Novel Drug & Emergent Therapeutics | Pharmaceuticals | Rare Diseases | Inflammatory Bowel Disease
First IL-23 Inhibitor shows robust results for the management of Crohn's disease
Time to read: 01:43 minutes
Originally published: 29 October 2024
Source: PRNewswire
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDC004
Category: Rare Diseases
Crossreference: Inflammatory Bowel Disease, Chrons
Category tags: Chrons disease, inflammatory disease, pro-inflammatory cytokines,IL-23
28 October 2024, PRNewswire
Johnson & Johnson has announced positive results from the Phase 3 GRAVITI study of TREMFYA® (guselkumab), an IL-23 inhibitor that showed strong outcomes in subcutaneous induction and maintenance therapy. The findings were presented at the 2024 American College of Gastroenterology conference, held October 25-30.
In the Phase 3 GRAVITI study, a greater proportion of patients treated with subcutaneous TREMFYA® (guselkumab) achieved clinical and endoscopic remission at 48 weeks compared to those receiving a placebo.
TREMFYA® received U.S. Food and Drug Administration (FDA) approval in September 2024 for the treatment of adults with moderately to severely active ulcerative colitis (UC), whilst the application for the treatment of moderately to severely active CD is currently under FDA review.
These promising results suggest that TREMFYA® could potentially become the first IL-23 treatment to offer both subcutaneous and intravenous induction regimens for Crohn's disease (CD), pending FDA approval.
Interleukin-23 (IL-23) is a pro-inflammatory cytokine that plays a significant role in enhancing the expansion of T helper type 17 (Th17) cells, which are implicated in various inflammatory autoimmune responses. Targeting IL-23, its receptor, or the IL-23 axis, represents a promising therapeutic strategy for autoimmune diseases, including psoriasis, inflammatory bowel disease, rheumatoid arthritis, and multiple sclerosis.
In the study, patients who received 400 mg of TREMFYA® subcutaneously at Weeks 0, 4, and 8 demonstrated significant clinical outcomes.
- At Week 12, over half of the patients (56.1%) achieved clinical remission, compared to just 21.4% in the placebo group.
- Additionally, the endoscopic response was noted in 41.3% of patients receiving TREMFYA®, significantly higher than the 21.4% in the placebo cohort.
- Notably, improvements in clinical remission were observed as early as Week 4, indicating a rapid onset of action.
- The Week 48 results further highlighted the efficacy of TREMFYA® in maintaining remission.
- Clinical remission rates were reported at 60.0% for the 100 mg subcutaneous maintenance dose administered every eight weeks) and 66.1% for the 200 mg subcutaneous dose given every four weeks compared to only 17.1% in the placebo group.
- Endoscopic response rates were 44.3% and 51.3% for the TREMFYA® 100 mg eight-week and 200 mg at four-week groups, respectively, while endoscopic remission rates were observed at 30.4% and 38.3% for the same groups compared to 6.0% in the placebo group.
These findings not only demonstrate the effectiveness of TREMFYA® but also reinforce its well-established safety profile.
According to representatives from Johnson & Johnson highlighted that the treatment offers flexibility and convenience, allowing for self-administration right from the start, thereby enhancing therapeutic options for individuals living with Crohn's disease.
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