First Phase 3 TREMFYA (guselkumab) Data in Inflammatory Bowel Disease Show Positive Induction Results Among Patients with Moderately to Severely Active Ulcerative Colitis

SPRING HOUSE, PA — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new efficacy and safety data from the Phase 3 QUASAR Induction Study evaluating the investigational use of TREMFYA^® (guselkumab) in adults with moderately to severely active ulcerative colitis (UC)^a who had an inadequate response or intolerance to conventional^b and/or advanced therapies.^1,c The data show statistically significant and clinically meaningful improvements across symptomatic and histo-endoscopic outcome measures.¹ Safety data were also consistent with the known safety profile of TREMFYA in approved indications.¹ These data, which were accepted as a late-breaking oral presentation to the Digestive Disease Week^® (DDW) Annual Meeting, comprise one of Janssen’s 17 oral and poster presentations at the conference taking place in Chicago, Illinois, May 6-9, 2023.

“Many people living with ulcerative colitis, especially those who have had inadequate response to other treatments, live with uncertainty and continue to experience debilitating symptoms,” said study author Jessica R. Allegretti, M.D., M.P.H., Medical Director, Crohn’s and Colitis Center at the Brigham and Women’s Hospital, Boston, MA, USA.^d “These Phase 3 data represent an important step in the advancement of a new treatment for moderately to severely active ulcerative colitis, as researchers continue to investigate therapeutic options that have the potential to provide relief for individuals at all stages of disease.”

QUASAR Phase 3 Induction Study Outcomes (Abstract #913b):¹
Among 701 patients^e randomized 3:2 to receive intravenous (IV) TREMFYA 200 mg or placebo at Weeks 0, 4, and 8, and observed through Week 12, results demonstrate:

• A significantly greater proportion of patients treated with TREMFYA compared with placebo (22.6 percent versus 7.9 percent, p<0.001, ∆^f=14.9 percent) achieved clinical remission^g at Week 12, the study’s primary endpoint¹
• At Week 4, 22.6 percent of patients receiving TREMFYA achieved symptomatic remission^h versus 12.9 percent placebo (p<0.001, ∆=9.9 percent). At Week 12, 49.9 percent of patients achieved symptomatic remission versus 20.7 percent placebo (p<0.001, ∆=29.4 percent)¹
• Compared to placebo, a greater proportion of TREMFYA-treated patients at Week 12 achieved:
  • Clinical responseⁱ (61.5 percent versus 27.9 percent placebo [p<0.001, ∆=33.8 percent])¹
  • Endoscopic improvement^j (26.8 percent versus 11.1 percent placebo [p<0.001, ∆=16.0 percent])¹
  • Histo-endoscopic mucosal improvement^k (23.5 percent versus 7.5 percent placebo [p<0.001, ∆=16.2 percent])¹
  • Endoscopic normalization^l (15.0 percent versus 5.0 percent placebo [nominal p<0.001, ∆=10.1 percent])¹
• Frequencies of treatment-emergent adverse events (AEs) in TREMFYA-treated patients were generally comparable to placebo¹
• There were numerically fewer serious AEs (2.9 percent TREMFYA versus 7.1 percent placebo) and AEs leading to discontinuation (1.7 percent TREMFYA versus 3.9 percent placebo) in TREMFYA-treated patients compared with placebo¹
• Overall, safety results through Week 12 were consistent with the known safety profile of TREMFYA in approved indications¹

“Results from the QUASAR study offer insights into the potential utility of TREMFYA for people living with this lifelong chronic condition and reinforce the known safety profile of TREMFYA observed in approved indications,” said Kavitha Goyal, M.D., Head of Global Medical Affairs, Gastroenterology, Janssen Global Services, LLC. “Janssen continues to investigate IL-23 pathway science with TREMFYA for treatment of complex immune-mediated diseases like ulcerative colitis, so that healthcare providers can have a range of treatment options that best fit patients’ needs and can bring them closer to the goal of remission.”

Further research is currently being conducted on TREMFYA for the treatment of patients with inflammatory bowel disease, which includes ongoing Phase 3 trials in Crohn’s disease (NCT03466411, NCT05197049) and UC (NCT04033445, NCT05528510).^2,3,4,5

TREMFYA is not approved for the treatment of adults living with UC in the U.S.

Notes:
a. Defined as a baseline modified Mayo score of 5 to 9, inclusive of a rectal bleeding subscore ≥1 and an endoscopy subscore ≥2 evaluated during central review of video endoscopy¹
b. i.e., thiopurines or corticosteroids¹
c. i.e., tumor necrosis factor alpha antagonists, vedolizumab or tofacitinib¹
d. Dr. Allegretti is a paid consultant for Janssen. Dr. Allegretti has not been compensated for any media work.
e. Mean age, 40.5 years; female, 43.1 percent; mean UC duration, 7.5 years; mean modified Mayo score, 6.9; Mayo endoscopy subscore of 3 indicating severe disease, 67.9 percent; median fecal calprotectin, 1641.0mg/kg; median C-reactive protein, 4.2mg/L; baseline oral corticosteroid use, 43.1 percent. Baseline demographic and disease characteristics were balanced across the two treatment groups. While half of the patients were receiving a biologic for the first time, approximately 50 percent of patients had a prior failure to advanced therapies for UC, and nearly half (47.4 percent) of these patients failed two or more advanced therapy classes, reflecting highly refractory disease.¹
f. Adjusted treatment difference based on Wald statistic with Cochran-Mantel-Haenszel weight¹
g. Clinical remission: A Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy¹
h. Symptomatic remission: A stool frequency subscore of 0 or 1 and not increased from baseline and a rectal bleeding subscore of 0¹
i. Clinical response: A decrease from baseline in the modified Mayo score by ≥30 percent and ≥2 points, with either a ≥1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1¹
j. Endoscopic improvement: An endoscopy subscore of 0 or 1 with no friability present on the endoscopy¹
k. Histo-endoscopic mucosal improvement: Achieving a combination of histologic improvement (neutrophil infiltration in <5 percent of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system, i.e., Geboes score ≤3.1) and endoscopic improvement (endoscopy subscore of 0 or 1, with no friability present on the endoscopy) ¹
l. Endoscopic normalization: An endoscopy subscore of 0¹

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