S1415 Effectiveness, Treatment Pattern, and Safety of Ustekinumab Among Bio-Naïve Patients With Crohn’s Disease in Real-World Clinical Settings in China
Bibliographic record
Abstract
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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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".