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
Kavanaugh, Arthur (University of California (San Diego, Estats Units))
Ritchlin, Christopher (University of Rochester Medical Center (Nova York, Estats Units))
Rahman, Proton (Memorial University (Newfoundland, Canadà))
Puig, Lluis (Institut d'Investigació Biomèdica Sant Pau)
Gottlieb, Alice B. (Tufts Medical Center (Massachusetts, Estats Units))
Li, Shu (Janssen Research and Development (Pennsylvania, Estats Units))
Wang, Yuhua (Janssen Research and Development (Pennsylvania, Estats Units))
Noonan, Lenore (Janssen Research and Development (Pennsylvania, Estats Units))
Brodmerkel, Carrie (Janssen Research and Development (Pennsylvania, Estats Units))
Song, Michael (Janssen Research and Development (Pennsylvania, Estats Units))
Mendelsohn, Alan M. (Janssen Research and Development (Pennsylvania, Estats Units))
McInnes, Iiain B. (University of Glasgow, Glasgow Biomedical Research Centre)
Universitat Autònoma de Barcelona. Departament de Medicina

Data:	2014
Resum:	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 <5% improvement in tender/swollen joint counts entered blinded early escape. All other placebo patients received ustekinumab 45 mg at wk 24 and wk 28, then q 12 wks. Radiographs of hands/feet at wks 0/24/52 were assessed using PsA-modified van der Heijde-Sharp (vdH-S) scores; combined PSUMMIT-1 and PSUMMIT-2 changes in total vdH-S scores from wk 0 to wk 24 comprised the prespecified primary radiographic analysis. Treatment effects were assessed using analysis of variance on van der Waerden normal scores (factors=treatment, baseline methotrexate usage, and study). 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 p<0. 02). From wk 24 to wk 52, inhibition of radiographic progression was maintained for ustekinumab-treated patients, and progression was substantially reduced among initial placebo recipients who started ustekinumab at wk 16 or wk 24 (wk 24 - wk 52, total vdH-S score mean change: 0. 08). Conclusions: Ustekinumab 45 and 90 mg treatments significantly inhibited radiographic progression of joint damage in patients with active PsA.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Anti-TNF ; Psoriatic Arthritis ; Spondyloarthritis
Publicat a:	Annals of the rheumatic diseases, Vol. 73 Núm. 6 (june 2014) , p. 1000-1006, ISSN 1468-2060

DOI: 10.1136/annrheumdis-2013-204741
PMID: 24553909

7 p, 960.8 KB

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