Khushbu Patel, MD1, Jaime A. Perez, PhD2, Ahmed Nadeem, MD3, Gregory Cooper, MD1, Vu Nguyen, MD1, Preetika Sinh, MD4, Jeffry Katz, MD1, Miguel Regueiro, MD5, Emad Mansoor, MD6 1Case Western Reserve/UHCMC, Cleveland, OH; 2University Hospitals Clinical Research Center, Cleveland, OH; 3Cleveland Clinic, Cleveland, OH; 4Medical College of Wisconsin, Milwaukee, WI; 5Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH; 6Case Western Reserve University / University Hospitals, Cleveland, OH
Introduction: Tofacitinib (TOFA) and Upadacitinib (UPA) are two small-molecule Janus kinase (JAK) inhibitors newly approved by the FDA for induction and maintenance therapy of ulcerative colitis (UC). Both agents are linked to opportunistic infections, mostly notably herpes zoster. Per CDC guidelines, prior to starting immunosuppressive therapy, e.g. TOFA or UPA, patients should be vaccinated with Shingrix. In this study, we analyzed the prevalence of Shingrix administration in patients aged ≥18-50 on TOFA or UPA for UC, and the demographic factors impacting overall vaccination rate.
Methods: We used a large de-identified health research network with data sourced from 80 health care organizations, within the United States (TriNetX). We identified all patients with UC (ICD-10: K51), aged ≥18-50 at diagnosis, on or after January 1, 2018 or 2022 who were on TOFA or UPA (RxNorm:1357536 or 2196092), respectively. Patients were stratified into two groups based on Shingrix vaccination status during treatment course (Shingrix, CPT: 90750, 90471, 90472; RxNorm: 1986821; SNOMED: 459891000124102; ICD-10: Z23). For continuous data, we performed independent t-tests or one-way ANOVA. For categorical data, chi-square tests were utilized. All tests were two-tailed with an alpha level of 0.05.
Results: There were 1,711 patients on TOFA and 357 patients on UPA. The frequency of vaccination with Shingrix for TOFA was 48.7% (N=834) and for UPA was 38.9% (N=139). Mean age at the time of vaccination was comparable between the two agents (TOFA 33.44 ± 9.35, UPA 34.17 ± 8.87). Vaccinated patients on UPA were on average older compared to unvaccinated patients on UPA (34.17 ± 8.87 vs 31.8 ± 9.51). Patients who received Shingrix were predominantly Caucasian (TOFA 78.8%, UPA 83.5%) and male (TOFA 51.3%, UPA 52.5%) for both groups. There were no statistically significant race- or sex-based differences in vaccinated vs un-vaccinated patients for either group of medications. The amount of Shingrix vaccine doses administered was highest at within 1-month prior to initiation of TOFA (N=333) or UPA (N=54).
Discussion: Less than one-half of the patients receiving TOFA or UPA were vaccinated with Shingrix. Patient race and sex may play a role in Shingrix vaccination status. Herpes Zoster is a known preventable adverse event in IBD patients receiving JAK inhibitors. Overcoming the barriers to low vaccination rates will be important.
Figure: Figure 1. Comparison of Shingrix Dose Administration Based on Time Prior to Initiation of TOFA and UPA
Disclosures:
Khushbu Patel indicated no relevant financial relationships.
Jaime Perez indicated no relevant financial relationships.
Ahmed Nadeem indicated no relevant financial relationships.
Gregory Cooper indicated no relevant financial relationships.