Background/Purpose: To describe the rates of serious infections in psoriasis patients with psoriatic arthritis(PsA) from PSOLAR.

Methods: PSOLAR is an international, disease-based, observational study in which patients eligible for, or receiving conventional systemic and biologic agents for the treatment of psoriasis are followed prospectively. The characteristics and cumulative incidence rates of serious infections, occurring within 91 days of biologic administration, for patients who reported PsA,including a subset with PsA confirmed by a joint-specialist are summarized. Cohorts were defined as and attribution was based on treatment exposure 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 immunodulators [eg MTX, cyclosporine], 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 serious infection (using exposure within 91 days for biologics [compared to no biologic use] and for immunomodulators [compared to no immunomodulator use]).

Results: As of Aug 23, 2014, PSOLAR was fully enrolled with 12093 patients (40388 total patient-years [PY] of follow-up).Number of patients with reported PsA was overall 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 and medical history were generally balanced across cohorts and were comparable to confirmed PsA subset; however, in overall PsA sub-group, more patients in 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 (15 029 PY of follow-up), rates of serious infections per 100 PY were:  UST 1.12, IFX 3.36, ADA/ETN 2.49, and NB 2.20. Among the confirmed PsA subset, rates per 100 PY were: UST 1.06, IFX 2.83, ADA/ETN 2.58, NB 1.63. In the overall PsA sub-group, increasing age, male gender, current/prior smoking, history of significant infection, diabetes, and use of biologics (other than UST as a combined group) were associated with increased risk for serious infection; no increased risk was observed with UST and immunomodulators. In patients with confirmed PsA, diabetes, history of significant infection, more severe skin psoriasis, and use of biologics other than UST (as a combined group) were significantly associated with increased infection risk; UST and immunomodulators were not associated. Inherent bias with respect to observational data may apply. Variability in size and clinical features was noted among treatment groups.Incidence rates are not adjusted for differences. Individual biologics beyond UST were not evaluated individually in statistical analyses. 

Conclusion: Results suggest a higher risk of serious infections with biologics (as a combined group), other than UST, in comparison with no biologic usage; increased risk was not observed with UST or immunomodulators.

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