How to monitor safety and efficacy of biologic treatment in rare, therapy-refractory immune-mediated inflammatory diseases? Making the right clinical decisions for rare diseases with the right tools.

The authors discuss how to monitor safety and efficacy of biologic treatment in rare immune-mediated inflammatory diseases (IMIDs). Topics discussed include lack of international treatment guidelines for the use of biologics in rare IMIDs, conditional reimbursement of targeted therapies in rare IMIDs, and evaluation of treatment for efficacy and safety every three months during the first year and every six months thereafter.