A drug evaluation narrative review of cladribine as a treatment for multiple sclerosis

Multiple sclerosis [MS] is an immune-mediated disease driven by peripherally mediated and central nervous system compartmentalized pathophysiologic processes. Major advances have led to a plethora of disease modifying therapies [DMTs] available for the treatment of MS. Among the wide range of DMTs, the immune reconstitution therapies [IRTs] are a unique subset of therapy that have the potential for durable benefit without the need for chronic administration. Cladribine tablets are a higher-efficacy oral IRT that selectively targets lymphocytes, causing a transient lymphopenia, followed by immune reconstitution of a different repertoire of lymphocytes that may result in durable benefit. The intermittent dosing schedule and efficacy in reducing measures of disease activity in both the short and long-term make cladribine an attractive DMT choice for a broad range of individuals with relapsing forms of MS. This narrative review summarizes the available efficacy and safety data from clinical trials and real-world studies on cladribine tablets.