Xeljanz Safety Data Could Mean Headache for JAK Inhibitor Class
Pfizer announced the co-primary endpoint results of the ORAL Surveillance (NCT02092467) post-marketing safety study of Xeljanz (tofacitinib), a Janus kinase (JAK) inhibitor, in RA patients with cardiovascular (CV) risk factors. According to the findings of the study, Xeljanz failed to demonstrate non-inferiority to treatment with a tumor necrosis factor inhibitor in terms of the risk of major adverse cardiovascular events (MACE) and cancer (excluding non-melanoma skin cancer) at doses of 5 mg and 10 mg twice daily, respectively. These results suggest that Xeljanz and possibly other JAK inhibitor products will face difficulties in the future. Janus Kinase Drugs Development market Surveillance trial in the middle of the study in early 2019 because of links between the 10 mg twice daily dose of Xeljanz and a higher risk of thrombosis and overall mortality. Despite the fact that there were no safety warnings for the 5mg twice-daily dose at the time, some important opinion leaders who...