Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
Department of Dermatology and Allergy, Technical University of Munich, Munich, Germany.
Br J Dermatol. 2022 Jan;186(1):30-39. doi: 10.1111/bjd.20481. Epub 2021 Aug 17.
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.
To compare risankizumab treatment to FAEs in patients with psoriasis.
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.
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.
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.
富马酸酯（FAEs；Fumaderm）是德国中重度斑块型银屑病的首选一线全身治疗药物。里莎鲁单抗（Skyrizi）是一种人源化 IgG1 单克隆抗体，特异性结合白细胞介素 23 的 p19 亚单位。
比较里莎鲁单抗与 FAEs 在银屑病患者中的治疗效果。
这是一项在德国进行的 III 期随机、活性对照、开放性标签研究，对疗效进行了盲法评估。患者按 1:1 随机分配接受皮下注射里莎鲁单抗 150mg（第 0、4 和 16 周）或口服 FAEs，剂量从第 0 周的每日 30mg 逐渐增加至第 8-24 周的每日 720mg。纳入的患者为既往未接受过全身治疗且适合全身治疗的成人，患有慢性中重度斑块型银屑病。研究期间禁止在 14 天内进行光疗。
在第 24 周，与 FAEs 相比，里莎鲁单抗（n=60）达到了主要疗效终点（P<0.001）：银屑病面积和严重程度指数（PASI；主要终点 83.3%对 10.0%）、PASI 改善≥100%（50.0%对 5.0%）、PASI 改善≥75%（98.3%对 33.3%）、PASI 改善≥50%（100%对 53.3%）和静态医师整体评估为清除/几乎清除（93.3%对 38.3%）。FAE 组中胃肠道疾病、潮红、淋巴细胞减少和头痛的发生率更高。接受里莎鲁单抗治疗的 1 例患者报告了 1 例严重感染（流感，需要住院治疗）。在治疗组中均未发生恶性肿瘤、结核病或机会性感染。
与 FAEs 相比，里莎鲁单抗疗效更优，能更早、更显著地改善银屑病结局，且持续治疗时疗效持续存在，安全性结果也更好，这与已知的安全性特征一致。未观察到里莎鲁单抗或 FAEs 的新安全性信号。
