Expert consensus on the clinical use of cladribine tablets for treating relapsing multiple sclerosis in the asia-pacific region

Abstract

Background: Cladribine Tablets (CladT) have emerged as a potent disease-modifying therapy (DMT) for relapsing multiple sclerosis (Pittock et al., 2019. While their efficacy and safety profiles have been well-documented in Western populations, there is a paucity of region-specific guidelines for their use in the Asia-Pacific context. This manuscript presents a consensus developed by Asia-Pacific experts, aiming to provide practical recommendations for the clinical application of CladT in this region. Methods: A steering committee (SC) comprising four multiple sclerosis (Pittock et al., 2019one international and three from the APAC region—led an advisory board and developed 16 clinical questions regarding the practical use of CladT. To address these questions, statements were formulated based on available evidence, expert insights, and perspectives from the SC, along with input from an extended faculty of six MS experts representing in total nine APAC countries. Consensus on the recommendations was established when at least 75 % of respondents rated their agreement between 7 and 9 on a 9-point scale. Results: A total of 16 clinical statements were drafted, and consensus was reached on 15 of them. The recommendations covered key aspects of CladT use, including indications for treatment initiation in both treatment-naïve and previously treated patients, strategies for managing disease activity over time, long-term safety considerations, and the role of CladT in special populations. CladT were recognized as an effective high-efficacy therapy for both highly and moderately active RMS, with robust long-term efficacy and safety profiles. It was also identified as a suitable option for patients requiring minimal hospital visits and those with limited access to healthcare facilities. While there was strong agreement on its use in treatment-naïve and early MS patients as well as a switch therapy, no consensus was reached on using CladT as a first-switch option for patients experiencing breakthrough disease on high-efficacy therapies. Recommendations also emphasized the importance of lymphocyte monitoring, appropriate patient selection, and the possibility of additional treatment courses beyond Year 5 in selected cases. Conclusion: The consensus encompasses patient selection criteria, therapeutic strategies, monitoring protocols, and safety considerations, tailored to the unique demographic and healthcare landscapes of APAC countries.