Objectives To describe the rates of serious infections (SI) in psoriasis (PsO) 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 & biologic agents for the treatment of PsO are followed prospectively. The characteristics & cumulative incidence rates of SIs 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 & 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 [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 predictors of time to first SI (using exposure within 91 days for biologics [compared to no biologic use] & 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 & medical history were generally balanced across cohorts & 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%)& 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 SIs/100 PY were: UST 1.12, IFX 3.36, ADA/ETN 2.49, and NB 2.20. Among the confirmed PsA subset, rates/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, & use of biologics (other than UST as a combined group) were associated with increased risk for SI; no increased risk was observed with UST & immunomodulators. In patients with confirmed PsA, diabetes, history of significant infection, more severe skin PsO, & use of biologics other than UST (as a combined group) were significantly associated with increased infection risk; UST & immunomodulators 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. Individual biologics beyond UST were not evaluated individually in statistical analyses.
Conclusions Results suggest a higher risk of SIs with biologics (as a combined group), other than UST, in comparison with no biologic usage; increased risk was not observed with UST or immunomodulators.
Disclosure of Interest C. Ritchlin Grant/research support from: Janssen Scientific Affairs, LLC, A. Gottlieb Grant/research support from: Janssen Scientific Affairs, LLC, A. Menter Grant/research support from: Janssen Scientific Affairs, LLC, P. Mease Grant/research support from: Janssen Scientific Affairs, LLC, S. Kalia Grant/research support from: Janssen Scientific Affairs, LLC, F. Kerdel Grant/research support from: Janssen Scientific Affairs, LLC, S. Kafka Employee of: Janssen Scientific Affairs, LLC, J. Morgan Employee of: Janssen Scientific Affairs, LLC, W. Langholff Employee of: Janssen Scientific Affairs, LLC, S. Fakharzadeh Employee of: Janssen Scientific Affairs, LLC, K. Goyal Employee of: Janssen Scientific Affairs, LLC