrexatePsoriasisSeverity of Illness IndexTreatment Outcome

Pub Type(s)

Journal Article

Multicenter Study

Randomized Controlled Trial

Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31376153

Clinical Trial Links

Clinical trial which this article describes

Citation

Reich, K, 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." The British Journal of Dermatology, vol. 182, no. 4, 2020, pp. 869-879.

Reich K, Augustin M, Thaçi D, 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. Br J Dermatol. 2020;182(4):869-879.

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. The British Journal of Dermatology, 182(4), 869-879. https://doi.org/10.1111/bjd.18384

Reich K, 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. Br J Dermatol. 2020;182(4):869-879. PubMed PMID: 31376153.

* Article titles in AMA citation format should be in sentence-case

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, Y1 - 2019/11/19/ PY - 2019/07/30/accepted PY - 2019/8/4/pubmed PY - 2021/5/15/medline PY - 2019/8/4/entrez SP - 869 EP - 879 JF - The British journal of dermatology JO - Br J Dermatol VL - 182 IS - 4 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. SN - 1365-2133 UR - https://www.unboundmedicine.com/medline/citation/31376153/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_ DB - PRIME DP - Unbound Medicine ER -