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SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- The phase 3 clinical trial program of TREMFYA in the treatment of adults with moderately to severely active Crohn’s disease did not evaluate retreatment with TREMFYA after a drug free interval.1,2
LITERATURE SEARCH
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 16 June 2025.
1 | Janssen Research & Development, LLC. A study of the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease (GALAXI). In: Clinical Trials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 April 25]. Available from: https://clinicaltrials.gov/ct2/show/NCT03466411 NLM Identifier: NCT03466411. |
2 | Janssen Research and Development, LLC. A study of guselkumab subcutaneous therapy in participants with moderately to severely active Crohn’s disease (GRAVITI). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 June 16]. Available from: https://clinicaltrials.gov/study/NCT05197049 NLM Identifier: NCT05197049. |