Tremfya (guselkumab) demonstrates impressive results across biologic-naïve and biologic-refractory patients in Crohn’s disease and ulcerative colitis
Johnson & Johnson announced Tremfya (guselkumab) data in both Crohn’s disease (CD) and ulcerative colitis (UC) showing high rates of endoscopic remission in both biologic-naïve and biologic-refractory patients (including UC patients refractory to JAK inhibitors), indicating a normal appearance of intestinal mucosa
These subgroup analyses are from pooled data from the Phase III GALAXI 2 & 3 studies of Tremfya in adults with moderately to severely active CD and the Phase III QUASAR maintenance study of Tremfya in adults with moderately to severely active UC. These findings are among 19 Johnson & Johnson abstracts being presented at the United European Gastroenterology (UEG) Week 2024. Tremfya is under review for the treatment of adults with moderately to severely active UC and CD by the European Medicines Agency (EMA).
“These results show the potential of Tremfya to offer a differentiated treatment option for patients with CD and UC, including those starting on a biologic for the first time, and those who have failed prior biologics and traditionally have been less likely to respond to other therapies,” stated Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “Tremfya builds upon our nearly three decades of leadership in IBD therapy and focused innovation in the IL-23 pathway to address the needs of people living with ulcerative colitis and delivering meaningful improvements in symptoms and the potential for sustained remission.”
Endoscopic remission in biologic-naïve patients
In the pooled Phase III GALAXI 2 & 3 dataset, Tremfya demonstrated greater rates of endoscopic remission compared to ustekinumab at Week 48 in biologic-naïve patients with CD. Endoscopic remission was achieved in 44% of patients treated with Tremfya 100 mg every eight weeks (q8w) subcutaneous (SC) injection and 46.1% of patients treated with Tremfya 200 mg every four weeks (q4w) SC injection, versus 29.8% of patients treated with ustekinumab. In the Phase III QUASAR study, Tremfya demonstrated greater rates of endoscopic remission compared to placebo at Week 44 in biologic/JAK inhibitor-naïve patients with UC. Endoscopic remission was achieved in 38.1% of patients treated with Tremfya 100 mg q8w SC injection and 41.7% of patients treated with Tremfya 200 mg q4w SC injection, versus 20.4% of patients treated with placebo.
Endoscopic remission in patients with a history of inadequate response or intolerance to biologics/JAK inhibitors
In the pooled Phase III GALAXI 2 & 3 dataset, Tremfya demonstrated greater rates of endoscopic remission compared to ustekinumab at Week 48 in biologic-refractory patients with CD. Endoscopic remission was achieved in 28.1% of patients treated with Tremfya 100 mg q8w SC injection and 28.6% of patients treated with Tremfya 200 mg q4w SC injection, versus 20.5% of patients treated with ustekinumab. In the Phase III QUASAR study, Tremfya demonstrated greater rates of endoscopic remission compared to placebo at Week 44 in biologic/JAK inhibitor-refractory patients with UC. Endoscopic remission was achieved in 31.2% of patients treated with Tremfya 100 mg q8w SC injection and 23.9% of patients treated with Tremfya 200 mg q4w SC injection, versus 8% of patients treated with placebo.2
Results from these studies reinforce the well-established safety profile of Tremfya including in the treatment of patients with UC and CD.
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