Rechallenge with Subcutaneous Ustekinumab After Hypersensitivity Reaction to Intravenous Ustekinumab

Crosby, Sheena; Schuh, Michael J.; Farraye, Francis A.

doi:10.1093/ecco-jcc/jjaa202

Cited by 2 publications

(1 citation statement)

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“…Importantly, ADR rates in our patients were low with ustekinumab treatment. This was consistent with the IM-UNITI study and published studies in psoriatic conditions, which show that hypersensitivity reactions are rare [ 24 ] and uncommon [ 12 ] with ustekinumab administration. About 4.6% of patients reportedly developed antibodies to the ustekinumab drug in the IM-UNITI trial [ 25 ].…”

Section: Discussionsupporting

confidence: 92%

Effectiveness and Safety of Ustekinumab for Moderate to Severely Active Crohn’s Disease: Results from an Early Access Program in Brazil

Chebli

Parra

Flores³

et al. 2022

JCM

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This prospective, observational, open-label study aimed to provide access to ustekinumab prior to market authorization and assess its safety and effectiveness in patients with Crohn’s disease (CD) refractory to anti-tumor necrosis factor-α and conventional drugs in Brazil. Patients with a diagnosis of moderate-to-severe active CD for ≥ 3 months before screening received ustekinumab in a single intravenous induction dose (~6 mg/kg) at week 0, and a 90 mg maintenance dose, subcutaneously, every 8 or 12 weeks, from week 8 through to 80. Serious adverse events (SAE), adverse drug reactions (ADR), clinical response (per CD Activity Index and Harvey Bradshaw Index (HBI) scores), remission (per HBI scores), biomarkers (C-reactive protein (CRP) and fecal calprotectin (FC)) and endoscopic improvement rate over 80 weeks were assessed. Patients with a mean age of 39.9 years were assessed. Discontinuation rate was low (23%) and most adverse events were mild (68.7%). The SAE rate was 21% (mostly infections/infestations or gastrointestinal disorder), and ADR rate was 44%. The CD Activity Index and HBI scores decreased (by 74% and 81%, respectively) with 50% of patients showing normalized CRP and FC, and 63% achieved endoscopic improvement. Ustekinumab was fairly safe, well tolerated and effective in a Brazilian cohort of CD patients.

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Section: Discussionsupporting

confidence: 92%