Abstract
Background: Multiple studies have described the effectiveness of ustekinumab (UST) and vedolizumab (VDZ) in patients with Crohn’s disease (CD) failing anti- Tumor necrosis factors (TNFs); however, the effectiveness of VDZ or UST as a third-class biologic has not yet been described. Aims and Methods: In this retrospective multicenter cohort study, we aimed to investigate the effectiveness of VDZ and UST as a third-class biologic in patients with CD. Results: Two-hundred and four patients were included; 156/204 (76%) patients received VDZ as a second- and UST as a third-class therapy (group A); the remaining 48/204 (24%) patients received UST as a second- and VDZ as a third-class therapy (group B). At week 16–22, 87/156 (55.5%) patients and 27/48 (56.2%) in groups A and B, respectively, responded to treatment (p = 0.9); 41/156 (26.2%) and 15/48 (31.2%) were in clinical remission (p = 0.5). At week 52; 89/103 (86%) patients and 25/29 (86.2%) of the patients with available data had responded to third-class treatment in groups A and B, respectively (p = 0.9); 31/103 (30%) and 47/29 (24.1%) were in clinical remission (p = 0.5). Conclusion: Third-class biological therapy was effective in more than half of the patients with CD. No differences in effectiveness were detected between the use of VDZ and UST as a third-class agent.
Highlights
In recent years, our arsenal of therapeutic options in Crohn’s disease (CD) has been expanding
Our study demonstrates that third-class biologic therapy is a feasible, effective, and safe option in Crohn’s disease
It is well established that the number of prior treatments is negatively associated with therapeutic success [29,31,32], and that biologic-naïve patients have a substantially higher likelihood of a response to treatment in inflammatory bowel diseases (IBDs) [17,33,34,35,36,37]
Summary
Our arsenal of therapeutic options in Crohn’s disease (CD) has been expanding. Of patients experience primary and at least 13% experience secondary loss of response per year [3,4] Both ustekinumab (UST) and vedolizumab (VDZ) are frequently used as second-class options, with response rates of 40–70% and loss of response rates approximating 20–30% within the first year [5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26]. Two real-world studies compared the effectiveness of VDZ and UST in CD patients following loss of response to anti-TNFs [27,28]. In both studies, UST was superior to VDZ. Loss of response to a subsequent second-class biologic is frequent
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