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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

TREMFYA® (guselkumab)

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TREMFYA - Occurrence of Congestive Heart Failure

Last Updated: 01/04/2025

SUMMARY

There were no specific reports of congestive heart failure (CHF) in three phase 3 clinical trials and one phase 2 clinical trials of TREMFYA for moderate to severe plaque psoriasis (PsO).¹^-⁴
There were no specific reports of CHF in two phase 3 clinical trials of TREMFYA for active psoriatic arthritis (PsA).⁵

CLINICAL TRIAL DATA

There were no specific reports of CHF in three phase 3 (VOYAGE 1, VOYAGE 2, and NAVIGATE) and one phase 2 (X-PLORE) clinical trials of TREMFYA in patients with moderate to severe plaque PsO (VOYAGE 1 and VOYAGE 2: 825 patients treated with TREMFYA through week 48; NAVIGATE: 135 patients treated with TREMFYA through week 60; X-PLORE: 235 patients treated with TREMFYA through week 52).¹^-⁴
There were no specific reports of CHF in two phase 3 (DISCOVER-1 and DISCOVER-2) clinical trials of TREMFYA in adult patients with active PsA (DISCOVER-1 and DISCOVER-2: 748 patients in the combined TREMFYA group through week 24).⁵

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 12 June 2024.

References

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1	Blauvelt A, Papp KA, Griffiths CE, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405-417.
2	Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76(3):418-431.
3	Langley RG, Tsai TF, Flavin S, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial. Br J Dermatol. 2018;178(1):114-123.
4	Gordon KB, Duffin KC, Bissonnette R, et al. A phase 2 trial of guselkumab versus adalimumab for plaque psoriasis. N Engl J Med. 2015;373(2):136-144.
5	Rahman P, Ritchlin CT, Helliwell P, et al. Integrated safety results of two phase-3 trials of guselkumab in patients with psoriatic arthritis, through the placebo-controlled periods. Poster presented at: European League Against Rheumatism; June 3-6, 2020; E-Congress.