Anti-TNFα Drugs and Interleukin Inhibitors: Epidemiological and Pharmacovigilance Investigation in COVID-19 Positive Patients.

Cytokine patterns and immune activation in patients with Coronavirus 2019 (COVID-19) seem to resemble the case of rheumatoid arthritis (RA), psoriasis and inflammatory bowel disease (IBD). Biological drugs, such as anti-tumor necrosis factor α (TNFα) and interleukin (IL) inhibitors, appear to be protective against adverse outcomes of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). However, these treatments are associated with an increased risk of secondary infections. The aim of the study was to examine the association between the use of immunomodulatory drugs and the risk of SARS-CoV-2-associated positivity, hospitalization and death compared to other commonly prescribed treatment regimens among patients with immune-mediated inflammatory diseases. METHODS: All patients with RA, Psoriasis and IBD were included in this observational analysis and treated with anti-TNFα, IL-inhibitors, Methotrexate (MTX) and Sulfasalazine drugs during the year 2020-2021. The population consisted of 932 patients and demographic, clinical and pharmacological data were analyzed. RESULTS: Although no significant differences were observed between patients treated with biological and synthetic drugs in terms of hospitalization and death, the multivariate logistic model showed that the type of drug influences the possibility of COVID-19 positivity. CONCLUSIONS: The results of this analysis support the use of biological drugs and justify further research investigating the association of these biological therapies with COVID-19 outcomes.

[Statin therapy: cost-effectiveness and evaluation of evidence as criterium for improving expenditure within the National Health Program]. / Terapia medica con le statine: valutazione costo/efficacia e della migliore evidenza clinica per razionalizzare la spesa del Servizio Sanitario Nazionale.

The choice is difficult in medicine. But individual physicians and patients must make medical decisions rather than organizations or pharmaceutical companies. The choice concerns the transparency of the decision-making process (evidence based medicine), and mistrust of the methods used in cost-effectiveness analysis. Medicare's policy of paying for any medical advance that has positive benefits, regardless of its costs, is un-sustainable. Cost-effectiveness information may assume a more important role in future coverage decisions with regard to outpatient prescription drugs, but at the private level, rather than at the national one. Functional equivalence of drugs reflects a reference-pricing technique applied to a therapeutic category--reimbursement for compounds of similar efficacy within a therapeutic class set to the lowest-priced product in the class. Essentially, a standard of functional equivalence applies a cost-effectiveness principle: assuming that alternative interventions are equivalent, one should not pay more for one of them.