Drug Survival of Risankizumab vs Other Biologics After 25 Months of Treatment Among Patients With Psoriatic Arthritis: An Interim Analysis of the VALUE Study
Notice bibliographique
Résumé
Background/Purpose: Risankizumab (RZB) is an approved, optimized inhibitor of IL-23 for treating adults with moderate-to-severe plaque psoriasis (PsO), psoriatic arthritis (PsA), Crohn’s disease and ulcerative colitis. VALUE is a post-marketing observational study (PMOS) assessing the durability of response of RZB in real world practice. In this post hoc analysis, we report the interim drug survival of RZB and other biologic therapies (OtherBios) in a subgroup of patients with PsO and concomitant PsA. Methods: VALUE (NCT03982394) is a multi-country, prospective PMOS. This post hoc analysis includes data from the subset of patients with PsO who were also diagnosed with concomitant PsA by a rheumatologist. Drug survival, defined as patients staying on the biologic they initiated at study enrollment, was assessed using the proportion of patients with treatment substance changes, and the cumulative probability of treatment changes. Treatment results were compared as RZB vs OtherBios at 25 months and RZB vs TNFα inhibitor (TNFi) vs IL-17i at 25 months. Results are reported from an interim database lock on 09 December 2024. All enrolled patients who received at least one dose of study medication were included in this treatment substance change analysis. Propensity score matching (PSM) with a 1:1 ratio using greedy algorithm and exact match for biologic-naive/biologic-experienced status was used to account for group imbalances. Nominal P values are reported. Results: This interim analysis included 255 (RZB) and 207 (OtherBios) patients diagnosed with PsO and concomitant PsA. Patients treated with RZB were older (53.5 years vs 49.3 years, P < 0.05) and had more severe skin disease as assessed by baseline psoriasis area and severity index (RZB vs OtherBios), (15.0 vs 13.1, P < 0.05), and body surface area (24.0% vs 19.1%, P < 0.05) than patients treated with OtherBios. Differences were balanced in the PSM set and results from PSM set are shown below. Patients receiving RZB were significantly less likely to require a treatment substance change than those receiving OtherBios (12.6% vs 30.3%, P <0.05) at month 25 of treatment. The probability of treatment substance change (95% CI) at month 25 based on the Kaplan-Meier curve for time to first treatment substance change was 0.11 (0.06, 0.17) for patients receiving RZB vs 0.31 (0.23, 0.41) for patients receiving OtherBios (P < 0.05). In assessing drug survival by mechanism of action (RZB as reference vs TNFi vs IL-17i) at 25 months, patients receiving RZB were less likely to require a treatment substance change (12.6% vs. 43.8% vs 26.4%, P <0.05). The probability of treatment substance change (95% CI) at month 25 based on the Kaplan-Meier curve for time to first treatment change was 0.11 (0.06, 0.19) in the RZB group, 0.44 (0.28, 0.63) in the TNFi group, and 0.28 (0.18, 0.44) in the IL-17i group (P < 0.05). Conclusion: Patients with PsO and concomitant PsA who were treated with RZB in real-world practice had higher drug survival and were less likely to require treatment changes compared to patients receiving OtherBios including TNFi and IL-17i.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,010 | 0,010 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,005 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».