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WED 185 Clarity: mri outcomes in high disease activity relapsing 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 The CLARITY study demonstrated the benefit of cladribine tablets 3.5 mg/kg (CT3.5) for patients with relapsing MS (RMS). Patients with high disease activity (HDA) RMS are at risk of clinical activity and disability progression.

Objective Post-hoc analysis of MRI outcomes in CLARITY for CT3.5 vs placebo.

Methods Retrospective analysis using HDA definitions based on relapse history, prior treatment, and MRI characteristics: high relapse activity (HRA) and HRA plus disease activity on treatment (HRA+DAT).

Results For cumulative new T1 Gd+ lesions, relative risk ratios (RRR) for both subgroups (HRA: 0.087; 95% CI: 0.052 to 0.144; p<0.0001) (HRA+DAT: 0.077; 95% CI: 0.046 to 0.128; p<0.0001) were lower for CT3.5 vs placebo. Risk reductions (RR) (91% and 92%, respectively) were similar to the 90% reduction in the overall CLARITY population (0.097; 95% CI: 0.070 to 0.134; p<0.0001). Cumulative active T2 lesions RRR favoured CT3.5 vs placebo for both subgroups (HRA: 0.263; 95% CI: 0.180 to 0.383, p<0.0001) (HRA+DAT: 0.254; 95% CI: 0.178 to 0.363; p<0.0001): RRs of 74% and 75%, reflecting the 73% overall population reduction (0.272; 95% CI: 0.221 to 0.335; p<0.0001). Cumulative combined unique lesions RRR favoured CT3.5 vs placebo for HRA (0.212; 95% CI: 0.145 to 0.311; p<0.0001) and HRA+DAT (0.203; 95% CI: 0.141 to 0.291; p<0.0001): RRs were 79% and 80%, reflecting the 77% overall population reduction (0.234; 95% CI: 0.190 to 0.290; p<0.0001). There were no significant interactions between HDA and non-HDA subgroups.

Conclusions The treatment benefit of CT3.5 on MRI outcomes was similar in HDA RMS subgroups and the overall CLARITY study population.


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