S869 Real World Clinical Effectiveness and Safety of Vedolizumab and Adalimumab in Biologic-Naïve Patients With Crohn’s Disease: Results From the EVOLVE Study
Notice bibliographique
Résumé
Introduction: Vedolizumab (VDZ, a gut selective anti-α4β7-integrin) and adalimumab (ADA, anti-tumor necrosis factor) are approved biologic treatments for moderate to severe Crohn’s disease (CD). We aimed to evaluate the real-world clinical effectiveness and safety of VDZ versus ADA in biologic-naïve patients with CD. Methods: This was a retrospective cohort study in adult patients with CD who received first-line biologic treatment with VDZ or ADA at 37 sites in the US, Canada, and Greece. The index date was defined as the date of first-line biologic initiation between May 2014 and March 2018. Cumulative rates of treatment persistence and clinical outcomes over 12 months were estimated using the Kaplan-Meier method. Patients were censored at loss of follow up, death, end of chart abstraction, treatment discontinuation, or dose escalation, whichever came first. Clinical outcomes were assessed using pre-defined hierarchical algorithms of standard measures.1 Survival analyses were conducted for safety outcomes, CD-related exacerbations and CD surgeries. Adjusted analyses were performed using stabilized inverse probability weighting using baseline covariates. Results: 362 patients were included (VDZ: 218; ADA: 144). Baseline characteristics are shown in Table. Cumulative rates of clinical response (68.5% vs 61.1%; p=0.59) and mucosal healing (67.7% vs 56.0%; p=0.56) over 12 months were similar between treatment cohorts, whilst clinical remission rates (66.3% vs 46.4%; p< 0.01) were greater in VDZ- versus ADA-treated patients. Over 12 months, VDZ-treated patients were more likely to persist on treatment versus ADA-treated patients (89.3% vs 77.5%; p=0.02). VDZ-treated patients were significantly less likely to experience (incidence rates per 1000 person-years; HR [95%CI]) serious adverse events within 1 year (78.9 vs 166.2; 0.45 [0.22-0.93]), but there were no statistical differences in CD exacerbations (207.7 vs 261.8; 0.91 [0.56-1.47]), CD-related surgeries (10.3 vs 16.0; 1.55 [0.21-11.15]) or serious infections (20.5 vs 71.2; 0.27 [0.06-1.20]) versus ADA-treated patients. Conclusion: In a real-world setting in biologic-naïve patients with CD, VDZ-treated patients had equivalent rates of response and mucosal healing but a greater likelihood of persisting on treatment and achieving clinical remission versus ADA-treated patients. Studies assessing outcomes after dose optimization are needed. Table 1. - Baseline Characteristics of Biologic Naïve Patients with Crohn’s Disease Treated with Vedolizumab or Adalimumab Baseline Characteristics VedolizumabN=218 AdalimumabN=144 p-value Age, Mean (SD) 51.7 (16.8) 40.0 (14.9) < 0.001 Male, n (%) 114 (52.3) 75 (52.1 0.969 Disease duration, n with available data 176 111 0.016 < 2 years, n (%) 50 (28.4) 50 (45.0) 2- < 5 years, n (%) 32 (18.2) 16 (14.4) ≥ 5 years, n (%) 94 (53.4) 45 (40.5) Median (min-max) observation period, (months)* 15.7 (4.2-45.9) 19.3 (6.1-49.3) < 0.001 Crohn’s disease location at index, n with available data 196 121 0.047 Colonic with/without upper GI disease, n (%) 42 (21.4) 35 (28.9) Ileal with/without upper GI disease, n (%) 85 (43.4) 36 (29.8) Ileocolonic with/without upper GI disease, n (%) 69 (35.2) 50 (41.3) Disease severity at index, n with available data 180 116 0.161 Moderate, n (%) 84 (46.7) 58 (50.0) Severe, n (%) 17 (9.4) 17 (14.7) Abbreviations: GI = gastrointestinal; SD = standard deviation.*While all patients were required to have 6 months follow-up from time of treatment initiation to data abstraction, some patients were lost to follow-up and therefore minimum duration during the observation period was <6 months.
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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 | 0,006 | 0,006 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,002 |
| Bibliométrie | 0,000 | 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) | 0,001 | 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 ».