Psoriasis Longitudinal Assessment and Registry: Global Update upon Full Enrollment

Bruce Strober¹, Alan Menter², Craig Leonardi³, Lyn Guenther⁴, Kavitha Goyal⁵, Wayne Langholff⁶, Steve Calabro⁵ and Steve Fakharzadeh⁷, ¹University of Connecticut Heatlh Center, Farmington, CT, ²Baylor Research Institute, Dallas, TX, ³Central Dermatology, St. Louis, MO, ⁴The Guenther Dermatology Research Centre, London, ON, Canada, ⁵Janssen Services, LLC, Horsham, PA, ⁶Janssen Research and Development, LLC, Spring House, PA, ⁷Janssen Services, LLC, Spring House, PA

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: psoriasis and psoriatic arthritis

Session Information

Title: Spondyloarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment II

Session Type: Abstract Submissions (ACR)

Background/Purpose To report the baseline demographics and clinical characteristics of participants enrolled in the Psoriasis Longtitudinal Assessment and Registry (PSOLAR) study.

Methods PSOLAR is a multicenter, prospective, longitudinal, observational study initiated by the FDA designed to follow psoriasis patients for 8 years in academic and community settings. Eligible patients are aged ≥18 years, have a diagnosis of psoriasis and are currently receiving or are candidates to receive systemic therapies for psoriasis. Demographics and medical/family history are collected at enrollment, including self-reported diagnosis of psoriatic arthritis. Evaluations at 6 month intervals include: adverse events, disease activity, quality of life, economic status, healthcare utilization and interval therapies.

Results PSOLAR is fully enrolled, with sites in North America, Latin America, and Europe having recruited 12 095 patients as of 23 August 2013. Baseline characteristics at enrollment were as follows: mean age 48.6 years; median age 49.0 years; 13% were≥65 years of age; 54.9% male; 82.9% white; mean body mass index (BMI) 30.9 (SD 7.2); and mean psoriasis duration 17.5 years (SD 13.5 years). Psoriatic arthritis was self-reported in 35.7% of patients and 96.9% of patients had plaque-type psoriasis. Mean and median historical peak psoriasis activity as measured by PGA were 3.11 and 3.0 respectively, and by BSA, 29.7% and 20.0% respectively.

Co-morbidities included cardiovascular disease in 38.3%, pulmonary disorders in 14.4% , psychiatric disorders in 20.7%, and endocrine disorders in 18.8%; 6.2% had a previous skin cancer. Infections requiring treatment in the 3 years preceding enrollment occurred in 24.5% of patients; 21.5% were bacterial. The mean body surface area (BSA) coverage was 12.1% (SD 17.5%) and mean physicians’ global assessment (PGA) score 2 (SD 1.2).

Psoriasis medications (current and historical) included topicals (96.9%), phototherapy (54.5%), systemic steroids (23.4%), systemic agents [e.g. MTX, cyclosporine] (47.9%), and biologic agents (etanercept 40.3%, adalimumab 29.4%, ustekinumab 18.8%, infliximab 16.0%, and efalizumab 11.1%).

Conclusion PSOLAR is fully enrolled with 12 095 patients with an accrual of 31 818 patient- years of followup as of August 23, 2013. Participation is global with the majority of patient representation from North America. Clinical features are as expected for a moderate to severe psoriasis population, including a 35.7% prevalence of self-reported psoriatic arthritis. Serious adverse events and adverse events of interest have been presented for the overall registry and future analyses will provide similar data with respect to various treatment groups represented in PSOLAR.

Disclosure:

B. Strober,