Crohn’s disease is a chronic inflammatory intestinal pathology of autoimmune origin for which until now there is no cure, so its treatment is aimed at reducing the inflammation it causes to relieve symptoms and improve the quality of life of patients and the long-term prognosis.
Now, and after seven years without the appearance of therapies to combat it, good news finally arrives for those affected: Health has approved the marketing in Spain of Skyrizi® (risankizumab), a medication developed by AbbVie and which is indicated for treatment of adults with moderate to severe Crohn’s disease who do not respond to other drugs or have shown intolerance to conventional or biological treatment.
The commercialization of Skyrizi has been announced by the biopharmaceutical company AbbVie. It is a monoclonal antibody that is the first specific IL-23/p19 inhibitor approved for the treatment of Crohn’s disease. This molecule already has authorized indications in Spain for other pathologies; specifically, for psoriasis and plaques and psoriatic arthritis.
“Achieve mucosal healing [en enfermedad de Crohn] “It is associated with a reduced risk of relapse, fewer requirements for hospitalizations and surgeries, and results in a better quality of life in the long term.”
“Despite the advances we have experienced in the management of Crohn’s disease in recent years, today there are significant unmet needs for patients and their families. This inflammatory bowel disease, whose incidence and prevalence has increased in recent years, has a high impact on people’s daily lives, even being associated with disability, anxiety or depression,” stated Felipe Pastrana, general director. from AbbVie Spain during the presentation. “This new indication is the result of the commitment that we at AbbVie have with patients and social-health professionals, contributing to continue developing new options that allow them to reduce the impact that Crohn’s disease has on quality of life.”
Therapeutic needs of people with Crohn’s disease
Current therapeutic options to combat this disease focus on reducing the inflammation that triggers symptoms and improving long-term prognosis, but even when patients do not show symptoms, management of mucosal inflammation is important because this inflammation can be maintained. , causing more intestinal damage and increasing the risk of relapse. “When we talk about mucosal healing we are referring to the absence of ulcerations in the intestinal tract. Achieving mucosal healing is associated with a reduction in the risk of relapse, a lower requirement for hospitalizations and surgeries, and results in a better quality of life in the long term,” said Dr. Julián Panés, Senior Researcher at the Biomedical Research Institute. August Pi i Sunyer (IDIBAPS) and member of the International Organization For the Study of Inflammatory Bowel Disease (IOIBD).
Therefore, and as Dr. Panés has highlighted: “If we want to achieve better results in the quality of life of our patients, we have to be more ambitious and consider mucosal healing as one of the main therapeutic objectives, in addition to continuing to reinforce “the current pharmacological arsenal, to achieve and maintain these more ambitious therapeutic objectives over time, is a reality for the majority of our patients.”
In this sense, Dr. Manuel Barreiro, head of the Inflammatory Bowel Disease Unit of the University Clinical Hospital of Santiago de Compostela and former president of the Spanish Working Group on Crohn’s Disease and Ulcerative Colitis (GETECCU), pointed out that “in the management CD we find ourselves with a complex disease, for which we have a limited therapeutic arsenal. “With current therapies, some patients with CD do not achieve mucosal healing or lasting control of symptoms, which increases the risk of disease progression and the presence of complications.”
How Skyrizi works to combat Crohn’s disease
Interleukin 23 (IL-23) is a key inflammatory cytokine composed of two subunits (p19, unique to IL-23, and p40, common to IL-23 and IL-12) that activates immune cells and could mediate the pathogenesis of several chronic immune diseases, such as Crohn’s disease. This is because IL-23 levels are higher in Crohn’s disease patients, especially during flares, and people with mutations in the IL-23 receptor are more likely to develop Crohn’s disease. .
In the case of this molecule, as Dr. Manuel Barreiro pointed out, “unlike other IL-23 inhibitors, the AbbVie molecule targets the p19 subunit of IL-23, allowing it to specifically inhibit IL-23 without “affect the IL-12 pathway, which opens new avenues in the management of moderate to severe CD.”
The authorization of this medicine has been based on the results of three phase III clinical trials, two induction studies (ADVANCE and MOTIVATE) and one maintenance study (FORTIFY), which include clinical remission and endoscopic response as co-primary objectives.
The recommended dose of AbbVie’s drug in moderate to severe Crohn’s disease is 600 mg administered by intravenous (IV) infusion at week 0, week 4, and week 8, followed by 360 mg administered by subcutaneous (SC) injection in the week 12 and every 8 weeks thereafter.
