Johnson & Johnson announces 48-week data from Phase 3 ASTRO study

Johnson & Johnson announced new 48-week data from the Phase 3 ASTRO study evaluating TREMFYA subcutaneous induction and maintenance therapy in adults with moderately to severely active ulcerative colitis. These data show clinically meaningful rates of clinical and endoscopic remission, making TREMFYA the first and only IL-23 inhibitor to demonstrate robust results with a fully SC regimen. The findings are among 20 Johnson & Johnson abstracts being presented at the United European Gastroenterology Week 2025. 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. Data through Week 48 show patients treated with TREMFYA 400 mg SC induction followed by SC maintenance dose regimens of either 100 mg every eight weeks or 200 mg every four weeks demonstrated clinically meaningful improvements across all clinical and endoscopic measures compared with patients receiving placebo. Furthermore, in prespecified analyses of subpopulations defined by prior advanced therapy treatment status, TREMFYA demonstrated clinically meaningful results across all endpoints in both biologic and JAK inhibitor-naive and biologic and JAK inhibitor-refractory patients. Safety data from the ASTRO study were consistent with the well-established safety profile of TREMFYA.