Bimekizumab Efficacy and Safety Over 48 Weeks in US and Canadian Patients with Psoriasis who had a Treatment Interruption After 3 Years of Treatment: Results from BE RADIANT
Notice bibliographique
Résumé
Patients with psoriasis treated with biologics frequently experience treatment interruptions; 1,2 therefore, it is important to assess recovery of response upon retreatment. ObjectiveTo report efficacy and safety of bimekizumab (BKZ) in patients from the US and Canada treated for 1 year following a treatment interruption during the BE RADIANT study. Methods • After 144 weeks of BE RADIANT (3 years; 48-week double-blinded period plus a 96-week open-label extension period [OLE]), 3 patients from the US and Canada could enter a second OLE (OLE2; 48 weeks); most had a treatment interruption before entering OLE2 (Figure 1).• Patients scoring ≤ 2 in the Investigator's Global Assessment (IGA) at OLE2 baseline received BKZ every 8 weeks (Q8W), and those scoring IGA ≥ 3 received BKZ Q4W for 16 weeks then Q8W thereafter (Q4W/Q8W).• The following efficacy outcomes are reported through OLE2, in patients who had a treatment interruption, using non-responder imputation (NRI) and observed cases (OC):-≥ 90%/100% improvement from baseline in Psoriasis Area and Severity Index (PASI 90/100); -IGA 0/1 (clear or almost clear); -Dermatology Life Quality Index (DLQI) 0/1 (no effect of skin disease on quality of life).4• Following a treatment interruption, the proportions of patients who had treatmentemergent adverse events (TEAEs) during OLE2 are reported, regardless of dosing regimen (BKZ Total).-Rates of TEAEs are also reported as exposure-adjusted incidence rates per 100 patient-years. Results Efficacy• Baseline characteristics at the start of BE RADIANT are shown in Table 1.• 66 patients had an IGA score of ≤ 2 at OLE2 entry and received BKZ Q8W, after a median (range) treatment interruption of 23 (6-51) weeks.-Among these patients, PASI 100 rates were high at Week 144 (74.2%; last visit before treatment interruption), decreased to OLE2 baseline (27.3%; after treatment interruption), regained to OLE2 Week 12 (69.7%; 3 months), and were maintained to OLE2 Week 48 (71.2%;Year 1; Figure 2A).-PASI 90, IGA 0/1, and DLQI 0/1 rates followed a similar trend (Figures 2B-D).• 59 patients had an IGA score ≥ 3 at OLE2 entry and received BKZ Q4W/Q8W, after a median treatment interruption of 28 (7-49) weeks.-Among these patients, PASI 100 rates were high at Week 144 (64.4%), decreased to OLE2 baseline (0%), regained after 3 months (64.4%), and were maintained to Year 1 (54.2%; Figure 2A).-PASI 90, IGA 0/1, and DLQI 0/1 rates followed a similar trend (Figures 2B-D). Safety• The proportions of patients who reported TEAEs and TEAEs of interest are shown in Table 2.• One death occurred in OLE2 (pneumonia on a background of metastatic cancer; patient had underlying risk factors).• The most common TEAEs were coronavirus infection (OLE2 started during the global COVID-19 pandemic), oral candidiasis, and nasopharyngitis.• Oral candidiasis events occurred in nine (7.2%) patients.No cases of oral candidiasis were serious, severe, or led to discontinuation. ConclusionsAfter bimekizumab retreatment following a treatment interruption, efficacy responses were regained and maintained through 1 year; bimekizumab was well-tolerated with no unexpected safety findings.
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 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 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,000 |
| Communication savante | 0,001 | 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) | 0,002 | 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 ».