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

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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

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