TY  - JOUR
A1  - Thaçi, Diamant
A1  - Eyerich, Kilian
A1  - Pinter, Andreas
A1  - Sebastian, Michael
A1  - Unnebrink, Kristin
A1  - Rubant, Simone
A1  - Williams, David  A.
A1  - Weisenseel, Peter
T1  - Direct comparison of risankizumab and fumaric acid esters in systemic therapy-naïve patients with moderate-to-severe plaque psoriasis: a randomized controlled trial
T2  - British journal of dermatology
N2  - Background: Fumaric acid esters (FAEs; Fumaderm®) are the most frequently prescribed first-line systemic treatment for moderate-to-severe plaque psoriasis in Germany. Risankizumab (Skyrizi®) is a humanized IgG1 monoclonal antibody that specifically binds to the p19 subunit of interleukin 23. Objectives: To compare risankizumab treatment to FAEs in patients with psoriasis. Methods: This phase III randomized, active-controlled, open-label study with blinded assessment of efficacy was conducted in Germany. Patients were randomized (1 : 1) to subcutaneous risankizumab 150 mg (weeks 0, 4 and 16) or oral FAEs at increasing doses from 30 mg daily (week 0) up to 720 mg daily (weeks 8–24). Enrolled patients were adults naïve to and candidates for systemic therapy, with chronic moderate-to-severe plaque psoriasis. Phototherapy was not allowed within 14 days before or during the study. Results: Key efficacy endpoints were met at week 24 for risankizumab (n = 60) vs. FAEs (n = 60) (P < 0·001): achievement of a ≥ 90% improvement in Psoriasis Area and Severity Index (PASI; primary endpoint 83·3% vs. 10·0%), ≥ 100% improvement in PASI (50·0% vs. 5·0%), ≥ 75% improvement in PASI (98·3% vs. 33·3%), ≥ 50% improvement in PASI (100% vs. 53·3%) and a Static Physician’s Global Assessment of clear/almost clear (93·3% vs. 38·3%). The rates of gastrointestinal disorders, flushing, lymphopenia and headache were higher in the FAE group. One patient receiving risankizumab reported a serious infection (influenza, which required hospitalization). There were no malignancies, tuberculosis or opportunistic infections in either treatment arm. Conclusions: Risankizumab was found to be superior to FAEs, providing earlier and greater improvement in psoriasis outcomes that persisted with continued treatment, and more favourable safety results, which is consistent with the known safety profile. No new safety signals for risankizumab or FAEs were observed.
Y1  - 2021
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/63946
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-639462
SN  - 1365-2133
N1  - AbbVie Inc. funded the research for this study and participated in the study design; study research; data collection, analysis and interpretation of data; reviewing; and approval of this publication. No honoraria or payments were made for authorship. AbbVie Inc. and the authors thank all study inves- tigators for their contributions and the patients who participated in this study. Medical writing support, funded by AbbVie Inc., was provided by Jody Bennett of AbbVie Inc., and Sonia Mohinta, Jennifer Venzie and Janet Matsuura of ICON (North Wales, PA, USA).
N1  - Plain language summary available online at: https://doi.org/10.1111/bjd.20844
VL  - 186
IS  - 1
SP  - 30
EP  - 39
PB  - Wiley-Blackwell
CY  - Oxford
ER  -