DORIS REMISSION IN PATIENTS WITH SLE TREATED WITH ANIFROLUMAB: POST HOC ANALYSIS FROM TULIP-1 AND TULIP-2 TRIALS IN PATIENTS WITH NO PRIOR IMMUNOSUPPRESSANT USE
Notice bibliographique
Résumé
PV253 / #124 Poster Topic: AS24 - SLE-Treatment Background/Purpose 2023 EULAR treatment recommendations for SLE present the option for early biologic use without prior failure of immunosuppressants/disease-modifying antirheumatic drugs (DMARDs), in patients with inadequate responses to antimalarials alone or in combination with glucocorticoids (GC).[1] There are limited data demonstrating clinical benefits with biologics in immunosuppressant-naïve patients with SLE treated with either antimalarials, oral GCs, or the combination. This post hoc analysis investigated DORIS (Definition of Remission in SLE) remission attainment in patients with moderate to severe SLE treated with intravenous anifrolumab 300 mg or placebo in the TULIP-1 ( NCT02446912 [2]) or TULIP-2 ( NCT02446899 [3]) phase 3 trials who had no reported history of prior immunosuppressant use. Methods This post hoc analysis included a subset of patients from the TULIP-1 and TULIP-2 trials who were ‘immunosuppressant-naïve,’ defined as patients with a treatment history of antimalarials or oral GCs at enrollment, or the combination of antimalarials and GCs, but without prior use of immunosuppressants or DMARDs. DORIS remission attainment was assessed for the period after randomization. DORIS remission was defined as total clinical SLEDAI-2K score (sum of all SLEDAI-2K items except increased DNA binding and low complement) = 0, Physician’s Global Assessment < 0.5, and prednisone/equivalent dosage ≤ 5 mg/day. DORIS attainment was analyzed using a stratified Cochran–Mantel–Haenszel approach. Results A total of 257 patients (anifrolumab 300 mg, n = 127; placebo, n = 130) in the pooled TULIP-1 and TULIP-2 trial dataset were immunosuppressant-naïve. Among this subgroup, 21 (16.2%) of immunosuppressant-naïve patients in the anifrolumab 300 mg group attained DORIS remission at Week 52 compared with 7 (6.0%) patients in the placebo group (treatment difference: 10.2% [95% CI: 1.3-19.1], nominal P = 0.0242). DORIS attainment rates generally increased from baseline through to Week 52 (Figure 1). Figure 1. Attainment of DORIS remission across 52 weeks in patinets with no reported history of poor immunosuppressant use. *denotes nominal P < 0.05 calculated using using a stratified Cochran-Mantel-Haenszel approach, with stratification factors of SLEDAI-2K at screening Day 1 glucocorticoid dosage, type I interferon gene signature at screening and study (TULIP-1 vs TULIP-2). Conclusions In this post hoc analysis, a higher proportion of immunosuppressant-naïve patients with moderate to severe SLE treated with anifrolumab attained DORIS remission at Week 52 compared with those who received placebo. These results are consistent with EULAR recommendations to consider initiating treatment with biologics early, before immunosuppressants. References: [1.] Fanouriakis A. Ann Rheum Dis 2019;78:736-45. [2.] Furie RA. Lancet Rheumatol 2019;1:e208-19. [3.] Morand EF. N Engl J Med 2020;382:211-21. Acknowledgments: This study was sponsored by AstraZeneca. Writing assistance was provided by Tamara Fink, PhD, of JK Associates Inc., part of Avalere Health, and funded by AstraZeneca. Presented at ACR 2024 and reused with permission of Andrea D. Arthritis Rheumatol . 2024; 76 (suppl 9). https://acrabstracts.org/abstract/doris-remission-in-patients-with-sle-treated-with-anifrolumab-posthoc-analysis-from-tulip-1-and-tulip-2-trials-in-patents-with-no-reported-history-of-prior-immunosuppressant-use/ . Accessed October 31, 2024. Permissions were requested from the original abstract as cited above.
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 distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,000 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 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 tête enseignante, 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 ».