No-evidence of disease activity (NEDA) means
- No Clinical Relapse
- No New Lesion activity
- No progression of EDSS
ProfG works some magic with Oreclizumab to make it better than any other chemical DMT.
What's he done?
Ocrelizumab has become the first treatment for PPMS but there have been complaints that the trials was loaded with people with active disease and so it would respond to treatment as shown with the earlier rituximab studies. However, is this not learning from the past and adapting studies to show a positive effect.
In this study, they rebaseline the MRI and the NEDA rates increase from about 45-50% to closer to 75%.
Is this a fudge too? Again it is learning from biology.
It appears that once triggered disease activity is destined to occur and it is too late to stop it with DMT. So rather than comparing to when drugs are started you give it a few months to work. Then use this as a baseline.
I predict that thiis will become the norm from now on.
Havrdová E, Arnold DL, Bar-Or A, Comi G, Hartung HP, Kappos L, Lublin F, Selmaj K, Traboulsee A, Belachew S, Bennett I, Buffels R, Garren H, Han J, Julian L, Napieralski J, Hauser SL, Giovannoni G. No evidence of disease activity (NEDA) analysis by epochs in patients with relapsing multiple sclerosis treated with ocrelizumab vs interferon beta-1a.
Mult Scler J Exp Transl Clin. 2018 Mar 12;4(1):2055217318760642.
BACKGROUND: No evidence of disease activity (NEDA; defined as no 12-week confirmed disability progression, no protocol-defined relapses, no new/enlarging T2 lesions and no T1 gadolinium-enhancing lesions) using a fixed-study entry baseline is commonly used as a treatment outcome in multiple sclerosis (MS).
OBJECTIVE:The objective of this paper is to assess the effect of ocrelizumab on NEDA using re-baselining analysis, and the predictive value of NEDA status.
METHODS:NEDA was assessed in a modified intent-to-treat population (n = 1520) from the pooled OPERA I and OPERA II studies over various epochs in patients with relapsing MS receiving ocrelizumab (600 mg) or interferon beta-1a (IFN β-1a; 44 μg).
RESULTS: NEDA was increased with ocrelizumab vs IFN β-1a over 96 weeks by 75% (p < 0.001), from Week 0‒24 by 33% (p < 0.001) and from Week 24‒96 by 72% (p < 0.001). Among patients with disease activity during Weeks 0‒24, 66.4% vs 24.3% achieved NEDA during Weeks 24‒96 in the ocrelizumab and IFN β-1a groups (relative increase: 177%; p < 0.001).
CONCLUSION: Superior efficacy with ocrelizumab compared with IFN β-1a was consistently seen in maintaining NEDA status in all epochs evaluated. By contrast with IFN β-1a, the majority of patients with disease activity early in the study subsequently attained NEDA status with ocrelizumab.
CoI : ProfG is a coauthor of this work.
Labels: NEDA, ocrelizumab