Available Methods for Benefit-risk Assessment: Lessons for Inflammatory Bowel Disease Drugs.

BACKGROUND AND AIMS: Medical treatment for inflammatory bowel disease has advanced significantly over the two past decades. The advent of biologics and small molecules has revolutionised outcomes for patients with inflammatory bowel disease. Knowledge of drug pharmacology, indications, and adverse events is essential to ensure the best clinical care while minimising toxicity. Our aim was to review the literature on current methods of benefit-risk assessment, and consider their practical applicability to inflammatory bowel disease. METHODS: A literature search was conducted to investigate studies documenting benefit-risk assessment. RESULTS: Several structured frameworks and quantitative methodologies have been developed to evaluate benefit-risk profiles of drugs in a more comprehensive and consistent framework. Quantitative methods integrate benefit and risk outcome measures or incorporate preference weights for benefit and risk criteria into the evaluation. Incorporation of preference weights from patients is an essential aspect of quantitative benefit-risk assessment. Benefit-risk assessment is still evolving in inflammatory bowel disease. CONCLUSIONS: The risks and benefits of each medical therapy must be discussed with the patient and a shared decision-making process is recommended. Future initiatives should be developed to perform a benefit-risk assessment considering the characteristics of inflammatory bowel disease drugs.

New magnetic resonance imaging sequences for fibrosis assessment in Crohn's disease: a pilot study.

BACKGROUND AND OBJECTIVE: Patients with Crohn's disease can develop intestinal strictures, containing various degrees of inflammation and fibrosis. Differentiation of the main component of a structuring lesion is the key for defining the therapeutic management. We evaluated new magnetic resonance imaging sequences (IVIM (Intravoxel Incoherent Motion imaging) and T1 mapping) for assessing fibrosis in Crohn's disease. METHODS: This was a prospective, single-center study of adult patients with Crohn's disease and magnetic resonance imaging examination, including IVIM and T1 mapping sequences, between March 2021 and April 2021. The association between the perfusion fraction (IVIM), reduction of relaxation time between pre- and postcontrast enhancement (T1 mapping), and the degree of fibrosis assessed by a visual analog scale from 0 to 10 was evaluated. RESULTS: A total of 33 patients were included. The perfusion fraction was significantly correlated with fibrosis, with lower perfusion fraction in severe fibrosis (p = .002). T1 mapping sequence was also correlated with the degree of fibrosis, reduction of relaxation time was higher in patients with severe fibrosis than in patients with mild fibrosis (p = .05). CONCLUSION: In Crohn's disease, these new tools could improve the performance of magnetic resonance imaging for transmural fibrosis quantification, and may be useful for improving care.