The interleukin-23 blocker guselkumab (Tremfya) continues to show promise in treating Crohn’s disease (CD). First winning FDA approval for plaque psoriasis in 2017, guselkumab recently demonstrated robust efficacy and a consistent safety profile in the long-term extension of the GALAXI Phase 2 study for CD.
Some 54.1% of patients receiving guselkumab achieved clinical remission by the three-year mark, compared to 46.0% for those treated with Stelara (ustekinumab), the company’s interleukin-12 and -23 antagonist that won FDA approval for CD in 2016. Patient-reported outcomes were also promising in the GALAXI trial, with 51.4% of guselkumab-treated patients achieving PRO-2 remission, a patient-reported outcome measurement used in inflammatory bowel disease (IBD) studies, compared to 39.7% for ustekinumab. From an endoscopic perspective, 34.7% of patients on guselkumab showcased a positive response, compared with 19.4% on ustekinumab.
An overview of GALAXI LTE data at three years for all randomized patients
| Endpoint | Combined TREMFYA | STELARA |
| Clinical remission | 54.1% (100/185) | 46.0% (29/63) |
| PRO-2 remission | 51.4% (95/185) | 39.7% (25/63) |
| Endoscopic response | 34.7% (61/176) | 19.4% (12/62) |
In the GALAXI LTE study, the safety profile of guselkumab was in line with previously approved indications related to psoriatic arthritis, suggesting that no new or unexpected adverse effects were observed during the study’s duration.
Exploring guselkumab’s potential in Crohn’s disease
Janssen has also conducted the phase 3 QUASAR induction study testing the investigational use of guselkumab in adults with moderately to severely active ulcerative colitis (UC) who had an inadequate response or intolerance to conventional and/or advanced therapies 2. The data showed statistically significant and clinically meaningful improvements across symptomatic and histo-endoscopic outcome measures.
In 2021, Johnson & Johnson released topline results from the GALAXI 1 clinical trial exploring guselkumab in patients with moderately to severely active Crohn’s disease (CD). Almost two-thirds (65%) of guselkumab recipients achieved clinical remission at week 48.
Broadening the therapeutic horizon in IBD
Guselkumab’s promising results in treating both CD and UC highlights the potential shift in therapeutic strategies for IBD. The IBD market is becoming increasingly competitive with new therapies and potential candidates nearing regulatory approvals. While several anti-TNF agents are FDA approved to treat IBD symptoms, including J&J’s infliximab and golimumab, AbbVie’s adalimumab and UCB’s certolizumab pegol, relatively few patients achieve remission with this drug class. Simultaneously, interest in JAK inhibitors, such as upadacitinib and filgotinib, remains strong for IBD,
Other therapies in development for Crohn’s disease include RHB-104, an antibiotic from RedHill Biopharma, that saw positive results in a phase 3 study. With a variety of therapies demonstrating encouraging results in clinical trials, outcomes for IBD patients may improve in the coming years.
Filed Under: Biologics, Gastroenterology
