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.
• The phase 3 clinical trial program of STELARA in the treatment of ulcerative colitis (UC) did not evaluate the use of intravenous (IV) formulation as maintenance treatment.¹
• Retrospective studies describing the use of STELARA IV infusion during maintenance treatment in UC and Crohn’s disease (CD) are summarized below.^2-4

clinical data

Retrospective Studies

Argüelles-Arias et al (2024)² conducted a retrospective multicenter, observational study evaluating the efficacy and safety of STELARA IV maintenance treatment in patients with IBD who had a partial or complete loss of response to SC dosing over 52 weeks.

• A total of 59 patients with IBD (CD, 84.7% [n=50]; UC, 15.3% [n=9]) who received STELARA IV maintenance treatment for 12 and 52 weeks were included.
• The primary endpoint was clinical remission at weeks 12 and 52, defined by either a Harvey-Bradshaw Index (HBI) of ≤4 for CD or a partial Mayo score (pMS) of ≤2 for UC.
• The secondary endpoints included a reduction in disease activity (FCP and CRP) and clinical response (defined as a decrease of ≥3 points in HBI for CD and of ≥3 points and 30% in pMS for UC, from baseline).
• Before STELARA IV maintenance treatment was initiated, 58.6%, 13.8%, and 27.6% of patients received STELARA SC every 4 weeks (q4w), 6 weeks (q6w), and 8 weeks (q8w), respectively.
• After a median duration of 25 months on SC maintenance treatment, patients were switched to STELARA IV dosing.
  • A total of 52.5% (n=31) of patients were switched to 130 mg IV q4w; 11.9% (n=7), to 130 mg IV q6w; and 18.6% (n=11), to 130 mg IV every q8w.
  • A total of 10.2% (n=6) patients were switched with 260 mg IV q4w, and 6.8% (n=4) patients were switched with 390 mg IV q4w.
• The median pMS for patients with UC was 8.5 (interquartile range [IQR]), 6.5-9) at baseline, and it reduced to 5.5 (IQR, 4.3-6) at 12 weeks and to 3 (IQR, 2-4.8) at
  52 weeks of STELARA IV maintenance treatment (P=0.017).
• Overall, clinical remission was achieved by 47.5% of patients at week 12 and increased to 64.3% at week 52 (P<0.01).
• Median FCP levels decreased from baseline to 12 and 52 weeks (800.2 μg/g to 520 μg/g and 220 μg/g, respectively; P<0.001).
• Median serum CRP levels decreased from baseline to 12 and 52 weeks (7.1 mg/L to 4 mg/L and 3 mg/L, respectively; P<0.001).
• Median ustekinumab trough levels before STELARA IV maintenance were 3.1 μg/mL (IQR, 1.1-7.4), which increased to 12 μg/mL (IQR, 9-20) after STELARA IV maintenance (P<0.001).
• At the end of follow-up, 96.6% of patients continued IV maintenance treatment.
• No adverse events (AEs) were reported during the study.

Win et al (2023)³ conducted a retrospective study to evaluate the effectiveness of STELARA IV vs STELARA subcutaneous (SC) as maintenance therapy in adult patients with inflammatory bowel disease (IBD).

• A total of 51 patients (CD, 88%; UC, 8%; indeterminate colitis, 4%) were included. Of the 43 patients who received STELARA SC maintenance treatment, 8 were switched to STELARA IV maintenance treatment due to lack of response.
• When comparing STELARA IV vs STELARA SC as maintenance therapy, 40% vs 42% of patients showed improvement (confirmed via endoscopy or imaging) and 20% vs 25% of patients showed significant progression, respectively.
• Hospital admission rates during treatment, mean C-reactive protein (CRP) levels, and mean fecal calprotectin [FCP] levels among patients receiving STELARA IV vs SC as maintenance therapy are presented in Table: Recorded Characteristics Among Patients Receiving STELARA IV vs SC as Maintenance Therapy.

Garcia-Alvarado et al (2022)⁴ conducted a retrospective study evaluating the effectiveness of STELARA IV administered at regular intervals (usually, every 4-6 weeks) in patients with CD or UC who had insufficient efficacy or loss of response to STELARA 90 mg SC every 4-6 weeks.

• Data were collected from patients with active CD (n=73) or UC (n=6) defined by HBI or pMS >4 points and/or persistent biomarker elevation (calprotectin >250 μg/g) and/or endoscopic or radiological evidence of disease activity.
• FCP levels before and after initiating STELARA IV were available for 44 patients, and ustekinumab trough levels were available for 48 patients.
• Before STELARA IV was initiated, 31.6% and 68.4% of patients received STELARA 90 mg SC q6w and q4w, respectively.
• Overall, 3.8% of the patients were biologic-naïve and 41.8% had received ≥1 biologic.
• Mean follow-up period after the first STELARA IV dose administration was 13.22 months (IQR, 2-37).
• After 12 weeks of the first STELARA IV dose, 43% of patients achieved clinical remission (HBI <5 or pMS 2). At the end of the follow-up, 59.5% of patients achieved clinical remission.
• FCP levels decreased significantly from baseline to 12 months (612.6 mg/kg vs 384.1 mg/kg; P=0.0002) and at the end of the follow-up (222 mg/kg; P=0.0048).
• Ustekinumab levels at the beginning of STELARA IV administration were 2.6 μg/mL (IQR, 0.1311.69) and significantly increased from baseline (weeks 12-16, 9.09 μg/mL; after 1 year, 10.7 μg/mL; P<0.001 for both).
• At the end of the follow-up, 81% of the patients maintained treatment.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 23 October 2024.