ABSTRACT
Implementing vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a major asset in slowing down the coronavirus disease 2019 (COVID-19) pandemic. For mRNA vaccines, the main severe adverse events reported in pharmacovigilance systems and post-authorization studies were anaphylaxis and myocarditis. Pancreatitis after Pfizer/BioNTech COVID-19 vaccination has been reported only in 10 patients.We report a 31-year-old female with a history of borderline personality disorder, intravenous drug abuse, allergic asthma, eating disorder, psoriatic arthritis treated with tofacitinib, neurogenic bladder disturbance, cholecystectomy, recurrent thoracic herpes zoster, vaginal candida infections and urinary tract infections, who developed pancreatitis associated with thrombotic microangiopathy and hemolytic-uremic syndrome 10 days after the second vaccination, whereas the first has been well tolerated. She was treated by plasma exchange, and eventually by transgastric drainage with implantation of a plastic stent to remove fluid abdominal retentions. She was discharged after 19 days. Since then her condition has improved continuously. Computed tomography after 12 months did not reveal retentions anymore.As other causes of pancreatitis have been excluded, this case of acute pancreatitis, microangiopathic hemolytic anemia and thrombocytopenia, temporally associated with the Pfizer-BioNTech COVID-19 vaccine, suggests a causal link.
ABSTRACT
Ulcerative colitis (UC) is one of the main forms of inflammatory bowel disease (IBD). Despite the widening range of drug treatment options, primary nonresponse, secondary loss of response as well as adverse events call for additional treatment alternatives.Tofacitinib is an oral small-molecule drug of the class of Janus kinase inhibitors which, in the European Union, was approved for the treatment of moderate to severe active UC in August 2018. This position paper, drawn up by the IBD Working Group of the Austrian Society of Gastroenterology and Hepatology, summarizes the mechanism of action, clinical development, marketing authorization status, efficacy and safety of tofacitinib. Also, by providing a synopsis of available data from both pivotal and post-marketing studies, clinical aspects of specific interest are highlighted and discussed.The available body of evidence indicates that tofacitinib is an additional effective medication for the treatment of UC that exhibits a good safety profile. This position paper aims at optimizing the safe and effective use of tofacitinib in daily clinical practice.