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P460 Efficacy of ustekinumab in patients with anti-TNF refractory Crohn’s disease: data from a real-world study in Brazil

R. S. Parra*1, M. R. Feitosa1, O. Féres1, J. J. Ribeiro da Rocha1, J. M. F. Chebli2, L. Chebli2, E. R. Bertges2, T. N. F. Gomes3, O. Ambrogini Jr3, A. J. T. Alves Junior4, M. Lubini5

1Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil, Surgery and Anatomy, Ribeirão Preto, SP, Brazil, 2Universidade Federal de Juiz de Fora, Juiz de Fora, MG, Brazil, 3Universidade Federal de São Paulo (Unifesp), São Paulo, Brazil, 4Clínica Reis Neto, Campinas, SP, Brazil, 5Universidade de Passo Fundo - RG, Passo Fundo / RG, Brazil

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 five academic medical centres with severely active, refractory CD starting on UST (IV infusions followed by scheduled subcutaneous [SC] injections) between November 2017 and October 2018. All patients signed the informed consent form. 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 44. CRP and FC were evaluated from baseline and at Week 16.

Results

Forty-four patients were treated with UST during the study period. The mean age was 37.1 years (IQR: 18–68), disease duration 9.8 years (IQR: 1–29), mean age at diagnosis was 26.9 (IQR: 6–66). Seventy-five per cent of patients had previous surgeries, 54.5% had historical of perianal disease and 63.6% had anaemia at baseline. Mean HBI at baseline was 10.4 (IQR: 5–19). At baseline mean CRP was 29.1 mg/l (IQR: 0.60–125) and mean FC was 1210 mg/kg (IQR: 150–3157, n = 29). The majority of patients received SC injections every 8 weeks. At Week 8, 84.1% achieved clinical response and 38.6% achieved clinical remission. Clinical remission at second, third, fourth and fifth SC injection (from Week 16 to 44) was 60.5% (23/38), 63.0% (17/27), 60.9% (14/23) and 75% (15/20), respectively. CRP decreased to 18.4 mg/l at Week 8 and to 14.6 mg/l at Week 16. Mean FC at Week 16 was 1011.1 mg/kg (IQR: 5–3077), exhibiting a decrease of 198.9 mg/kg after induction. Two patients stopped UST due to non-response. No new safety signals were observed.

Conclusion

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 44 were well tolerated. This results support a favourable safety profile.