Thaçi Diamant, Ohtsuki Mamitaro, Maul Julia-Tatjana, Szegedi Andrea, Luna Paula C, Lynde Charles W, Soliman Ahmed M, Wang Hongwei, Kaufmann Christian, Ashley Doug G, Madihlaba Tshepiso, Rubant Simone, Papp Kim A
Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Ratzeburger Allee 160, Haus 50, Lübeck, Schleswig-Holstein, Germany.
Department of Dermatology, Jichi Medical University, Shimotsuke, Japan.
Dermatol Ther (Heidelb). 2025 Feb;15(2):381-394. doi: 10.1007/s13555-025-01342-0. Epub 2025 Feb 4.
Risankizumab is approved for treating moderate-to-severe psoriasis. This interim analysis at 25 months evaluated the effectiveness of risankizumab compared with other approved biologics (OtherBios) among patients with moderate-to-severe psoriasis in the 37-month VALUE post-marketing observational study.
Patients diagnosed with psoriasis were enrolled in a 2:1 ratio to risankizumab or OtherBios, as prescribed by their physicians. A ≥ 90% improvement in Psoriasis Area Severity Index (PASI) 90 at months 4, 13, and 25 and the time to first treatment change at 25 months were evaluated. Additionally, PASI 100 and 75, static Physician Global Assessment (sPGA 0/1), Dermatology Life Quality Index (DLQI), and Treatment Satisfaction Questionnaire for Medication (TSQM) scores were evaluated. All patients treated with ≥ 1 dose of biological therapy with ≥ 1 post-baseline measurement were included in the analysis. Modified non-responder imputation was used to handle missing data, and propensity score matching accounted for imbalances between comparison groups.
Overall, 1765 patients received risankizumab and 874 received OtherBios. At baseline, the mean (SD) age of the overall population was 48.5 (14.7) years and mean (standard deviation [SD]) PASI scores were 15.0 (9.0) and 13.9 (8.8) in the risankizumab and OtherBios groups, respectively. At 25 months, 70.9% of those treated with risankizumab vs. 51.5% of those treated with OtherBios achieved PASI 90. The cumulative treatment change probability was 0.16 (95%, confidence interval [CI] 0.14, 0.18) in the risankizumab group and 0.29 (95% CI 0.26, 0.32) in the OtherBios group. At 25 months, a higher proportion of patients achieved PASI 100 (56.6% vs. 40.2%), PASI 75 (84.3% vs. 67.7%), sPGA 0/1 (82.6% vs. 66.2%), and DLQI 0/1 (70.0% vs. 52.9%) in the risankizumab vs. OtherBios group, respectively, and the change in mean TSQM global score was higher in the risankizumab group (86.0 vs. 79.4). All comparisons were nominally significant (P < 0.0001). No new safety signals were identified.
In this prospective study, risankizumab demonstrated higher effectiveness, longer drug survival, and better improvement of patient-reported outcomes at 25 months compared with OtherBios.
ClinicalTrials.gov identifier: NCT03982394.
司库奇尤单抗已被批准用于治疗中度至重度银屑病。这项在25个月时进行的中期分析，评估了在为期37个月的VALUE上市后观察性研究中，司库奇尤单抗与其他已批准生物制剂（OtherBios）相比，在中度至重度银屑病患者中的有效性。
诊断为银屑病的患者按照医生的处方，以2:1的比例入组接受司库奇尤单抗或OtherBios治疗。评估了在第4、13和25个月时银屑病面积和严重程度指数（PASI）改善≥90%（PASI 90）的情况，以及在25个月时首次治疗改变的时间。此外，还评估了PASI 100和75、静态医师整体评估（sPGA 0/1）、皮肤病生活质量指数（DLQI）以及药物治疗满意度问卷（TSQM）得分。所有接受≥1剂生物治疗且有≥1次基线后测量值的患者均纳入分析。采用改良无反应者插补法处理缺失数据，倾向得分匹配法处理比较组之间的不均衡问题。
总体而言，1765例患者接受了司库奇尤单抗治疗，874例患者接受了OtherBios治疗。在基线时，总体人群的平均（标准差[SD]）年龄为48.5（14.7）岁，司库奇尤单抗组和OtherBios组的平均（SD）PASI得分分别为15.0（9.0）和13.9（8.8）。在25个月时，接受司库奇尤单抗治疗的患者中有70.9%达到PASI 90，而接受OtherBios治疗的患者中这一比例为51.5%。司库奇尤单抗组的累积治疗改变概率为0.16（95%，置信区间[CI] 0.14，0.18），OtherBios组为0.29（95% CI 0.26，0.32）。在25个月时，司库奇尤单抗组达到PASI 100（56.6%对40.2%）、PASI 75（84.3%对67.7%）、sPGA 0/1（82.6%对66.2%）和DLQI 0/1（70.0%对52.9%）的患者比例更高；司库奇尤单抗组的平均TSQM总体得分变化更高（86.0对79.4）。所有比较在名义上均具有显著性（P < 0.0001）。未发现新的安全信号。
在这项前瞻性研究中，与OtherBios相比，司库奇尤单抗在25个月时显示出更高的有效性、更长的药物生存期以及患者报告结局的更好改善。
ClinicalTrials.gov标识符：NCT03982394。
