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Sustained Efficacy

MAVENCLAD® DELIVERS EFFICACY IN PATIENTS WITH HIGH DISEASE ACTIVITY

Only MAVENCLAD® can deliver high-efficacy* vs. placebo across all relevant clinical endpoints in patients with high disease activity with a maximum of 20 days of oral dosing17

High disease activity population:17

  • Patients with ≥2 relapses during the year prior to study entry, whether on DMT treatment or not, or
  • Patients with 1 relapse during the year prior to study entry while on DMT treatment and ≥1 T1 Gd+ or ≥9 T2 lesions
*High-efficacy, defined by the Association of British Neurologists as “[DMTs] with an average relapse reduction substantially more than 50%”14
ARR=annualised relapse rate; CI=confidence interval; DMT=disease modifying therapy; EDSS=Expanded Disability Status Scale; HDA=high disease activity; HR=hazard ratio; RR=relative risk; T1 Gd+=T1 Gadolinium enhancing lesion; T2=active T2-weighted lesions

 

CLARITY and CLARITY EXT: Study Design2-4

Endpoints in the CLARITY trial2

Primary endpoint

  • Rate of relapse over 2 years

Key secondary endpoints

  • Proportion of patients who were relapse-free
  • Time to sustained increase (for at least 3 months) of EDSS score (>1 point in the EDSS score or an increase of >1.5 points if the baseline EDSS score was 0)
  • Time to the first relapse
  • Use of rescue therapy with interferon beta-1a
  • Mean number of Gd+ T1 lesions per scan after 2 years
  • Mean number of active T2-weighted lesions after 2 years
  • Combined unique lesions on MRI
  • Safety

Endpoints in the CLARITY extension trial3

Primary endpoint (safety)

  • Proportion of participants with Grade 3 or 4 lymphopenia at year 4
  • Number of participants with AEs and serious AEs at year 4
  • Median time to recovery from Grade 3 or 4 lymphopenia
  • Number of participants who developed herpes zoster and malignancies

Key secondary endpoints (efficacy and MRI outcomes)

  • Annualised relapse rate at year 4
  • Proportion of relapse-free patients
  • Time to 3-month sustained disability progression
  • Mean number of combined unique lesions
  • Mean number of new T1 Gd+ and active T2 lesions
*These regimens/doses are not approved
** There was a gap period between the final CLARITY and first EXT visits, with an overall median duration of ~41 weeks. Therefore, while all patients were intended to be in the study for 2.5 years, this period of observation ended between ~4.5 and 6.5 years after the beginning of the CLARITY study
AE=adverse event; EDSS=Expanded Disability Status Scale; Gd+=gadolinium enhancing; MRI=magnetic resonance imagery; RRMS=relapsing-remitting multiple sclerosis

MAVENCLAD® delivered efficacy vs. placebo across relevant clinical and radiological endpoints over years 1 and 21,2,15

*Defined as the time to a sustained increase (for at least 6 months) of >1 point in the EDSS score or an increase of >1.5 points if the baseline EDSS score was 01
ARR=annualised relapse rate; EDSS=Expanded Disability Status Scale; Gd+=gadolinium enhancing; HR=hazard ratio

Almost 1 out of 2 high disease activity* patients on MAVENCLAD® achieved NEDA at the end of the 2-year CLARITY study, with a maximum of 20 days of oral dosing**18

*In this post-hoc analysis, high disease activity was defined as patients with ≥2 relapses during the year prior to study entry, whether on DMT treatment or not, PLUS patients with ≥1 relapse during the year prior to study entry while on therapy with other DMTs and ≥1 T1 Gd+ or ≥9 T2 lesions18
**Maximum of 20 days of oral treatment in the first 2 years. NEDA is defined as no relapses, no 3-month sustained change in EDSS score, and no new T1 gadolinium-enhancing lesions or active T2-weighted lesions
EDSS=Expanded Disability Status Scale; Gd+=gadolinium-enhancing; NEDA=no evidence of disease activity; T1=gadolinium-enhancing lesions; T2=active T2-weighted lesions

ONLY MAVENCLAD® CAN DELIVER AND SUSTAIN UP TO 4 YEARS OF DISEASE CONTROL WITH A MAXIMUM OF 20 DAYS OF ORAL DOSING IN THE FIRST 2 YEARS

TAILORED DOSING REGIMEN

Weight-based treatment annually for 2 years1,2

Illustrative example for a patient weighing 67 kg. Each treatment week consists of 4 or 5 days on which a patient receives 10 mg or 20 mg (one or two tablets) as a single daily dose, depending on body weight. Re-initiation of therapy after Year 4 has not been studied. MAVENCLAD® 10 mg tablets are not scored.

 

RELAPSE-FREE PATIENTS37

Patients who received MAVENCLAD® 3.5 mg/kg in the CLARITY trial and were randomised to placebo (no further treatment) in CLARITY EXT. No patients were relapse-free in the year prior to the CLARITY trial
  • The recommended dose of MAVENCLAD® is 3.5 mg/kg over 2 years, given in two treatment courses of 1.75 mg/kg/year
  • Each treatment course consists of two treatment weeks (week 1 and week 5), each of 4 or 5 days’ oral therapy
  • Patients require no further treatment with MAVENCLAD® in years 3 and 4
  • MAVENCLAD® dosage is calculated by patient weight
MAVENCLAD® Dosing Calculator
Find out the correct dose for your patients based on their weight.

FIND OUT MORE

VIEW REFERENCES

1. MAVENCLAD® Summary of Product Characteristics. Merck.
2. Giovannoni G, et al. N Engl J Med. 2010;362:416–26.
3. Giovannoni G, et al. N Engl J Med. 2010;362:416–26 (Supplementary information).
4. Giovannoni G, et al. Mult Scler. 2018;24:1594–1604.
5. Data on file CLAD005
6. Montalban X, et al. AAN. 2016;[P3.029].
7. Leist TP, et al. Lancet Neurol. 2014;13:257–67.
8. PREMIERE Clinical trials registry. Available at: https://clinicaltrials.gov/ct2/show/NCT01013350 [Accessed 19th November 2018].
9. Baker D, et al. Neurol Neuroimmunol Neuroinflamm. 2017;4:e360.
10. Soelberg-Sørensen P, et al. ENS. 2009;[P359].
11. Soelberg-Sørensen P, et al. ENS. 2010;[P442].
12. Giovannoni G. Neurotherapeutics. 2017;14:874-7.
13. Giovannoni G. Curr Opin Neurol. 2018;31:233–43.
14. Scolding N, et al. Pract Neurol. 2015;15:273–9.
15. Cook S, et al. AAN. 2016;[P3.058].
16. Giovannoni G, et al. Lancet Neurol. 2011;10:329–37.
17. Giovannoni G, et al. Mult Scler. 2018;doi: 10.1177/1352458518771875.
18. Giovannoni G, et al. ECTRIMS. 2017;[P1143].
19. Alemtuzumab Summary of Product Characteristics. Sanofi Genzyme.
20. Natalizumab Summary of Product Characteristics. Biogen.
21. Ocrelizumab Summary of Product Characteristics. Roche.
22. Cook S, et al. EAN. 2017;[P0543].
23. Cook S, et al. Mult Scler. 2011;17:578–93.
24. Cook S, et al. ECTRIMS-ACTRIMS. 2017;[P1142].
25. Galazka A, et al. ECTRIMS-ACTRIMS. 2017;[P1878].
26. MAVENCLAD® European Public Assessment Report, September 2017.
27. Soelberg-Sørensen P, et al. EAN. 2017;[EP3120]
28. Data on File, CLAD001 – Incidence of Lymphopenia, June 2018.
29. Pakpoor J, et al. Neurol Neuroimmunol Neuroinflamm. 2015;2:e158.
30. Stuve O, et al. ECTRIMS. 2017;[P690].
31. Soelberg-Sørensen P, et al. ECTRIMS. 2017;[P1141].
32. Cvetanovich GL, Hafler DA. Curr Opin Immunol. 2010;22:753–60.
33. Ceronie B, et al. J Neurol. 2018;265:1199–1209.
34. Leist TP, et al. Clin Neuropharmacol. 2011;34:28–35.
35. Giovanni G, et al. Mult Scler. 2017; doi:10.1177/1352458517727603.
36. Giovanni G, et al. EAN. 2017; [PO542].
37. Giovanni G, et al. ECTRIMS. 2016.

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Reporting Adverse Events
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk. In the Republic of Ireland information can be found at www.hpra.ie. Adverse events should also be reported to Merck Serono Limited – Tel: +44(0)20 8818 7373 or email: medinfo.uk@merckgroup.com.