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
Bibliographic record
Abstract
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. The VALUE study is an ongoing 37-month post-marketing observational study that evaluates the effectiveness of risankizumab with other approved biologics (OtherBios) in treating moderate-to-severe plaque psoriasis in daily practice. Patients with a known diagnosis of psoriasis were included in the study by their treating physician in a 2:1 ratio to receive risankizumab or OtherBios. The treatment decision was made before and independent of study participation. The results presented here are from the interim analysis at 25 months. The study evaluated if patients achieved a 90% improvement in their skin clearance (Psoriasis Area Severity Index [PASI 90]) at months 4, 13, and 25 and if they stayed on the treatment before switching to a different treatment. The study also evaluated if patients achieved a complete (PASI 100) or 75% (PASI 75) improvement in skin clearance, assessed the overall skin condition (via the static Physician Global Assessment [sPGA 0/1]), and examined quality of life (via the Dermatology Quality of Life Index 0/1) and treatment satisfaction (via the Treatment Satisfaction Questionnaire for Medication scores). A total of 1,765 patients received risankizumab, while 874 received OtherBios. The average age was 48.5 years. At 25 months, 70.9% of the patients on risankizumab achieved PASI 90, compared to 51.5% on OtherBios, showing a clear advantage. The probability of a treatment change was lower for risankizumab patients. Additionally, 56.6% vs. 40.2% achieved PASI 100, 84.3% vs. 67.7% achieved PASI75, and 82.6% vs. 66.2% achieved sPGA0/1 with risankizumab vs. OtherBios, respectively. Quality of life and satisfaction scores were also higher for those on risankizumab. After accounting for differences between the two treatment groups, the results were better for risankizumab (nominal P < 0.0001). These findings show that risankizumab treatment is consistent with clinical trial results for risankizumab.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".