SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• A case series and several case reports describing the use of STELARA in patients with a history of transplantation (heart, kidney, and liver) are summarized below.^1-7

CLINICAL DATA

Case Series

Magavi et al (2022)¹ reported 2 patients with moderate to severe Crohn’s disease (CD) or ulcerative colitis (UC) and a history of liver transplantation who received STELARA.

Case 1

• A 41-year-old male with a history of UC, autoimmune hepatitis and primary sclerosing cholangitis (PSC) cirrhosis. He was later diagnosed with CD of the pouch and pre-pouch ileum (post-proctocolectomy) and was started on STELARA.
• Within 2 weeks of STELARA induction therapy, the patient underwent liver transplant; post-transplant course was complicated by primary non-function requiring
  re-transplantation. STELARA was discontinued.
• Post-liver transplant, the patient was receiving tacrolimus and mycophenolate. He was evaluated for diarrhea which revealed persistent moderate to severe CD.
• Vedolizumab was initiated which resulted in mild clinical improvement; however, further treatment with vedolizumab was deferred due to cytomegalovirus enteritis requiring antiviral therapy.
• STELARA every 8 weeks (q8w) was reinitiated due to active CD observed during pouchoscopy. After 5 months of therapy, the patient sustained clinical response and began budesonide taper at the time of this report.
• No malignancies or adverse events (AEs) were reported on STELARA maintenance therapy.

Case 2

• A 56-year-old male patient with a past medical history of pan-UC and a liver-transplant due to PSC cirrhosis. Post-liver transplant, patient was receiving oral mesalamine, tacrolimus and mycophenolate, and received high-dose prednisone for acute cellular rejection.
• The patient was evaluated for diarrhea which revealed mild to moderate ileitis and right-sided colitis on colonoscopy.
• He was initiated on vedolizumab therapy and despite escalation to every 4 weeks, the patient still required budesonide for flares and was unable to achieve endoscopic remission.
• The patient was switched to STELARA q8w and has been in steroid-free clinical remission for 3 to 4 months.
• No malignancies or AEs were reported on STELARA maintenance therapy.

Case Reports

Okamura et al (2024)² reported the use of STELARA in a 65-year-old male patient with de novo CD post-heart transplant.

• The patient received a heart transplant at age 62 due to dilated cardiomyopathy. Post-transplant he was started on prednisolone, tacrolimus, mycophenolate mofetil, and valganciclovir (prophylaxis for cytomegalovirus [CMV] for 3 months).
• The patient was hospitalized several times post-transplant at 6 months, 17 months, and 21 months due to colitis (abdominal pain, severe diarrhea, and a transient fever). He developed ulcers throughout the colon except the terminal ileum, which progressed in severity overtime.
• At 21 months post-transplant, he was started on 5-aminosalicylic acids (5-ASAs) and an elemental diet for possibility of de novo CD. The patient’s symptoms and inflammation began to improve; findings upon colonoscopy revealed improvements in ulcerations.
• Treatment with 5-ASAs was later discontinued due to drug-induced liver injury, and at 30 months post-transplant, he was hospitalized again due to exacerbation of de novo CD.
  • He was started on STELARA 90 mg every 12 weeks (q12w). A few weeks later, his condition and ulcers improved, as observed upon colonoscopy. He responded well for >1 year while on STELARA. Myocardial biopsy, performed 6 months after starting STELARA, showed no rejection and cardiac function was well maintained.

Meneghello et al (2023)³ reported the use of STELARA in a 53-year-old male patient with psoriasis and a history of kidney transplant.

• The patient received a kidney transplant due to diabetic glomerulopathy.
• Post-transplant, he received azathioprine, prednisone and cyclosporine for 5 years, which controlled his psoriasis.
• The patient developed moderately differentiated invasive squamous cell carcinoma on the face and perineum. Treatment was changed to sirolimus due to the possible development of additional lesions.
• His psoriasis recurred (psoriasis area and severity index [PASI] score of 39.4; body surface area [BSA] of 48, and Dermatological Life Quality Index [DLQI] of 18). Therefore, he was started on acitretin 35 mg/day to further decrease the lesions and control his psoriasis, which involved pustular lesions.
• Since there was no response observed after 3 months of follow-up, STELARA was started at 90 mg at weeks 0 and 4 then q12w, while maintaining the use of sirolimus and acitretin at 10 mg/day. After 8 weeks of treatment, his PASI score was 5, BSA was 12, and DLQI was 1.
• The patient’s psoriasis was stable for 4 years after which the patient was diagnosed with a metastatic tumor in the lung and died.

Richetta et al (2021)⁴ reported the case of a 50-year-old male patient with moderate to severe plaque psoriasis and a history of liver transplantation.

• The patient presented with a flare of plaque-type psoriasis after liver transplantation for nonalcoholic steatohepatitis (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 psoriasis, 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 psoriasis, 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 q12w.
• After 1 month of treatment, an improvement in erythematous plaques was indicated by 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 psoriasis and it was maintained at the 6-month follow-up visit.
• No AEs were reported.

Shibuya et al (2021)⁵ reported the case of a 44-year-old female patient with UC and a history of liver transplantation.

• In 2013, the patient underwent liver transplantation for hepatic failure due to acetaminophen and was treated with tacrolimus to prevent liver rejection.
• Three years after transplantation, she experienced onset of UC (pancolitis) and was treated with mesalazine and remained stable.
• After childbirth, the condition relapsed with hematochezia and diarrhea, and vedolizumab was administered, which induced remission.
• Subsequently, the patient was also diagnosed with chronic eosinophilic pneumonia, for which she received prednisolone 50 mg. Vedolizumab was discontinued since a causal relationship between vedolizumab and pneumonia could not be ruled out.
• UC remained in remission for 3 months, then relapsed. Endoscopy revealed multiple ulcers with a Mayo endoscopic score of 3.
• The patient was given STELARA 260 mg as the first dose, followed by maintenance doses of STELARA 90 mg SC.
• Her UC symptoms improved, and she achieved clinical remission (clinical activity index [CAI]=0) after the STELARA second dose.
• Nine months after receiving the first dose of STELARA, she maintained steroid-free clinical and mucosal remission without adverse events.

Peverelle et al (2020)⁶ reported the case of a 58-year-old male patient diagnosed with CD and a history of liver and kidney transplantation.

• 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 with 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 of 174 μg/mg.
• The patient was initiated with STELARA 390 mg intravenously (IV), 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 score of 3 points) and histologic remission.
• Mesalazine was discontinued, and 3 months later, the patient remained in clinical remission with no episodes of graft rejection or infectious complications.

Martínez-Montiel et al (2015)⁷ reported the case of a 44-year-old male patient with CD and a history of liver transplantation.

• In 1992, the patient was diagnosed with CD with ileocecal involvement. He was refractory to corticosteroids and required ileocecal resection with ileocolic anastomosis.
• In 1998, the patient was diagnosed with cryptogenic cirrhosis, and liver transplantation was performed. The patient was given tacrolimus to prevent transplant failure.
• In 2001, the patient experienced postoperative recurrence of CD and was treated with prednisolone and 5-acetylsalicylic acid, with a good response.
• Since 2003, he had experienced multiple relapses and was started on adalimumab in 2011.
• In 2012, adalimumab was switched to infliximab, followed by certolizumab in 2013 due to a loss of response.
• In 2014, the patient was admitted due to a severe flare-up of CD. Colonoscopy revealed left segmental colitis with ulcers and an SES-CD score of 7 points in the affected segment.
• The patient was then started on IV corticosteroids and STELARA 90 mg SC per week for 1 month, followed by maintenance therapy of STELARA 45 mg SC per month.
• After 12 months of treatment with STELARA, the patient achieved clinical remission without corticosteroids, and endoscopy revealed mucosal healing.
• Problems related to rejection or associated infections were not observed.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 28 January 2025.