Portuguese consensus for the use of cladribine tablets in multiple sclerosis

Multiple sclerosis (MS) is a chronic immune-mediated neurodegenerative disease. Cladribine tablets, an immune reconstitution therapy, are approved for the treatment of highly active relapsing-remitting MS (RRMS). Evidence on how to manage patients, particularly beyond the fourth year after treatment initiation, is scarce. This study aimed to formulate recommendations to guide cladribine treatment in MS patients.

Delphi methodology was followed with the participation of 33 Portuguese neurologists. Statements regarding treatment schemes, selection of patients, treatment decisions, assessment and monitoring, safety recommendations, and family planning were voted on. Consensus was obtained when ≥80% of experts agreed on a five-point scale.

Consensus was obtained for 50% of the statements. Experts were unanimous in stating that MS patients should start treatment as soon as possible after diagnosis and that treatment decisions should be based on a personalized approach. Experts defined criteria for patient selection, additional cladribine cycles, and therapy switching. Experts also defined monitoring schedules, treatment assessments, safety recommendations, and family planning.

This study guides the use of cladribine tablets in clinical practice, supporting treatment decision-making in patients with RRMS, and summarizes the current knowledge from clinical trials and real-world studies of the efficacy and safety of cladribine tablets.