Neurology and Therapy (Aug 2024)

Practical Recommendations from the Gulf Region on the Therapeutic Use of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis: Impact of the Latest Real-World Evidence on Clinical Practice

  • Bassem Yamout,
  • Raed Alroughani,
  • Jihad Inshasi,
  • Samar Farouk,
  • Fatema Abdulla,
  • Namareq Y. Al-Jarki,
  • Abdulla Alasmi,
  • Sarmad Al Fahad,
  • Jaber Alkhabouri,
  • Khalid Al-Saffar,
  • Beatrice Benedetti,
  • Beatriz Canibano,
  • Dirk Deleu,
  • Ali Hassan,
  • Pournamy Sarathchandran,
  • Ahmed Shatila,
  • Mohammad Abouelnaga,
  • Mona Thakre,
  • Miklos Szolics,
  • Amir Boshra

DOI
https://doi.org/10.1007/s40120-024-00650-5
Journal volume & issue
Vol. 13, no. 5
pp. 1321 – 1335

Abstract

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Abstract Cladribine tablets (CladT), like alemtuzumab, acts as an immune reconstitution therapy. However, CladT is administered orally (alemtuzumab is given by infusion) and without the potential for serious side effects that limit the therapeutic use of alemtuzumab in multiple sclerosis (MS). Treatment with CladT, given initially as short courses of treatment 1 year apart, provides years of freedom from MS disease activity in responders to treatment. The appearance of mild or moderate MS disease activity after the initial 2 years of treatment may prompt careful follow-up or a further course of CladT, depending on the nature of the activity and individual circumstances. The appearance of severe MS disease activity requires a switch to an alternative high-efficacy disease-modifying treatment (DMT). The accumulating data from CladT-treated people with MS in real-world studies, including those with follow-up durations extending for years beyond the initial treatment, have demonstrated long-term freedom from MS disease activity in a good proportion of patients. This clinical experience has also confirmed that treatment with CladT is generally safe and well tolerated. The best time to prescribe a high-efficacy DMT is the subject of debate, with evidence that earlier versus later use of such agents may provide more effective long-term protection from disability progression. High-efficacy DMTs have traditionally been reserved for use in people with MS and high disease activity on presentation or breakthrough disease on one or more DMTs, as per the current product labels. The latest evidence from real-world studies suggests that CladT is effective and safe in DMT-naïve patients, including those with shorter disease duration.

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