The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new results from the Phase 2 GALAXI 1 clinical trial showing the majority (57.4-73 percent) of adults with moderately to severely active Crohn’s disease (CD) who were treated with TREMFYA® (guselkumab) achieved clinical remission (Crohn’s Disease Activity Index [CDAI]<150)a at week 48.1 The week 48 results also show the majority (57.4-73 percent) of patients who achieved clinical remission with TREMFYA were free of corticosteroid treatment.1,b TREMFYA is not currently approved for the treatment of CD in the U.S.2 These data are being presented today as an oral presentation (OP24) at the 17th Congress of the European Crohn’s and Colitis Organisation (ECCO), taking place virtually from February 16-19.1
“These 48-week GALAXI 1 data represent a major step in the development of TREMFYA,” said presenting study author Professor Silvio Danese, Director, Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy.c “Further, remission was achievable for patients in this study without corticosteroids, which is important to note as avoidance of long-term steroid use is an important consideration when treating these patients.”
Week 48 results showed
• Clinical remission:a 63.9 percent of patients treated with TREMFYA 200 mg intravenous (IV)/100 mg subcutaneous (SC), 73 percent treated with TREMFYA 600 mg IV/200 mg SC and 57.4 percent treated with TREMFYA 1200 mg IV/200 mg SC achieved clinical remission.1,a With STELARA® (ustekinumab), which was used as a reference arm, 58.7 percent of patients achieved clinical remission.1 The study was not powered to evaluate differences between treatment groups.1
• Corticosteroid-free clinical remission:b 59 percent of patients treated with TREMFYA 200 mg IV/100 mg SC, 71.4 percent treated with TREMFYA 600 mg IV/200 mg SC, and 55.7 percent treated with TREMFYA 1200 mg IV/200 mg SC, achieved corticosteroid-free clinical remissionb (CDAI<150 and no corticosteroid therapy at week 48). The proportion of patients in the STELARA group was 58.7 percent.1
• Patient-Reported Outcome (PRO)-2 remission:e 57.4 percent of patients treated with TREMFYA 200 mg IV/100 mg SC, 69.8 percent treated with TREMFYA 600 mg IV/200 mg SC, and 50.8 treated with TREMFYA 1200 mg IV/200 mg SC achieved PRO-2 remission.1,e The proportion of patients in the STELARA group was 46 percent.1
All TREMFYA dose groups during the 48-week treatment period in GALAXI 1 had comparable safety data, consistent with the known safety profile for TREMFYA in approved indications.1,2 Key safety event rates were similar among the three dosing groups.1 In the TREMFYA 200 mg IV/100 mg SC, 600 mg IV/200 mg SC, 1200 mg IV/200 mg SC and STELARA groups, adverse events (AEs) occurred in 71.2 percent, 80.8 percent, 69.9 percent, and 84.5 percent, respectively.1 Serious adverse events (SAEs) occurred in 8.2 percent, 6.8 percent, 6.8 percent, and 12.7 percent, respectively.1 No opportunistic infections, cases of tuberculosis, or deaths were reported in any group.1 Infectionsf occurred in 34.2 percent, 41.1 percent, 34.2 percent, and 36.6 percent, respectively.1 Serious infections occurred in 2.7 percent, 2.7 percent, 1.4 percent, and 1.4 percent, respectively.1
“With a life-long progressive condition like Crohn’s disease, it’s critical to investigate potential new treatment options with the understanding that remission is the ultimate goal,” said Jan Wehkamp, M.D., Ph.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. “These new data underscore Janssen’s continued commitment to investigating pathway science with TREMFYA in the development of additional therapies that can potentially address the multifaceted nature of immune-mediated diseases like Crohn’s disease.”
Janssen previously announced results from the 12-week interim analysis and top-line 48-week data from the GALAXI Phase 2 study.3,4 Phase 3 clinical trials evaluating TREMFYA for the treatment of moderately to severely active CD are ongoing and actively enrolling participants. Learn more through the Janssen Global Trial Finder.
هن آرٽيڪل مان ڇا وٺو:
- All TREMFYA dose groups during the 48-week treatment period in GALAXI 1 had comparable safety data, consistent with the known safety profile for TREMFYA in approved indications.
- 1 In the TREMFYA 200 mg IV/100 mg SC, 600 mg IV/200 mg SC, 1200 mg IV/200 mg SC and STELARA groups, adverse events (AEs) occurred in 71.
- 9 percent of patients treated with TREMFYA 200 mg intravenous (IV)/100 mg subcutaneous (SC), 73 percent treated with TREMFYA 600 mg IV/200 mg SC and 57.
