Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease

Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease: a Retrospective Observational Study

The primary purpose of this study is to evaluate the efficacy and safety of intravenous administration at regular intervals of Ustekinumab in participants with loss of response to standard regimen or have evidence of high activity clinically, biochemically or endoscopically.

This study evaluates the efficacy and safety of intravenous administration at regular intervals of Ustekinumab. It consists of escalation treatment period (Week 0 to 52); and safety follow up visit (24 weeks after last dose). Study assessments will include Harvey-Bradshaw index (HBI), Physician Global Assessment Score (PGA), laboratory evaluations, endoscopic evaluation, review of concomitant medications and adverse events (AEs).

Inclusion Criteria:

• Agree to participate in the study
• With active Crohn's disease
• Undergoing Ustekinumab dose intensification with at least two or more intravenous infusions at the discretion of the treating physician
• HBI ≥ 5 before Ustekinumab therapy
• Over 18 years of age

Exclusion Criteria:

• Who had received Ustekinumab for an indication
• Pregnant or nursing
• L4 type
• History of enterectomy or enterostomy related to disease
• Who used total enteral nutrition for more than 2 weeks due to complications such as obstruction, abscess and perforation after starting Ustekinumab therapy
• Pregnant and lactating women