Safety and effectiveness of SARS-CoV-2 vaccination in patients with autoimmune liver diseases-a multi-center, questionnairesbased study

ABSTRACT

Purpose: The efficacy and safety of SARS-CoV-2 vaccination have been confirmed in several clinical trials. However, patients with autoimmune liver disease were not subject to clinical trials, and data on the efficacy and safety of vaccines have been not available in these population. Therefore, we retrospectively investigated the safety and effectiveness of SARS-CoV-2 vaccination by questionnaire survey targeting Japanese patients with autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC). Method(s) This is a multi-center, retrospective, cross-sectional, questionnaires-based study. Patients with AIH and PBC who are outpatients at participating facilities, 18 years of age or older, and have given consent to participate in this study are included. We distributed questionnaires asking about sex, date of birth, number and type of vaccinations, the presence and degree of adverse effects (AEs), and the presence or absence of SARS-CoV-2 infection before and after vaccination, and asked them to fill in the questionnaire. In addition, we collected the result of liver tests before and after vaccinations of participating patients from each facility. Result(s) The survey was conducted from September 2021 to May 2022. A total of 471 questionnaires were collected from 220 AIH patients (male/female = 33/187, average age 63.5 +/- 13.1 years old) and 251 PBC patients (38/213, 65.8 +/- 10.1). The number of vaccinations was 0/1/2/unknown = 4/0/210/6 for AIH and 4/2/244/1 for PBC. The median time from the second dose to the completion of the questionnaire was 156 days for AIH and 148 days for PBC. By vaccine type, 193 Pfizer, 11 Moderna, and 16 unknown in AIH, and 223/12/16 in PBC. As for AEs, pain and swelling at the injection site were the most common in both AIH and PBC (75% in the first and 64% in the second in AIH, 64%/61% in PBC), followed by general malaise (19%/21% in AIH, 19%/31% in PBC), and myalgia (16%/ 19% in AIH, 19%/14% in PBC). Fever above 38.5 degreeC was observed in 11%/11% of AIH and 11%/24% of PBC, indicating that more patients with PBC experiencing fever that AIH. Only 1 case of PBC had an anaphylactic reaction. By comparing liver tests before and after vaccinations, 4 (1.8%) and 16 (6.4%) patients with AIH and PBC, respectively, demonstrated elevation to 1.5 times the pre-vaccination value and exceeding the upper normal limit. No patients experienced severe deterioration of liver function. SARS-CoV-2 infection was reported in 4 cases (1.8%) in AIH and 3 cases (1.3%) in PBC. Conclusion(s) The safety and effectiveness of SARS-CoV-2 vaccination is comparable to those in the general population.