S1415 Effectiveness, Treatment Pattern, and Safety of Ustekinumab Among Bio-Naïve Patients With Crohn’s Disease in Real-World Clinical Settings in China
Notice bibliographique
Résumé
Introduction: Ustekinumab (UST) is a human interleukin-12/23 monoclonal antibody. Clinical trials have shown UST’s efficacy and safety in Crohn’s disease (CD). However, relevant real-world evidence in China is scarce particularly among bio-naïve patients with CD. This study evaluates UST’s endoscopic and clinical effectiveness, treatment pattern, and safety among bio-naïve patients with CD in real-world clinical settings in China. Methods: A multicentre, retrospective observational study was performed in bio-naïve patients with CD initiating UST between 05/20/2020 and 09/16/2022. Effectiveness was assessed at week 24 (± 4 weeks), including endoscopic remission, endoscopic response, (steroid-free) clinical remission, and (steroid-free) clinical response. Treatment pattern was evaluated by the UST treatment persistence and the CD-related concomitant treatment. Safety was measured by the frequency of adverse events (AEs). Results: A total of 200 patients initiating UST as 1st-line were included; 44.5% were < 30 years old, 66% had CD for ≤2 years, and 53.5% had moderately-to-severely active CD at baseline. Of patients with endoscopic/clinical outcomes available, at week 24 (± 4 weeks), 46.38% and 69.49% achieved endoscopic remission and response, respectively; 64.95% and 78.53% achieved clinical remission and response, respectively; and 64.4% and 77.37% achieved steroid-free clinical remission and response, respectively (Figure 1). Of 200 patients, most (93%) persisted in UST while 14 (7%) discontinued UST due to a lack of response (n=7; switched to other biologics), surgery (n=5), AE (n=1; switched to other biologics), and patient’s decision (n=1). Two (1%) patients received concomitant immunosuppressants and 9 (4.5%) received concomitant steroids during observation. Fifteen patients reported 15 AEs, with fatigue (n=3) and mild infusion reaction (n=3) being most common. Conclusion: Among these patients who were relatively young and had short CD duration, almost half achieved endoscopic remission at week 24 after UST initiation. Multiple clinical outcomes consistently improved, and the magnitude of improvement appeared more prominent than in registrational trials. Most patients persisted in UST without switching to other biologics and were treated without concomitant medications. No serious AEs or unexpected safety signals occurred. Findings of this study support the consideration of UST as 1st-line biologics for CD (see Table 1).Figure 1.: Summary of Endoscopic and Clinical Effectiveness at Week 24 (± 4 Weeks). Table 1. - Baseline Patient Characteristics, and Treatment Pattern and Adverse Event During Observation Baseline Entire observation period Age group (years), % (n/N) 18-29 44.5% (89/200) 30-39 23.5% (47/200) 40-49 19% (38/200) ≥50 13% (26/200) CD duration ≤2 years, % (n/N) 66% (132/200) Moderately-to-severely active CD (CDAI = 221–450 or >450), % (n/N) 53.5% (107/200) Montreal classification – Location, % (n/N) L1 27.5% (55/200) L2 2% (4/200) L3 51.5% (103/200) L4 19% (38/200) Montreal classification – Behavior, % (n/N) B1 48% (96/200) B2 37% (74/200) B3 15% (30/200) Perianal disease 57.5% (115/200) Extraintestinal manifestations, % (n/N) 21% (42/200) Ustekinumab treatment persistence, % (n/N) Yes 93% (186/200) No 7% (14/200) Due to a lack of response; switch to other biologics 7 Due to adverse event; switch to other biologics 1 Due to surgery; no switch to other biologics 5 Due to patient's decision; no switch to other biologics 1 Concomitant treatment of immunosuppressant, % (n/N) 1% (2/200) Concomitant treatment of steroid, % (n/N) 4.5% (9/200) Concomitant CD-related treatment*, % (n/N) 5.5% (11/200) AE, % (n/N) Fatigue 20% (3/15) Mild infusion reaction 20% (3/15) Mild abdominal pain 13.33% (2/15) Nasopharyngitis 13.33% (2/15) Mild elevation in liver enzymes 13.33% (2/15) Arthralgia 6.67% (1/15) Dizzy 6.67% (1/15) Decreased leucocyte 6.67% (1/15) *Immunosuppressant or steroid treatment; CD: Crohn’s Disease; CDAI: Crohn’s Disease Activity Index; AE: Adverse Event.
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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 | 0,001 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 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 ».