A statistical approach to measuring the impact of medication use on the lived experience of patients with inflammatory bowel disease

Quality of life assessment involves a highly complex assessment of individual well-being within a specific contextual framework. The aim of this study is to investigate the quality of life of people diagnosed with inflammatory bowel disease (IBD) and to assess whether the use of certain medications administered by experimental methods can improve the quality of life of these patients. The participants in this study suffer from IBD, which includes two chronic idiopathic inflammatory diseases: Crohn's disease (CD) and ulcerative colitis (UC). The primary therapeutic goal for IBD patients is to achieve sustained remission without relapse or the need for surgery while maintaining a high level of well-being. Infliximab (IFX) was the first biologic drug approved by the Food and Drug Administration (FDA) for the treatment of Crohn’s disease and ulcerative colitis. In recent years, several studies have supported the commercialization of CT-P13, a biosimilar of IFX SC (subcutaneous formulation). This other formulation has demonstrated equivalent efficacy, bioavailability and safety for maintenance therapy in patients with moderate to severe active Crohn's disease and ulcerative colitis. Subsequently, vedolizumab (VDZ) was also approved, with the subcutaneous formulation (VDZ SC) recently launched. Numerous scientific studies have confirmed that subcutaneous vedolizumab has a high safety and tolerability profile in patients with these diseases. This study focuses on evaluating the impact of novel subcutaneous biologic therapies on quality of life in patients with moderate-to-severe IBD, filling a critical gap in patient-centered outcomes research.