P277 Assessment of disease activity using RAPID3 and evaluation of treatment effect of guselkumab in patients with PsA: results from a randomised placebo-controlled Phase 2 clinical trial
Notice bibliographique
Résumé
Abstract Background To evaluate the effect of guselkumab (GUS) on Routine Assessment of Patient Index Data 3 (RAPID3) in patients with psoriatic arthritis (PsA). Methods In a Phase 2 trial, patients with active PsA and ≥3% body surface area of plaque psoriasis despite current or previous treatment with standard-of-care therapies, including anti-TNFα agents, were randomized 2:1 to receive GUS 100 mg (n = 100) or placebo (PBO, n = 49) subcutaneously at weeks 0, 4, and every 8 weeks (q8w) thereafter through W44. At W16, patients from either group with <5% improvement from baseline in both swollen and tender joint counts were eligible for early escape to open label ustekinumab. At W24, all remaining PBO patients crossed over to receive GUS 100 mg, and then received GUS at W28 and q8w thereafter through W44. RAPID3 (0-30) is derived from the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) and numerical rating scales (0-10) for pain and patient global assessment. A change of 5.1 in RAPID3 score was identified as the minimally important difference (MID) in PsA, and RAPID3 ≤3.0 was used to define PsA remission. Change in RAPID3 and proportion of patients achieving MID were compared between treatments. Correlations of RAPID3 scores with the PsA Disease Activity Score (PASDAS), GRACE index, Disease Activity in Psoriatic Arthritis (DAPSA), and Modified Composite Psoriatic Disease Activity Index (mCPDAI) were evaluated using Spearman correlation. Results The mean (SD) RAPID3 score at baseline was 16.9 (5.19). At W24, patients in the GUS group (n = 100) achieved statistically significantly greater decrease from baseline (improvement) in RAPID3 (-5.81 ± 6.0) than the PBO group (n = 49) (-0.57 ± 5.1, p < 0.001), and 50% of patients in the GUS group vs 20.4% in the PBO group achieved an MID (p < 0.001). Higher RAPID3 remission rate in the GUS than the PBO group (14.0% vs 2.4%, p = 0.022) was observed. The mean ± SD decrease from baseline in RAPID3 was -6.36 ± 6.2 at W24, and -7.48 ± 6.3 at W44 in those who continued GUS (n = 86). Among patients who switched from PBO to GUS at W24 (n = 28), mean ± SD change from baseline (improvement) in RAPID3 was -2.28 ± 5.2 at W24 while on placebo and -7.60 ± 6.6 at W44 after switching to GUS. The RAPID3 score was highly correlated with PASDAS (r = 0.84, p < 0.001), GRACE index (r = 0.89, p < 0.001), DAPSA (r = 0.77 p < 0.001) and mCPDAI (r = 0.65, p < 0.001) at W16. Conclusion GUS-treated PsA patients demonstrated significant improvement in RAPID3 compared to PBO. RAPID3 is simple and feasible to use in routine clinical care, and it correlates well with other comprehensive PsA-specific disease activity measures. Disclosures A. Deodhar: Other; A.D. has been a study investigator for Janssen. B. Kirkham: Other; B.K. has been a study investigator for Janssen. P. Rahman: Other; P.R. has been a study investigator for Janssen. P. Helliwell: Other; P.H. has been a study investigator for Janssen. A.B. Gottlieb: Other; A.G. has been a study investigator for Janssen. W. Boehncke: Other; W.B. has been a study investigator for Janssen. X.L. Xu: Other; X.X. is a Janssen employee. P.C. Gorecki: Other; P.G. is a Janssen employee. C. Han: Other; C.H. is a Janssen employee.
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 | 0,003 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,002 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,007 | 0,001 |
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 ».