Background/Purpose: To describe characteristics & potential risk factors(including treatment exposure) for all-cause mortality & malignancies (excluding NMSC) in psoriasis (PsO) patients (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 & biologic agents for PsO are followed prospectively. Characteristics & adverse events for pts who reported PsA, including a subset with PsA confirmed by a joint-specialist are summarized. For characteristics & incidence rates, the 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], phototherapy&topical therapy). Exposure to any therapy higher in the order precluded inclusion in the lower cohorts. Multivariate analyses using Cox hazard regression(without attribution bias)were used to identify factors associated with time to first malignancy&mortality[compared to no biologic use]&for IMM [compared to no IMM use].

Results: As of Aug 23, 2015, PSOLAR is fully enrolled with 12090 pts(48870 total pt-yrs [PY] of follow-up). Overall, 4315 pts reported having PsA:1551 UST, 754 IFX, 1650 ADA/ETN, 360 NB;of these, 1719 had confirmed PsA(689 UST, 346 IFX, 566 ADA/ETN,118 NB). Baseline demographics & medical history were generally balanced across cohorts; however, in overall PsA subgroup, more pts in NB cohort were >65yrs of age&had a medical history of cancer. In overall PsA subgroup, cumulative incidence rates/100PY for all-cause mortality: UST0.34, IFX0.37, ADA/ETN0.57, NB0.75; in statistical analysis: age, history of cardiovascular disease, history of diabetes&smoking were associated with increased risk of mortality(P<0.05). Cumulative incidence rates/100PY for malignancy:UST0.57, IFX0.71, ADA/ETN0.60,& NB0.96. Statistical analysis identified the following significant(p<0.05) risk factors for malignancy:severity of PsO, age, smoking,&history of malignancy. For confirmed PsA subset, cumulative incidence rates/100PY for all-cause mortality: UST0.29, IFX0.37, ADA/ETN0.44, NB0.44; age & smoking were associated with increased risk of mortality, Cumulative incidence rates/100PY for malignancy: UST0.53, IFX0.66, ADA/ETN0.96, NB 1.10;age was the only significant factor associated with increased risk of malignancy(p=<0.05). Inherent bias with observational data may apply. Variability in group size & clinical features was noted.Incidence rates are not adjusted for differences in demographics & disease characteristics (adjustment for such key factors are included in statistical analyses). Statistical analyses interpretation may be limited due to number of deaths in subset of confirmed PSA (24).

Conclusion: Unadjusted rates of all-cause mortality & malignancies for biologics were generally comparable among both PsA subsets with the exception of generally numerically higher rates in pts in NB cohort. The common risk factors associated with mortality for the overall & confirmed PsA subsets were age & smoking; age alone was the common risk factor associated with malignancy. Biologics & IMM use were not associated with increased risk of mortality or malignancy.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/updated-results-for-all-cause-mortality-and-malignancies-in-psoriasis-patients-with-psoriatic-arthritis-in-the-psoriasis-longitudinal-assessment-and-registry-study/