Ustekinumab, an anti-IL-12/23 p40 monoclonal antibody, inhibits radiographic progression in patients with active psoriatic arthritis: results of an integrated analysis of radiographic data from the phase 3, multicentre, randomised, double-blind, placebo-controlled PSUMMIT-1 and PSUMMIT-2 trials
Open Access
- 19 February 2014
- journal article
- research article
- Published by BMJ in Annals Of The Rheumatic Diseases
- Vol. 73 (6), 1000-1006
- https://doi.org/10.1136/annrheumdis-2013-204741
Abstract
Objective Evaluate ustekinumab, an anti-interleukin (IL)-12 and IL-23 antibody, effects on radiographic progression in psoriatic arthritis (PsA). Methods We conducted preplanned integrated analyses of combined radiographic data from PSUMMIT-1 and PSUMMIT-2 phase 3, randomised, controlled trials. Patients had active PsA despite prior conventional and/or biologic disease-modifying antirheumatic drugs (≥5/66 swollen, ≥5/68 tender joints, C-reactive protein ≥3.0 mg/L, documented plaque psoriasis). Patients (PSUMMIT-1, n=615; PSUMMIT-2, n=312) were randomised to ustekinumab 45 mg, 90 mg, or placebo, at weeks (wk) 0, 4 and every (q) 12 wks. At wk 16, patients with Results Integrated data analysis results indicated that ustekinumab-treated patients (regardless of dose) demonstrated significantly less radiographic progression at wk 24 than did placebo recipients (wk 0–24 total vdH-S score mean changes: 0.4-combined/individual ustekinumab dose groups, 1.0-placebo; all pConclusions Ustekinumab 45 and 90 mg treatments significantly inhibited radiographic progression of joint damage in patients with active PsA.Keywords
This publication has 23 references indexed in Scilit:
- 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 trialThe Lancet, 2013
- The TICOPA protocol (TIght COntrol of Psoriatic Arthritis): a randomised controlled trial to compare intensive management versus standard care in early psoriatic arthritisBMC Musculoskeletal Disorders, 2013
- The Th17/IL-23 Axis and Natural Immunity in Psoriatic ArthritisInternational Journal of Rheumatology, 2012
- Psoriatic ArthritisJournal of the American Academy of Orthopaedic Surgeons, 2012
- Effects of inflammatory and anti‐inflammatory cytokines on the boneEuropean Journal of Clinical Investigation, 2011
- Comparison of Ustekinumab and Etanercept for Moderate-to-Severe PsoriasisThe New England Journal of Medicine, 2010
- 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)The Lancet, 2008
- 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)The Lancet, 2008
- Adalimumab for long‐term treatment of psoriatic arthritis: Forty‐eight week data from the adalimumab effectiveness in psoriatic arthritis trialArthritis & Rheumatism, 2007
- Biannual Radiographic Assessments of Hands and Feet in a Three‐Year Prospective Followup of Patients with Early Rheumatoid ArthritisArthritis & Rheumatism, 1992