Lebrikizumab Dosed Every 8 Weeks as Maintenance Provides Long-Lasting Response in Patients with Moderate-to-Severe Atopic Dermatitis
Notice bibliographique
Résumé
Introduction Lebrikizumab dosed every 4 weeks (LEBQ4W) in ADjoin demonstrated sustained response up to 3 years in patients with atopic dermatitis (AD) who were Week-16 responders. In ADvocate1/ADvocate2 during the maintenance period (Weeks 16-52), a high proportion of patients exhibited durable efficacy in the lebrikizumab withdrawal (placebo) arm, suggesting the possibility of less frequent dosing. We report results from a 32-week extension to ADjoin assessing efficacy and safety of LEBQ8W. Methods ADjoin is a 100-week long-term extension study assessing lebrikizumab 250 mg every 2 weeks (LEBQ2W) and every 4 weeks (LEBQ4W) in patients who completed qualifying parent studies. Qualifying patients from ADvocate1, ADvocate2, ADore, and ADopt-VA who completed ADjoin Week 100 were re-randomized to open-label LEBQ8W or LEBQ4W for a 32-week extension. Primary outcomes were percentages of patients achieving Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) and ≥75% improvement in Eczema Area and Severity Index (EASI 75) at Week 32. Key secondary outcomes included percentage of patients achieving EASI 90 and change from baseline in the Patient-Oriented Eczema Measure (POEM). Safety data were collected throughout the extension. A combined non-responder imputation and multiple imputation method were used to address intercurrent events and missing data. The study was not powered to detect if LEBQ4W dosing is comparable to LEBQ8W dosing. Results 103 patients (LEBQ8W, N=51; LEBQ4W, N=52) enrolled in the 32-week extension (mean 60 days without lebrikizumab from ADjoin Week 100 to start of extension). Mean values for parent study baseline characteristics in LEBQ8W and LEBQ4W, respectively, were: AD disease duration, 17.1 and 17.7 years; EASI, 31.0 and 26.6; body surface area, 48.3% and 39.3%; and POEM, 20.9 and 19.8. Upon entering the extension, 64.7% and 73.1% of LEBQ8W and LEBQ4W patients, respectively, had achieved EASI 90, and mean (SD) POEM scores were 8.7 (7.6) and 6.0 (5.4), respectively. At Week 32 of the extension, percentages of patients (95% confidence interval) who achieved IGA 0/1 were 62.0% (48.3, 75.8) and 73.0% (60.9, 85.1) in LEBQ8W and LEBQ4W, respectively; 79.1% (67.6, 90.5) and 86.2% (76.8, 95.7) of patients achieved EASI 75 and 68.7% (55.8, 81.6) and 78.2% (66.8, 89.5) achieved EASI 90; POEM mean (SD) absolute scores (as observed) were 9.2 (7.3) in LEBQ8W and 5.4 (5.2) in LEBQ4W. All adverse events (AEs) were mild or moderate in severity. No serious AEs or AEs leading to discontinuation were reported; there was no evidence of increased risk of anti-drug antibodies with less frequent dosing. Conclusion Lebrikizumab dosed every 8 or 4 weeks provided long-lasting response in patients with moderate-to-severe AD, supporting its durable and potential disease-modifying effect in AD.
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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 | 0,002 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| 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) | 0,001 | 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 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 ».