Johnson & Johnson’s subcutaneous Tremfya holds potential to set new standard in Crohn’s disease treatment: GlobalData

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.

Guselkumab showed efficacy at both induction and maintenance using the new formulation, which is a significant advancement over current therapies that utilise 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.

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.

Sumaira Malik, Senior Immunology Analyst at GlobalData, comments, “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.”

According to GlobalData’s Sales and Forecast database, total sales for Tremfya are expected to reach $7.8 billion globally by 2029.

Malik adds, “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 per cent drop in global total sales in Q3 2024, likely due to current EU and upcoming US loss of exclusivity.”

The GRAVITI trial demonstrates that SC Tremfya’s safety is consistent with its well-characterised profile in its approved indications.

Malik concludes, “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.”