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  • 039 Rates of lymphopenia in years 1–4 in patients with relapsing multiple sclerosis treated annually with cladribine tablets

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The Australian & New Zealand Association of Neurologists (ANZAN)
2018 ASM
May 29th–June 1st
Darwin Convention CentreAustralia
039 Rates of lymphopenia in years 1–4 in patients with relapsing multiple sclerosis treated annually with cladribine tablets
  1. Stuart Cook1,
  2. Giancarlo Comi2,
  3. Gavin Giovannoni3,
  4. Peter Rieckmann4,
  5. Per Soelberg Sorensen5,
  6. Patrick Vermersch6,
  7. Fernando Dangond7,
  8. John King8,
  9. Christine Hicking9
  1. 1Rutgers, The State University of New Jersey, New Jersey Medical School, Newark, New Jersey, USA
  2. 2Department of Neurology and Institute of Experimental Neurology, Università Vita-Salute San Raffaele, Ospedale San Raffaele, Milan, Italy
  3. 3Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK
  4. 4Department of Neurology, Medical Park Loipl and University of Erlangen, Erlangen, Germany
  5. 5Department of Neurology, Danish MS Center, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark
  6. 6Université de Lille, CHU Lille, LIRIC-INSERM U995, FHU Imminent, Lille, France
  7. 7EMD Serono, Inc., Billerica, Massachusetts, USA
  8. 8Department of Neurology, Royal Melbourne Hospital, Parkville, VIC, Australia
  9. 9Merck KGaA, Darmstadt, Germany

Abstract

Introduction The CLARITY and CLARITY Extension studies demonstrated the efficacy of cladribine tablets in patients with relapsing multiple sclerosis. The most common adverse event was lymphopenia, consistent with the mechanism of action of cladribine tablets. Objective was to evaluate whether lymphopenia persists following annual treatment with cladribine tablets.

Methods Lymphopenia by grade (NCI CTCAE v3.0) for patients randomised to cladribine tablets 3.5 mg/kg in CLARITY and re-randomised to cladribine tablets 3.5 mg/kg in CLARITY Extension (7 mg/kg cumulative dose over 4 years; n=186) are reported. Patients with Grade 0 lymphopenia (≥1.0×109 cells/L) before the first course of cladribine tablets and Grade 0/1 (≥0.8×109 cells/L) prior to administration in Years 2, 3 and 4 were included in the analysis.

Results 176 patients were Grade 0 at CLARITY baseline and 167 were Grade 0/1 at CLARITY Extension baseline. Grade 3 lymphopenia was observed in 1% of patients at Week 13 in Year 1, and in 7%, 11% and 12% at Week 12 in Years 2, 3 and 4, respectively. By Week 24 in Years 1, 2, 3 and 4, Grade 3 lymphopenia was observed in 1%, 4%, 4% and 4% of patients, respectively. By Week 36 in Years 1, 2, 3 and 4, Grade 3 lymphopenia was observed in 1%, 2%, 2% and 2% of patients, respectively. Grade 3 lymphopenia was only observed in Week 48 of Year 2 (1% of patients). Grade 3 lymphopenia was reported in <18% of patients at any time point. No patients had Grade 4 lymphopenia at the end of any years.

Conclusion No patients included in this analysis experienced Grade 4 lymphopenia at the end of any treatment year. Grade 3 lymphopenia was uncommon. This study demonstrates the effectiveness of lymphocyte-based treatment criteria in minimising the incidence of severe, sustained lymphopenia during treatment with cladribine tablets.

https://doi.org/10.1136/jnnp-2018-ANZAN.38

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