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WED 184 Cladribine tablets in clarity patients with high disease activity ms
  1. Gavin Giovannoni1,
  2. Kottil Rammohan2,
  3. Stuart Cook3,
  4. Giancarlo Comi4,
  5. Peter Rieckmann5,
  6. Per Soelberg-Sorensen6,
  7. Patrick Vermersch7,
  8. Fernando Dangond8,
  9. Christine Hicking9
  1. 1Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK
  2. 2University of Miami School of Medicine, Department of Neurology, MS Research Center, Miami, FL, USA
  3. 3Rutgers, The State University of New Jersey, New Jersey Medical School, Newark, NJ, USA
  4. 4Università Vita-Salute San Raffaele, Ospedale San Raffaele, Milan, Italy
  5. 5Medical Park Loipl and University of Erlangen, Germany
  6. 6Department of Neurology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark
  7. 7Université de Lille, CHU Lille, LIRIC- INSERM U995, FHU Imminent, Lille, France
  8. 8EMD Serono Research and Development Institute, Inc., a business of Merck KGaA, Darmstadt Germany
  9. 9Merck KGaA, Darmstadt, Germany


Background Patients with high disease activity (HDA) relapsing-remitting MS are less likely to attain no evidence of disease activity (NEDA; no relapses, MRI activity or progression).

Objective Post-hoc analysis to compare the proportion of patients with NEDA with cladribine tablets 3.5 mg/kg (CT3.5) vs placebo.

Methods Patients from CLARITY were retrospectively stratified using 2 definitions of HDA based on relapse history, prior treatment, and MRI characteristics: HRA (n=261) and HRA plus disease activity on treatment (HRA+DAT) [n=289]). Data for patients treated with CT3.5 or placebo who fulfilled these criteria and achieved NEDA status were compared over the 2 years using odds ratios (OR) and 95% CI.

Results HRA subgroup: 76% of CT3.5-treated patients were relapse-free and 84% were T1 Gd+ lesion free vs 49% and 31%, respectively, for placebo. HRA+DAT subgroup: 77% of CT3.5-treated were relapse-free and 85% were T1 Gd+ lesion free vs 50% and 32%, respectively, for placebo. In the HRA and HRA+DAT subgroups, 43.2% and 43.7%, respectively, of CT3.5-treated patients were disease activity free compared with 8.7%, (OR: 8.02; 95% CI: 3.93 to 16.35; p<0.0001) and 9.0% (OR: 7.82; 95% CI: 4.03 to 15.19; p<0.0001) respectively, for placebo. In the overall population, composite NEDA score favored CT over placebo (OR: 4.46; 95% CI: 3.18 to 6.26; p<0.0001).

Conclusions Treatment with CT3.5 significantly increased the proportion of HDA patients with NEDA vs placebo.


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