Safety and efficacy of ustekinumab in the treatment of Crohn Disease: a systematic review and meta-analysis

ABSTRACT Background and Aims The present systematic review and meta-analysis was designed to estimate the safety and effectiveness of ustekinumab in the treatment of Crohn disease (CD) in clinical trials and observational studies. Methods We retrieved all the related publications from the PubMed, Cochrane, EBSCO, Google Scholar and EMBASE databases using a systematic search strategy. We only included clinical trials and observational studies that were published in English. Results Only 31 studies that met the eligibility criteria out of the 733 identified studies were included. The overall clinical response rate in the cohort studies was of 0.539 (95% confidence interval [95%CI]: 0.419-0.659), and in the clinical trials it was of 0.428 (95%CI: 0.356-0.501). The pooled clinical remission rate was of 0.399 (95%CI: 0.295-0.503) in randomized control trials (RCTs,) and of 0.440 (95%CI: 0.339-0.542) in cohort studies. The rate of adverse effects was of 0.158 (95%CI: 0.109-0.207) in cohort studies and of 0.690 (95%CI: 0.633-0.748) in RCTs. Conclusion Ustekinumab is effective in the treatment of CD. However, more research is required on the safety profiles because there was considerable variation among the included studies. (AU)

¿Es efectivo el ustekinumab para la artritis psoriásica que no responde a tratamiento inicial? / Is ustekinumab effective for psoriatic arthritis with insufficient response to initial treatment?

INTRODUCCIÓN: La artritis psoriásica es una artritis inflamatoria sin una clara etiología, con el tratamiento biológico como un pilar fundamental en pacientes más complejos. Existen varias alternativas para tratamiento biológico, debido a su alto costo, es importante evaluar la real efectividad de estos para un buen tratamiento. MÉTODOS: Para responder esta pregunta utilizamos Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud a nivel mundial, la cual es mantenida mediante búsquedas en múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, reanalizamos los datos de los estudios primarios, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE. RESULTADOS Y CONCLUSIONES: Identificamos 12 revisiones sistemáticas que en conjunto incluyen tres ensayos aleatorizados. Concluimos que el ustekinumab logra una mejoría clínica en pacientes con psoriasis, y probablemente no se asocia a efectos adversos graves.

INTRODUCTION: Psoriatic arthritis is an inflammatory arthritis without a clear etiology. Biological therapy is key for its treatment, especially in more complex patients. There are several alternatives for biological treatment, but due to its high cost, it is important to evaluate their real effectiveness. METHODS: To answer this question we used Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS: We identified 12 systematic reviews including three randomized trials overall. We concluded ustekinumab leads to clinical improvement in psoriatic arthritis, and probably is not associated to severe adverse effects.