Long-Term Safety and Efficacy of Tralokinumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis Treated for up to 6 Years
Notice bibliographique
Résumé
Introduction: Tralokinumab, a monoclonal antibody that specifically neutralizes interleukin-13, is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in patients ≥12 years of age. ECZTEND (NCT03587805) is an open-label extension study evaluating the long-term safety and efficacy of tralokinumab in patients with moderate-to-severe AD. Interim analyses previously demonstrated the benefit-risk profile of tralokinumab in patients followed up to 3.5 years in ECZTEND; here, we present the final study results. Methods: Patients completing any of 9 parent trials (ECZTRA 1-8 and the TraSki investigator-initiated study) were able to enter ECZTEND. Patients in ECZTEND received tralokinumab 300 mg every other week, with topical corticosteroids and/or calcineurin inhibitors allowed. The primary objective of ECZTEND was to assess safety of tralokinumab treatment from baseline up to Week 268. Secondary objectives were to assess efficacy, including proportions of patients achieving Investigator’s Global Assessment score of 0 or 1 (IGA 0/1; clear/almost clear skin) or ≥75% improvement in Eczema Area and Severity Index (EASI-75) from parent trial baseline, and quality of life (QoL) measures up to Week 248. Results: In total, 1672 patients were treated with tralokinumab for up to 5.1 years in ECZTEND. Median exposure was 2.6 years, with 4466.2 total patient years of exposure. Maximum tralokinumab exposure, including the parent trial period, was 6.1 years. In ECZTEND, exposure-adjusted incidence rate (IR) of patients with ≥1 treatment-emergent adverse event (AE) was 114.3, which was lower than the initial 16-week treatment period of the parent trials (IR=424.8 for tralokinumab; IR=475.3 for placebo). Over 5 years of ECZTEND, serious AEs were reported in 9.0% of patients (IR=3.54). AEs that led to permanent discontinuation of treatment occurred in 4.5% of patients (IR=1.71). The most frequently reported AEs (≥5% of patients) were nasopharyngitis (22.2%), dermatitis atopic (21.4%), coronavirus infection (17.9%), upper respiratory tract infection (8.8%), headache (6.8%), and conjunctivitis (6.2%). Pre-defined AEs of special interest (eye disorders, skin infections requiring systemic treatment, eczema herpeticum, malignancies) were observed at rates similar to, or lower than, the initial treatment period of the parent trials. At Week 248, response rates (95% CI) for IGA 0/1 and EASI-75 were 66.7% (56.1-75.8) and 92.9% (85.3-96.7), respectively. Additionally, itch, sleep, and QoL improvements were sustained at levels equivalent to no-to-mild disease throughout ECZTEND. Conclusions: Long-term use of tralokinumab, up to 1 year in parent trials plus up to 5 years in ECZTEND, was well-tolerated with no new safety signals identified in patients aged 12 and up with moderate-to-severe AD. Tralokinumab treatment demonstrated robust long-term efficacy with sustained improvements in AD signs, symptoms, and QoL.
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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 | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| 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 ».