TREMFYA®
(guselkumab)
TREMFYA® (guselkumab)
TREMFYA - pivotal clinical trial publications
Psoriatic arthritis (PsA)
DISCOVER 1
Deodhar A, Helliwell P, Boehncke W, et al. 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.
DISCOVER 2
Mease P, Rahman P, Gottlieb A et al. Guselkumab in biologic-naïve patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020; 395(10230):1126-1136.
Plaque psoriasis (PsO)
VOYAGE 1
Blauvelt A, Papp K, Griffiths C, 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-blind, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76:405-417.
VOYAGE 2
Reich K, Armstrong A, 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.
NAVIGATE
Langley R, Tsai T, 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.
ORION
Ferris L, Ott E, Jiang J, et al. Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study. J Dermatol Treat. 2020;31(2):152-159.
Ulcerative Colitis (UC)
QUASAR
Rubin DT, Allegretti JR, Panés J, et al. Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies. Lancet. 2025;405(10472):33-49.
Crohn's Disease (CD)
GALAXI
Panaccione R, Feagan B, Afzali A, et al. Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials. Lancet. 2025;406;358-375.
GRAVITI
Hart A, Panaccione R, Steinwurz F, et al. Efficacy and Safety of Guselkumab Subcutaneous Induction and Maintenance in Participants With Moderately to Severely Active Crohn’s Disease: Results From the Phase 3 GRAVITI Study. Gastroenterology. 2025;169:308-325.