| Title: |
Durability of no evidence of disease activity-3 (NEDA-3) in patients receiving cladribine tablets: The CLARITY extension study |
| Authors: |
Giovannoni, Gavin; Singer, Barry A; Issard, Delphine; Jack, Dominic; Vermersch, Patrick |
| Source: |
Multiple Sclerosis Journal ; volume 28, issue 8, page 1219-1228 ; ISSN 1352-4585 1477-0970 |
| Publisher Information: |
SAGE Publications |
| Publication Year: |
2021 |
| Description: |
Background: No evidence of disease activity (NEDA-3) is a patient-centric outcome increasingly used as the goal of multiple sclerosis treatment. Objective: Determine treatment durability of cladribine tablets beyond 2 years considering the variable bridging interval of 0.1–116.0 weeks between CLARITY and CLARITY Extension. Methods: Between CLARITY and CLARITY Extension, patients transitioned from cladribine tablets 3.5 mg/kg to placebo (CP3.5 group, n = 98) or continued further treatment with cladribine tablets 3.5 mg/kg (CC7.0 group, n = 186). Treatment assignment was randomized and blinded in both CLARITY and CLARITY Extension. Results: The 2-year NEDA-3 in CLARITY Extension (encompassing both years of CLARITY Extension) was 29.6% in the CP3.5 group and 32.8% in the CC7.0 group. There was no evidence that treatment effect differed with varying bridging intervals. For patients in the CP3.5 group with a bridging interval of ⩽48 weeks, 1 year NEDA-3 (the first year of CLARITY Extension) was 44.4% (28/63) compared with 31.4% (11/35) in patients with a bridging interval of >48 weeks. Conclusion: Treatment with cladribine tablets in CLARITY, followed by either placebo or cladribine tablets in CLARITY Extension, produced sustained benefits for NEDA-3 and its constituent elements for a follow up period up to 6 years from CLARITY baseline. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1177/13524585211049392 |
| Availability: |
https://doi.org/10.1177/13524585211049392; https://journals.sagepub.com/doi/pdf/10.1177/13524585211049392; https://journals.sagepub.com/doi/full-xml/10.1177/13524585211049392 |
| Rights: |
https://creativecommons.org/licenses/by-nc/4.0/ |
| Accession Number: |
edsbas.F82CE3B3 |
| Database: |
BASE |