Crohn Disease, Inflammatory Bowel Diseases, Treatment Side Effects, Ulcerative Colitis
Conditions
Brief summary
New types of biologics have brought advantages in therapy strategies for Crohn's disease. However, clinical data evaluating their efficacy and adverse in China is lacking. We aimed to evaluate the short-term and long-term therapeutic effect as well as drug adverse of Ustekinumab (UST) and Vedolizumab (VED). Besides, we aim to figure out the independent factors predicting the effectiveness of new biologics. Relations between drug exposure (trough concentration and antibody concentration) and therapeutic efficacy are study in-depth by this retrospective observational study.
Interventions
None listed
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
17 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Consecutive adult patients with confirmed diagnosis of Crohn's disease and administration of new type biologics.
Exclusion criteria
* loss of follow-up, incomplete clinical data, without confirmed diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| endoscopic remission | short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks) | Endoscopic remission referred to those with simple endoscopic score for Crohn's disease (SES-CD)≤2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical remission | short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks) | Clinical remission was defined as Crohn's disease activity index (CDAI) below 150 |
| clinical response | short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks) | endoscopic response referred to those with a reduction of SES-CD \> 50% baseline |
| endoscopic response | short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks) | endoscopic response referred to those with a reduction of SES-CD \> 50% baseline |
Countries
China
Outcome results
None listed