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Introduction <p>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.</p> Methods <p>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.</p> Results <p>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 (<i>P</i> &lt; 0.0001). No new safety signals were identified.</p> Conclusions <p>In this prospective study, risankizumab demonstrated higher effectiveness, longer drug survival, and better improvement of patient-reported outcomes at 25 months compared with OtherBios.</p> Clinical Trials <p>ClinicalTrials.gov identifier: NCT03982394.</p>

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Real-World Effectiveness of Risankizumab in Patients with Moderate-to-Severe Psoriasis: Interim Analysis from the VALUE Global Prospective Post-marketing Observational Study at 25 Months

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年2月4日

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  • Diamant Thaçi,
  • Mamitaro Ohtsuki,
  • Julia-Tatjana Maul,
  • Andrea Szegedi,
  • Paula C. Luna,
  • Charles W. Lynde,
  • Ahmed M. Soliman,
  • Hongwei Wang,
  • Christian Kaufmann,
  • Doug G. Ashley,
  • Tshepiso Madihlaba,
  • Simone Rubant,
  • Kim A. Papp

摘要

Introduction

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.

Methods

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.

Results

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.

Conclusions

In this prospective study, risankizumab demonstrated higher effectiveness, longer drug survival, and better improvement of patient-reported outcomes at 25 months compared with OtherBios.

Clinical Trials

ClinicalTrials.gov identifier: NCT03982394.