Objectives To describe characteristics&incidence rates of all-cause mortality & malignancies (excluding NMSC) in PsO patients with PsA from PSOLAR.

Methods PSOLAR,an international, disease-based, observational study in which patients eligible for, or receiving conventional systemic & biologic agents for PsO are followed prospectively.Characteristics & safety for patients who reported PsA, including a narrower subset with PsA confirmed by a joint-specialist,are summarized. Cohorts were defined as & attribution was based on treatment exposure prior to/during registry, in the following order (regardless of sequence & duration): (1) ustekinumab (UST) (2) other sponsor biologic (primarily infliximab [IFX]) (3) non-sponsor biologic (primarily adalimumab/etanercept [ADA/ETN]),& (4) non-biologic therapies (NB) (including immunomodulators {IMM} [eg. MTX, CsA], phototherapy, & topical therapy). Exposure to any therapy higher in the order precluded inclusion in the lower cohorts. Multivariate analyses using Cox hazard regression were used to identify predictors of time to first malignancy & mortality [compared to no biologic use] & for IMM [compared to no IMM use].

Results As of Aug 23, 2014, PSOLAR is fully enrolled with 12093 patients (40388 total patient-years [PY] of follow-up).Number of patients with reported PsA overall was 4316: 1489 UST, 776 IFX, 1680 ADA/ETN, 371 NB; of these patients, 1719 had confirmed PsA (664 UST, 356 IFX, 576 ADA/ETN, 123 NB). Baseline demographics & medical history were generally balanced across cohorts; however, in overall PsA sub-group, more patients in the NB cohort were ≥65 yrs of age (UST 9.9%, IFX 13.9%, ADA/ETN 12.5%, NB 25.6%) & had a medical history of cancer (UST 3.3%, IFX 3.5%, ADA/ETN 3.9%, NB 8.4%). In the overall PsA subgroup, cumulative incidence rates/100PY for all-cause mortality were UST 0.28, IFX 0.30, ADA/ETN 0.52, NB 0.70; age, obesity, history of cardiovascular disease (CVD), history of diabetes& smoking were predictors of time to mortality. Cumulative incidence rates/100PY for malignancy were UST 0.57, IFX 0.67, ADA/ETN 0.64, & NB 1.01; age & history of malignancy were predictors of time to first malignancy. Biologic & IMM use were not predictors for mortality or malignancy. Among the confirmed PsA subset, cumulative incidence rates per 100PY for all-cause mortality UST 0.21, IFX 0.36, ADA/ETN 0.38, NB 0.25 & for malignancy UST 0.52, IFX 0.54, ADA/ETN 1.02, NB 1.25. Inherent bias with observational data may apply. Variability in size & clinical features was noted among groups. Incidence rates are not adjusted for differences (adjustment for key factors are included in statistical analyses). Small numbers of patients in the confirmed PsA subset precluded assessment of risk factors.

Conclusions Unadjusted rates of all-cause mortality&malignancies for biologics were generally comparable among both PsA subsets. Advanced age, history of malignancy were predictors of time to first malignancy & age, obesity, CVD history, diabetes history & smoking were predictors for time to mortality based on overall PsA subset; biologics & IMM were not predictors for mortality or malignancy.

Disclosure of Interest None declared