Rinvoq outperforms placebo in drainage resolution, closure in perianal fistulizing Crohn’s
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Key takeaways:
- Drainage resolution was achieved in 44.7% of upadacitinib-treated patients at the end of induction and up to 28.6% in maintenance.
- Up to 22.1% achieved closure of perianal fistula external openings.
Treatment with Rinvoq resulted in higher rates of closure of external openings and drainage resolution vs. placebo in perianal fistulizing Crohn’s disease, according to pooled data from the U-EXCEL, U-EXCEED and U-ENDURE trials.
“Perianal fistulizing CD is an aggressive phenotype of CD characterized by abnormal connections between the rectum or anal canal and adjacent tissue, occurring with an estimated prevalence of 18% to 32%,” Jean-Frédéric Colombel, MD, internal medicine specialist in the Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai, and colleagues wrote in Clinical Gastroenterology and Hepatology. “Uncontrolled studies with integrin antagonist (vedolizumab) and anti-interleukin 12/IL-23 therapy (ustekinumab) evaluated their effect in perianal fistulizing CD with unclear results.”
They continued: “Therefore, the unmet medical need remains high, with a key research focus in CD on optimizing perianal fistulizing disease treatment.”
In a post-hoc analysis of pooled data from the phase 3 U-EXCEL and U-EXCEED induction trials and the U-ENDURE maintenance trial, Colombel and colleagues assessed the safety and efficacy of Rinvoq (upadacitinib, AbbVie) among patients with fistulizing disease.
Of 1,021 patients with moderately to severely active CD in the induction trials, 14% had fistulas at baseline and received upadacitinib 45 mg (n = 96) or placebo (n = 47) for 12 weeks. Most patients had perianal fistulas (89.6% and 89.4%, respectively), the majority of which were nondraining (58.3% and 61.7%) vs. draining (39.6% and 38.3%).
Those rerandomized in the maintenance trial received upadacitinib 15 mg (n = 38) or 30 mg (n = 28) or placebo (n = 32) for 52 weeks.
Outcomes of interest included closure of external openings, resolution of drainage, clinical remission and endoscopic response.
According to study results, more patients with draining perianal fistulas achieved drainage resolution on upadacitinib vs. placebo at the end of induction (44.7% vs. 5.6%) and maintenance (28.6% vs. 23.1% vs. 0%), as well as closure of external openings (22.1% vs. 4.8% and 18.8% vs. 16% vs. 0%).
Results also demonstrated greater rates of clinical remission and endoscopic response with upadacitinib at each time point (P ≤ .05).
“Upadacitinib induction treatment resulted in higher rates of closure of external fistula openings, resolution of drainage in draining fistulas and clinical remission, along with luminal disease and [quality of life] improvements compared with placebo,” Colombel and colleagues wrote. “This analysis suggests the potential for upadacitinib to treat patients with perianal fistulizing CD, especially for refractory patients with difficult-to-treat CD.”
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