SUMMARY

• The company cannot recommend any practices, procedures, usage or dosing that deviate from the approved labeling.
• Data regarding the use of STELARA in adult patients with Crohn’s disease (CD) or ulcerative colitis (UC) and comorbid primary sclerosing cholangitis (PSC) are summarized below from 2 retrospective studies and 2 case reports.^1-4

CLINICAL DATA

Retrospective Study

Holvoet et al (2024)¹ reported a retrospective, multicenter case series as part of the European Crohn's and Colitis Organization (ECCO) Collaborative Network of Exceptionally Rare case reports (CONFER) project, that evaluated the safety and effectiveness of STELARA vs vedolizumab for inflammatory bowel disease (IBD) after liver transplantation (LTX) for PSC.

• Primary endpoints included:
  • Clinical and endoscopic remission at week 52
  • Occurrence of infectious complications, malignancies, hospitalizations, and death after LTX
• The study included 58 patients, who were treated with STELARA (n=24 [38%]) and vedolizumab (n=40 [63%]).
• At week 52
  • Clinical remission (per the physician global assessment) was achieved in 38% of patients in the STELARA group and 44% of patients in the vedolizumab group (P=0.17).
  • Endoscopic remission was achieved in 33% of patients in the STELARA group and 17% of patients in the vedolizumab group (P=0.87).
• Infectious complications were reported in 21 patients, see Table: Infectious Complications, Malignancies, Hospitalizations, and Death Post LTX.

Tursi et al (2021)² reviewed patients with CD refractory to biologic therapy (eg, anti-TNF agents or vedolizumab) treated with STELARA for CD extraintestinal manifestations (EIMs), including sclerosing cholangitis.

• All patients with at least 1 induction treatment with STELARA were included in this analysis.
• There were 24 patients identified with EIMs who were treated with STELARA. One of these patients had sclerosing cholangitis.
  • This patient was in remission at the time of STELARA initiation and did not have recurrence of sclerosing cholangitis at follow-up (mean follow-up time: 6 months).

Case Reports

Almomen et al (2023)³ reported the case of a 34-year-old male patient with a 15-year history of UC and PSC post-LTX.

• The patient was diagnosed with PSC 1 year after his diagnosis of UC.
• Prior to LTX, he was treated with mesalamine and infliximab but did not achieve remission at the time of his LTX.
• Following LTX, his UC remained refractory to reintroduction of infliximab 10 mg/kg every 4 weeks, vedolizumab, adalimumab, and tofacitinib. He was started on STELARA, with the dose escalated to 90 mg subcutaneously every 4 weeks.
• After 10 months of STELARA, his laboratory findings (fecal calprotectin [FCP], 1600 µg/g; C-reactive protein [CRP], 7.2 mg/L; hemoglobin [Hb], 7.7-10.1 g/dL) necessitated iron infusions and periodic packed red blood cell (RBC) transfusions. Additionally, his colonoscopy revealed continuous inflammation from the rectum to the terminal ileum including erosions and ulcerations with a Mayo UC endoscopic subscore of 3.
• Since remission of UC could not be achieved, the patient was eventually started on oral vancomycin 500 mg twice daily, which led to clinical remission 3 months later while on the same dose of STELARA.
• Six months after vancomycin, his laboratory parameters (FCP, 277 µg/g; CRP, 0.6 mg/L; Hb, 13.4 g/dL) showed improvement without needing further packed RBC transfusions or iron infusions.
• His oral vancomycin was reduced to 250 mg twice daily and his liver test results remained normal during vancomycin treatment.
• A repeat colonoscopy revealed complete endoscopic healing, (Mayo endoscopic subscore, 0). Colonic biopsies revealed quiescent colitis without activity.

Kayal et al (2021)⁴ reported the case of a 30-year-old male patient with PSC and a past medical history of refractory UC and CD-like pouch inflammation (CDLPI).

• The patient was originally diagnosed with UC. Colectomy pathology confirmed that the patient had extensive UC and backwash ileitis.
• He underwent a 3 stage total proctocolectomy with IPAA due to medically refractory UC.
• Approximately 1-year post-IPAA, the patient developed antibiotic refractory pouchitis and was diagnosed with CDLPI due to severe chronic ileitis of the afferent limb. He was started on STELARA every 8 weeks.
• The patient initially reported decreased frequency of rectal urgency and joint pain with STELARA; 6 months after STELARA induction, he presented with an exacerbation of symptoms and aphthous ulcerations. He was given a prednisone taper and the STELARA dose was increased to every 4 weeks.
• Within 3 weeks of receiving STELARA every 4 weeks, the patient reported resolution of stool frequency, abdominal pain, rectal urgency, and joint pain.
• Six months after dose optimization of STELARA, a pouchoscopy revealed normal afferent limb, patchy erythema in the pouch body with no ulcerations in either segment.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 27 February 2025.