Guselkumab, the first fully human monoclonal antibody selectively directed against the p19 subunit of IL-23, has proven to be an effective and safe therapy in both ulcerative colitis and Crohn’s disease. This is what emerges from three registration studies (Quasar and Galaxi 2 and 3) on the treatment of ulcerative colitis and Crohn’s disease, presented by Johnson & Johnson on the occasion of Digestive Disease Week in Washington. Johnson & Johnson communicated this in a note.
The Quasar study – we read – demonstrated that guselkumab is effective and safe in adult patients with moderate to severe ulcerative colitis in the active phase. In Galaxi 2 and 3, treatment with guselkumab in adult patients with moderately to severely active Crohn’s disease met co-primary endpoints compared to placebo, setting new standards of efficacy in the treatment of the disease.
The drug – recalls J&J – is already available in our country for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy, and of active psoriatic arthritis in adult patients who have had an inadequate response or who have showed intolerance to previous therapy with disease-modifying antirheumatic drugs.
The phase 3 Quasarm, randomized, double-blind maintenance study – details the note – evaluated two different treatment regimens with subcutaneous guselkumab in adult patients with moderate to severe ulcerative colitis: 100 mg every 8 weeks (q8w) and 200 mg every 4 weeks (q4w). According to the data presented at the congress, both the primary endpoint of the study, i.e. clinical remission at week 44, and all 9 major secondary endpoints were achieved in both guselkumab treatment groups, with high statistical significance and clinical improvements. relevant. At week 44, 45.2% of patients who received guselkumab 100 mg subcutaneously and 50% of patients who received guselkumab 200 mg subcutaneously achieved clinical remission (a rigorous parameter, which includes clinical evaluation and endoscopic), compared to 18.9% who received placebo. No new safety risks were observed compared to the profile of guselkumab already known from the approved indications.
Galaxi 2 and 3 are two 48-week phase 3 studies with identical experimental design, which evaluated the efficacy and safety of guselkumab, compared to placebo and ustekinumab, in adult patients with moderate to severe Crohn’s disease who had failed or were intolerant to conventional (immunosuppressants or corticosteroids) biological (TNF antagonists or vedolizumab) therapy. For both studies, a treat-through design was adopted, in which patients in the active treatment arms continued to take the therapy to which they were initially randomized, regardless of clinical response at week 12, except for the non-treatment group. -responder from the placebo arm, who switched to treatment with ustekinumab in a blinded manner. In each of the two studies, the co-primary endpoints were clinical response at week 12 and clinical remission at week 48 and clinical response at week 12 and endoscopic response at week 48, comparing each dosing regimen to placebo .
The two guselkumab dosing regimens tested (200 mg as an induction dose intravenously at weeks 0, 4, and 8, followed by 100 mg subcutaneously every 8 weeks or 200 mg sc every 4 weeks) met the co- primary compared to placebo in both studies, thus establishing a new, highly rigorous standard for efficacy in the treatment of Crohn’s disease. Each dosing regimen of guselkumab was compared to placebo, and at week 48, both resulted in statistically and clinically significant differences in efficacy compared to ustekinumab across multiple endoscopic endpoints.
“The results of these studies – comments Silvio Danese, director of the Gastroenterology and Digestive Endoscopy Unit of the Irccs San Raffaele Hospital and full professor of Gastroenterology at the Vita-Salute San Raffaele University of Milan – are encouraging for all those who continue to experience the persistent and debilitating symptoms of chronic inflammatory bowel disease (Mici) has proven to be a promising therapy, potentially capable of inducing rapid and sustained efficacy and leading to long-lasting remission, both in ulcerative colitis and Crohn’s disease. , thanks to its mechanism of action targeting IL-23. The efficacy demonstrated by this molecule in terms of disease remission and clinical improvement represents the type of progress we expect from the development of new treatments for IBD. early lines, and in more advanced lines”.
In May 2024 – the note reports – J&J submitted to the European Medicines Agency (EMA) a request for an extension of indication for guselkumab in the treatment of adult patients with moderate to severe Crohn’s disease and ulcerative colitis. Furthermore, in March of the same year the company submitted a supplemental biologics license application to the FDA to obtain approval of guselkumab for the treatment of adults with moderate to severe ulcerative colitis.
In Europe, almost 2 million people live with the persistent and debilitating symptoms of Crohn’s disease on a daily basis. Added to these are the over 2 million patients with ulcerative colitis. “This is where our commitment to carrying out research in the field of IBD comes from, with the aim of improving the standards of care, guaranteeing a continuous evolution of therapeutic solutions – says Ludovic de Beaucoudrey, Senior Director, Therapeutic Area Lead , Immunology, Johnson & Johnson Innovative Medicine – Our Phase 3 Galaxi program includes two rigorous independent studies demonstrating guselkumab’s potential for people with moderate to severe Crohn’s disease, where there is still significant unmet need , the Phase 3 Quasar maintenance study addresses the need to offer new treatment options to patients facing the challenges of ulcerative colitis.”
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