P626 Prevalence of inflammatory bowel disease amongst patients with psoriasis and incidence of serious infections in this subset: results from the PSOLAR Registry
E. Loftus, Jr1, M. Augustin2, R. Bissonnette3, G. Krueger4, S. Calabro5, W. Langholff6, J. Popp7, K. Goyal5, S. Sloan*8
1Mayo Clinic Rochester, Department of Gastroenterology, Rochester, Minnesota, United States, 2University Clinics of Hamburg, Hamburg, Germany, 3Innovaderm Research, Inc, Montreal, Canada, 4University of Utah, Salt Lake City, Utah, United States, 5Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, United States, 6Janssen R & D, LLC, Horsham, Pennsylvania, United States, 7Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, United States, 8Janssen Global Services, Horsham, Pennsylvania, United States
The aim of the study was to assess the prevalence of inflammatory bowel disease (IBD) in the PSOLAR registry and to summarise serious infection (SI) rates in pts treated for psoriasis (PsO) with ustekinumab (UST), and other therapies (biologic and non-biologic) in this IBD subset.
PSOLAR is an, international, longitudinal, disease-based registry for adult pts with PSO, who are eligible to receive systemic therapy based on standards of clinical practice. A subset of PSO pts with a medical history of IBD per pt report at enrolment (including Crohn’s disease [CD], ulcerative colitis [UC], and indeterminate colitis [IC]) were identified. Pts reporting IBD could then choose one or more of the following: CD, UC, IC, or select none of them. Serious adverse events per investigator report within the MedDRA Infections SOC, are collected during registry follow-up. Treatment cohorts within this subset include UST, other sponsor biologics primarily (infliximab [IFX]), non-sponsor biologics (eg, adalimumab or etanercept), and non-biologics (eg, MTX, cyclosporine, phototherapy, and topical therapy). Demographics and clinical characteristics are summarised. Cumulative incidence rates of SI based on biologic exposure within 91 days are reported across treatment cohorts, for both IBD subset and the total PSOLAR population.
As of August 23, 2014, PSOLAR was fully enrolled with 12 093 pts (40 388 total pt-years of follow-up). The number of pts with IBD overall is listed in Table 1, with a prevalence of 2.3%, as well as in each cohort; the prevalence was numerically highest in the IFX cohort (5.1%). Demographic and baseline characteristics across biologic cohorts were generally comparable; however, the non-biologic cohort was older, had fewer women, and lower weight than other cohorts. Cumulative incidence rates of SI per 100 PY (35 total events) within 91 days of biologic administration are listed in Table 1. Limitations include lack of confirmed IBD diagnoses; various forms of bias, including treatment selection bias; lack of adjusted comparisons amongst cohorts; and small size of groups and number of events.
The overall prevalence of IBD in PsO pts in PSOLAR is 2.3%. Reflecting a median of 3.4 years of follow-up in this subset, cumulative incidence rates of SI for pts with IBD were higher compared with the total PSOLAR population, in general and for treatment cohorts. Additionally, patients treated with UST had numerically lower rates of SI compared with pts receiving other biologic and systemic therapies for PsO in IBD subset as well as overall.
Table 1 PSOLAR IBD