A3: Efficacy and Safety of Adalimumab in Pediatric Patients With Enthesitis Related Arthritis
Notice bibliographique
Résumé
Background/Purpose: Enthesitis related arthritis (ERA) is a subcategory of juvenile idiopathic arthritis (JIA) which primarily affects peripheral joints and entheses but also can involve the sacroiliac joints and spine. It causes long‐term effects on both physical and quality aspects of a child's life (). Adalimumab (ADA) has been previously demonstrated to be effective in polyarticular JIA. The purpose of this study was to evaluate the efficacy and safety of adalimumab compared to placebo in children and adolescents with ERA. Methods: This is a phase 3, multicenter, randomized, double‐blind (DB) study in patients (pts) aged ≥6 to <18 years (yr) with ERA (ILAR criteria) with active disease not responsive to ≥1 nonsteroidal antiinflammatory drug and ≥1 disease‐modifying antirheumatic drug. Active disease was defined as ≥3 active joints (swelling or loss of motion + pain/tenderness) and enthesitis in ≥1 location (past or present). Pts were randomized 2:1 to receive blinded ADA (24 mg/m2 BSA up to 40 mg every other week (wk) [eow]) or placebo (PBO) for 12 wks followed by open‐label (OL) ADA eow up to 144 wks. The primary endpoint was % change from baseline (BL) in the number of active joints with arthritis (AJC) at wk 12. Secondary variables assessed included enthesitis count (EC), tender and swollen joint counts, and American College of Rheumatology (ACR) Pediatric (Pedi) 30/50/70 responses. Results are summarized through 52 wks of treatment. Safety was assessed in terms of adverse events (AE), laboratory values, and vital sign measurements. Results: 46 pts were randomized (31 to ADA, 15 to PBO). No pts discontinued during the DB period; however, 7 pts early escaped to OL ADA. Mean age was 12.9±2.9 yrs. At BL, mean duration of ERA symptoms was 2.6±2.3 yrs; mean AJC was 7.8±6.6, and mean EC was 8.1±8.4. The % change from BL at wk 12 in AJC was greater in the ADA group vs. PBO (−62.6±59.5 vs −11.6±100.5, P=0.039). Most secondary variables showed numerically greater, but not statistically significant improvement at wk 12 in favor of ADA vs. PBO (). Treatment response was maintained with continued ADA therapy up to 52 wks (% change from BL at wk 52 in AJC, −88.7±26.1). During the DB period AE incidence rates were similar [ADA/PBO (%)]: any AE (67.7/53.3), serious AE (3.2/0, 1 pt in the ADA group [abdominal pain and headache]), and infectious AEs (29.0/20.0). Among pts who received at least 1 dose of ADA through wk 52, any AE, serious AEs, and infectious AEs were reported in 91.3%, 10.9%, and 76.1%, respectively. No deaths, TB, or malignancies were reported. At Week 12 ADA (N=31) PBO (N=15) Change from Baseline a (mean ± SD) # enthesitis sites (0–35) −4.4 ± 6.2 −2.7 ± 5.0 Tender joint count (0–72) −7.9 ± 8.3 −4.5 ± 9.0 Swollen joint count (0–68) −3.5 ± 5.6 −2.4 ± 4.7 ACR Pedi Responseb (n, %) ACR Pedi30 responder 21 (67.7) 10 (66.7) ACR Pedi50 responder 20 (64.5) 7 (46.7) ACR Pedi70 responder 16 (51.6) 4 (26.7) Conclusion: ADA reduced the signs and symptoms of ERA at wk 12 and efficacy was sustained up to 52 wks. The safety profile observed in pediatric patients with ERA was consistent with that observed in children aged ≥2 years treated for polyarticular JIA.
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 | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 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 ».