OA34 Post-hoc analysis of spinal MRI SPARCC inflammation scores in patients with radiographic axial spondyloarthritis treated with ixekizumab: results from the COAST-V study at week 16
Notice bibliographique
Résumé
Abstract Background/Aims Ixekizumab, an interleukin-17A inhibitor, has demonstrated efficacy in radiographic axial spondyloarthritis (r-axSpA) irrespective of baseline local inflammation as measured by spinal magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) inflammation scores. This post-hoc analysis assessed the efficacy of ixekizumab in patients with r-axSpA categorized by MRI SPARCC score at baseline and 16-week change from baseline (CFB). Methods COAST-V (NCT02696785) was a phase 3, randomized, controlled trial enrolling patients with active r-axSpA naïve to biologic disease-modifying antirheumatic drugs, randomized 1:1:1:1 to 80-mg ixekizumab every 2 weeks, 80-mg ixekizumab every 4 weeks (Q4W), adalimumab, or placebo for the 16-week blinded treatment period. Three categories were defined according to spinal MRI SPARCC inflammation score at baseline and CFB (based on published minimally important change): 1) low baseline (baseline SPARCC score <5.0 points), 2) low responder (baseline SPARCC score ≥5.0 points and CFB <5.0 points), 3) high responder (baseline SPARCC score ≥5.0 points and CFB ≥5.0 points). Proportions of patients achieving Assessment in SpondyloArthritis international Society 40% (ASAS40), Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1, and BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) 50 were determined. Means at baseline and week-16 least squares means of CFBs were calculated for ASDAS, BASDAI, Spinal Pain, Bath Ankylosing Spondylitis Functional Index (BASFI), and 36-item Short Form Health Survey Physical Component Summary (SF-36 PCS). Non-responder imputation and modified baseline observation carried forward were used for missing week-16 data in discrete and continuous variables, respectively. Results Of 78 patients receiving ixekizumab Q4W, 35 (44.9%), 11 (14.1%), and 32 (41.0%), were MRI SPARCC low baseline, low responders, and high responders, respectively. Similar proportions of ixekizumab-treated patients in all categories achieved ASAS40, ASDAS<2.1, and BASDAI50 week-16 responses; week-16 improvements in other efficacy endpoints were broadly similar, with high responders showing greater improvements in ASAS40 and ASDAS CFB (Table). In adalimumab-treated patients, week-16 improvements were less pronounced in the low baseline and low responder categories. Conclusion Patients with r-axSpA receiving ixekizumab Q4W showed broadly similar reduction in the signs and symptoms of r-axSpA irrespective of their spinal MRI SPARCC inflammation score category at week 16. Disclosure H. Marzo-Ortega: Honoraria; Abbvie, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer, Takeda, UCB, Biogen. Grants/research support; Janssen, Novartis. W. Tsai: Consultancies; Abbvie, Pfizer, Roche. H. Kameda: Consultancies; Abbvie, Asahikasei Pharma, Bristol-Myers Squibb, Eisai, Eli Lilly and Company, Janssen, Mitsubishi Tanabe Pharma, Novartis, Chugai, Pfizer. Member of speakers’ bureau; Abbvie, Asahikasei Pharma, Bristol-Myers Squibb, Eisai, Eli Lilly and Company, Janssen, Mitsubishi Tanabe Pharma, Novartis, Chugai, Pfizer. A. Konomi: Shareholder/stock ownership; Eli Lilly and Company. Other; Employment - Eli Lilly and Company. A.J. Bradley: Shareholder/stock ownership; Eli Lilly and Company. Other; Employment - Eli Lilly and Company. K. Ng: Shareholder/stock ownership; Eli Lilly and Company. Other; Employment - Eli Lilly and Company. Y. Schymura: Shareholder/stock ownership; Eli Lilly and Company. Other; Employment - Eli Lilly and Company. S. Liu-Leage: Shareholder/stock ownership; Eli Lilly and Company. Other; Employment - Eli Lilly and Company. W.P. Maksymowych: Corporate appointments; CARE Arthritis Limited. Consultancies; Abbvie, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Galapagos, Janssen, Novartis, Pfizer, UCB. Member of speakers’ bureau; Abbvie, Janssen, Novartis, Pfizer, UCB. Grants/research support; Abbvie, Novartis, Pfizer, UCB. M. Østergaard: Consultancies; Abbvie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, UCB. Member of speakers’ bureau; Abbvie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, UCB. Grants/research support; Abbvie, Celgene, Centocor, Merck, 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 | 0,005 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,004 | 0,005 |
| 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 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,004 | 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 ».