Description:
<jats:sec><jats:title>Background</jats:title><jats:p> Treatment-emergent adverse events (TEAEs) that occur close to treatment initiation may negatively affect overall tolerability and adherence. It is important to develop a clear understanding of potential early TEAEs after initiating treatment with cladribine tablets. </jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p> To identify TEAEs that begin early in the course of treatment in patients enrolled in CLARITY and ORACLE-MS studies. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> This post hoc analysis of CLARITY and ORACLE-MS safety populations assessed the incidence of TEAEs, serious TEAEs, drug-related TEAEs, and TEAEs leading to discontinuation in patients receiving cladribine tablets or placebo within 2, 6, and 12 weeks after treatment initiation. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> By Week 12, 61.3% of patients treated with cladribine tablets 3.5 mg/kg and 55.2% treated with placebo experienced a TEAE. More patients receiving cladribine tablets versus placebo experienced a drug-related TEAE by Week 12 (34.7% vs. 23.2%). The most common TEAEs reported with cladribine tablets were: headache (7.2%), lymphopenia (6.8%), and nausea (6.0%). Patients receiving cladribine tablets and placebo reported similar proportions of serious TEAEs (2.2% vs. 1.7%) and TEAEs leading to treatment discontinuation (1.6% vs. 1.4%). </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Cladribine tablets were well tolerated during the first 12 weeks as evidenced by a low incidence of TEAEs leading to treatment discontinuation. </jats:p></jats:sec>