Presenting Author:

Regine Mathieu, B.S.

Principal Investigator:

Dennis West, Ph.D.

Department:

Dermatology

Keywords:

psoriasis, ustekinumab, infection, pharmacovigilance

Location:

Ryan Family Atrium, Robert H. Lurie Medical Research Center

C28 - Clinical

Rate of infection for ustekinumab versus standard oral systemic agents

Introduction Infections occurring in patients with psoriasis while exposed to ustekinumab, a biologic agent targeting interleukin 12 (IL-12) and interleukin 23 (IL-23), have not previously been compared to the standard non-biologic agents, acitretin (A), cyclosporine (C) and methotrexate (M). The aim of this study is to determine the rate of all infection occurring in ustekinumab-exposed patients compared to A, C or M-exposed patients in a large academic center. Methods We searched a large, urban, single-center medical record data repository to detect all patients (ages 18-89 years) with a diagnosis of psoriasis (ICD 9 code 696.1) who had any infection (bacterial, fungal or viral) (ICD 9 codes 001-139), or no infection, while exposed to ustekinumab or A, C, or M (January 2015–September 2016). Results 818 patients met criteria for analysis in this study as follows: 11 (3.9%) of 305 patients exposed to ustekinumab were diagnosed with one or more infections: 8 infections were viral (V), 3 were fungal (F) and none were bacterial (B). In comparison, one or more infections were diagnosed in those exposed to: acitretin (N=5 (6.5%) of 77 patients; 3 V, 0 F, 2 B), cyclosporine (N=12 (17.6%) of 68 patients; 9 V, 2 F, 0 B), or methotrexate (N=29 (7.9%) of 368 patients; 16 V, 4 F, 9 B). In this study population, the rate of all infection for ustekinumab-exposed patients was significantly lower when compared to cyclosporine (p=0.001). Conclusion Analyses of data from this large patient population indicate that ustekinumab has a significantly lower rate of all infection compared to cyclosporine and no significantly different rate compared to acitretin or methotrexate. Findings from this population serve to inform that targeting IL-12/23 by ustekinumab exposure poses no undue risk for infection compared to standard oral pharmacotherapeutic agents used in the management of psoriasis.