SUMMARY

• The company cannot recommend any practices, procedures, or dosing modifications that deviate from the approved product labeling.
• Case reports and case series describing the use of STELARA in patients with comorbid heart failure (HF) are summarized.
• Patients were excluded from the following STELARA phase 3 studies if they had severe, progressive, or uncontrolled cardiac disease: PHOENIX 1 and PHOENIX 2 (moderate to severe plaque psoriasis [PsO]), PSUMMIT I and PSUMMIT II (active psoriatic arthritis [PsA]), UNIFI (moderately to severely active ulcerative colitis [UC]), and UNITI (moderately to severely active Crohn’s disease [CD]).^1-8

Case Report for Crohn’s disease

Keating et al (2020)⁹ reported a case of a 32-year-old female with Turner syndrome, hypothyroidism, and a bicuspid aortic valve (BAV) who presented with a chronic history of diarrhea and diagnosis of Crohn’s colitis, demonstrated and confirmed by colonoscopy and histopathology.

• The patient failed to improve on oral budesonide 9 mg and was started on adalimumab induction therapy (160 mg/80 mg), followed by maintenance therapy (40 mg nightly).
• Normal left ventricular ejection fraction (LVEF) >55% and known BAV was demonstrated.
• After 8 weeks of starting adalimumab treatment, the patient presented with a 3-week history of progressive dyspnea, bilateral pedal edema, dilated left ventricle, and reduced ejection fraction <20% upon repeat trans-thoracic echocardiography (TTE).
• A diagnosis of drug-induced cardiomyopathy was hypothesized due to the simultaneous use of adalimumab and the deterioration in cardiac function.
• Adalimumab was discontinued and after inpatient treatment, the patient was discharged on optimized HF medications. The patient made a full clinical recovery with an LVEF 54% after 4 weeks, confirmed by cardiac magnetic resonance imaging (MRI).
• In February 2018, a repeat colonoscopy indicated active Crohn's colitis with aphthous ulceration affecting the distal transverse colon.
• STELARA was started after poor tolerance with azathioprine due to fatigue.
• In July 2019, a repeat colonoscopy demonstrated endoscopic remission.
• The patient remains on HF medications with continued LVEF preservation.

Case Reports for PLAQUE PSORIASIS

Aceituno et al (2017)¹⁰ presented two case studies of patients with HF and severe PsO who were treated with STELARA.

• Case 1: An 86-year-old male patient with a 40-year history of plaque PsO was referred to the hospital with a PASI 18 and BSA 44%. Plaque PsO treatment included etanercept with previous failed treatments of methotrexate and acitretin.
  • The patient had complications of hypertension, gastric ulcer, and hypercholesterolemia.
  • Mantoux test was positive and chest x-ray showed non-evidence of active tuberculosis (TB).
  • Prophylactic treatment for TB was started and etanercept was re-introduced.
  • A month later, he suffered an acute MI, HF, and atrial fibrillation.
  • Once the patient’s cardiovascular disease (CVD) was stabilized, STELARA was initiated for plaque PsO.
  • Following 3 months treatment with STELARA, the patient’s psoriasis had practically cleared and CVD was controlled.
• Case 2: A 65-year-old male patient with a 7-year history of plaque PsO was referred to the hospital with a PASI 11 and BSA 30% following treatment with acitretin and etanercept.
  • Past medical history included excess post-exercise oxygen consumption (EPOC), hyperlipidemia, sacroiliitis, depression, and basal cell carcinoma.
  • The patient was initiated on cyclosporine with good response, but he developed hypertension.
  • Cyclosporine dose was reduced and amlodipine was co-administered.
  • Eight months later, following a significant loss of response, the patient was switched to adalimumab.
  • The patient continued to worsen (PASI 25, BSA 38%) and he developed HF.
  • Treatment was changed again to STELARA and the patient’s PASI score improved to 1.5 and BSA 2%, while his CVD remained under control.

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 03 December 2024.