The Italian Medicines Agency (AIFA) has approved the reimbursement of mirikizumab, the first interleukin-23p19 (IL-23p19) antagonist for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients. It is the only drug currently reimbursed in Italy for the disease that can selectively target the p19 subunit of IL-23, which plays a crucial role in UC-related inflammation. The mechanism of action – explains the pharmaceutical group Lilly in a note – allows relief from key symptoms such as bowel frequency, rectal bleeding and intestinal urgency, regardless of previous use of biological drugs.
Ulcerative colitis is an inflammatory condition that is estimated to affect approximately 150,000 people in Italy. Each year, over 4,000 new diagnoses are estimated, mostly in young people. Like chronic intestinal diseases, of which it is a part, UC has a strong impact on the quality of life of those who suffer from it. “Ulcerative colitis is a disease that strikes on average at a young age and is characterized by severe inflammation of the intestine – says Alessandro Armuzzi, head of the Uo Ibd Istituto clinico Humanitas, Rozzano, and full professor of Gastroenterology Humanitas University, Milan – Although most patients are initially diagnosed with mild disease and begin conventional therapy, many will progress to have moderate to severe active disease, with a strong impact on quality of life. Despite the availability of current treatments, there remains a significant need for new therapeutic options capable of addressing disruptive symptoms, such as intestinal urgency”.
Mirikizumab responds to this need with a new mechanism of action. It targets one of the pathways by which inflammation is sustained in the disease. The Lucent clinical trial program, on which the drug approval was based, shows that, after 12 weeks of treatment, almost two-thirds (63.5%) of patients achieved clinical response and almost a quarter (24.2%) clinical remission (42.2% and 13.3% respectively with placebo). Efficacy was also shown to be superior to placebo in patients previously treated with a biological or Janus kinase inhibitor (Jaki) and leads to a reduction in steroid therapy. Among those who achieved clinical response at 12 weeks, half had steroid-free clinical remission at one year (27% with placebo). Almost all patients (97.8%) who achieved clinical remission at one year were no longer using steroids. The action of mirikizumab is sustained over time: among those who achieved clinical remission at 12 weeks, approximately two-thirds (63.6%) maintained clinical remission with one year of continuous treatment (36.9% with placebo).
As Massimo Claudio Fantini, general secretary of Ig-Ibd (Italian Group for the study of Inflammatory Bowel Disease), full professor of Gastroenterology at the University of Cagliari and director of the Sc of Gastroenterology at Aou Cagliari, observes, “mirikizumab, in addition to having demonstrated its efficacy in the context of relevant clinical objectives such as steroid-free remission at one year, is able to determine a rapid improvement in symptoms, such as rectal bleeding and evacuation frequency, already after three weeks. In particular, the studies that led to the registration of the drug were the first and only ones to use a patient-centered intestinal urgency rating scale (NRS), recording a clear improvement in the symptom of urgency especially in those who respond best to induction therapy”.
For people living with UC, the symptoms that have the greatest impact are diarrhea, intestinal urgency, and related accidents. These conditions are the main reasons why people avoid having a social life. “The impact of this disease on the quality of life is significant,” emphasizes Salvo Leone, general director of Amici Italia and chairman of the European Federation of Crohn’s & Ulcerative Colitis Associations (EFCCA). “It is not just about dealing with physical pain and chronic fatigue, but also managing psychological implications. In fact, the invisible disability that characterizes it and the difficulty in describing symptoms, such as diarrhea, amplify physical discomfort, transforming it into profound psychological discomfort. This often leads to feelings of shame and insecurity, which can result in social isolation. For people with UC, being able to control symptoms, such as intestinal urgency, represents an important goal in managing the disease.”
The American College of Gastroenterology in its guidelines recognizes the importance of intestinal urgency as a major concern for patients living with UC and recommends giving it priority when considering treatments. “The design of our clinical development program in this area, which also introduced the quantitative assessment of intestinal urgency – concludes Veronica Rogai, Associate VP-Medical Italy Hub at Lilly – demonstrates Lilly’s constant commitment to innovation and to responding to patients’ health needs. The availability of mirikizumab for patients marks our entry into the area of chronic inflammatory bowel diseases: we are happy and proud to be able to collaborate with the entire scientific community that deals with these diseases and to be able to make available to people with ulcerative colitis a new therapeutic opportunity capable of translating into a tangible improvement in their quality of life”.
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