MAVENCLAD effectiveness was studied in CLARITY, a Phase III, multicenter, randomized, double-blind, placebo-controlled clinical trial vs placebo in patients with RRMS. Patients were recruited from 155 clinical centers in 32 countries.2 Out of 1,326 patients randomized, 1,184 patients completed the study at 96 weeks (2 years).2
*The approved dose for MAVENCLAD is 3.5 mg/kg. Cladribine 5.25 mg/kg dose is not included in MAVENCLAD Prescribing Information clinical study results; no data will be discussed.1
Patients were eligible if they met certain criteria, including at least 1 MS relapse within the past 12 months, EDSS scores ≤5.5, and <2 prior DMT failures.2
Select exclusion criteria included2,3:
†In CLARITY, the baseline demographics and clinical characteristics were well balanced across study groups, except for mean disease duration, which was shorter in the MAVENCLAD group (7.9 years) than the placebo group (8.9 years) (P=0.005).2
‡A relapse was defined as a 2-point increase in ≥1 functional system of the EDSS or a 1-point increase in ≥2 functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for ≥24 hours and preceded by ≥30 days of clinical stability or improvement.2
§Disability progression was measured in terms of a 3-month sustainedchange in EDSS score of at least 1 point, if the baseline EDSS score was between 0.5 and 4.5 inclusively, or at least 1.5 points if the baseline EDSS score was 0, or at least 0.5 point if the baseline EDSS score was at least 5, over a period of at least 3 months.2
CLARITY: CLAdRIbine Tablets treating multiple sclerosis orallY; DMT: disease-modifying therapy; EDSS: Expanded Disability Status Scale; RRMS: relapsing-remitting MS; T1-Gd+: T1 gadolinium-enhanced.
MAVENCLAD® (cladribine) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS.
Limitations of Use: MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.
WARNING: MALIGNANCIES and RISK OF TERATOGENICITY
WARNINGS AND PRECAUTIONS
Adverse Reactions: The most common adverse reactions (incidence of >20%) are upper respiratory tract infection, headache, and lymphopenia.
Drug Interactions: Concomitant use of with immunosuppressive or myelosuppressive drugs and some immunomodulatory drugs (e.g., interferon beta) is not recommended and may increase the risk of adverse reactions. Acute short-term therapy with corticosteroids can be administered. Monitor for additive effects on the hematological profile with use of hemotoxic drugs. Avoid concomitant use of antiviral and antiretroviral drugs. Avoid concomitant use of BCRP or ENT/CNT inhibitors as they may alter bioavailability of MAVENCLAD.
Use in Specific Populations: Studies have not been performed in pediatric, or elderly patients >65 years, pregnant or breastfeeding women. Use in patients with moderate to severe renal or hepatic impairment is not recommended.
To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono, Inc. at 1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.