In ASCLEPIOS I and II vs Aubagio® (teriflunomide): Primary end point, ARR 51% (0.11 vs 0.22), 58% (0.10 vs 0.25). Key secondary end points: number of Gd+ T1 lesions per scan 98% (0.01 vs 0.46), 94% (0.03 vs 0.52); annualized rate of new or enlarging T2 lesions 82% (0.72 vs 4.00), 85% (0.64 vs 4.16); 3-month CDP 34% (10.9 vs 15.0).1
No conclusions of clinical outcomes can be drawn.
*Defined as no 6-month confirmed disability progression, no confirmed MS relapse, no new/enlarging T2 lesions, and no Gd+ T1 lesions.
NEDA-3 post hoc analysis study design | |
POPULATION | All patients from the pivotal trial full analysis set population (all randomized patients with assigned treatments) and who received KESIMPTA in the ALITHIOS extension study (data cutoff: September 25, 2022) were included in the intent-to-treat principle, but patients who discontinued from the study drug prematurely for reasons other than “lack of efficacy” or “death” and had NEDA-3 before early discontinuations were excluded.2,4 |
METHODS | The outcomes presented here are the proportion of study patients within a treatment group who met the NEDA-3 criteria vs those who did not. The proportion of patients meeting NEDA-3 criteria was analyzed cross-sectionally in 1-year time intervals across 5 years.2,4 |
NEDA-3 Criteria4 Within the prespecified time period, patients who achieved NEDA-3 experienced no
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% Achieving NEDA-33 Calculated as n/M, where n is the number of patients who achieved NEDA-3 and M is the total number of patients in the treatment group. | |
Re-baselining After Year 1
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LIMITATIONS | This analysis considers patients without evidence of disease activity (which may also include patients with partially missing information) as NEDA-3. A sensitivity analysis was conducted for the population of patients who completed the full 24 months of treatment.4 |
Actual patient taking KESIMPTA who was compensated for time. Individual results may vary.
ARR, annualized relapse rate; CDP, confirmed disability progression; CI, confidence interval; DMT, disease-modifying therapy; Gd+, gadolinium-enhancing; MOA, mechanism of action; MS, multiple sclerosis; NE, new or enlarging; OR, odds ratio.
Contraindication: KESIMPTA is contraindicated in patients with active hepatitis B virus (HBV) infection.
Warnings and Precautions
Infections: Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with anti-CD20 B-cell depleting therapies....
KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults...
