STELARA® (ustekinumab)

STELARA - Pivotal Clinical Trial Publications

Inflammatory Bowel Disease (IBD)

UNITI (Crohn’s Disease)

Feagan BG, Sandborn WJ, Gasink C et al. Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2016;375(20):1946-60.

Feagan BG, Sandborn WJ, Gasink C, et al. Supplement to: Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2016;375(20):1946-1960.

UNIFI (Ulcerative Colitis)

Sands BE, Sandborn WJ, Panaccione R et al. Ustekinumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2019;381(13):1201-1214.

Sands BE, Sandborn WJ, Panaccione R, et al. Supplement to: Ustekinumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2019;381(13):1201-1214.

Psoriatic Arthritis (PsA)

PSUMMIT 1

McInnes IB, Kavanaugh A, Gottlieb A et al. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet. 2013;382(9894):780-789.

PSUMMIT 2

Ritchlin C, Rahman P, Kavanaugh A et al. Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumor necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial. Ann Rheum Dis. 2014;73(6):990-999.

Plaque Psoriasis (PsO)

PHOENIX 1

Leonardi C, Kimball A, Papp Kim et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371 (9625):1665-1674.

PHOENIX 2

Papp K, Langley R, Lebwohl M et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008;371 (9625):1675-1684.

CADMUS

Landells I, Marano C, Hsu M et al. Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: results of the randomized phase 3 CADMUS study. J Am Acad Dermatol. 2015;73(4):594-603.

CADMUS Jr

Philipp S, Menter A, Nikkels AF et al. Ustekinumab for the treatment of moderate-to-severe plaque psoriasis in pediatric patients (≥ 6 to < 12 years of age): efficacy, safety, pharmacokinetic and biomarker results from the open-label CADMUS Jr study. Br J Dermatol. 2020;183(4):664-672.

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