Tofacitinib

Abstract

While tofacitinib was the initial oral medication to exhibit similar efficacy to that of biological disease-modifying anti-rheumatic drugs, it was also the first JAK inhibitor to exhibit increased herpes zoster（HZ）, and could not demonstrate non-inferiority to TNF inhibitors in regard to safety. The ORAL Surveillance study（OS study）was launched during the ENTRACTE study, which aimed to demonstrate non-inferiority of an IL-6 inhibitor in comparison to a TNF inhibitor in regard to safety. The OS trial also had the identical aim for a JAK inhibitor in comparison to a TNF inhibitor. Although both drugs are known to cause dyslipidemia with no substantial increase in cardiovascular events in clinical trials, a new approach was adopted to prove the safety of the drug. Non-inferiority was observed for the IL-6, but not for the JAK inhibitor. It is essential to note that the TNF inhibitor was used as a control treatment and not as an indicator of a safe drug. Although there has been a growing concern on cardiovascular events in the Western world, the OS trials have revealed that when RA patients with active disease and high risk who receive regular or excessive doses of tofacitinib are more likely to develop malignancies. A recent study from Japan suggests that mortality decreased by one-tenth in patients who underwent CT screening during biologic agent induction rather than those who received only plain radiographs. This indicates the potential for deploying molecular-targeted therapy with enhanced safety in Japan, as CT is more prevalent compared to Western nations. Subunit vaccines are highly efficacious to prevent herpes zoster and require strategizing efforts to facilitate immunization while considering financial strain of the patient.