Background/Purpose: To describe the rates of serious infections (SI) in psoriasis (PsO) pts with psoriatic arthritis (PsA) from PSOLAR, & assess risk with biologic therapy.

Methods: PSOLAR, an international, disease-based, observational study in which pts eligible for, or receiving conventional systemic & biologic agents for PsO are followed prospectively. Characteristics&cumulative incidence rates of SIs occurring within 91 days of biologic administration, for pts who reported PsA, including a subset with PsA confirmed by a joint-specialist are summarized. Cohorts were defined as & attribution was based on treatment exposure 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 immunodulators(IMMs)[eg MTX, cyclosporine], 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 factors, including treatments, associated with time to first SI(using exposure within 91 days for biologics vs no biologic use]&for IMMs vs no IMM use]),without use of attribution rules.

Results: As of Aug 23, 2015, PSOLAR was fully enrolled with 12090 pts(48870 total pt-yrs [PY] of follow-up).Number of pts with reported PsA was overall 4315: 1551 UST, 754 IFX, 1650 ADA/ETN, 360 NB; of these pts, 1719 had confirmed PsA(689 UST, 346 IFX, 566 ADA/ETN, 118 NB). Baseline demographics & medical history were generally balanced across cohorts & were comparable to confirmed PsA subset; however, in overall PsA sub-group, more pts in NB cohort were >65yrs of age (UST9.9%, IFX14.2%, ADA/ETN12.4% , NB26.4%) & had a medical history of significant infections(UST29%, IFX35.3%, ADA/ETN28.7%, NB21.7%).In the overall PsA subgroup(18 152 PY of follow-up), rates of SIs/100 PY were:UST1.29, IFX3.13, ADA/ETN2.47,&NB2.29. Among the confirmed PsA subset, rates/100 PY: UST 1.27, IFX 2.64, ADA/ETN 2.42, NB 1.95. In the overall PsA subgroup, age, smoking, history of significant infection, diabetes, & use of biologics other than UST(as a combined group) were associated(p<0.05) with increased risk for SI, no increased risk was observed with UST or with IMMs.In pts with confirmed PsA, a history of significant infections&use of biologics other than UST(as a combined group) were significantly associated(p<0.05) with increased infection risk;UST&IMMs were not associated.Inherent bias with respect to observational data may apply. Variability in size&clinical features was noted among treatment groups. Incidence rates are not adjusted for differences. Biologics other than UST were not evaluated individually in statistical analyses.

Conclusion: Unadjusted rates of SIs showed general agreement between the 2 PsA subsets with numerically higher rates for IFX&ADA/ETN. Although some variability was noted in risk factors for 2 PSA groups(overall&confirmed), a history of significant infection & use of biologics other than UST (as a combined group) were found to be associated with increased risk for SIs for both groups. An increased risk was not observed with IMMs in comparison with no IMMs in either PSA group. Similarly, an increased risk was not observed with UST individually or in combination with other biologics in either PsA group.

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