STELARA®
(ustekinumab)
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STELARA® (ustekinumab)
Medical Information
Re-induction with IV Infusion of STELARA During Maintenance Therapy in Ulcerative Colitis
Last Updated: 01/02/2025
SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- Please refer to the local labeling for relevant information on dosage and administration for STELARA.
- An observational study assessing the efficacy of re-induction with an intravenous (IV) infusion of STELARA during maintenance therapy in ulcerative colitis (UC) is summarized below.1
- The phase 3 clinical trial program of STELARA in the treatment of UC did not evaluate re-induction with IV infusion during maintenance therapy.2
Clinical data
Observational Study
Iborra et al (2023)1 conducted an observational, multicenter study to determine the efficacy of STELARA in patients with refractory UC, including those requiring IV re-induction with STELARA.
- Partial Mayo score (PMS), C-reactive protein (CRP) and fecal calprotectin (FCP) levels were recorded at baseline and at 8, 24, and 52 weeks, and at 18 and 24 months.
- There were 108 patients included in this analysis:
- Dosing interval reduction was required in 58 (54%) patients, of whom 76% were reduced to every 4 weeks and 24% to every 6 weeks after a median of 22.3 (11.6-41.2) weeks.
- Intravenous re-induction was required in 20/58 (18.5%) patients after a median of 27.7 (6.64-56.3) weeks.
- Three patients required maintenance therapy with IV administration.
- Data specific to patients who required IV re-induction is not reported in this abstract. For the proportion of patients who achieved clinical remission and normal FCP or CRP in the overall study population, please see Table: Efficacy Outcomes in Patients Receiving STELARA.
| Week 8 | Week 24 | Week 52 | 18 Months | 24 Months | |
|---|---|---|---|---|---|
| Clinical Remissiona | 39.6 | 41 | 51 | 61 | 57.7 |
| Normal CRPb | 79 | 75 | 76.5 | 71 | 70 |
| Normal FCPc | 39.6 | 41 | 51 | 61 | 58 |
| Abbreviations: CRP, C-reactive protein; FCP, fecal calprotectin; PMS, Partial Mayo Score. aClinical remission was defined as PMS≤2. bNormal CRP was defined as CRP<3 mg/mL. cNormal FCP was defined as FCP<250 µg/g. | |||||
- Of the 17 patients who had an endoscopy prior to and after treatment with STELARA, 6 were in remission and 3 had mild activity.
- Adverse events were reported in 5 patients; 12 were hospitalized and 9 required surgery.
Literature Search
A literature search of MEDLINE®
References
| 1 | Colomino I, Ferreiro-Iglesias R, Martin-Arranz M, et al. Real life 2 year experience with ustekinumab in a Spanish open-label cohort of ulcerative colitis patients [abstract]. J Crohn Colitis. 2023;17(Suppl. 1):i629-i630. Abstract P500. |
| 2 |