P066 Real-World Experience of Ustekinumab in Crohn's Disease Patients With Prior Anti-TNF Therapy at a Tertiary Care Hospital.

Background: Ustekinumab (UST) is a monoclonal antibody against the p40 subunit of IL-12/23. It is approved for the treatment of moderate to severe Crohn's disease (CD) and Ulcerative Colitis. We performed a retrospective study to demonstrate the efficacy and outcomes of UST in CD patients who received prior anti-TNF therapies.

Methods: We collected a list of all patients who received UST until May 2021. In addition, the list was screened for patients who were on anti-TNFs for treatment of CD in the past. Data was collected for patient demographics, disease characteristics, comorbidities, disease phenotype, age of initiation of UST, prior biologic therapy, time since last biologic therapy, concomitant use of steroids or immunomodulator, inflammatory markers, induction of remission, deep remission. Chi-square tests were used for statistical analysis.

Results: We identified 34 patients (59% females) with CD on UST who failed at least one anti-TNFs before induction with UST. Clinical remission was documented in 70.5% of patients. 29 percent of patients who achieved clinical remission were on concomitant steroids or immunomodulators at the time of induction of remission along with UST. Fifty percent of patients had a fistulizing disease, of which 70% achieved clinical remission with UST. C-reactive protein (CRP) was reported in 70 percent of patients. Mean CRP prior to initiation of UST was 2.4. CRP trended down to 1.98 (p = 0.079, 95% CI: -0.064-1.08). Eighteen percent of patients had fecal calprotectin reported. Mean fecal calprotectin before initiation of UST was 386, and it trended down 175 while on UST (p = 0.148, 95% CI: -106.25-528.46).

Conclusion: Our study demonstrates that remission rates in CD patients who have failed prior anti-TNF therapy are high, including for patients with perianal disease. In patients with fistulizing CD, we suggest using UST for higher rates of remission after induction. We also found that for fecal calprotectin, although an excellent surrogate of colon inflammation, compliance amongst patients remains low.