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PHOENIX — , according to results from the phase 2b RELIEVE UCCD study.
“Additional clinical and endoscopic endpoints supported the primary endpoint of endoscopic response observed with duvakitug,” study author Vipul Jairath, MB ChB, DPhil, MRCP, professor of medicine at the Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada, reported.
These findings “support further development of duvakitug as a treatment option” for these patients, said Jairath, who presented the data at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
In the 14-week randomized controlled induction study, 138 adults aged 18-75 years with moderately to severely active Crohn’s disease were randomized to receive a 2250-mg loading dose of duvakitug or placebo subcutaneously, followed by either duvakitug 450 mg, 900 mg, or placebo every 2 weeks. Each arm of the study contained 46 patients, with a mean age of about 40 years, and a mean duration of disease of 9-11 years. The mean Simple Endoscopic Score for Crohn’s Disease (SES-CD) score at baseline was 12.
Half to two thirds of the patients had taken advanced therapies, either approved or investigational. The trial participants were allowed to take concomitant corticosteroids, 5-aminosalicylic acid drugs, and immunosuppressants (including 6-mercaptopurine, azathioprine, and methotrexate).
Notably, the primary endpoint of endoscopic response — defined as ≥ 50% reduction from baseline in SES-CD score — was achieved in almost half of the patients taking the 900-mg higher dose (22 of 46 patients). The endoscopic response was achieved in 13 of 27 patients who had previous experience with advanced therapies, including approved biologics (anti-TNF, anti-integrins, anti-interleukin [IL]-12/23, or anti-IL-23), and JAK inhibitors.
In the high-dose arm, 26% of participants achieved endoscopic remission, and 54% achieved clinical remission.
Just 13% of patients in the duvakitug arms had a treatment-related adverse event, with serious adverse events slightly higher in the 450 mg arm than in the 900 mg arm (13% vs 2%). The most common side effects were anemia, headache, and nasopharyngitis. One patient in the 900 mg group and four in the lower-dose group discontinued due to an adverse event.
When asked to comment by GI & Hepatology News, Jordan Axelrad, MD, MPH, co-director of the Inflammatory Bowel Disease Center at the NYU Langone Health, New York City, said the “results demonstrate that duvakitug is a promising therapy for patients with Crohn’s disease, with 14-week induction placebo-adjusted endoscopic response rates rivaling or exceeding our currently FDA-approved advanced, effective therapies.”
The efficacy in patients with prior exposure to advanced therapies is especially noteworthy, as it is “a population in which most existing and investigational agents show limited clinical benefit,” said Axelrad, who is also an associate professor of medicine at the NYU Grossman School of Medicine, New York City.
Axelrad said there were no concerning safety signals, “which strengthens its appeal for clinical use.”
He said he sees promise in the anti-TL1a inhibitor class, noting that TL1A “is a key cytokine that spans innate and adaptive mucosal inflammation and also directly influences fibroblast and epithelial biology, contributing to intestinal fibrosis and barrier dysfunction.”
Because therapies in the class simultaneously target inflammatory and fibrotic pathways, “TL1A inhibition offers the potential for more durable disease control than conventional cytokine-directed therapies,” he said.
But, noted Axelrad, it is early in duvakitug’s development. “We certainly need a larger cohort in a phase 3 study with maintenance data,” he said.
Jairath disclosed having financial relationships with AbbVie, Alimentiv, Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris Pharmaceuticals, AstraZeneca, Avoro Capital, Bristol Myers Squibb, Celltrion, Eli Lilly and Company, Endpoint Health, Enthera, Ferring Pharmaceuticals, Flagship Pioneering, Fresenius Kabi, Galapagos NV, Genentech, Gilde Healthcare, GlaxoSmithKline, Innomar, JAMP, Johnson & Johnson, Merck, Metacrine, Mylan, Pandion Therapeutics, Pendopharm, Pfizer, Prometheus Therapeutics and Diagnostics, Protagonist Therapeutics, Reistone Biopharma, Roche, Roivant, Sandoz, Second Genome, Shire, Sorriso Pharmaceuticals, Syndegen, Takeda, TD Securities, Teva, Topivert, Ventyx Biosciences, and Vividion Therapeutics. Axelrad reported receiving research grants from BioFire Diagnostics, Genentech, Janssen, and Takeda; consultant, advisory board fees or honorarium from Abbvie, Abviax, Adiso, BioFire Diagnostics, Biomerieux, Bristol-Myers Squibb, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, Janssen, Merck, Pfizer, Sanofi, Takeda, and Vedanta.
A version of this article appeared on Medscape.com .
PHOENIX — , according to results from the phase 2b RELIEVE UCCD study.
“Additional clinical and endoscopic endpoints supported the primary endpoint of endoscopic response observed with duvakitug,” study author Vipul Jairath, MB ChB, DPhil, MRCP, professor of medicine at the Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada, reported.
These findings “support further development of duvakitug as a treatment option” for these patients, said Jairath, who presented the data at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
In the 14-week randomized controlled induction study, 138 adults aged 18-75 years with moderately to severely active Crohn’s disease were randomized to receive a 2250-mg loading dose of duvakitug or placebo subcutaneously, followed by either duvakitug 450 mg, 900 mg, or placebo every 2 weeks. Each arm of the study contained 46 patients, with a mean age of about 40 years, and a mean duration of disease of 9-11 years. The mean Simple Endoscopic Score for Crohn’s Disease (SES-CD) score at baseline was 12.
Half to two thirds of the patients had taken advanced therapies, either approved or investigational. The trial participants were allowed to take concomitant corticosteroids, 5-aminosalicylic acid drugs, and immunosuppressants (including 6-mercaptopurine, azathioprine, and methotrexate).
Notably, the primary endpoint of endoscopic response — defined as ≥ 50% reduction from baseline in SES-CD score — was achieved in almost half of the patients taking the 900-mg higher dose (22 of 46 patients). The endoscopic response was achieved in 13 of 27 patients who had previous experience with advanced therapies, including approved biologics (anti-TNF, anti-integrins, anti-interleukin [IL]-12/23, or anti-IL-23), and JAK inhibitors.
In the high-dose arm, 26% of participants achieved endoscopic remission, and 54% achieved clinical remission.
Just 13% of patients in the duvakitug arms had a treatment-related adverse event, with serious adverse events slightly higher in the 450 mg arm than in the 900 mg arm (13% vs 2%). The most common side effects were anemia, headache, and nasopharyngitis. One patient in the 900 mg group and four in the lower-dose group discontinued due to an adverse event.
When asked to comment by GI & Hepatology News, Jordan Axelrad, MD, MPH, co-director of the Inflammatory Bowel Disease Center at the NYU Langone Health, New York City, said the “results demonstrate that duvakitug is a promising therapy for patients with Crohn’s disease, with 14-week induction placebo-adjusted endoscopic response rates rivaling or exceeding our currently FDA-approved advanced, effective therapies.”
The efficacy in patients with prior exposure to advanced therapies is especially noteworthy, as it is “a population in which most existing and investigational agents show limited clinical benefit,” said Axelrad, who is also an associate professor of medicine at the NYU Grossman School of Medicine, New York City.
Axelrad said there were no concerning safety signals, “which strengthens its appeal for clinical use.”
He said he sees promise in the anti-TL1a inhibitor class, noting that TL1A “is a key cytokine that spans innate and adaptive mucosal inflammation and also directly influences fibroblast and epithelial biology, contributing to intestinal fibrosis and barrier dysfunction.”
Because therapies in the class simultaneously target inflammatory and fibrotic pathways, “TL1A inhibition offers the potential for more durable disease control than conventional cytokine-directed therapies,” he said.
But, noted Axelrad, it is early in duvakitug’s development. “We certainly need a larger cohort in a phase 3 study with maintenance data,” he said.
Jairath disclosed having financial relationships with AbbVie, Alimentiv, Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris Pharmaceuticals, AstraZeneca, Avoro Capital, Bristol Myers Squibb, Celltrion, Eli Lilly and Company, Endpoint Health, Enthera, Ferring Pharmaceuticals, Flagship Pioneering, Fresenius Kabi, Galapagos NV, Genentech, Gilde Healthcare, GlaxoSmithKline, Innomar, JAMP, Johnson & Johnson, Merck, Metacrine, Mylan, Pandion Therapeutics, Pendopharm, Pfizer, Prometheus Therapeutics and Diagnostics, Protagonist Therapeutics, Reistone Biopharma, Roche, Roivant, Sandoz, Second Genome, Shire, Sorriso Pharmaceuticals, Syndegen, Takeda, TD Securities, Teva, Topivert, Ventyx Biosciences, and Vividion Therapeutics. Axelrad reported receiving research grants from BioFire Diagnostics, Genentech, Janssen, and Takeda; consultant, advisory board fees or honorarium from Abbvie, Abviax, Adiso, BioFire Diagnostics, Biomerieux, Bristol-Myers Squibb, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, Janssen, Merck, Pfizer, Sanofi, Takeda, and Vedanta.
A version of this article appeared on Medscape.com .
PHOENIX — , according to results from the phase 2b RELIEVE UCCD study.
“Additional clinical and endoscopic endpoints supported the primary endpoint of endoscopic response observed with duvakitug,” study author Vipul Jairath, MB ChB, DPhil, MRCP, professor of medicine at the Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada, reported.
These findings “support further development of duvakitug as a treatment option” for these patients, said Jairath, who presented the data at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
In the 14-week randomized controlled induction study, 138 adults aged 18-75 years with moderately to severely active Crohn’s disease were randomized to receive a 2250-mg loading dose of duvakitug or placebo subcutaneously, followed by either duvakitug 450 mg, 900 mg, or placebo every 2 weeks. Each arm of the study contained 46 patients, with a mean age of about 40 years, and a mean duration of disease of 9-11 years. The mean Simple Endoscopic Score for Crohn’s Disease (SES-CD) score at baseline was 12.
Half to two thirds of the patients had taken advanced therapies, either approved or investigational. The trial participants were allowed to take concomitant corticosteroids, 5-aminosalicylic acid drugs, and immunosuppressants (including 6-mercaptopurine, azathioprine, and methotrexate).
Notably, the primary endpoint of endoscopic response — defined as ≥ 50% reduction from baseline in SES-CD score — was achieved in almost half of the patients taking the 900-mg higher dose (22 of 46 patients). The endoscopic response was achieved in 13 of 27 patients who had previous experience with advanced therapies, including approved biologics (anti-TNF, anti-integrins, anti-interleukin [IL]-12/23, or anti-IL-23), and JAK inhibitors.
In the high-dose arm, 26% of participants achieved endoscopic remission, and 54% achieved clinical remission.
Just 13% of patients in the duvakitug arms had a treatment-related adverse event, with serious adverse events slightly higher in the 450 mg arm than in the 900 mg arm (13% vs 2%). The most common side effects were anemia, headache, and nasopharyngitis. One patient in the 900 mg group and four in the lower-dose group discontinued due to an adverse event.
When asked to comment by GI & Hepatology News, Jordan Axelrad, MD, MPH, co-director of the Inflammatory Bowel Disease Center at the NYU Langone Health, New York City, said the “results demonstrate that duvakitug is a promising therapy for patients with Crohn’s disease, with 14-week induction placebo-adjusted endoscopic response rates rivaling or exceeding our currently FDA-approved advanced, effective therapies.”
The efficacy in patients with prior exposure to advanced therapies is especially noteworthy, as it is “a population in which most existing and investigational agents show limited clinical benefit,” said Axelrad, who is also an associate professor of medicine at the NYU Grossman School of Medicine, New York City.
Axelrad said there were no concerning safety signals, “which strengthens its appeal for clinical use.”
He said he sees promise in the anti-TL1a inhibitor class, noting that TL1A “is a key cytokine that spans innate and adaptive mucosal inflammation and also directly influences fibroblast and epithelial biology, contributing to intestinal fibrosis and barrier dysfunction.”
Because therapies in the class simultaneously target inflammatory and fibrotic pathways, “TL1A inhibition offers the potential for more durable disease control than conventional cytokine-directed therapies,” he said.
But, noted Axelrad, it is early in duvakitug’s development. “We certainly need a larger cohort in a phase 3 study with maintenance data,” he said.
Jairath disclosed having financial relationships with AbbVie, Alimentiv, Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris Pharmaceuticals, AstraZeneca, Avoro Capital, Bristol Myers Squibb, Celltrion, Eli Lilly and Company, Endpoint Health, Enthera, Ferring Pharmaceuticals, Flagship Pioneering, Fresenius Kabi, Galapagos NV, Genentech, Gilde Healthcare, GlaxoSmithKline, Innomar, JAMP, Johnson & Johnson, Merck, Metacrine, Mylan, Pandion Therapeutics, Pendopharm, Pfizer, Prometheus Therapeutics and Diagnostics, Protagonist Therapeutics, Reistone Biopharma, Roche, Roivant, Sandoz, Second Genome, Shire, Sorriso Pharmaceuticals, Syndegen, Takeda, TD Securities, Teva, Topivert, Ventyx Biosciences, and Vividion Therapeutics. Axelrad reported receiving research grants from BioFire Diagnostics, Genentech, Janssen, and Takeda; consultant, advisory board fees or honorarium from Abbvie, Abviax, Adiso, BioFire Diagnostics, Biomerieux, Bristol-Myers Squibb, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, Janssen, Merck, Pfizer, Sanofi, Takeda, and Vedanta.
A version of this article appeared on Medscape.com .
FROM ACG 2025