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SUMMARY
- Specific studies of TREMFYA have not been conducted in patients with renal insufficiency.1
RELEVANT INCLUSION/EXCLUSION CRITERIA FROM CLINICAL TRIALS
The safety and efficacy of TREMFYA in patients diagnosed with moderate to severe plaque psoriasis were evaluated in 3 phase 3 (VOYAGE 1, VOYAGE 2, NAVIGATE) multicenter, randomized, double-blind clinical studies. Patients with a history or current signs or symptoms of severe, progressive, or uncontrolled renal disturbances from the 3 studies were excluded.2-4
The safety and efficacy of TREMFYA in adult patients with active psoriatic arthritis were evaluated in 2 phase 3 pivotal studies (DISCOVER-1 and DISCOVER-2). Patients with a history or current signs or symptoms of severe, progressive, or uncontrolled renal disturbances were excluded.5,6
LITERATURE SEARCH
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® databases (and/or other resources, including internal/external databases) conducted on 16 August 2024 did not identify any relevant citations pertaining to this topic.
| 1 | Data on File. Guselkumab Company Core Data Sheet v017. Janssen Research & Development, LLC. EDMS-ERI-111962822. US-SRSM-4111. 2024. |
| 2 | Janssen Research & Development, LLC. A study of guselkumab in the treatment of participants with moderate to severe plaque-type psoriasis (VOYAGE 1). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2020 [cited 2020 April 29]. Available from: https://clinicaltrials.gov/ct2/show/NCT02207231 NLM Identifier: NCT02207231. |
| 3 | Janssen Research & Development, LLC. A study of guselkumab in the treatment of participants with moderate to severe plaque-type psoriasis with randomized withdrawal and retreatment (VOYAGE 2). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2019 [cited 2020 April 29]. Available from: https://clinicaltrials.gov/ct2/show/NCT02207244 NLM Identifier: NCT02207244. |
| 4 | Janssen Research & Development, LLC. A study of guselkumab in participants with moderate to severe plaque-type psoriasis and an indadequate response to ustekinumab (NAVIGATE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2017 [cited 2020 April 29]. Available from: https://clinicaltrials.gov/ct2/show/NCT02203032 NLM Identifier: NCT02203032. |
| 5 | Deodhar A, Helliwell P, Boencke WH. Supplement to: Guselkumab in patients with active psoriatic arthritis who were biologic-naïve or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1115-1125. |
| 6 | Mease PJ, Rahman P, Gottlieb AB. Supplement to: Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136. |
