P-105 Dermatologic Complications in Patients Treated with Certolizumab Pegol
Notice bibliographique
Résumé
Tumor necrosis factor (TNF) inhibitors have significantly changed the management of patients with inflammatory bowel diseases (IBD). Cutaneous reactions are among the most common adverse events (AEs) seen with anti-TNF therapy. Certolizumab pegol (CZP) is a subcutaneously (sc) administered PEGylated Fc-free Fab' fragment of a humanized TNF alpha monoclonal antibody. Dermatologic complications in patients using CZP are not fully described. The aim of this analysis was to assess the effect of CZP in patients with Crohn's disease (CD) on dermatologic complications of clinical interest, including immune-mediated complications (e.g., psoriasis and lupus-like syndrome). Pooled safety data including 2570 CZP-treated adult CD patients from 15 Phase 2 or 3 placebo (PBO)-controlled or open-label studies were analyzed. In the short-term, PBO-controlled studies 919 patients received CZP and 875 patients received PBO. Patients received CZP 400 mg sc every 4 weeks (74% of patients) or 400 mg every 2 weeks. The frequency and incidence rate (IR, events per 100 patient-years) of dermatologic complications were calculated for patients receiving PBO, CZP (in PBO-controlled, short-term studies), and CZP in all studies. The mean duration of CZP exposure was 568 days (approximately 1.6 years, range 14 days—7.7 years). The 2570 CZP-treated patients contributed to 4378 patient-years. For the PBO-controlled studies, there were 299 and 262 patient-years for the CZP and PBO groups, respectively. Demographics were similar for age, gender, race and BMI. Disease distribution, using the Montreal classification, disease behavior and history of prior surgical resections were also similar between the groups. Immunosuppressant and corticosteroid use was similar amongst the groups. In the PBO-controlled studies, the selected dermatologic complications occurred in 8/919 patients (0.87%) in the CZP group and 4/875 patients (0.46%) in the PBO group. One patient in the PBO group and 3 in the CZP group from the PBO-controlled studies developed psoriatic conditions. There were no cases of psoriasiform dermatitis, guttate psoriasis, or pustular psoriasis in any of the groups, nor any cases of skin vasculitides. There was 1 case of bullous conditions in the CZP group (0 in the PBO group). Alopecia occurred in 3 cases on PBO and 4 cases on CZP (of which 1 was attributed to alopecia areata). Alopecia totalis and madarosis were not observed. The long-term IR for the key dermatologic conditions did not appear to differ considerably from the CZP or PBO rates reported in the PBO-controlled studies (Table). Data from 2570 CD patients with 4378 patient-years of follow up suggest that CZP may not be associated with a high rate of dermatologic complications. The most common dermatologic adverse event was psoriasis. The IR for psoriatic conditions appeared to be nominally higher in the CZP group whereas the IR for skin vasculitis, bullous conditions and alopecia were similar between PBO and CZP in the PBO-controlled studies. These findings are favorable as there was minimal occurrence of dermatological complications.
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) | 0,000 | 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 ».