S965 Real-World Treatment Persistence Among Bio-Naïve Patients With Ulcerative Colitis Initiated on Ustekinumab or Adalimumab
Notice bibliographique
Résumé
Introduction: Therapy persistence is a useful measure of real-world therapy performance, including effectiveness and safety. Biologics are used for management of moderate-to-severe ulcerative colitis (UC). This study aimed to compare treatment persistence among bio-naïve patients with UC initiated on ustekinumab or adalimumab. Methods: Adults with UC initiated on ustekinumab or adalimumab (index date) between 10/21/2019 and 03/02/2022 were selected from the IQVIA PharMetrics® Plus database. Patients were excluded if, during the 12-month baseline period before the index date, they used other UC-indicated biologics/advanced therapies or had other immune conditions. Cohorts were balanced on baseline characteristics using inverse probability of treatment weights. Persistence was defined as absence of gaps >120 days (ustekinumab) or >60 days (adalimumab) between days of therapy supply. Additionally, composite endpoints of being persistent and corticosteroid-free (< 14 consecutive days of corticosteroid supply after day 90 post-index) and persistent and on monotherapy (no immunomodulators, non-index biologics, or advanced therapies) were assessed. All endpoints were estimated during maintenance phase until earlier of 12 months follow-up, end of insurance eligibility or end of data using weighted Kaplan-Meier and Cox proportional hazards models. Results: There were 371 and 1,726 patients in the ustekinumab and adalimumab cohorts, respectively. Baseline characteristics were balanced in weighted cohorts (Table 1). At 12 months of maintenance phase, a higher proportion of patients initiated on ustekinumab compared to adalimumab were persistent on index biologic, including persistent and corticosteroid-free, and persistent and on monotherapy (Figure 1; log-rank P-values< 0.001). Patients initiated on ustekinumab had a 77% higher rate of persistence (hazard ratio [HR] 1.77; 95% confidence interval [CI]: 1.44-2.18), 58% higher rate of persistence while being corticosteroid-free (HR: 1.58; 95% CI: 1.33-1.88), and 80% higher rate of persistence while on monotherapy (HR: 1.80; 95% CI: 1.48-2.18) than those initiated on adalimumab. Conclusion: Bio-naïve patients with UC treated with ustekinumab were more persistent, including persistent while corticosteroid-free and persistent while on monotherapy, than patients treated with adalimumab. These findings may aid healthcare providers in choosing a biologic for bio-naïve patients with UC. Funded by Janssen Scientific Affairs, LLC.Figure 1.: Kaplan-Meier curves of being: a) persistent on index biologic, b) persistent and corticosteroid-free, c) persistent and on monotherapy in weighted* ustekinumab and adalimumab cohorts. *Cohorts were weighted on baseline characteristics using inverse probability of treatment weights. Table 1. - Selected baseline characteristics in weighted ustekinumab and adalimumab cohorts* Mean ± SD [median] or n (%) UstekinumabN=371 AdalimumabN=1,726 Std diff (%) Age (years) 42.0 ± 13.5 [42.1] 42.2 ± 13.9 [41.5] 0.8 Female 178 (48.1) 823 (47.7) 0.8 Any intestinal complication 59 (15.9) 239 (13.8) 5.8 Selected general comorbid condition Diarrhea 182 (49.1) 883 (51.2) 4.1 Pain 166 (44.8) 765 (44.3) 1.0 Anemia 103 (27.7) 451 (26.1) 3.5 UC-related medication Corticosteroids 283 (76.4) 1,343 (77.8) 3.5 5-ASA 284 (76.5) 1,320 (76.5) 0.1 Immunomodulators 45 (12.2) 226 (13.1) 2.9 Antidiarrheals 17 (4.7) 73 (4.2) 2.2 Concomitant medication Opioids 115 (31.0) 559 (32.4) 2.9 Antibiotics 97 (26.0) 489 (28.3) 5.2 All-cause costs (US$ 2022) 18,702 ± 35,981 [10,942] 16,889 ± 27,018 [10,420] 5.7 Pharmacy costs 5,912 ± 16,753 [3,126] 5,216 ± 9,011 [3,366] 5.2 Medical costs 12,790 ± 30,399 [5,629] 11,672 ± 25,146 [5,009] 4.0 *Cohorts were weighted on baseline characteristics using inverse probability of treatment weights; characteristics considered well balanced if standardized difference is <10%. 5-ASA: 5-aminosalicylic acid; SD: standard deviation; Std diff: standardized difference; UC: ulcerative colitis; US: United States.
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 | 0,001 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,006 | 0,001 |
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 ».