ABSTRACT Background: Real-world data on the use of Ustekinumab (UST) in Brazilian and Latin American patients with Crohn’s disease (CD) are scarce. Objective: The primary endpoint was assessment of clinical remission at weeks 8 and 52, and secondary endpoints were: assessment of clinical response at weeks 8 and 52, endoscopic remission, adverse events, and rates of CD-related abdominal surgery during follow-up. Methods: observational and retrospective study, including patients with CD treated at two centers, who received UST at any time during their treatment. Remission and clinical response were defined as a Harvey-Bradshaw index ≤4 and ≥3 points reduction, respectively. Results: Seventy-four patients were included, 85.1% previously exposed to anti-TNFs. Clinical remission was observed in 45.8% and 59.4% of patients at weeks 8 and 52, respectively. The clinical response rates were 54.2% and 67.6% at weeks 8 and 52. Endoscopic remission was observed in 21.8% of patients. Seventeen patients had adverse events, mostly mild infections, with 22.9% of patients undergoing abdominal surgery (ileocolectomy being the most common procedure). Conclusion UST therapy resulted in significant rates of remission and clinical response, as described in other real-world studies. Few patients had adverse events during treatment, showing its adequate safety profile. Background Realworld Real world (UST Crohns Crohn s (CD scarce Objective 52 CDrelated related followup. followup follow up. up follow-up Methods study centers treatment HarveyBradshaw Harvey Bradshaw 4 ≤ 3 ≥ reduction respectively Results Seventyfour Seventy four included 851 85 1 85.1 antiTNFs. antiTNFs anti TNFs. TNFs anti-TNFs 458 45 45.8 594 59 59.4 542 54 2 54.2 676 67 6 67.6 218 21 21.8 infections 229 22 9 22.9 ileocolectomy procedure. procedure . procedure) realworld real studies profile 5 85. 45. 59. 54. 67. 21. 22.
RESUMO Contexto: Dados de vida real sobre o uso de Ustequinumabe (UST) em pacientes brasileiros e latino-americanos com doença de Crohn (DC) são escassos. Objetivo: O desfecho primário foi a avaliação da remissão clínica nas semanas 8 e 52, e os desfechos secundários foram: avaliação da resposta clínica nas semanas 8 e 52, remissão endoscópica, eventos adversos e taxas de cirurgia abdominal relacionada à DC durante o seguimento. Métodos: Estudo observacional e retrospectivo, incluindo pacientes com DC tratados em dois centros, que receberam UST em qualquer momento do tratamento. A remissão e a resposta clínica foram definidas como índice de Harvey-Bradshaw ≤4 e ≥3 pontos de redução, respectivamente. Resultados: Foram incluídos 74 pacientes, 85,1% previamente expostos a anti-TNFs. A remissão clínica foi observada em 45,8% e 59,4% dos pacientes nas semanas 8 e 52, respectivamente. As taxas de resposta clínica foram de 54,2% e 67,6% nas semanas 8 e 52. A remissão endoscópica foi observada em 21,8% dos pacientes. Dezessete pacientes apresentaram eventos adversos, principalmente infecções leves, sendo 22,9% dos pacientes submetidos à cirurgia abdominal (sendo a ileocolectomia o procedimento mais comum). Conclusão: A terapia com UST resultou em taxas significativas de remissão e resposta clínica, conforme descrito em outros estudos do mundo real. Poucos pacientes apresentaram eventos adversos durante o tratamento, mostrando seu adequado perfil de segurança. Contexto (UST latinoamericanos latino americanos (DC escassos Objetivo 52 seguimento Métodos retrospectivo centros tratamento HarveyBradshaw Harvey Bradshaw 4 ≤ 3 ≥ redução respectivamente Resultados 7 851 85 1 85,1 antiTNFs. antiTNFs anti TNFs. TNFs anti-TNFs 458 45 45,8 594 59 59,4 542 54 2 54,2 676 67 6 67,6 218 21 21,8 leves 229 22 9 22,9 comum. comum . comum) Conclusão segurança 5 85, 45, 59, 54, 67, 21, 22,