Model-informed precision dosing during infliximab rescue therapy for patients with steroid-refractory acute severe ulcerative colitis: an exploratory study

Acute severe ulcerative colitis

A description of the workload experienced by the healthcare personnel involved in the MIPD process, using the National Aeronautics and Space Association task load index (NASA-TLX, cf. Appendix 1). [feasibility], A relative bias (rBias) within 20% between observation and model prediction, with a 95% confidence interval including zero. [performance]

colectomy-free survival at 12 weeks (± one week) after start of infliximab therapy (short- term);, colectomy-free survival at 24 weeks (± one week) (i.e., the end of the safety follow-up) ;, (steroid-free) clinical response at 12 weeks (± one week) after start of infliximab therapy (short-term);, (steroid-free) clinical remission at 12 weeks (± one week) after start of infliximab therapy (short-term);, biological response at 12 weeks (± one week) after start of infliximab therapy (short-term);, biological remission at 12 weeks (± one week) after start of infliximab therapy (short-term);, endoscopic response at 12 weeks (± one week) after start of infliximab therapy (short-term);, endoscopic remission at 12 weeks (± one week) after start of infliximab therapy (short- term);, minimal histological disease activity at 12 weeks (± one week) after start of infliximab therapy (short-term);, intestinal ultrasound (IUS) based disease activity during the first 12 weeks after the start of infliximab therapy (short-term), histological remission at 12 weeks (± one week) after start of infliximab therapy (short-term), percentage of target concentration attainment during the first 12 weeks;, length of hospital admission after start of infliximab therapy;, mortality;, relapse-free survival in patients achieving clinical remission;, need for rescue therapy other than infliximab;, postoperative complications;, the total infliximab dose, the number of infliximab infusions, and the direct cost of infliximab therapy during the first 12 weeks (± one week) of the model-guided infliximab rescue therapy., the ratio of the direct cost to the proportion of patients achieving colectomy-free survival at week 12 (± one week) after the start of model-guided infliximab rescue therapy

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