Janssen Pharmaceuticals has announced that its Tremfya (guselkumab) demonstrated improving rates of clinical remission and endoscopic response maintained across the three-year Phase II Crohn’s disease study.
Tremfya was able to maintain its key efficacy endpoints throughout the GALAXI Phase II trial, including the long-term extension period, showing clinical remission, patient-reported outcome remission, and endoscopic response.
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After completing the week 48 Phase II study, patients with moderate-to-severe Crohn’s disease were enrolled in the long-term extension, receiving one of three maintenance regimens of Tremfya.
The data analysis from the long-term extension at three years found that for all randomised patients, 54.1% demonstrated clinical remission, 51.4% achieved patient-reported outcome remission, and 34.7% saw an endoscopic response.
Jan Wehkamp, vice president for Janssen, said: “Establishing the long-term efficacy and safety profile of Tremfya is an important step as we work to bring relief and remission to the millions of people worldwide living with Crohn’s disease.
“We remain committed to researching and developing novel therapies, and to deepening our understanding of the interleukin (IL)-23 pathway with the goal of offering patients a range of treatment options that best fit their needs.”
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By GlobalDataOwned by Johnson & Johnson, Janssen is also conducting a Phase III trial with Tremfya in patients with inflammatory bowel disease. The company stated that the trial is fully recruited and ongoing.
Earlier this year, Janssen released its latest findings from real-world analyses of Tremfya in moderate-to-severe plaque psoriasis. The drug was approved by the US Food and Drug Administration in 2017 for the treatment of plaque psoriasis and psoriatic arthritis.
Janssen’s Tremfya data announcement comes a day after its competitor AbbVie announced positive results from its Phase III head-to-head study evaluating the efficacy and safety of Skyrizi against Janssen’s own Stelara. The data showed that in Skyrizi saw a 19% higher rate of remission than Stelara.
According to GlobalData, there are seven Crohn’s disease-related drugs in Phase II and Phase III trials, with the total global market for the treatment of the illness valued at $9.5bn. This is expected to grow to around $15bn by 2033. GlobalData is the parent company of Clinical Trials Arena.
