Irma Hashmi, DO1, Taylna Putnam, NP2, Joseph Spataro, MD2 1VCU, Richmond, VA; 2McGuire VA, Richmond, VA
Introduction: Ustekinumab is indicated for moderate to severe Crohn’s disease (CD) patients who failed previous treatment. Standard dosing is combining a single intravenous (IV) weight-based induction with subcutaneous (subQ) maintenance every 8 weeks. Although effective, secondary loss of response occurs despite dose optimization. Our aim was to evaluate the safety and effectiveness of Ustekinumab re-induction and IV maintenance in patients with refractory CD.
Methods: We identified four individuals with CD at a single tertiary Veterans Affairs medical center. Each patient received IV induction with Ustekinumab after failed previous treatment with corticosteroids and anti-TNF inhibitors. Following transition to subQ maintenance dosing, these individuals had loss or inadequate response as seen with objective measures (C-reactive protein, fecal calprotectin, endoscopy, radiography). Despite dose optimization to every four weeks, drug trough levels remained subtherapeutic (< 4.5 µg/dL) with ongoing active disease. As salvage therapy, these patients then received weight-based IV maintenance dosing every four weeks. Disease activity was reassessed after three months.
Results: All achieved endoscopic and/or radiographic remission with therapeutic drug troughs. No adverse effects were reported.
Discussion: In our early observation, ustekinumab re-induction with continued IV maintenance was a safe and effective treatment. This novel approach may be an option for patients with a loss or inadequate response to standard ustekinumab therapy. Our sample size is small, so our study may be underpowered; however, data collection is ongoing.
Disclosures:
Irma Hashmi indicated no relevant financial relationships.
Taylna Putnam indicated no relevant financial relationships.
Joseph Spataro indicated no relevant financial relationships.
Irma Hashmi, DO1, Taylna Putnam, NP2, Joseph Spataro, MD2. C0410 - Upending Ustekinumab: IV Dosing as Maintenance Dosing, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.