261 Secukinumab 150 mg provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 4-year results from the Phase 3 trial, MEASURE 2
Notice bibliographique
Résumé
Background: Secukinumab (SEC), a fully human monoclonal antibody that neutralises interleukin-17A, has shown significant and sustained improvement in the signs and symptoms of active ankylosing spondylitis (AS) through 3 years in the MEASURE 2 study (NCT01649375). Objectives: To report the longer-term (4 year) efficacy and safety of subcutaneous (s.c.) SEC 150 mg in the MEASURE 2 study. Methods: AS patients (n = 219) were randomised to receive s.c. SEC 150 mg (approved dose), 75 mg or placebo (PBO) at baseline (BL), weeks (weeks) 1, 2 and 3, and every 4 weeks from week 4. At week 16, PBO-treated patients were re-randomised to receive SEC 150/75 mg. Efficacy results are reported for pts initially randomised to SEC 150 mg and those who switched from PBO to SEC 150 mg at week 16. Safety analyses included all patients who received ≥1 dose of SEC. Results are reported as observed. Results: The retention rate from week 16 to 208 was 85% (85/100) for SEC 150 mg. Sustained improvements were observed with SEC 150 mg across all endpoints through 4 years (Table 1). These improvements were maintained regardless of prior exposure to anti-tumour necrosis factor (TNF) therapy; greater responses were demonstrated in anti-TNF-naive patients. Over the entire study period, the mean exposure (±standard deviation [SD]) to SEC was 1189.3±452.9 days. Exposure-adjusted incidence rates (per 100 patient-years) with any SEC dose for selected adverse events were: serious infections/infestations (1.5), Candida infections (1.2), Crohn’s disease (0.6), major adverse cardiovascular events (0.6), uveitis (0.6), and malignant/unspecified tumours (0.4). Conclusion: SEC 150 mg provided sustained improvement in signs, symptoms and physical function in patients with AS through 4 years of treatment, with 85% retention rate. The safety profile of SEC remained favourable and was consistent with previous reports. Clinical improvements with SEC 150 mg at Wks 52 and 208 Includes PBO switchers. Data are reported as observed. ASAS, Assessment in Spondyloarthritis International Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; IR, inadequate response; PBO, placebo; SD, standard deviation; SEC, secukinumab; SF-36 PCS, Short Form 36 Health Survey Physical Component Summary; TNF, tumour necrosis factor; Wk, week. Disclosures: H. Marzo-Ortega: Member of speakers’ bureau; H. M. participated in speaker bureaus for: AbbVie, Celgene, Janssen, Novartis, Pfizer and UCB. Grants/research support; H. M. received grant/research support from: Celgene and Janssen. J. Sieper: Consultancies; J. S. consulted for: AbbVie, Merck, Novartis, Pfizer and UCB. Member of speakers’ bureau; J. S. participated in speaker bureaus for: AbbVie, Merck, Pfizer and UCB. Grants/research support; J. S. received grant/research support from: AbbVie, Merck and Pfizer. A. Kivitz: Consultancies; A. K. consulted for: AbbVie, Amgen, Boehringer Ingeleheim, Celgene and Genetech. Grants/research support; A. K. received grant/research support from: Altoona Centre for Clinical Research. R. Blanco: Consultancies; R. B. consulted for: AbbVie, Bristol-Myers, Janssen, Lilly, MSD, Pfizer and Roche. Member of speakers’ bureau; R. B. participated in speaker bureaus for: AbbVie, Bristol-Myers, Janssen, Lilly, MSD, Pfizer and Roche. Grants/research support; R. B. received grant/research support from: AbbVie, MSD and Roche. M. Cohen: Consultancies; M. C. consulted for: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Merck, Novartis, Paladin, Pfizer, Roche, Sanofi and UCB. E. Delicha: Other; M. D. is an employee of Novartis. S. Rohrer: Other; R. is an employee of Novartis. H. Richards: Other; H. R. is an employee of Novartis.
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 | 0,001 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 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 ».