256 Secukinumab provides sustained improvements in the signs and symptoms of active psoriatic arthritis: 4-year results from the Phase 3 FUTURE 2 study
Notice bibliographique
Résumé
Background: Secukinumab (SEC), a fully human monoclonal antibody that selectively neutralises interleukin-17A, provided significant and sustained improvement in the signs and symptoms of active psoriatic arthritis (PsA) over 2 years in the FUTURE 2 study (NCT01752634). Objectives: To report 4-year efficacy and safety results from the FUTURE 2 study. 3-year data is presented here, with 4-year data to follow. Methods: Overall, 397 patients with active PsA were randomised to receive subcutaneous SEC (300, 150 or 75 mg) or placebo (PBO) at baseline (BL), Weeks 1, 2, 3 and 4, and every 4 weeks thereafter. Assessments at week 156 are from patients originally randomised to SEC and included ACR20/50, PASI 75, HAQ-DI, and resolution of dactylitis and enthesitis. Analyses by prior anti-tumour necrosis factor (TNF) use (naive/inadequate response [IR]) and with/without concomitant methotrexate (MTX) were assessed. Data are reported as observed for SEC 300 and 150 mg (approved doses). Safety analyses included all patients who received ≥1 dose of SEC. Results: In total, 73/100 (73.0%) and 72/100 (72.0%) patients in the SEC 300 and 150 mg groups, respectively, completed 156 weeks of treatment. Sustained clinical improvements were observed in those continuing with SEC across all endpoints through week 156 (Table 1). ACR20 response rates at week 156 in anti-TNF-naive patients were 85.2% and 76.5% with SEC 300 and 150 mg respectively; corresponding rates in anti-TNF-IR patients were 55.6% and 54.5%, respectively. ACR20 response rates in patients receiving concomitant MTX were 73.0% and 77.1% with SEC 300 and 150 mg, respectively; rates in patients without concomitant MTX use were 77.3% and 63.2%, respectively. Over the study (mean SEC exposure of 991.3 days) the type, incidence and severity of adverse events (AEs) were consistent with that reported previously. Exposure adjusted incidence rates with SEC for selected AEs of interest were: serious infections (1.8), Candida infections (1.8), inflammatory bowel disease (0.1), major adverse cardiovascular event (0.2) and malignant/unspecified tumours (1.2). Conclusion: SEC 300 and 150 mg provided sustained improvements in the signs and symptoms of active PsA through 3 years. Secukinumab was well tolerated, with a safety profile consistent with that reported previously. Summary of efficacy results at Wk 156 PASI responses assessed in pts with psoriasis affecting ≥3% body surface area at BL (n = 41 [300 mg] and n = 58 [150 mg]); Assessed in pts (n = 56 [300 mg] and n = 64 [150 mg]) with this symptom at BL; Assessed in pts (n = 46 [300 mg] and 32 [150 mg]) with this symptom at BL. SEC 150 mg arm includes 42 pts who were up-titrated to SEC 300 mg starting at Wk 128. ACR, American College Rheumatology; BL, baseline; HAQ-DI, health assessment questionnaire-disability index; N, number of pts randomised; n, number of pts with evaluation; PASI, psoriasis area and severity index; pts, patients; SEC, secukinumab; s.c., subcutaneous; Wk, week. Disclosures: I.B. McInnes: Consultancies; I. M. consulted for: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB. Member of speakers’ bureau; I. M. participated in speaker bureaus for: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB. Grants/research support; I. M. received grant/research support from: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB. B. Kirkham: Consultancies; B. K consulted for: AbbVie, Janssen, Lilly, MSD, Novartis. B. K.. Member of speakers’ bureau; B. K. participated in speaker bureaus for: Janssen, Lilly, Novartis. Grants/research support; B. K. received grant/research support from: AbbVie, Lilly, Novartis, UCB. P. Nash: Consultancies; P. N. consulted for: Novartis, AbbVie, Roche, Pfizer, BMS, Janssen, Celgene. Grants/research support; P. N. received grant/research support from: Novartis, AbbVie, Roche, Pfizer, BMS, Janssen, Celgene. P. Rahman: Consultancies; P. R. consulted for: Abbott, AbbVie, Amgen, BMS, Celgene, Janssen, Novartis, Pfizer Roche and pharmaceutical companies dealing with biologic agents in rheumatology. A.B. Gottlieb: Consultancies; A.G. consulted for: AbbVie, Allergan, Bristol Myers Squibb Co., Beiersdorf, Inc., Celgene Corp., Dermira, Incyte, Janssen Inc., Lilly, Novartis, Reddy Labs, Sun Pharmaceutical Industries, UCB, Valeant. Member of speakers’ bureau; A.G. participated in speaker bureaus with: AbbVie, Allergan, Beiersdorf, Inc., Grants/research support; A. G. received grant/research support from: Janssen, Incyte. K. Ding: Shareholder/stock ownership; K. D. is a shareholder at Novartis. Other; K. D. is an employee of Novartis. L. Pricop: Shareholder/stock ownership; L. P. is a shareholder at Novartis. Other; L. P. 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 | 0,003 | 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 | 0,001 |
| 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 | 0,001 |
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 ».