ABSTRACT
BackgroundKidney transplant patients due to both primary kidney involvement of chronic/autoimmune inflammatory diseases and end-stage kidney disease related to amyloidosis are followed up in rheumatology clinics. Biological agents one of the treatment options in kidney transplant recipients with chronic/autoimmune inflammatory disease.ObjectivesHowever, there is insufficient data on the development of infection in kidney transplant recipients who received biological treatment. Herein, we aimed to determine the incidence of serious infections in patients with kidney transplant recipients who are received biological therapy.MethodsKidney transplant recipients who are received biological agents due to rheumatologic disease were included in the study. Patients' demographic features, transplantation data, biological treatment, development of infection and severity of infection were screened retrospectively. Infections that requiring hospitalization were defined as severe infections.ResultsA total of 31 patients were included in the study, 14 (45%) of whom were female and mean age was 41 ±9 years. Twenty-five patients (80%) of them were non-preemptive kidney transplant and mean duration of hemodialysis before the transplantation was 40 ±40 months. Twenty-three patients (74%) had end stage kidney failure due to FMF-amyloidosis(Figure-1-). Seventeen patients (54%) received anakinra, 11 patients (35%) received canakinumab and 3 patients (10%) received etanercept with other immunosuppressive treatment. Mean treatment duration of biological agents was 4.2±2.6 years. Two patients developed solid organ malignancy and one patient developed hematological malignancy after transplantation. Sixteen of the patients (52%) were hospitalized at least once due to infection and 4 patients (13%) died due to infection. The cause of decease in two patients was COVID-19.ConclusionRheumatic diseases are an important cause of end-stage renal disease and definitive treatment is kidney transplantation. Kidney transplant recipients due to rheumatological disease also use biological agents in the post-transplantation period. Kidney transplant recipients have higher risk for the development of infection since they receive immunosuppressive therapy and use of biologic agents may further increase the risk for development infection. Meyer et al reported that infection developed in 54 of 187 solid organ transplant recipients using biological agents.[1] Mean treatment duration of biological agents was 12 months in this study. The incidence of infection was 54% in our study. Mean treatment duration of biological agent was 4.2 year was considered main reason for higher incidence of infection in our study.Reference[1]Meyer F, Weil-Verhoeven D, Prati C, Wendling D, Verhoeven F. Safety of biologic treatments in solid organ transplant recipients: A systematic review. Semin Arthritis Rheum. 2021 Dec;51(6):1263-1273. doi: 10.1016/j.semarthrit.2021.08.013. Epub 2021 Aug 26. Erratum in: Semin Arthritis Rheum. 2022 Aug;55:152015. PMID: 34507811.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
ABSTRACT
Background: Considering the concerns regarding COVID-19 vaccine safety among patients with rheumatic diseases due to a lack of data, an urgent need for studies evaluating safety profiles of vaccines emerged. Objectives: Vaccination against the coronavirus disease-2019 (COVID-19) started in March 2021 in the group using biological therapy in our country. In this study, post-vaccine real-life data of patients with spondyloarthritis (SpA) followed up with biological therapy were analyzed. Methods: Adult patients diagnosed with SpA who were followed up under biological therapy and vaccinated by CoronaVac inactive SARS-CoV-2 orBNT162b2 messenger RNA (mRNA) COVID-19 (Pfzer-BioNTech) vaccine were included in our observational, multicenter, prospective study. Results: A total of 287 patients (58.2% male;mean age: 47) were included in the study. 202 (%70,4) of patients were being followed up with the diagnosis of AS, 40 (%13,9) of them with PsA, 32 (%11,1) of them with nr-axSpA, 11 (%3,8) of them with enteropathic arthritis, and 2 (%0,7) of them with uSpA. The most common comorbidities were found to be HT (n:65;22.6%) and DM (n:38;13.2%). While 221 (77%) of the patients were receiving biological therapy alone, 27 (9.4%) patients were using methotrexate, 25 (8.7%) patients were using sul-fasalazine, and 12 (4.2%) patients were using lefunomide. The median duration of biological therapy was 40 weeks (19-75 IQR). The most commonly used treatment was infiximab (26.8%), adalimumab (23.3%) was the second (Table 1). It was determined that 207 (72.1%) of the patients preferred inactivated virus vaccine, while 80 (27.9%) preferred mRNA vaccine. When the time between the biological treatment and the day of vaccination is examined, detected median time between biological treatment and the frst dose of vaccination is 11.5 days (5-19 IQR), between the frst dose of vaccination and biological treatment is 14 days (7-21 IQR), between treatment and the second dose of vaccine is 14 days (5-23.5 IQR), and between the second dose of vaccine and the next biological treatment is 12.5 days (7-15 IQR). While 25 (8.7%) of the patients had COVID-19 infection before vaccination, 7 (2.4%) patients were found to have COVID-19 after vaccination (p<0.001). While two of the patients who had COVID-19 infection in the pre-vaccination period required hospitalization, none of the patients who had COVID-19 in the post-vaccination period required hospitalization. The rate of patients who developed side effects after the frst dose of the vaccine was 20.6%. The side effects seen, respectively, were detected as pain-redness at the injection site (16%), fatigue (11.8%), headache (8.4%), muscle-joint pain (7.3%) and fever (5.6%). The rate of patients reporting side effects after the second dose of the vaccine was 17.1%. The incidence of side effects after mRNA vaccine was found to be statistically signifcant compared to inactivated virus vaccine in terms of both doses (p=0.011, p<0.001). Major side effects such as myocarditis, ana-phylaxis-angioedema, myocardial infarction, and thrombosis were not observed in any of the patients included in the study. There was no evidence of disease activation in the median follow-up of 209 days (145-280 IQR) after vaccination. Conclusion: During the follow-up of the patients during the study, no major vaccine-related side effects, post-vaccine disease activation and the need for treatment change were not detected. In order to more accurately evaluate the efficacy of the vaccination program in the patient population using biologic agents, larger-scale studies including unvaccinated individuals are needed.