Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Autoantibody positive, Biopsy muscle, Blood creatine phosphokinase, Immune-mediated myositis
Clinical narrative: stimulate immune-mediated autoantibody formation; Statin-Induced Necrotizing Autoimmune Myopathy; This is a literature report for the following literature source(s). Other Case identifier(s): US-MLMSERVICE-20221226-4002044-1, NZ-Adis-3743469-322644, US-MYLANLABS-2022M1140938. Introduction: Statins have become the most prescribed medications. We examine the case of a woman who developed statin induced necrotizing myopathy after receiving the Pfizer COVID-19 vaccine after 15 years of statin use. Case: A 67-year-old woman with history of hypothyroidism, hyperlipidemia, and a remote history of breast cancer, treated with surgical excision, presented with a two-month history of progressive proximal muscle weakness in all four extremities. During this time, she noticed unusual difficulty in her habitual exercise routine, culminating in being suddenly unable to walk or lift her arms. Prior to the onset of her symptoms, she reported that she had received the Pfizer COVID-19 booster vaccine. She had been adherent to her daily medications for over fifteen years (atorvastatin 20mg and levothyroxine 75mcg). Labs revealed creatine phosphokinase of 10,354. Muscle biopsy of the thigh was indicative of necrotizing myopathy. 3-hydroxy-3-methylglutaryl coenzyme A reductase antibodies were elevated at over 200 units, suggesting an immune-mediated myopathy. She was treated with intravenous immune globulin and placed on a prednisone taper. Her strength improved, and she was discharged home with physical therapy. Discussion: Statin-induced necrotizing autoimmune myopathy (SNAM) is a rare manifestation of autoimmune myositis. In the anti-HMG-CoA reductase subtype, the immune system is sensitized to HMG-CoA reductase resulting in immune-mediate cellular injury. The duration of exposure to statins prior to development of SNAM varies from 2 months to 10 years, with an average of 3 years. The authors' patient had previously been on statin therapy for 15 years without issue and subsequently developed SNAM after receiving a COVID-19 booster. This highlights the possibility that ribonucleotide vaccines, in particular COVID-19, may stimulate immune-mediated autoantibody formation and lead to increased risk for SNAM in patients on statin therapy. These patients would benefit from alternative lipid lowering therapies, such as Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) inhibitors.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case, a possible causal association between the reported events Autoantibody response , Immune-mediated necrotizing myopathy and the suspect drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.