SUMMARY  

• The company cannot recommend any practices, procedures, usage, or dosing that deviate from the approved labeling. Please refer to the local labeling for relevant information on dosage and administration for STELARA.
• The STELARA phase 3 clinical trial programs for Crohn’s disease (CD) and ulcerative colitis (UC) did not evaluate re-induction with intravenous (IV) infusion during the induction period.^1,2
• A retrospective, observational study that evaluated clinical outcomes for a group of patients with CD who received standard STELARA IV dosing versus double STELARA IV dosing during the induction period is summarized below. There was no significant difference between groups in the primary outcome, clinical remission, at week 52 (P=0.10).³

CLINICAL DATA

Retrospective Study

Chin et al (2023)³ conducted a retrospective, observational study to compare clinical outcomes in a cohort of adult patients with CD who received the standard STELARA IV induction compared to a double IV induction: IV dose at week 0 and 4 (STEADY study).

Study Design

• The study assessed patients with CD from a single tertiary inflammatory bowel disease (IBD) center using a prospectively maintained database from October 2015 to October 2022.
• Based on the discretion of the treating physician, patients received either standard IV induction or double IV induction, which included an IV dose at weeks 0 and 4.
• The primary outcome was clinical remission, defined as Harvey Bradshaw Index (HBI) <5 at week 52.

Results

• A total of 47 patients were included in the study, of which 38 patients received standard IV induction and 9 patients received double IV induction.
• At week 52, all 9 patients in the double IV induction group compared to 29/38 patients (76%) in the standard IV induction group were in clinical remission (P=0.10).
• Of the 9 patients in the standard IV induction group who were not in clinical remission, 5 had treatment failures (3 required surgery and 2 switched medical therapy).
• The remaining 4 patients remained on STELARA treatment until week 52 (1 had a clinical response and 3 had no clinical response).
• There were no serious infections or malignancy reported in the double IV induction group.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 25 October 2024.