An increased risk of developing severe infections has been evidenced in rheumatic disease (RD) patients, and anti-COVID-19 vaccination is strictly recommended for RD patients. However, up to now, no data are available on safety, immunogenicity and efficacy of COVID-19 vaccinations in RD patients. The possible development of adverse events (AEs), including the flare-up of underlying RD, represents a matter of growing importance. The aim of our study is to assess, in RD patients, the safety profile of different types of approved vaccines and the possible influence of immunosuppressive therapies and clinical or demographic characteristics of RD patients on development of AEs. Participants (n = 185; 30.7%) received anti-COVID-19 vaccinations, 137 with autoimmune/chronic inflammatory RD (Au/cIn-RD) and 48 with nonautoimmune/chronic inflammatory RD (no-Au/cIn-RD). AEs were recorded in 42% of patients after the first dose of vaccine, and in 26% of patients after the second dose. The most common reported AEs after anti-COVID 19 vaccines were site injection pain (17%), headache (12%), fever (12%), myalgia (10%) and fatigue (10%). Relapses of the underlying Au/c-In-RD were recorded in 2.2% of patients after the first dose of vaccine. In Au/c-In-RD the risk of developing AEs after the first dose of vaccine was lower in older patients (OR = 0.95; p = 0.001), and in the group of patients with complete control of RD (OR: 0.2; p = 0.010). A lower percentage of AEs was observed in patients with complete control of their Au/cIn-RD (29%) compared to those with low (57%) or moderate-high disease activity (63%) (p = 0.002 and p = 0.006 respectively). In this study all types of COVID-19 vaccines in use in Italy seemed safe in RD patients. The results of this study might provide reassuring information for Au/cIn RD patients and clinicians and could strengthen the data on vaccine safety to guide the use of COVID-19 vaccines in Au/cIn-RD on immunosuppressive agents.
BackgroundCoronavirus 19 disease (COVID-19) represents the most important pandemic of the last century. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection has produced more than 170 million cases and more than 3 million deaths. Due to the easy spread of the infection and the possibility of serious clinical manifestations, the role of anti-COVID 19 vaccination is essential. Vaccines with different mechanisms of action have been developed: mRNA-based, such as Biontech-Pfizer and Moderna, and viral vectored, such as AstraZeneca and Janssen. Despite possible adverse events, benefits afforded by these vaccines significantly outweigh potential risks associated with their administration in the general population.ObjectivesThis study aimed to evaluate incidence and severity of adverse events (AEs), secondary to vaccination, in patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Spondyloarthritis (SpA), immune-mediated diseases treated with immunomodulating drugs, by administering a questionnaire.Methods294 patients (201 f and 93 m) were enrolled with a diagnosis of arthritis (RA 28%, PsA 43%, SpA 28%).ResultsOf the 294 enrolled patients, 107 underwent COVID vaccination, 73% with Biontech-Pfizer vaccine, 20% Astrazeneca and 6% Moderna. 50% of patients completed the entire vaccination cycle.46% of patients presented AEs after the first dose of vaccine (45% of vaccinated with Biontech-Pfizer; 48% of vaccinated with Astrazeneca, 33% of vaccinated with Moderna). The most frequently observed AEs are: pain at the injection site (17%), fever (13%), headache (12%), myalgia (12%), fatigue (7.5%). Only 2.9% of patients had arthritis flares. The greatest trend of AEs was observed in patients with PsA (48%), and RA (26%).32% of patients receiving the second dose of vaccine presented AEs (40% Moderna, 32% Biontech-Pfizer). The most frequently observed AEs after the second dose are: pain at the injection site (4.7%), fever (9%), headache (2.8%), myalgia (6%). No patient had arthritis flare after the second dose. The greatest trend of AEs was observed in patients with SpA (66%).Only 11% of patients presented AEs after the administration of both doses.Thirteen percent of patients did not follow the clinician’s recommendations for immunomodulatory drug management, provided as per ACR or SIR recommendations.ConclusionThe incidence of adverse events in arthritis patients was in line with that of the general population, without presenting serious manifestations, such as thrombosis, and without indicating a preference on the type of vaccine.References[1]Tsai SC, Lu CC, Bau DT, Chiu YJ, Yen YT, Hsu YM, Fu CW, Kuo SC, Lo YS, Chiu HY, Juan YN, Tsai FJ, Yang JS. Approaches towards fighting the COVID‑19 pandemic (Review). Int J Mol Med. 2021 Jan;47(1):3-22. doi: 10.3892/ijmm.2020.4794. Epub 2020 Nov 20. PMID: 33236131; PMCID: PMC7723515.[2]Hodgson SH, Mansatta K, Mallett G, Harris V, Emary KRW, Pollard AJ. What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. Lancet Infect Dis. 2021 Feb;21(2):e26-e35. doi: 10.1016/S1473-3099(20)30773-8. Epub 2020 Oct 27. PMID: 33125914; PMCID: PMC7837315.Disclosure of InterestsNone declared
BackgroundJanus kinase inhibitors (JAK-i) are increasingly used in the treatment of Rheumatoid Arthritis (AR). Hypertransaminasemia is one of the described side effects of this class of drugs.ObjectivesThe aim of the study is to evaluate the possible hepatotoxicity, the risk of NAFLD onset, and the reactivation of HBV and HCV in patients with AR and JAK-i therapy.Methods78 patients with AR (81%F) were enrolled with an average disease duration of 15±7 years, BMI 26±4. The inclusion criteria were age > 18 years, fulfillment of ACR/EULAR 2010 criteria for AR, and stable intake for at least 3 months of JAK-i in monotherapy or combined therapy with methotrexate (MTX) and/or steroid.ResultsThe average therapy duration of JAK-i treatment (Baricitinib, Filgotinib, Tofacitinib or Upadacitinib) was of 67±50 weeks. 32% of patients were on combined therapy with MTX and 22% took steroids (mean dose in prednisone equivalents of 5.5±2.5 mg/day). No patients had positivity for HCV antibodies at the beginning of JAK-i therapy, and no one reported alcohol abuse. At the beginning of JAK-i therapy, 9% of patients had hepatic steatosis on abdominal ultrasound and 26% had occult HBV infection. 8% of patients had hypertransaminasemia before starting therapy with JAK-i. During treatment with JAK-i, hypertransaminasemia occurred in 6% of patients; of these 20% had already known hepatic steatosis, 40% were occult HBV carriers and 40% were with combined therapy with MTX. Particularly, hypertransaminasemia was detected in 8% of patients treated with Baricitinib and in 8% of patients with Tofacitinib. No patients treated with Filgotinib and Upadacitinib developed hypertransaminasemia during follow-up. JAK-i treatment was not stopped in any patient with hypertransaminasemia. 14% had NAFLD during treatment with JAK-i, and no patients had hepatic steatosis with hypertransaminasemia above 3 times normal values. Among patients who developed NAFLD after JAK-i treatment, 18% were overweight, 36% were obese, 27% were in therapy with steroids, and 18% were with combined therapy with MTX. NAFLD has been detected in 16% of patients treated with Baricitinib, 8% of patients treated with Tofacitinib, and 15% of patients treated with Upadacitinib, no patients treated with Filgotinib showed onset of NAFLD. Among patients with previous episodes of hypertransaminesia for other reasons, JAK-i treatment didn’t cause alterations of bio-humoral indexes of hepatic function. No HBV reactivation occurred in patients with occult HBV infection during treatment with JAK-i.ConclusionJAK-i treatment in patients with occult HBV infection or previous NAFLD has a good safety profile. In terms of hypertransaminasemia with or without NAFLD, the risk of liver dysfunction appears to be very low during JAK-i treatment, both in monotherapy or in MTX combination treatment.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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