{"id":893232,"date":"2025-10-07T09:15:27","date_gmt":"2025-10-07T13:15:27","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/tremfya-guselkumab-is-first-and-only-il-23-inhibitor-to-demonstrate-sustained-clinical-and-endoscopic-outcomes-with-a-fully-subcutaneous-regimen-through-48-weeks-in-ulcerative-colitis\/"},"modified":"2025-10-07T09:15:27","modified_gmt":"2025-10-07T13:15:27","slug":"tremfya-guselkumab-is-first-and-only-il-23-inhibitor-to-demonstrate-sustained-clinical-and-endoscopic-outcomes-with-a-fully-subcutaneous-regimen-through-48-weeks-in-ulcerative-colitis","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/tremfya-guselkumab-is-first-and-only-il-23-inhibitor-to-demonstrate-sustained-clinical-and-endoscopic-outcomes-with-a-fully-subcutaneous-regimen-through-48-weeks-in-ulcerative-colitis\/","title":{"rendered":"TREMFYA\u00ae (guselkumab) is first and only IL-23 inhibitor to demonstrate sustained clinical and endoscopic outcomes with a fully subcutaneous regimen through 48 weeks in ulcerative colitis"},"content":{"rendered":"
\n

PR Newswire<\/p>\n<\/p><\/div>\n

\n

\n Patients treated with subcutaneous TREMFYA\u00ae <\/sup>achieved clinically meaningful results in both clinical remission (36.7%) and endoscopic remission (25.9%) at Week 48 in the Phase 3 ASTRO study<\/i>\n <\/p>\n

\n Clinical and endoscopic outcomes were demonstrated across both biologic-na\u00efve and biologic-refractory sub-groups<\/i>\n <\/p>\n

\n TREMFYA<\/i>
\n
\n \u00ae<\/sup>
\n <\/i>
\n \u00a0is the only IL-23 inhibitor with a fully subcutaneous regimen, following recent FDA approval of SC induction in adults with ulcerative colitis<\/i>\n <\/p>\n

\n
\n SPRING HOUSE, Pa.<\/span>
\n <\/span>, Oct. 7, 2025<\/span><\/span> \/PRNewswire\/ — Johnson & Johnson (NYSE: JNJ) today announced new 48-week data from the Phase 3 ASTRO study evaluating TREMFYA\u00ae<\/sup> (guselkumab) subcutaneous (SC) induction and maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). These data show clinically meaningful rates of clinical and endoscopic remission, making TREMFYA\u00ae<\/sup> the first and only IL-23 inhibitor to demonstrate robust results with a fully SC regimen.1<\/sup> The findings are among 20 Johnson & Johnson abstracts being presented at the United European Gastroenterology (UEG) Week 2025.<\/p>\n

\n

\n
\n \"(PRNewsfoto\/Johnson
\n <\/a>\n <\/p>\n<\/p><\/div>\n

TREMFYA\u00ae <\/sup>is the first and only approved, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte\/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC. Findings are based on in vitro<\/i> studies.2,<\/sup>3,<\/sup>4,<\/sup>5,<\/sup>6<\/sup><\/p>\n

The ASTRO Week 48 data build on the previously reported Week 12 SC induction data, which showed statistically significant and clinically meaningful improvements compared to placebo across all clinical and endoscopic measures.7<\/sup>\u00a0Data through Week 48 show patients treated with TREMFYA\u00ae<\/sup> 400 mg SC induction followed by SC maintenance dose regimens of either 100 mg every eight weeks (q8w) or 200 mg every four weeks (q4w) demonstrated clinically meaningful improvements across all clinical and endoscopic measures compared with patients receiving placebo (all nominal p<0.001).1<\/sup><\/p>\n

\n\n\n\n\n\n\n
\n

\n
\n At Week 48:\u00a0<\/b>
\n <\/span>\n <\/p>\n<\/td>\n

\n

\n
\n TREMFYA\u00ae<\/sup><\/span> 100 mg
q8w<\/b>\u00a0<\/span>\n <\/p>\n<\/td>\n

\n

\n
\n TREMFYA\u00ae<\/sup><\/span> 200 mg
q4w<\/b>\u00a0<\/span>\n <\/p>\n<\/td>\n

\n

\n
\n Placebo<\/b>\u00a0<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n Clinical remissiona<\/sup>\u00a0<\/span>\n <\/p>\n<\/td>\n

\n

\n 36.7\u00a0%<\/span>\n <\/p>\n<\/td>\n

\n

\n 42.9\u00a0%<\/span>\n <\/p>\n<\/td>\n

\n

\n 7.2\u00a0%<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n Endoscopic improvementb<\/sup>\u00a0<\/span>\n <\/p>\n<\/td>\n

\n

\n 44.6\u00a0%<\/span>\n <\/p>\n<\/td>\n

\n

\n 47.1\u00a0%<\/span>\n <\/p>\n<\/td>\n

\n

\n 11.5\u00a0%<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n Endoscopic remissionc<\/sup><\/span>\n <\/p>\n<\/td>\n

\n

\n 25.9\u00a0%<\/span>\n <\/p>\n<\/td>\n

\n

\n 26.4\u00a0%<\/span>\n <\/p>\n<\/td>\n

\n

\n 5\u00a0%<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n Symptomatic remissiond<\/sup>\u00a0<\/span>\n <\/p>\n<\/td>\n

\n

\n 47.5\u00a0%<\/span>\n <\/p>\n<\/td>\n

\n

\n 53.6\u00a0%<\/span>\n <\/p>\n<\/td>\n

\n

\n 14.4\u00a0%<\/span>\n <\/p>\n<\/td>\n<\/tr>\n<\/table><\/div>\n

Furthermore, in prespecified analyses of subpopulations defined by prior advanced therapy treatment status, TREMFYA\u00ae<\/sup>\u00a0demonstrated clinically meaningful results across all endpoints in both biologic and JAK inhibitor-na\u00efve and biologic and JAK inhibitor-refractory patients.\u00a0Safety data from the ASTRO study were consistent with the well-established safety profile of TREMFYA\u00ae<\/sup>.1<\/sup><\/p>\n

“For many patients, having a subcutaneous induction option is an important step forward\u2014offering the flexibility of at-home administration after proper training without compromising efficacy,” said Prof. Silvio Danese<\/span>, IRCCS Ospedale San Raffaele and University VitaSalute San Raffaele in Milan, Italy<\/span> and study investigator.e<\/sup> “These results show that a fully subcutaneous regimen of guselkumab can deliver meaningful clinical and endoscopic benefits that are sustained for a full year, supporting long-term disease control in ulcerative colitis.”\u00a0<\/p>\n

“These results reflect our unwavering commitment to advancing the science that delivers both meaningful outcomes and more choices for healthcare providers and their patients,” said Esi Lamous\u00e9-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “TREMFYA is the only IL-23 inhibitor to offer a subcutaneous induction option in both Crohn’s disease and ulcerative colitis, the latter of which was recently approved by the U.S. FDA and supported by findings from the ASTRO study. \u00a0This latest development offers patients and providers the choice of starting treatment for UC with a self-administered subcutaneous injection, with the same efficacy and safety that were established with IV induction.”<\/p>\n

TREMFYA\u00ae<\/sup> has received U.S. Food and Drug Administration (FDA) and European Commission (EC) approval for both SC and IV induction options for the treatment of adults with moderately to severely active Crohn’s disease and U.S. FDA approval for both SC and IV induction options for the treatment of adults with moderately to severely active ulcerative colitis. TREMFYA\u00ae<\/sup> is approved by the EC for the treatment of adult patients with moderately to severely active ulcerative colitis and is currently administered via an IV induction regimen, followed by a SC maintenance regimen.\u00a0<\/p>\n

For a full list of all Johnson & Johnson data being presented at UEG Week visit: https:\/\/www.jnj.com\/innovativemedicine\/immunology\/gastroenterology<\/a><\/p>\n

\n Editor’s Notes:<\/b>\u00a0<\/p>\n

\n\n\n\n\n\n\n
\n

\n a.<\/span>\n <\/p>\n<\/td>\n

\n

\n Clinical remission was defined as a Mayo stool frequency\u00a0subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopic subscore of 0 or 1 with no friability present on the endoscopy.\u00a0<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n b.<\/span>\n <\/p>\n<\/td>\n

\n

\n Endoscopic improvement was defined as an endoscopy subscore of 0 or 1 with no friability present on the endoscopy.<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n c.<\/span>\n <\/p>\n<\/td>\n

\n

\n Endoscopic remission (normalization) was defined as a Mayo endoscopic subscore (MES) of 0.<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n d.<\/span>\n <\/p>\n<\/td>\n

\n

\n Symptomatic remission per Mayo score was defined as a stool frequency\u00a0subscore of 0 (normal number of stools) or 1 (1 to 2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen).\u00a0<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n e.<\/span>\n <\/p>\n<\/td>\n

\n

\n Prof.\u00a0Danese is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.\u00a0<\/span>\n <\/p>\n<\/td>\n<\/tr>\n<\/table><\/div>\n

\n ABOUT THE ASTRO STUDY (NCT05528510<\/a>)<\/b>\n <\/p>\n

ASTRO is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, treat-through Phase 3 study designed to evaluate the efficacy and safety of TREMFYA\u00ae<\/sup> SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active ulcerative colitis (UC) who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and\/or ozanimod or approved JAK inhibitors. Patients (n = 418) were randomized 1:1:1 to receive TREMFYA\u00ae<\/sup> 400 mg SC induction at Weeks 0, 4 and 8 followed by TREMFYA\u00ae <\/sup>200 mg SC every 4 weeks (q4w); or TREMFYA\u00ae<\/sup> 400 mg SC induction at Weeks 0, 4 and 8, followed by TREMFYA\u00ae<\/sup> 100 mg SC every 8 weeks (q8w); or placebo. The maintenance dose regimens in ASTRO (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 QUASAR program which established the efficacy and safety profile of IV induction followed by SC maintenance therapy in patients with moderate to severely active UC.8<\/sup>\u00a0<\/p>\n

\n ABOUT ULCERATIVE COLITIS<\/b>\u00a0<\/p>\n

Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system’s overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.9<\/sup><\/p>\n

\n ABOUT TREMFYA\u00ae<\/sup> (guselkumab)<\/b>\n <\/p>\n

Developed by Johnson & Johnson, TREMFYA\u00ae<\/sup>\u00a0is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to\u00a0in vitro<\/i>\u00a0studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.<\/p>\n

TREMFYA\u00ae<\/sup>\u00a0is a prescription medicine approved in the U.S. to treat:<\/p>\n