4CPS-141 Real-life impact of including montelukast as premedication on the incidence of infusion-related reactions to isatuximab and description of risk factors
Notice bibliographique
Résumé
<h3>Background and Importance</h3> Infusion-related reactions (IRR) are one of isatuximab’s most frequent and significant adverse reactions that may lead to treatment discontinuation despite premedicating with dexamethasone, paracetamol, and anti-H1 antihistamines. Similarly to daratumumab, adding montelukast as premedication could improve its tolerability. Additionally, there are no studies to date describing which risk factors (RF) may affect the likeliness of an isatuximab IRR. <h3>Aim and Objectives</h3> The primary objective was to assess the impact of including montelukast as premedication on the incidence of IRR (iIRR) associated with the administration of isatuximab. Secondary objectives included describing the iIRR in a real-life setting and evaluating possible risk factors: food, environmental or medicine allergies; previous IRR; and infusion bag concentration. <h3>Material and Methods</h3> Multicentric retrospective study conducted in one secondary and three tertiary hospitals. Eligibility criteria included adults having started isatuximab and excluded patients receiving off-label corticosteroid doses and those enrolled in clinical trials. Follow-up was carried out until September 2023, treatment discontinuation or death. Baseline characteristics were sex, age, treatment regimen, premedication regimen, number of isatuximab doses and occurrence of IRR. These numerical and categorical variables were expressed as number of observations and medians respectively. Odds ratios (OR) and Mann-Whitney U tests were calculated to evaluate qualitative and quantitative RF, respectively. Absolute risk reduction (ARR) and number needed to treat (NNT) were used to assess the impact of montelukast as premedication. 95% confidence intervals (95%CI) were applied. <h3>Results</h3> 40 patients were included, with a median age of 66 (54 – 72) years, 60.0% being men. The median number of isatuximab doses per patient was 8 (4–18). The iIRR for cycle-one-day-one was 7.7% for the group premedicated with montelukast and 29.6% without. OR was 0.20 (95% CI 0.02 – 1.79), ARR was 0.22 (95% CI -0.01 – 0.44) and NNT was 5. No IRR were found for second or further doses in any patient and no risk factors were found. <h3>Conclusion and Relevance</h3> In our experience, iIRR observed for isatuximab was lower compared to pivotal clinical trials. The inclusion of montelukast as premedication might reduce IRR, which should be confirmed in subsequent studies. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest.
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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 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 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 | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| 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 ».