Efficacy and safety of ustekinumab in psoriatic arthritis patients with peripheral arthritis and physician-reported spondylitis: post-hoc analyses from two phase III, multicentre, double-blind, placebo-controlled studies (PSUMMIT-1/PSUMMIT-2)
- 20 April 2016
- journal article
- research article
- Published by BMJ in Annals Of The Rheumatic Diseases
- Vol. 75 (11), 1984-1988
- https://doi.org/10.1136/annrheumdis-2015-209068
Abstract
Objective To evaluate ustekinumab efficacy and safety in psoriatic arthritis (PsA) patients with peripheral arthritis and physician-reported spondylitis (termed the ‘spondylitis subset’). Methods Adults with active PsA (PSUMMIT-1/PSUMMIT-2, n=615/312) were randomised to ustekinumab 45 mg, 90 mg or placebo at week 0/week 4/q12 week. At week 16, patients with Results 256/927 (27.6%) PSUMMIT-1/PSUMMIT-2 patients (placebo/ustekinumab, n=92/164) comprised the evaluable spondylitis subset. At week 24, in this analysis subset, significantly more patients achieved BASDAI20/50/70 responses (54.8%/29.3%/15.3% vs 32.9%/11.4%/0%; p≤0.002), improvement in BASDAI question 2 concerning axial pain (1.85 vs 0.24; pConclusions In this post-hoc analysis of PsA patients with baseline peripheral arthritis and physician-reported spondylitis, ustekinumab-treated patients demonstrated significant improvements in axial signs and symptoms through week 24. Trial registration number PSUMMIT-1 (NCT01009086, EudraCT 2009-012264-14) and PSUMMIT-2 (NCT01077362, EudraCT 2009-012265-60); post-study results.This publication has 19 references indexed in Scilit:
- Does Concomitant Methotrexate with Adalimumab Influence Treatment Outcomes in Patients with Psoriatic Arthritis? Data from a Large Observational StudyThe Journal of Rheumatology, 2015
- Updated Guidelines for the Management of Axial Disease in Psoriatic ArthritisThe Journal of Rheumatology, 2014
- Psoriatic arthritis: current therapy and future approachesRheumatology, 2014
- 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 trialsAnnals Of The Rheumatic Diseases, 2014
- 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, placebo-controlled, randomised PSUMMIT 2 trialAnnals Of The Rheumatic Diseases, 2014
- Prevalence of psoriatic arthritis in psoriasis patients according to newer classification criteriaClinical Rheumatology, 2013
- 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
- Is ASDAS better than BASDAI as a measure of disease activity in axial psoriatic arthritis?Annals Of The Rheumatic Diseases, 2010
- Development of an ASAS-endorsed disease activity score (ASDAS) in patients with ankylosing spondylitisAnnals Of The Rheumatic Diseases, 2008
- The prevalence of sacroiliitis in psoriatic arthritis: new perspectives from a large, multicenter cohortSkeletal Radiology, 1999