Patients with higher MS disease activity | The CLARITY Study [22] demonstrated reduced relapse rates over 2 years of randomised treatment in patients with active RRMS at baseline (one relapse in the previous year or two relapses in the previous 2 years |
2-year extension to CLARITY demonstrated reduced relapse rate [25], reduced MRI progression [24, 26], and increased achievement of NEDA-3 [27] without further treatment; about 75% of patients who had received cladribine tablets in the randomised phase remained relapse-free when cladribine tablets were switched to placebo for a further 2 years | |
Post hoc analysis from CLARITY suggested reduced 6-month progression of disability in patients with vs. without high disease activity at baseline (≤ 2 relapses during the year prior to study entry), irrespective of prior treatment with a disease-modifying therapy [28] | |
Patients considered unlikely to adhere well to a continuous DMT regimen | Long-term freedom from disease activity without continuous treatment is possible for a majority of patients treated with the 2-year course of cladribine tablets (see above)a |
Patients planning a family | Long-term freedom from MS disease activity following the initial 2-year course of treatment (see above) may provide a window of opportunity to complete a pregnancy uncomplicated by concurrent administration of a DMTa |
aAlso applies in principle to any disease-modifying therapy (DMT) that acts like an immune reconstitution therapy (e.g. alemtuzumab); NEDA: no evident disease activity