Nella malattia di Crohn perianale fistolizzante, Ustekinumab mostra un segnale di attività clinica interessante, confermando un possibile ruolo nelle forme complesse e refrattarie, dove il controllo dell’infiammazione e la gestione della fistola restano sfide aperte. La review su Drugs in R&D rafforza l’idea che l’asse IL-12/23 possa rappresentare un’opzione terapeutica utile soprattutto nei pazienti con risposta subottimale ai trattamenti convenzionali.
Ustekinumab in the Management of Perianal Fistulizing Crohn’s Disease: Current Evidence and Practical Strategies
Bolin Yang
Sintesi Evidence-Based – Ustekinumab nella Malattia di Crohn Fistulizzante Perianale
Ustekinumab ha dimostrato efficacia promettente nel trattamento della malattia di Crohn fistulizzante perianale, con tassi di risposta e remissione clinica significativi anche in pazienti biologici-naïve. L’approccio multimodale, che integra terapia biologica, interventi chirurgici e antibiotici, sembra ottimizzare i risultati. Tuttavia, sono necessari studi prospettici dedicati per definire con precisione il ruolo di ustekinumab e sviluppare algoritmi terapeutici personalizzati. Con il contributo di Dinaimed
Abstract
Perianal fistulizing Crohn’s disease (PFCD) is a severe and complex manifestation associated with high morbidity and limited treatment durability. Ustekinumab is a monoclonal antibody targeting the interleukin-12/23 pathway, which is involved in the pathogenesis of PFCD. Evidence from post hoc analyses and real-world studies has shown the therapeutic potential of ustekinumab in both anti-tumor necrosis factor-experienced and selected biologic-naïve patients with PFCD. Preliminary evidence has indicated that the treatment effect may be improved when used in combination with surgical interventions such as seton placement or sphincter-preserving procedures. Adjunctive antibiotics during induction and early monitoring of clinical and radiologic response may further enhance outcomes. While ustekinumab is increasingly being incorporated into multidisciplinary PFCD management, prospective fistula-specific trials are needed to clarify its optimal positioning. Future research should also focus on predictive biomarkers and treatment algorithms to support personalized and durable care.
Key Points
| Ustekinumab is a monoclonal antibody targeting the interleukin-12/23 pathway, which plays an important role in the inflammation and epithelial-to-mesenchymal transition process in perianal fistulizing Crohn’s disease. |
| Post hoc analysis and real-world studies have demonstrated treatment effect of ustekinumab for perianal fistulizing Crohn’s disease, with a quick and sustained response. |
| A favorable response with ustekinumab was seen in both anti-tumor necrosis factor-experienced and biologic-naïve patients, indicating its potential to be used as either the first- or subsequent-line biologic for perianal fistulizing Crohn’s disease. |





