00:00The European Commission has approved Mirichizumab, an antagonist of Interleukin 23p19, for the treatment of Crohn's disease in an active phase, from moderate to severe in adult patients who have had an inadequate response, have lost their response or have been intolerant to conventional therapy or a biological treatment.
00:26The drug has already been approved in Italy in 2024 by the Agency of the Drug as a treatment for adults with active ulcerative colitis, from moderate to severe, and acts by targeting a specific protein, Interleukin 23p19, key factor of intestinal inflammation in Crohn's disease, which is associated with progressive intestinal damage, disability and worsening of quality of life.
00:51But what is more specific this pathology and how many suffer from it in Italy?
01:22The causes of Crohn's disease are still partially known.
01:28It is a multifactorial pathogenic disease in which individuals who are predisposed in the sense of the genetic side, at a certain point in their life due to environmental factors that have not yet been well clarified, but who still act by modifying the intestinal bacteria,
01:46in these individuals, young or young adults, at a certain point a chronic inflammatory response is induced, which then determines the intestinal damage and the progressive loss of the function of the intestine if it is not intervened early.
02:04And it is essential to recognize it soon to be able to start the most effective treatments, because before you intervene, you prevent the progression of the disease.
02:16The Mirichizumab, which is a monoclonal antibody that selectively blocks Interleukin 23p19, has been approved.
02:23This is a drug that first of all manages to induce patients in remission, to improve endoscopy, so not only to send them in endoscopic response but also in endoscopic remission,
02:38and it is also able to maintain clinical remission in the long term, improving the quality of life.
02:46In fact, patients often report symptoms such as chronic diarrhea, abdominal pain and intestinal urgency, which have a strong impact on their psychological well-being and their sociality.
02:58Many patients, then, Lilly specifies, do not reach complete remission despite the treatments or do not keep the disease under control for a long time.
03:08It is therefore necessary to act with target treatments that can represent a turning point in the management of the disease and the symptomatology.
03:16The approval by the European Commission therefore represents an important advancement in the management of Crohn's disease.
03:22A decision to which it was mainly added based on the results of the randomized study, controlled with placebo, of phase 3, Vivid 1, and therefore of the Vivid 2 study,
03:34which evaluates the effectiveness and safety of the drug up to 3 years in adults with Crohn's disease from moderate to severe.
03:41In particular, it has been shown how patients who obtain a clinical response in 12 weeks and then reach a complete remission of symptoms in one year, reach almost 50%.
03:56And above all, we have seen how in these patients the remission is characterized by a remission without the need for corticosteroid therapy,
04:05which is one of the therapies that we try to avoid due to the important side effects that corticosteroid therapies can give.
04:16New clinical points have also been taken into account, such as the evacuation emergency,
04:23whose results show how, already from the first weeks of treatment,
04:30it is possible to have a reduction of this symptom and therefore the consequently improvement of the patient's quality of life.
04:39Instead, the data derived from Vivid 2 have shown how those patients who reach the end of the first year of these about 80-90% then remain in remission,
04:51which means that if this therapy works, it works for a long period of time,
04:58so there is the possibility of treating these patients for a long time with excellent results.
05:03What changes then for patients and doctors with the extension of the approval of Mirichizumab also for Crohn's disease?
05:11It certainly allows doctors and patients to have a new weapon with which it is possible to block the disease.
05:20It should be remembered that in the clinical and registrative studies, Mirichizumab has been used not only in naive patients,
05:27but also in patients who have failed more lines of treatment.
05:31This is a very important aspect, because today we have patients who we define as difficult to treat,
05:38they have failed all therapies, so drugs like this are certainly welcome.
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