Malignancies in the Psoriasis Longitudinal Assessment and Registry Study: Cumulative Experience

David Fiorentino¹, Mark Lebwohl², Vincent Ho³, Richard Langley⁴, Kavitha Goyal⁵, Steve Fakharzadeh⁶, Steve Calabro⁵ and Wayne Langholff⁷, ¹Department of Dermatology, Stanford University School of Medicine, Redwood City, CA, ²Mount Sinai Medical Center, New York, NY, ³University of British Columbia, Vancouver, BC, Canada, ⁴Dalhousie University, Halifax, NS, Canada, ⁵Janssen Services, LLC, Horsham, PA, ⁶Janssen Services, LLC, Spring House, PA, ⁷Janssen Research and Development, LLC, Spring House, PA

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Malignancy, 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 cumulative incidence of malignancies excluding non-melanoma skin cancers (NMSC) in the 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. The incidence of malignancies excluding NMSC (ie, basal/squamous cell carcinomas) in PSOLAR overall and by treatment groups is reported. Rates of malignancy are assessed using a definition of exposure based on whether patients had ever been exposed to a given therapy at any time prior to the event. In cases of exposure to >1 therapy, the rule for attribution of malignancy 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 and as of the August 23, 2013 data cut has 31, 818 cumulative patient-years of follow up with 12, 095 patients; 36% of those patients had self-reported psoriatic arthritis. Unadjusted cumulative rates of malignancy (excluding NMSC) overall and across treatment groups: overall 0.68 events per 100 patient years of observation (PYO) [95% CI: 0.59, 0.77; 215/31818], ustekinumab 0.51 per 100 PYO [95% CI: 0.37, 0.68; 45/8870 PYO], infliximab/golimumab (almost exclusively infliximab) 0.64 per 100 PYO [95% CI: 0.42, 0.93; 27/4205, other biologics (almost exclusively etanercept/adalimumab) 0.74 per 100 PYO [95% CI: 0.60, 0.91; 98/13167], and non-biologic therapy 0.81 per 100 PYO [95% CI: 0.59, 1.08; 45/5576]. The cumulative rates per 100 PY for the overall registry population for the most frequent specific malignancies were: breast cancer 0.13 [40], prostate cancer 0.09 [30], lung cancer 0.08 [26], and melanoma 0.07 [22]. Limitations: Rates have not been adjusted for demographic and clinical differences among treatment groups and are subject to attribution rules.

Conclusion In the current evaluation, reflecting a median duration of 2.5 years of follow-up, cumulative unadjusted rates of malignancies in PSOLAR are comparable across treatment groups. The most frequently reported malignancies in the registry are comparable with the most frequently reported malignancies in the general population. Additional evaluation of malignancies with accruing longitudinal exposure will be informative.

Disclosure:

D. Fiorentino,