Date: Monday, November 9, 2015
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose: Describe characteristics and incidence rates of all-cause mortality and malignancies (excluding NMSC) in psoriasis pts with psoriatic arthritis (PsA) from PSOLAR.
Methods: PSOLAR is an international, disease-based, observational study in which pts eligible for, or receiving conventional systemic and biologic agents for psoriasis are followed prospectively. Characteristics and safety for pts who reported PsA, including a narrower subset with PsA confirmed by a joint-specialist,are summarized. Cohorts were defined as and attribution was based on treatment exposure prior to/during registry, in the following order (regardless of sequence and duration): (1)ustekinumab(UST) (2)other sponsor biologic(primarily infliximab[IFX]) (3)non-sponsor biologic(primarily adalimumab/etanercept [ADA/ETN]), and (4)non-biologic therapies(NB) (including immunomodulators [eg.MTX, CsA], phototherapy, and 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 and mortality [compared to no biologic use] and for immunomodulators [compared to no immunomodulator use].
Results: As of Aug 23, 2014,PSOLAR is fully enrolled with 12093 pts (40388 total pt-years [PY] of follow-up). Number of pts with reported PsA overall was 4316: 1489 UST, 776 IFX, 1680 ADA/ETN, 371 NB; of these pts, 1719 had confirmed PsA (664 UST, 356 IFX, 576 ADA/ETN, 123 NB). Baseline demographics and medical history were generally balanced across cohorts; however, in overall PsA sub-group, more pts in the NB cohort were >=65yrs of age (UST 9.9%, IFX 13.9%, ADA/ETN 12.5%, NB 25.6%) and 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 per 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 and smoking were predictors of time to mortality. Cumulative incidence rates per 100PY for malignancy were UST 0.57, IFX 0.67, ADA/ETN 0.64, and NB 1.01; age and history of malignancy were predictors of time to first malignancy. Biologic and immunomodulator 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 and 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 and 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 pts in the confirmed PsA subset precluded assessment of risk factors.
Conclusion: Unadjusted rates of all-cause mortality and malignancies for biologics were generally comparable among both PsA subsets. Advanced age, history of malignancy were predictors of time to first malignancy and age, obesity, CVD history, diabetes history and smoking were predictors for time to mortality based on overall PsA subset; biologics and immunomodulators were not predictors for mortality or malignancy.
To cite this abstract in AMA style:Mease PJ, Gottlieb AB, Menter A, Ritchlin CT, Kalia S, Kerdel F, Kafka S, Morgan J, Langholff W, Fakharzadeh S, Goyal K. All-Cause Mortality and Malignancies in Psoriasis Patients with Psoriatic Arthritis in the Psoriasis Longitudinal Assessment and Registry Study [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/all-cause-mortality-and-malignancies-in-psoriasis-patients-with-psoriatic-arthritis-in-the-psoriasis-longitudinal-assessment-and-registry-study/. Accessed May 26, 2018.
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