Adnkronos (Adnkronos) – Reimbursement has been approved in Italy for two new therapeutic indications for guselkumab, a selective IL-23 inhibitor developed by Johnson & Johnson. The drug, the company announced in a statement, is reimbursed for intravenous induction and subcutaneous maintenance administration for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or are intolerant to conventional therapy or a biologic.
Guselkumab is also reimbursed, in both intravenous and subcutaneous administration modalities in the induction phase and in subcutaneous administration modalities for the maintenance regimen, for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, have lost response, or have been intolerant to conventional therapy or a biologic treatment.
Crohn's disease and ulcerative colitis are chronic inflammatory bowel diseases (IBDs) characterized by inflammation of the gastrointestinal tract, with periods of exacerbations alternating with phases of remission.
In Italy, the statement states, an estimated 250.000 people live with these diseases, with a prevalence increase of 85% in the last 30 years. These two conditions present fundamental differences in the location and extent of inflammation in the intestinal wall.
Crohn's disease, which accounts for 30-40% of IBD diagnoses, can affect any part of the gastrointestinal tract, from the mouth to the anus, and the entire thickness of the intestinal wall, with ulcers alternating with sections of healthy intestine,” explains Edoardo Vincenzo Savarino, associate professor of Gastroenterology at the University of Padua and general secretary of Ig-Ibd. “Typical symptoms include abdominal pain, long-lasting diarrhea, weight loss, anal fissures, fistulas, and perianal abscesses.
Ulcerative colitis, on the other hand, usually has an acute onset, primarily affecting the rectal mucosa and can spread continuously throughout part or all of the colon, manifesting with diarrhea and blood in the stool. Unfortunately, ulcerative colitis is often considered a less severe version of Crohn's disease, but this is absolutely not the case. In fact, no two patients are the same, and each disease has its own natural history. Both require significant clinical efforts to achieve therapeutic goals that go beyond symptomatic relief, and advances in research allow us to do just that.
Guselkumab – it states – is a biological therapy belonging to the class of anti-interleukin 23 (anti-IL-23) agents with a dual mechanism of action – evaluated in in vitro studies – which, in addition to blocking the p19 subunit of IL-23, acts at the cellular level on the CD64+ receptors involved in the production of IL-23 itself, offering a concrete advantage to the most complex patients, those with severe disease or who have already failed previous lines of therapy. Already used in the management of psoriasis and psoriatic arthritis, guselkumab is the first selective IL-23 inhibitor to be approved subcutaneously for both induction and maintenance therapy for Crohn's disease, marking a major step forward for hospital and patient management.
"Despite the progress made in the management of Crohn's disease, many patients, especially young ones, still live with debilitating symptoms and currently lack a definitive surgical solution. The availability of a drug that simultaneously guarantees profound symptom remission and improved quality of life," emphasizes Silvio Danese, Professor of Gastroenterology at Vita-Salute San Raffaele University and Director of the Gastroenterology and Digestive Endoscopy Unit at the IRCCS San Raffaele Hospital in Milan, "represents a real advance in the management of this disease, as demonstrated by the Graviti study, which evaluated the efficacy and safety of this innovative administration method in Crohn's disease, with a significant impact on therapy adherence and patient satisfaction. Also of particular interest are the results of the Galaxi study, in which guselkumab showed significantly higher rates of profound remission and intestinal mucosal healing compared to ustekinumab, an already established therapy in the treatment of Crohn's disease. These The findings are particularly significant in the fistulizing form of the disease, one of the most complex manifestations, associated with a significant impact on patients' quality of life. In this context, guselkumab represents a step forward, combining the ability to achieve ambitious therapeutic goals with a treatment modality compatible with the demands of daily life.
Even in ulcerative colitis, J&J highlights, the results obtained with guselkumab contribute to the evolution of standards of care, placing attention on increasingly ambitious therapeutic objectives. "In IBD, including ulcerative colitis, we often tend to focus solely on eliminating 'visible' symptoms (such as diarrhea, urgency, or rectal bleeding). Instead, we need to broaden the treat-to-target approach, a treatment model aimed at achieving a pre-established clinical goal, to guide the patient toward recovery and deep, histological remission," explains Alessandro Armuzzi, Professor of Gastroenterology at Humanitas University and Head of the Inflammatory Bowel Diseases Unit at the Humanitas Clinical Institute in Rozzano. "In this sense, the data from the Quasar study highlight how treatment with guselkumab significantly improved the symptoms of ulcerative colitis, achieving clinical remission, restoring intestinal mucosal integrity, and ultimately achieving endoscopic normalization and, finally, histological remission. This approval truly represents significant progress in the management of this disease, improving patients' quality of life. Achieving these goals allows us to prevent relapses and dramatically reduces the risk of hospitalization, the need for surgery and the development of long-term complications.”
Clinical data from major study programs (such as Quasar for ulcerative colitis and Galaxi or Graviti for Crohn's disease) – the note continues – confirm the molecule's efficacy in achieving deep remission of the disease, but also suggest that therapeutic innovation has a significant impact on patients' psychological and social well-being. "A diagnosis of Crohn's disease or ulcerative colitis can profoundly change a person's life, but it shouldn't erase their plans," observes Salvo Leone, general director of Amici Ets, the National Association for Chronic Inflammatory Bowel Diseases. "Behind every patient are loved ones, studies, work, and a future that deserves space. This is why the value of innovation is also measured in everyday life: in the ability to regain independence, experience relationships with greater serenity, and make plans without the disease taking over everything. Making treatments more compatible with people's lives is part of this progress. At Amici, we work to ensure that the voice of patients guides research and care choices, that access to care is equitable, and that psychological and social needs are also met. Hope gains strength when it becomes a real possibility: to be able to imagine one's future again and feel supported in building it."
The arrival of guselkumab in IBD in Italy represents another step forward in Johnson & Johnson's more than 20-year commitment to immunology, the company notes. "We have always invested in innovation, identifying new and increasingly advanced approaches capable of transforming the course of immune-mediated diseases like IBD, which have a significant impact on the psychological, emotional, and social life of those who suffer from them. Our commitment to research leads us to go beyond superficial aspects, but to delve deeper into the biological mechanisms underlying the disease. At the same time, by listening to patients and their daily experiences outside of clinical settings, we want to help achieve a deep remission, so they can regain control of their lives and daily routines. We will continue to strive to develop increasingly innovative therapies capable of controlling and, we hope, one day curing immune-mediated diseases," states Alessandra Baldini, Medical Director, Innovative Medicine, Johnson & Johnson Italy.
"For over twenty years, we have invested in research and innovation to transform the treatment of immune-mediated diseases and strengthen our role in immunology, with the ambition of becoming the leading provider in this therapeutic area by 2030. For Johnson & Johnson, healthcare represents an essential investment to address the unmet needs of patients and contribute to the sustainability of the healthcare system. In Italy, we work alongside institutions, the scientific community, and patient organizations to translate scientific progress into concrete and measurable benefits for people," concludes Jacopo Murzi, CEO, Innovative Medicine, Johnson & Johnson Italy.
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