Serious Infection Events in the Psoriasis Longitudinal Assessment and Registry Study: Cumulative Experience

Robert Kalb¹, David Fiorentino², Mark Lebwohl³, Craig Leonardi⁴, John Toole⁵, Kavitha Goyal⁶, Steve Calabro⁶, Wayne Langholff⁷ and Steve Fakharzadeh⁸, ¹SUNY at Buffalo, School of Medicine and Biological Sciences, Buffalo, NY, ²Dermatology, Stanford University, Redwood City, CA, ³Mount Sinai Medical Center, New York, NY, ⁴Central Dermatology, St. Louis, MO, ⁵University of Manitoba, Dermadvances Research, Winnipeg, MB, Canada, ⁶Janssen Services, LLC, Horsham, PA, ⁷Janssen Research and Development, LLC, Spring House, PA, ⁸Janssen Services, LLC, Spring House, PA

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: psoriasis and psoriatic arthritis

Session Information

Title: Spondyloarthropathies and Psoriatic Arthritis III - Clinical Aspects Psoriatic Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose To report the cumulative rates of serious infections in the Psoriasis Longitudinal Assessment and Registry (PSOLAR) study.

Methods PSOLAR is a multicenter, longitudinal, observational study evaluating long-term safety and clinical outcomes for patients eligible to receive treatment with biologics and/or conventional systemic agents for psoriasis (includes patients with self-reported psoriatic arthritis. Serious infections are defined as serious events (e.g. requiring hospitalization) classified into the MedDRA system organ class of Infections and infestations. The rates of serious infections in PSOLAR overall and by treatment groups are reported through the most recent data cut-off date (Aug 23, 2013) using exposure within 91 days preceding the event. In cases of exposure to >1 therapy, the rule for attribution of serious infections to a treatment group is ustekinumab first, infliximab/golimumab second, other biologics third (nearly all adalimumab or etanercept), or non-biologic therapy fourth, which is consistent with the pre-specified analytic plan.

Results PSOLAR is fully enrolled with 12 095 patients reflecting 31 818 cumulative patient-years of follow up. 36% of the 12 095 patients had a self-reported diagnosis of psoriatic arthritis. The median duration of follow-up is 2.5 years. Unadjusted rates of serious infection, based on exposure within 91 days preceding the event were: ustekinumab 0.95 events per 100 patient years of observation (PY)[95% CI: 0.71, 1.24; 52/5497 PY, infliximab 2.77 per 100PY[ 95% CI: 2.15, 3.51; 68/2457 PY], etanercept 1.67 events per 100 PY [95% CI: 1.32, 2.09; 78/4666 PY], adalimumab 1.88 per PY [95% CI: 1.54, 2.27; 106/5645 PY], non-biologics 1.26 per 100 PY[95% CI: 1.08, 1.46; 169/13421 PY], and overall 1.50[95% CI: 1.37, 1.64; 478/31817]. Limitations: Rates have not been adjusted for demographic and clinical differences among treatment groups and are subject to attribution rules.

Conclusion With nearly 32 000 patient years of follow-up, the overall rate of unadjusted cumulative rate of serious infections in the PSOLAR registry population is 1.50 per 100 PY. The rates of serious infection for ustekinumab and the no biologic treatment groups are lower than rates for infliximab, adalimumab and etanercept. Future analyses may characterize infections further and adjust for differences among treatment groups.

Disclosure:

R. Kalb,