In 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on tofacitinib, an oral Janus kinase inhibitor, recommending the refusal of the marketing authorisation for the treatment of moderate to severe active rheumatoid arthritis in patients in whom treatment with at least one other DMARD had been unsuccessful. The Committee considered that the studies were not sufficient to show a consistent reduction in disease activity and structural damage to joints, particularly at the lower 5-mg dose and in the target population of patients in whom treatment with at least two other DMARDs has been unsuccessful. It had major concerns about the overall safety profile and there were significant and unresolved concerns about the risk and type of serious infections seen with tofacitinib. The safety concerns also included an increased risk of other severe side effects including certain cancers, gastro-intestinal perforations, liver damage and problems with increased lipid levels. The Committee was not convinced that these risks could be managed successfully in medical practice.