MAVENCLAD™ (cladribine tablets) │ EMD Serono
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Demonstrated efficacy



Measuring efficacy – the CLARITY study

CLARITY study design1

92% of MAVENCLAD patients (vs. 87% of the placebo group) completed the full 96-week study. 3.5% of MAVENCLAD patients discontinued the study due to AEs.1,2

§ The 5.25 mg/kg dosage regimen is not available.

¶ Combined unique lesions were defined as new GD+ T1-weighted lesions or new nonenhancing or enlarging T2-weighted lesions (without double-counting).  

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Demonstrated reduction in ARR


Demonstrated reduction in 3-month EDSS progression

Demonstrated reduction in brain lesions



achieved a 57.6% relative reduction in ARR over
96 weeks vs. placebo
(p<0.001, 0.14 vs. 0.33, respectively).

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See how MAVENCLAD delivered a 33%
reduction in risk of disability progression (EDSS) vs. placebo (p=0.02, HR: 0.67,
secondary endpoint).

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Discover how MAVENCLAD
demonstrated an 86% relative
reduction in T1 Gd+ lesions and
73% in T2 lesions over 96 weeks
vs. placebo (p<0.001; mean lesions:
T1 Gd+, 0.12 vs. 0.91; T2,  0.38 vs. 1.43; secondary endpoint). 

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Footnotes and References

ARR=annualized relapse rate; EDSS=Expanded Disability Status Scale; Gd+=gadolinium-enhancing; MRI=magnetic resonance imaging; RRMS=relapsing-remitting multiple sclerosis

* 96-week, phase III, multicentre, double-blind, placebo-controlled trial to evaluate the safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis. 1,326 patients were randomized (1:1:1) to receive a cumulative dose of cladribine tablets (3.5 mg/kg [n=433] or 5.25 mg/kg [n=456]) or placebo (n=437), in two treatment courses. The 5.25 mg/kg dosage regimen is not available.1

† 10th percentile of time to event.

  1. MAVENCLAD™ Product Monograph. EMD Serono. November 2017.
  2. Giovannoni G, et al. A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N Engl J Med 2010;362:416-26.

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