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 a retrospective study and 2 case reports.^1-3

CLINICAL DATA

Retrospective Study

Tursi et al (2021)¹ reviewed patients with CD refractory to biologic therapy (eg, anti-tumor necrosis factor agents or vedolizumab) treated with STELARA for CD extraintestinal manifestations (EIMs), including sclerosing cholangitis.

• All patients with at least one 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)² reported the case of a 34-year-old male patient with a 15-year history of UC and PSC post-liver transplantation.

• The patient was diagnosed with PSC 1 year after his diagnosis of UC.
• Prior to liver transplantation, he was treated with mesalamine and infliximab but did not achieve remission at the time of his liver transplantation.
• Following liver transplantation, 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)³ 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 three-stage total proctocolectomy with ileal pouch anal anastomosis (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 07 March 2024.