SUMMARY

• The company cannot recommend any practices, procedures, usage, or dosing that deviate from the approved labeling.
• There are no pharmacokinetic data in patients receiving STELARA with impaired hepatic function.¹
• Data regarding the use of STELARA in adult patients with comorbid liver cirrhosis are available through several retrospective studies and case reports, which are summarized below.^2-5

COMPANY CORE DATA SHEET

STELARA PHARMACOLOGICAL PROPERTIES

Pharmacokinetic Properties

Hepatic Impairment

No pharmacokinetic data are available in patients with impaired hepatic function.¹

CLINICAL DATA

Retrospective Studies

Li et al (2021)² conducted a retrospective study to evaluate the safety of biologics and small molecules in patients with inflammatory bowel disease (IBD) and comorbid cirrhosis. Results pertinent to STELARA are summarized below.

• Adult patients with IBD and cirrhosis (confirmed by liver biopsy or Fibroscan) were included in this analysis.
• The primary outcome was the rate of adverse events (AEs) categorized by infection, infusion reaction, IBD-related hospitalization, and mortality.
• There were 18 patients included in this analysis; 22.2% were receiving STELARA. The median follow-up time was 24.3 months (interquartile range [IQR], 10.3-46.2).
• Of the 5 AEs reported, infection was reported in 1 patient receiving STELARA.

Begon et al (2018)³ assessed the safety of biologics, including STELARA, in patients with psoriasis (PsO) and comorbid alcoholic cirrhosis through a multicenter, retrospective, observational analysis.

• Of the 23 patients assessed in this analysis, 10 received STELARA.
  • One patient with extensive skin disease and decompensated Child-Pugh C cirrhosis died of generalized sepsis of unknown origin after a single dose of STELARA.

Case Reports

Richetta et al (2021)⁴ reported the case of a 50-year-old male patient with moderate to severe plaque PsO and cirrhosis due to nonalcoholic steatohepatitis (NASH).

• The patient presented with a flare of plaque-type PsO after liver transplantation for NASH, which progressed to cirrhosis.
• The patient had a good clinical status after the transplant and was started on immunosuppressive therapy with tacrolimus, mycophenolate mofetil, and prednisone.
• After 6 months, the patient presented with a flare up of plaque PsO, with erythematous plaques covered by lamellar scales on his legs, arms, and trunk. Erythematous plaques were also observed on the face, genitals, and nails.
• Due to recurring symptoms of plaque PsO, treatment with a biologic agent was re-evaluated.
• Methotrexate and acitretin were considered unsafe due to the history of liver transplantation, and cyclosporin was excluded as the patient was receiving immunosuppressive therapy. Hence, STELARA 45 mg subcutaneously (SC) was initiated initially, after 4 weeks, then every 12 weeks.
• After 1 month of treatment, an improvement in erythematous plaques was observed with a decrease in the Psoriasis Area Severity Index (PASI) score from 14 to 6 and a decrease in the Dermatology Life Quality Index (DLQI) score from 15 to 3.
• AEs or deterioration of the transplanted organ was not observed.
• After 2 months of treatment, the patient showed complete resolution of PsO and it was maintained at the 6-month follow-up visit.
• No AEs were reported.

Peverelle et al (2020)⁵ reported the case of a 58-year-old male patient diagnosed with Crohn’s disease (CD) and cirrhosis due to recurrent hepatitis C.

• In 2013, the patient was diagnosed with hepatitis C cirrhosis and membranoproliferative glomerulonephritis, and in 2014, he underwent combined liver-kidney transplantation.
• The patient received post-transplant immunosuppressive therapies with tacrolimus and prednisolone.
• His post-transplant course was complicated by recurrent hepatitis C, which progressed to cirrhosis in 2015.
• In 2016, the patient presented with diarrhea (10 motions/day) with a Harvey-Bradshaw Index (HBI) score of 11. Index colonoscopy revealed ileitis with ulceration and mild stricturing, and histological examination revealed active ileitis, consistent with a diagnosis of CD. The patient was started on mesalazine 4 g/day, to which he had a good clinical response.
• In 2018, his disease relapsed, and colonoscopy indicated persistent ileitis with moderate structuring (Simple Endoscopic Score for Crohn's Disease [SES-CD] of 7 points).
• Histology confirmed acute-on-chronic inflammation and superficial erosions in the terminal ileum and transverse colon.
• The patient was initiated on budesonide and azathioprine; however, he complained of ongoing abdominal pain, diarrhea (10 motions/day), with an HBI score of 14 and fecal calprotectin level of 174 μg/mg.
• The patient was initiated with STELARA 390 mg intravenously, followed by 90 mg SC every 8 weeks (q8w) thereafter.
• Clinical response was observed within 6 weeks, and clinical remission was noted within 6 months of treatment. The HBI score and fecal calprotectin level were reduced to 4 and 55 μg/mg, respectively.
• Colonoscopy revealed erythema in the terminal ileum but with a significant endoscopic improvement (SES-CD of 3 points) and histologic remission.
• Mesalazine was discontinued; 3 months later, the patient remained in clinical remission, with no episodes of graft rejection or infectious complications.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 11 June 2024.