Johnson & Johnson‘s subcutaneous (SC) Tremfya (guselkumab) demonstrated strong results in the Phase III GRAVITI trial, marking a major breakthrough in the treatment of Crohn’s disease (CD). This patient-friendly regimen could enhance patient autonomy, improve adherence, and lead to better outcomes. The GRAVITI results position guselkumab as a significant new option in CD, says GlobalData, a data and analytics company.
“Guselkumab showed efficacy at both induction and maintenance using the new formulation, which is a significant advancement over current therapies that utilize an intravenous (IV) formulation for induction and SC for maintenance. The trial results will be presented in detail at the upcoming American College of Gastroenterology (ACG) 2024 conference on October 25–30,” the company said in a statement.
In GRAVITI, guselkumab achieved both co-primary endpoints at Week 12, mirroring the clinical success of the GALAXI program, which showed efficacy in CD with IV induction and SC maintenance, as presented at Digestive Disease Week (DDW) 2024.
“With both IV and SC delivery options from the outset, guselkumab provides choice and versatility for patients. Tremfya faces considerable in-class competition from AbbVie’s already-approved Skyrizi (risankizumab) and Eli Lilly’s Omvoh (mirikizumab). However, disappointing results obtained in CD from the oral pipeline sphingosine-1-phosphate (S1P) receptor class, including Bristol Myers Squibb’s Zeposia (ozanimod) and Pfizer’s Velsipity (etrasimod), may reduce overall competition. This leaves AbbVie’s oral Janus kinase (JAK)-1 inhibitor Rinvoq (upadacitinib) as SC guselkumab’s primary non-IV competitor,” Sumaira Malik, Senior Immunology Analyst at GlobalData said.
According to GlobalData’s Sales and Forecast database, total sales for Tremfya are expected to reach $7.8 billion globally by 2029.
“The CD market is evolving rapidly, with patient convenience and adherence emerging as critical factors. Tremfya’s approval in ulcerative colitis (UC) in September 2024, coupled with its future CD and UC approvals with SC regimens, may drive further uptake and help offset losses from Johnson & Johnson’s Stelara, which saw a 6.6% drop in global total sales in Q3 2024, likely due to current EU and upcoming US loss of exclusivity,” Malik said.
The GRAVITI trial demonstrates that SC Tremfya’s safety is consistent with its well-characterized profile in its approved indications.
“The upcoming presentation of GRAVITI results is timely, with Johnson & Johnson already submitting regulatory filings for SC Tremfya, suggesting near-term market availability. Guselkumab’s positive clinical profile, coupled with its unique dual-binding mechanism, positions it as a differentiated option within its class. This strategic advantage will be highlighted at ACG 2024, the first major US gastroenterology conference post-UC approval. There is substantial evidence to suggest that guselkumab’s SC regimen will be a significant step forward for patients, potentially transforming treatment practices and setting a new benchmark in CD care,” Malik added.
