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Risankizumab (Skyrizi\u00ae) is a humanized IgG1 monoclonal antibody that specifically binds to the p19 subunit of interleukin 23.<\/jats:p>\n               <jats:p>Objectives<\/jats:p>\n               <jats:p>To compare risankizumab treatment to FAEs in patients with psoriasis.<\/jats:p>\n               <jats:p>Methods<\/jats:p>\n               <jats:p>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\u201324). Enrolled patients were adults na\u00efve 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.<\/jats:p>\n               <jats:p>Results<\/jats:p>\n               <jats:p>Key efficacy endpoints were met at week 24 for risankizumab (n = 60) vs. FAEs (n = 60) (P &amp;lt; 0\u00b7001): achievement of a \u2265 90% improvement in Psoriasis Area and Severity Index (PASI; primary endpoint 83\u00b73% vs. 10\u00b70%), \u2265 100% improvement in PASI (50\u00b70% vs. 5\u00b70%), \u2265 75% improvement in PASI (98\u00b73% vs. 33\u00b73%), \u2265 50% improvement in PASI (100% vs. 53\u00b73%) and a Static Physician\u2019s Global Assessment of clear\/almost clear (93\u00b73% vs. 38\u00b73%). 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.<\/jats:p>\n               <jats:p>Conclusions<\/jats:p>\n               <jats:p>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.<\/jats:p>","DOI":"10.1111\/bjd.20481","type":"journal-article","created":{"date-parts":[[2021,5,15]],"date-time":"2021-05-15T15:24:40Z","timestamp":1621092280000},"page":"30-39","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Direct comparison of risankizumab and fumaric acid esters in systemic therapy\u2013na\u00efve patients with moderate-to-severe plaque psoriasis: a randomized controlled trial"],"prefix":"10.1093","volume":"186","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8513-550X","authenticated-orcid":false,"given":"D.","family":"Tha\u00e7i","sequence":"first","affiliation":[{"name":"Institute and Comprehensive Center for Inflammation Medicine University of L\u00fcbeck L\u00fcbeck Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0094-2674","authenticated-orcid":false,"given":"K.","family":"Eyerich","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergy Technical University of Munich Munich Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1330-1502","authenticated-orcid":false,"given":"A.","family":"Pinter","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Venerology and Allergology University Hospital Frankfurt Frankfurt am Main Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Sebastian","sequence":"additional","affiliation":[{"name":"Gemeinschaftspraxis f\u00fcr Dermatologie Mahlow Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Unnebrink","sequence":"additional","affiliation":[{"name":"AbbVie Deutschland GmbH & Co. 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