327. LONG-TERM SAFETY OF RITUXIMAB IN GRANULOMATOSIS WITH POLYANGIITIS OR MICROSCOPIC POLYANGIITIS: RESULTS OF THE FOUR-YEAR RITUXIMAB IN ANCA-ASSOCIATED VASCULITIS REGISTRY
Notice bibliographique
Résumé
Background: Potential therapy-related toxicities are important causes of morbidity in patients with the ANCA-associated vasculitides granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Long-term safety studies of rituximab in GPA/MPA are limited. Methods: Analysis of RaVeR (NCT01613599), an open-label real-world study of adult patients with GPA or MPA receiving rituximab (dosing regimen determined by treating physician according to standard practice and discretion), was conducted after ⩽4 years of observation or until withdrawal of consent, loss to follow-up or death. Adverse events (AEs) of interest included serious AEs (SAEs), serious infection events (SIEs), infusion- related reactions (IRR), serious cardiac or vascular events and malignancies. Crude incidence rates and 95% CI were calculated. Results: A total of 97 patients (338 patient-years [PYs]; median age 58.0 years; mean [SD] baseline VDI 2.0 [2.7]) received rituximab (mean of 8 infusions [range 1-28]). Median duration on study was 3.94 (range 0.05-4.32) yrs. 74% of patients completed the study. 91% of patients were ANCA-positive and 74% had GPA. 20% were receiving rituximab plus cyclophosphamide at baseline. During the study, 38 patients had 94 SAEs, 14 had 24 SIEs, and 10 had 17 serious cardiac events, most of which were arrhythmias (described in the existing label for rituximab; Table). Six patients had 8 serious vascular events and 3 patients had malignancy-related events. There were no serious IRRs or SAEs within 24 hours of rituximab infusion. There were 9 deaths; none were considered by the treating physician to be related to rituximab. Causes of death included septic shock, interstitial lung disease, congestive heart failure, cardio-respiratory arrest, lung adenocarcinoma and 4 of unknown etiology. The severe disease flare (worsening disease activity prompting treatment) rate was 4.44/100 PYs (95% CI: 2.49-7.33). Among patients who received rituximab repeat treatment, the rates of SAEs (23.90/100 PYs) and SIEs (6.07/100 PYs) were not increased compared with the overall cohort. Conclusion: In this cohort study there were no new safety findings related to the use of rituximab for GPA or MPA, and rates for any AE, including SIEs, cardiovascular events, malignancies, or fatal AEs did not increase over time with repeated infusions of rituximab. These results are consistent with the known safety profile of rituximab in GPA and MPA and in other autoimmune diseases for which rituximab is approved. RaVeR provides clinicians with long-term, practice-level safety data. Disclosures: J. Niles: grant/research support: ChemoCentryx; P. Merkel: Grant/research support: Boeringher-Ingelheim, Bristol-Meyers Squibb, ChemoCentryx, Genentech/Roche, GlaxoSmithKline, Kypha TerumoBCT; consultant: AbbVie, Biogen, Boeringher-Ingelheim, Celgene, ChemoCentryx, Genentech/Roche, GlaxoSmithKline, InflaRx, Insmed, Kiniksa, Medimmune/AstraZeneca, Sanofi ; L Mertz: non declared; P. Pordeli: Employee of Roche Products Ltd; P. Lehane: Employee of Roche Products Ltd.; F. Erblang: Employee of: F. Hoffman-La Roche, Ltd. This study was funded by Genentech, Inc. Observed Adverse Events of Interest Among Patients with Granulomatosis with Polyangiitis or Microscopic Polyangiitis Receiving Rituximab IR = incidence rate; PY = patient year; CI = confidence interval; SAE = serious adverse event.
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 | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,001 | 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 ».