VIDEO: Tremfya maintains clinical, endoscopic efficacy through 3 years in Crohn’s disease
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In a Healio video exclusive, Jan Wehkamp, MD, PhD, reports that treatment with Tremfya maintained clinical remission and endoscopic response through 3 years among patients with moderate to severe Crohn’s disease.
“There is still tremendous unmet need for patients with inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis,” Wehkamp, vice president and gastroenterology disease area leader at Johnson & Johnson Innovative Medicines, said. “Only about 10% of patients are in remission today and patients are in need for therapies which bring them into symptomatic remission.
“The long-term extension data we presented [at UEG Week] support our strategy to move Tremfya forward and to further invest in Tremfya.”
After completing the GALAXI-1 48-week phase 2 study, participants could join the long-term extension phase and receive subcutaneous Tremfya (guselkumab, Johnson & Johnson) 100 mg every 8 weeks or 200 mg every 4 weeks or ustekinumab 90 mg every 8 weeks. Key efficacy endpoints included CD Activity Index (CDAI) clinical remission, patient-reported outcome (PRO)-2 remission and endoscopic response.
“The aim of the study was mostly to understand Tremfya long-term and to see how many patients stay on the drug and also to study the safety profile of the drug,” Wehkamp said. “It is very important to have long-term data to really understand safety.”
At 144 weeks, 54.1% of patients in the combined guselkumab group maintained clinical remission (CDAI < 150), 51.4% were in PRO-2 remission and 34.7% maintained endoscopic response.
Researchers reported few serious adverse events (15.9%) and infections (5.5%) in the combined guselkumab group, most of which were mild to moderate in severity and resolved without discontinuation of treatment.
“The safety profile shows basically no changes and nothing unexpected compared to what we already know about Tremfya,” Wehkamp said. “Overall, there were no cases of tuberculosis and the percentage of infections are in line with expectation.”
He continued: “The study is enrolled and ongoing and we are excited, of course, to report more about Tremfya in the future.”
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D’Haens GR, et al. Efficacy and safety of guselkumab for Crohn’s disease through 3 years: GALAXI-1 long-term extension. Presented at: UEG Week; Oct. 14-17, 2023; Copenhagen, Denmark (hybrid meeting).
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