Significant Improvements in Psoriatic Arthritis With Ustekinumab: Research

by Rukmani Krishna on  June 15, 2013 at 9:32 PM General Health News   - G J E 4
New PSUMMIT 2* data further demonstrate the efficacy of ustekinumab in Psoriatic Arthritis (PsA). The data was first presented at EULAR 2013, the Annual Congress of the European League Against Rheumatism.
 Significant Improvements in Psoriatic Arthritis With Ustekinumab: Research
Significant Improvements in Psoriatic Arthritis With Ustekinumab: Research

Anti-TNF naÔve and anti-TNF-experienced patients randomised to one of two ustekinumab doses (45mg or 90mg) demonstrated significant and sustained improvements in the signs and symptoms of PsA, with favourable safety profiles.

PsA is a chronic inflammatory arthritis associated with psoriasis which significantly impacts health-related quality of life and function in patients, and increases risk of co-morbid cardiovascular and gastrointestinal diseases.2 Prevalence of psoriasis varies from 0.3% to 3% of the population, with PsA occurring in 25% of cases.3

Lead author of the study Dr Christopher Ritchlin, University of Rochester Medical Centre, Rochester, US, commented "While the development of anti-TNF treatments has drastically improved the treatment of PsA, there are still substantial numbers of patients who fail to respond to therapy. That ustekinumab demonstrates improvements not just in anti-TNF-naÔve patients, but in those who have been treated with one or more drugs, shows that it has the potential to fulfil a significant unmet patient need."

312 adults with active PsA were randomised to ustekinumab 45mg or 90mg (week 0, week 4 and every 12 weeks subsequent to Week 40) or placebo (week 0, week 4 and week 16) followed by crossover to ustekinumab 45mg (week 24, week 28 and week 40). The primary endpoint was ACR20Ü at week 24; secondary endpoints were HAQ-DI, ACR50, ACR70 and >75% improvement in the Psoriasis Area and Severity Index (PAS175).á

Anti-TNF-experienced patients in PSUMMIT 2 had more active disease at baseline than anti-TNF naÔve. At week 24, more patients treated with ustekinumab than placebo had achieved ACR20 (combined 43.8%; 45mg 43.7%; 90mg 43.8%; placebo 20.2% - all p>0.001). Efficacy was sustained at week 52, with patients on 45mg, 90mg and placebo-ustekinumab reaching ACR20 (46.8%, 48.4% and 55.8% respectively).

Efficacy demonstrated was more robust in anti-TNF-naÔve (ACR 20 59-73%) than anti-TNF-experienced (37-41%) patients, and patients who had previously received one (50-55%) vs. two (13-39%) or three or more (13-30%) agents.

Ustekinumab was well tolerated with no deaths or TB and similar rates of adverse events (45mg 78.6%; 90mg 77.9%), serious adverse events (45mg 5.8%, 90mg 5.8%) and adverse events leading to discontinuation (45mg 5.8%, 90mg 3.8%) reported through to week 60.

Source: Eurekalert

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