Serious Adverse Events Profile for Cladribine Confirmed With Extended Data
Researchers pooled long-term data on the safety of cladribine tablets monotherapy that extended 3 or more years beyond the data included in the last clinical study.
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An updated analysis of long-term safety data on cladribine tablets confirms the serious treatment emergent adverse event (TEAE) profile associated with cladribine 3.5mg/kg for patients with relapsing forms of multiple sclerosis (MS), according to research presented at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, held October 10-12 in Berlin, Germany.
For this integrated analysis, researchers pooled long-term data on the safety of cladribine tablets (3.5mg/kg) monotherapy that extended 3 or more years beyond the data included in the last clinical study. Data on 923 patients treated with cladribine and 643 patients treated with placebo were taken from the PREMIERE registry and the ORACLE-MS, CLARITY and CLARITY Extension trials. Adjusted adverse events were calculated per 100 patient-years (PY), and 2 data cutoffs were compared: Period 1, which is cumulative to February 2015; and Period 2, which is cumulative to May 2017. Serious adverse drug reactions (implied causality), taken from post-marketing sources, were also summarized.
Demographics within the respective studies were balanced among the various treatment groups. The rates of adjusted adverse events per 100 person-years for experiencing 1 or more serious TEAEs were 3.57 for placebo vs 4.00 for cladribine in Period 1, and 3.24 for placebo vs 3.88 for cladribine in Period 2. The adjusted adverse events rates per 100 person-years for serious neoplasms (system organ class), unspecified, malignant, and benign were 0.50 for placebo vs 0.74 for cladribine in Period 1 and 0.35 for placebo vs 0.65 for cladribine in Period 2. The adjusted adverse events rates per 100 person-years for serious lymphopenia were 0 for placebo vs 0.12 for cladribine in Period 1 and 0 for placebo vs 0.11 for cladribine for Period 2. For serious infections and infestations (system organ class), the rates were 0.50 for placebo vs 0.69 for cladribine in Period 1 and 0.44 for placebo vs 0.63 for cladribine in Period 2. Finally, for serious herpes zoster, the rates were 0 for placebo vs 0.06 for cladribine in Period 1 and 0 for placebo vs 0.05 for cladribine in Period 2. Eleven serious adverse drug reactions were reported through post-marketing data, none of which reveal new safety findings for cladribine.
Study investigators concluded that "[t]his integrated analysis confirms the serious TEAE profile associated with [cladribine 3.5mg/kg] treatment of patients with early and active [relapsing] MS… No new major safety findings were identified in the updated dataset, where patients were followed for up to 10 years."
Disclosures: This research was sponsored by EMD Serono Inc, a business of Merck KGaA, Darmstadt, Germany (in the USA), and Merck Serono SA, Geneva, an affiliate of Merck KGaA Darmstadt, Germany (ROW).
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Cook S, Giovannoni G, Soelberg Sorensen P, et al. Updated safety analysis of cladribine tablets in the treatment of patients with multiple sclerosis. Presented at: 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis 2018. October 10-12, 2018; Berlin, Germany. Poster 875.