P039 Efficacy and safety of ustekinumab in patients with refractory Crohn's disease: data from a real world study in Brazil

Abstract

BACKGROUND: Ustekinumab (UST) is a fully human monoclonal antibody against IL-12/23. UST induced a clinical response and maintained a higher rate of response than placebo in patients with Crohn's disease (CD). UST was approved in Brazil in November 2017. Real world data regarding efficacy and safety to UST in CD is lacking in our country. We report our experience of UST use in patients with CD refractory to anti-TNF therapy. METHODS: An open-label prospective not controlled study was performed including patients from 4 academic medical centers with severely active, refractory CD starting on UST (IV infusions followed by scheduled subcutaneous [SC] injections) between November 2017 and August 2018. We evaluated clinical response and remission (based on Harvey-Bradshaw index [HBI]), C-reactive protein (CRP) and faecal calproprotectin (FC) levels. Clinical response and clinical remission were defined by HBI decrease ≥3 and HBI ≤3, respectively. Patients were evaluated by HBI from baseline until week 32. CRP and FC were evaluated from baseline and at week 16. RESULTS: Thirty-seven patients were treated with UST during the study period. The mean age was 37.5 years (IQR: 22–68), disease duration 10.7 years (IQR: 1–29), 75.6% had previous surgeries, 54% had perianal disease, 68.5% had anaemia. Mean HBI at baseline was 10.5 (IQR: 5–19). At baseline mean CRP was 25.9 mg/L and mean FC was 1,134.6 mg/kg (IQR: 150–3,157). At week 8, 81.1% achieved clinical response and 40.5% achieved clinical remission. At second SC injection (week 16 or 20), 63.3% of individuals achieved clinical remission (19/30). After the third SC injection (week 24 or 32), 66.7% of patients presented clinical remission (14/21). CRP decreased to 15.9 mg/L at week 8 and to 10.8 mg/L at week 16. Mean FC at week 16 was 996.2 mg/Kg (IQR: 5–2,362), exhibiting a decrease of 138.4 mg/Kg from baseline. One patient stopped UST due to non-response. No new safety signals were observed. CONCLUSION(S): UST therapy was successful for inducing clinical remission and improving laboratory biomarkers of disease activity in patients with refractory CD. Both UST induction and maintenance regimens until week 32 were well tolerated. This result support a favorable safety profile.