Friday, September 30, 2022

561.316.3330

Biotechnology News Magazine

Ulcerative Colitis- Phase 2b Data with TREMFYA® (guselkumab) at 12 Weeks

Latest Posts

City of Hope to Accelerate Immunotherapy Research & Treatment Innovation with $15 Mil Gift from Ted Schwartz Family

Ted Schwartz, who is now cancer free, achieved complete remission at City of Hope in 2020 with the center's leading CAR T cell therapy after a 16-year battle with lymphoma, provided the gift to City of Hope to advance treatment options that offer better outcomes and quality of life for people living with cancer.

Neurocrine Biosciences Appoints Dr Ingrid Delaet as Chief Regulatory Officer

Prior to joining Neurocrine Biosciences, Dr Ingrid Delaet served as Senior Vice President, Regulatory Affairs at Intercept Pharmaceuticals, which she joined in 2016.

Astrea Bioseparations Introduces Nereus LentiHERO, a Fit-for-purpose Solution for Lentiviral Vector Purification

“We believe that AstreAdept will be a game-changer,” explained Astrea Bioseparations’ CEO Terry Pizzie. “Our approach was to rapidly develop and incorporate this material into the Nereus LentiHERO, a simple, fit-for-purpose device that radically transforms how lentivirus can be purified [in terms of speed, recovery, and efficiency].

At Pack Expo, Schreiner MediPharm to Debut Functional Labels Designed from More Sustainable Materials

Schreiner MediPharm advises he new label concepts are based on existing items in Schreiner MediPharm’s roster of functional labeling solutions.

Ulcerative Colitis- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 2b QUASAR Induction Study 1.

Results showed a significantly greater proportion of adults with moderately to severely active ulcerative colitis (UC) who previously had an inadequate response or intolerance to conventional therapies and/or selected advanced therapies and were treated with TREMFYA® (guselkumab) achieved clinical responsea at week 12, the study’s primary endpoint (intravenous [IV] TREMFYA 200 mg: 61.4 percent [62/101] and IV TREMFYA 400 mg: 60.7 percent [65/107]) compared with placebo (27.6 percent [29/105]).1

Safety data at week 12 were consistent with the safety profile for TREMFYA in approved indications.1,2 TREMFYA is not currently approved for the treatment of adults with UC in the U.S.2

These new efficacy and safety data are the first reported on the investigational use of TREMFYA for moderately to severely active UC in an analysis of 313 patients enrolled in the QUASAR clinical program.3

These findings were presented today as an oral presentation (OP23) at the 17th Congress of the European Crohn’s and Colitis Organisation (ECCO) taking place virtually from February 16-19.1

“Despite available treatment options, there are patients with moderately to severely active ulcerative colitis who are still in need of additional therapeutic approaches due to inadequate response or intolerance to their current treatment,” said presenting study author Axel Dignass, M.D., Ph.D., Head of the Department of Medicine and Professor of Medicine and Gastroenterology at the Agaplesion Markus Hospital, Goethe University in Frankfurt, Germany.b

He added, “Results from the QUASAR study show both IV induction doses of TREMFYA achieved clinical responses in patients with moderately to severely active ulcerative colitis at rates greater than placebo.”

In the study, the primary endpoint of the clinical response is defined as a decrease from induction 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 1.1,c Major secondary endpoints in the QUASAR study include clinical remission,d symptomatic remission,e endoscopic improvement,f histo-endoscopic mucosal improvementg and endoscopic normalizationh at week 12.1,c

Results from the five secondary endpoints showed:1,c

  • Clinical remission ratesd were achieved in 25.7 and 25.2 percent of patients in the 200 and 400 mg TREMFYA groups, respectively, compared with 9.5 percent in the placebo group.
  • Symptomatic remission ratese were achieved in 50.5 and 47.7 percent of patients in the respective 200 and 400 mg TREMFYA groups compared with 20.0 percent in the placebo group.
  • Endoscopic improvement ratesf were achieved in 30.7 and 30.8 percent of patients in the respective 200 and 400 mg TREMFYA groups compared with 12.4 percent in the placebo group.
  • Histo-endoscopic mucosal improvement ratesg were achieved in 19.8 and 27.1 percent of patients in the respective 200 and 400 mg TREMFYA groups compared with 8.6 percent in the placebo group.
  • Endoscopic normalization ratesh were achieved in 17.8 and 14 percent of patients in the respective 200 and 400 mg TREMFYA groups compared with 6.7 percent in the placebo group.

Safety findings for both TREMFYA dose groups were consistent with the known safety profile for TREMFYA in approved indications.1,2 The proportions of patients reporting adverse events (AEs), serious AEs, and AEs leading to discontinuation in both TREMFYA dose groups were not greater compared with placebo.1 No serious infections, cases of malignancy or death were reported for TREMFYA.1

“Data from the Phase 2b QUASAR study provide the initial evidence in the development of TREMFYA as a potential treatment for adult patients with moderately to severely active ulcerative colitis,” said Jan Wehkamp, M.D., Ph.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. “We look forward to advancing this important research in the ongoing QUASAR Phase 3 induction and maintenance studies as we continue in our commitment to develop therapeutic options for patients with debilitating diseases like ulcerative colitis.”

Phase 3 clinical trials evaluating TREMFYA for the treatment of adults with moderately to severely active UC are ongoing and enrolling participants. Learn more through the Janssen Global Trial Finder.

Editor’s Notes:

a. 

Clinical response is defined as a decrease from induction 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 1.1 Modified Mayo score is a three-component (stool frequency, rectal bleeding, and endoscopy subscores) Mayo score without the physician’s global assessment.4

b. 

Professor Dignass is a paid consultant for Janssen. He has not been compensated for any media work.

c. 

Please see the ‘About QUASAR Induction Study 1’ section below for further details regarding the study design.

d. 

Clinical remission is defined as a stool frequency subscore of 0 or 1, a rectal bleeding score of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.1

e. 

Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.1

f.  

Endoscopic improvement is defined as an endoscopy subscore of 0 or 1 with no friability present on the endoscopy.1

g.

Histo-endoscopic mucosal improvement is defined as 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) and endoscopic improvement.1

h. 

Endoscopic normalization is defined as an endoscopy subscore of 0.1

 

Latest Posts

Learn More

spot_img

Subscribe

spot_img

Our Sister Publication

Medical Device News Magazine