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New interim data from the ongoing PROFUNDUS study, presented at the European Crohn’s and Colitis Organisation Congress, provide important real-world insight into the effectiveness and safety of upadacitinib (Rinvoq) in patients with moderate-to-severe ulcerative colitis (UC). While randomized controlled trials established the drug’s efficacy under tightly controlled conditions, the PROFUNDUS findings help clarify how those results translate into everyday clinical practice. In an interview with HCPLive, Remo Panaccione, MD, director of the inflammatory bowel disease unit at the University of Calgary, explained that randomized controlled trials rely on strict inclusion and exclusion criteria, often excluding the complex patients physicians routinely encounter. Real-world studies like PROFUNDUS, by contrast, include patients with diverse comorbidities, varied steroid tapering approaches, and heterogeneous prior treatment histories. “When we complement those findings from the randomized controlled trials with real world evidence, if we see that the response rates and remission rates that we're seeing in the clinical trials hold up in the real world in these complex settings, it gives us a lot more confidence that the trial results are valid and that they can be translated into our clinical practice,” Panaccione explained. “Plus, it gives us that experience in those patients that are not necessarily included in the clinical trials.” Read more: https://www.hcplive.com/view/profundu...