Significant improvements in psoriatic arthritis with ustekinumab

(Press-News.org) Madrid, Spain, 12 June 2013: New PSUMMIT 2* data first presented at EULAR 2013, the Annual Congress of the European League Against Rheumatism, further demonstrate the efficacy of ustekinumab in Psoriatic Arthritis (PsA).

Anti-TNF naïve 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-naïve 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 ACR20† at week 24; secondary endpoints were HAQ-DI, ACR50, ACR70 and >75% improvement in the Psoriasis Area and Severity Index (PAS175).‡

Anti-TNF-experienced patients in PSUMMIT 2 had more active disease at baseline than anti-TNF naïve. 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-naïve (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.

### * PSUMMIT II, Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled trial of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis Including Those Previously Treated with Biologic Anti-TNF-alpha Agent(s) † ACR (American College of Rheumatology) criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate), patient assessment, physician assessment, pain scale and disability/functional questionnaire. ACR20 refers to a 20% improvement in tender/swollen joint counts, as well as in three of the five criteria. ACR50 and ACR70 refer to 50% or 70% improvement respectively ‡HAQ-DI, Health Assessment Questionnaire for Rheumatoid Arthritis. PASI, Psoriasis Area Severity Index; index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area

1. Ritchlin C et al., Maintainence of efficacy and safety of ustekinumab in patients with active psoriatic arthritis despite prior conventional nonbiologic and anti-TNF biologic therapy: 1 yr results of the PSUMMIT 2 trial [abstract]. EULAR Annual European Congress of Rheumatology; 12-15 June 2013; Madrid, Spain. Abstract nr. OP0001 2. Gladman DD. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005; 64:ii14-ii17 3. Zachariae H. Prevalence of joint disease in patients with psoriasis: implications for therapy. Am J Clin Dermatol. 2003;4:441=7

NOTES TO EDITORS:

For further information on this study, or to request an interview with the study lead, please do not hesitate to contact the EULAR congress Press Office in room A10:14 of the Congress Centre during EULAR 2013 or on: Email: eularpressoffice@cohnwolfe.com EULAR Press Office Onsite tel: +44 (0) 20 7331 5364 / 5380 / 5318 / 2305

About EULAR

The European League Against Rheumatism (EULAR) is an umbrella organisation which represents scientific societies, health professional associations and organisations of people with rheumatic diseases throughout Europe In line with the European Union of Medical Specialists (UEMS), EULAR defines rheumatology as including rheumatic diseases of the connective tissue, locomotor and musculoskeletal systems. EULAR aims to promote, stimulate and support the research, prevention, treatment and rehabilitation of rheumatic diseases With 45 scientific member societies, 36 People with Arthritis and Rheumatism in Europe (PARE) organisations and 11 health professionals associations, EULAR underscores the importance of combating rheumatic diseases not only through medical means, but also through patient care EULAR 2013 is set to be the biggest rheumatology event in Europe with over 14,000 scientists, physicians, allied health professionals and related audiences in attendance from more than 110 countries. Over the course of the congress there will be more than 320 oral and 1,800 poster abstract presentations, and 750 lectures with 330 invited speakers To find out more about the activities of EULAR, visit: http://www.eular.org