Regine Mathieu, B.S.
Dennis West, Ph.D.
Dermatology
psoriasis, ustekinumab, infection, pharmacovigilance
Ryan Family Atrium, Robert H. Lurie Medical Research Center
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.