PSOLAR: Design, Utility, and Preliminary Results of a Prospective, International, Disease-Based Registry of Patients With Psoriasis Who are Receiving, or are Candidates for, Conventional Systemic Treatments or Biologic Agents
October 2012 | Volume 11 | Issue 10 | Original Article | 1210 | Copyright © October 2012
Kim A. Papp MD PhD,a Bruce Strober MD PhD,a,b Matthias Augustin MD PhD,c Steve Calabro MS,d Anil Londhe PhD,e Marc Chevrier MD PhD,d on behalf of the PSOLAR investigators and Steering Committee
aProbity Medical Research, Waterloo, Ontario, Canada bUniversity of Connecticut School of Medicine, Farmington, CT cUniversity Clinics of Hamburg, Hamburg, Germany; dJanssen Biotech, Inc., Horsham, PA eJanssen Research & Development, LLC, Horsham, PA
Abstract
Background: Long-term observational studies can better characterize the impact of systemic agents on psoriasis.
Objective: To describe the on-going Psoriasis Longitudinal Assessment and Registry (PSOLAR) study.
Methods: PSOLAR is a large, international, long-term, prospective, disease-based registry enrolling patients with psoriasis who are receiving, or are candidates for, treatment with systemic therapies. The registry fulfills postmarketing regulatory commitments and charges a global Steering Committee to manage epidemiological research on psoriasis and its therapies. Key demographics, disease characteristics, and medication history are collected at enrollment. Adverse events and efficacy data are collected longitudinally.
Results: The August 2011 annual database extract includes 9,495 patients enrolled at 266 global centers. At entry, mean percent of body surface area affected by psoriasis was 12.3% (peak, 29.5%). Approximately 80% of patients were overweight/obese, more than one-third had cardiovascular disease (38.8%) or psoriatic arthritis as captured by the treatment center (37.1%), and over half had received one or two biologic agents (58.8%) or phototherapy (54.8%). Mean duration of participation is 1.3 years, and annual withdrawal rates are less than 6.5%. Of 9,495 patients, 7,476 have been exposed to at least one biologic agent. Serious infections, malignancies, all-cause mortality, and major adverse cardiovascular events (ie, myocardial infarction, stroke, cardiovascular death) occurred at rates of 1.40, 0.61, 0.37, and 0.36 per 100 patient-years of follow-up, respectively.
Limitations: PSOLAR may be subject to limitations common to observational studies (eg, participation bias and potential confounders).
Conclusion: PSOLAR is a disease-based registry designed to assess therapeutic risk and benefit in the general psoriasis population.
J Drugs Dermatol. 2012;11(10):1210-1217.
INTRODUCTION
Over the past ten years, several biologic agents have been marketed following randomized controlled trials
in patients with psoriasis for the indication of plaque psoriasis and/or psoriatic arthritis1,2 for adalimumab,3,4 alefacept,5,6 efalizumab,7,8 etanercept,9,10 infliximab,11,12 and ustekinumab.13-15 With the advent of these newer biologic agents, an even wider array of treatment options in addition to established conventional systemic treatments or phototherapies
are available to dermatologists for patients with psoriasis. The long-term safety of these therapies in plaque psoriasis in actual clinical use has not been fully characterized, prompting the development of several types of patient registries. These registries serve an important role,16 often replicating randomized
controlled trial results in a broader population of interest and may detect less common safety events that were not identified
in clinical studies.
Based on the method of data collection, registry studies include
three important categories (voluntary, retrospective, and prospective). In a voluntary registry, events are reported by health-care providers or patients and entered into regulatory, national, or manufacturer databases. In a retrospective registry,
