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-tumour necrosis factor therapy : 6-month and 1-year results of the phase 3, multicentre, double-blind, placebocontrolled, randomised PSUMMIT 2 trial
Ritchlin, Christopher (University of Rochester Medical Center (Nova York, Estats Units))
Rahman, Proton (Memorial University (Newfoundland, Canada))
Kavanaugh, Arthur (University of California (San Diego, Estats Units))
McInnes, Iain B. (University of Glasgow (Regne Unit))
Puig, Lluis (Institut d'Investigació Biomèdica Sant Pau)
Li, Shu (Janssen Research and Development (Pennsylvania, Estats Units))
Wang, Yuhua (Janssen Research and Development (Pennsylvania, Estats Units))
Shen, Yaung-Kaung (Janssen Research and Development (Pennsylvania, Estats Units))
Doyle, Mittie K. (Alexion Pharmaceuticals Inc (Massachusetts, Estats Units))
Mendelsohn, Alan M. (Janssen Research and Development (Pennsylvania, Estats Units))
Gottlieb, Alice B. (Tufts Medical Center (Massachusetts, Estats Units))
Universitat Autònoma de Barcelona. Departament de Medicina

Data:	2014
Resum:	Objective Assess ustekinumab efficacy (week 24/week 52) and safety (week 16/week 24/week 60) in patients with active psoriatic arthritis (PsA) despite treatment with conventional and/or biological anti-tumour necrosis factor (TNF) agents. Methods: In this phase 3, multicentre, placebocontrolled trial, 312 adults with active PsA were randomised (stratified by site, weight (≤100 kg/ >100 kg), methotrexate use) to ustekinumab 45 mg or 90 mg at week 0, week 4, q12 weeks or placebo at week 0, week 4, week 16 and crossover to ustekinumab 45 mg at week 24, week 28 and week 40. At week 16, patients with <5% improvement in tender/swollen joint counts entered blinded early escape (placebo→45 mg, 45 mg→90 mg, 90 mg→90 mg). The primary endpoint was ≥20% improvement in American College of Rheumatology (ACR20) criteria at week 24. Secondary endpoints included week 24 Health Assessment Questionnaire-Disability Index (HAQ-DI) improvement, ACR50, ACR70 and ≥75% improvement in Psoriasis Area and Severity Index (PASI75). Efficacy was assessed in all patients, anti-TNF-naïve (n=132) patients and anti- TNF-experienced (n=180) patients. Results: More ustekinumab-treated (43. 8% combined) than placebo-treated (20. 2%) patients achieved ACR20 at week 24 (p<0. 001). Significant treatment differences were observed for week 24 HAQ-DI improvement (p<0. 001), ACR50 (p≤0. 05) and PASI75 (p<0. 001); all benefits were sustained through week 52. Among patients previously treated with ≥1 TNF inhibitor, sustained ustekinumab efficacy was also observed (week 24 combined vs placebo: ACR20 35. 6% vs 14. 5%, PASI75 47. 1% vs 2. 0%, median HAQ-DI change -0. 13 vs 0. 0; week 52 ustekinumab-treated: ACR20 38. 9%, PASI75 43. 4%, median HAQ-DI change -0. 13). No unexpected adverse events were observed through week 60. Conclusions: The interleukin-12/23 inhibitor ustekinumab (45/90 mg q12 weeks) yielded significant and sustained improvements in PsA signs/symptoms in a diverse population of patients with active PsA, including anti-TNF-experienced PsA patients.
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. 990-999, ISSN 1468-2060

DOI: 10.1136/annrheumdis-2013-204655
PMID: 24482301

10 p, 1.3 MB

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