Janssen Presents Results of Tremfya (guselkumab) in P-II (GALAXI 1) Trial and Long-Term Safety Profile for Stelara (ustekinumab) to Treat IBD at DDW 2022
- The P-II (GALAXI 1) trial evaluating Tremfya in adult patients with active CD with an inadequate response or intolerance to conventional therapies or biologics
- The results showed that the patients achieved high levels of clinical-biomarker response (47.5-66.7%), endoscopic response (44.3-46%) & clinical remission with CRP ≤3 mg/L or fecal calprotectin ≤250μg/g (39.3-66.7%) @48wks. The safety results were consistent with the safety profile of Tremfya in approved indications
- The Stelara pooled analyses of long-term safety data in bio-naïve & bio-failure CD/UC patients showed a favorable safety profile consistent with the overall IBD population & no increased incidence of malignancy from 13 studies across all approved indications
Ref: Janssen | Image: Janssen
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