Real-World Use of Cladribine Tablets (Completion Rates and Treatment Persistence) in Patients with Multiple Sclerosis in England: the CLARENCE Study

• Published in: Multiple sclerosis and related disorders Vol. 71; p. 104286
• Main Authors: Brownlee, Wallace, Amin, Amerah, Ashton, Luke, Herbert, Alex
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 01.03.2023
• ISSN: 2211-0348; 2211-0356
• DOI: 10.1016/j.msard.2022.104286

Cladribine tablets (CladT; 3.5 mg/kg cumulative dose over 2 years) have been available in England for the treatment of highly active relapsing multiple sclerosis (MS) since 2017. As a compulsory requirement of National Health Service (NHS) reimbursement, all disease-modifying therapies (DMTs) prescribed for MS within NHS England must be registered via the Blueteq® high-cost drug database. The objective of current analysis was to evaluate real-world use of CladT in England using data collected by the Blueteq®platform, as part of the CLARENCE study. Here, we describe baseline characteristics, treatment completion rates (full course of CladT received) and treatment persistence (no need for switching/discontinuation) in patients treated with CladT in the real-world setting. NHS England collect data on CladT use via the Blueteq®platform and provided the associated anonymised patient-level data to the study sponsor on a quarterly basis. Longitudinal data were collated for patients prescribed CladT between November 2017 and September 2021. Treatment history and Expanded Disability Status Scale (EDSS) scores were recorded at CladT initiation. Change in EDSS score, treatment completion, and persistence were evaluated over the length of the study. Data were analysed descriptively. In total, 1934 patients prescribed CladT had a completed Blueteq form®; at treatment initiation, median (minimum; maximum) EDSS score was 2.5 (0; 8.5) and 691 (36%) patients were treatment naïve. Over the 2-year treatment course, 505 (83%) patients had a stable EDSS score (defined as no change; or decrease). At data cut-off, 1020 (53%) patients had completed the full course of CladT, 742 (38%) had received the first course with <18 months of follow-up, and 172 (9%) discontinued treatment before completing the second course of CladT. Overall, 78 (4%) patients switched to another DMT; of those, 45 (58%) received one treatment course of CladT and 33 (42%) received two courses. Patients treated with CladT in England showed high rates of treatment completion and persistence (low switching rate of 4%), with stable EDSS scores across the planned 2 years of treatment. These findings highlight the real-world effectiveness of CladT in patients with highly active relapsing MS.