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Abstract

Background

Despite advancements in the therapeutic armamentarium for Crohn’s disease (CD), biologic and small molecule monotherapies are associated with sub-optimal response and remission rates. Utilizing dual biologic therapy (DBT) holds the potential to increase efficacy in the treatment of refractory or partially responsive CD. Evidence pertaining to this strategy remains limited. Methods

We retrospectively examined refractory CD patients treated with a combination of ustekinumab and vedolizumab. Outcomes to DBT at week (wk) 52 were compared to monotherapy. The primary outcome constituted corticosteroid-free remission. Secondary outcomes included adverse events, infections, hospitalizations, surgeries, treatment persistence, and disease clearance. Results

Sixteen of 21 active refractory CD patients (76%) on DBT achieved disease remission at wk 52. Mucosal healing was observed in 38% (n = 6), biochemical remission in 25% (n = 4), and both clinical and biochemical remission in 38% (n = 6). Of these patients, 50% (n = 8) achieved corticosteroid-free remission. Three patients (37.5%) with corticosteroid-free remission achieved complete disease clearance. Paired median fecal calprotectin decreased from 508 to 118 µg/g (P <  .0001). Paired C-reactive protein median decreased from 1.04 to 0.50 mg/dL (P <  .0001). Median Harvey Bradshaw Index score reduced from 7 to 2 (P = .003). Endoscopic healing was achieved with a paired simple endoscopic score for CD decrease from 6 to 3 (P = .013). Corticosteroid dependency reduced from 17 to 8 patients discontinuing altogether. Patients still requiring corticosteroids experienced a decrease in average daily dose from 9 to 6 mg (P = .045). At wk 52, 5 patients (24%) did not meet the criteria for remission with 4 requiring CD-related surgical intervention. Mean CD-related hospitalizations reduced from 2.95 ± 2.33 to 0.52 ± 1.12 (P <  .001) and surgeries from 1.76 ± 1.3 to 0.14 ± 0.4 (P <  .001). Three infections with 1 requiring hospitalization and 1 report of headache were noted. Two patients discontinued DBT. Conclusions

Dual biologic therapy with ustekinumab and vedolizumab is a safe and effective strategy to induce disease remission in refractory CD. Large-scale studies are necessary to validate findings in a prospective setting.

Document Type

Article

Publication Date

2025

Notes/Citation Information

© The Author(s) 2024. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

Digital Object Identifier (DOI)

https://doi.org/10.1093/crocol/otae080

Funding Information

No funding to declare.

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