POST HOC ANALYSIS
In ASCLEPIOS I and II vs Aubagio: 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).
KESIMPTA® (ofatumumab) post hoc analysis of pooled data from ASCLEPIOS I and II
KESIMPTA NEDA-3 outcomes
Review ASCLEPIOS I and II Study DesignNo evidence of disease activity (NEDA-3)
Post hoc analysis of ASCLEPIOS I and II studies2
Post hoc analysis of ASCLEPIOS
I and II studies2
Up to 9 out of 10 patients
taking KESIMPTA achieved
NEDA-3 in year 2
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.
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NEDA-3 post hoc analysis study design
POPULATION
All patients from the pivotal trial full analysis set population (all randomized patients with assigned treatments) 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.3
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 time intervals including year 1 (month 0-12) or in year 2 (month 12-24).3
NEDA-3 Criteria3
Within the prespecified time period (ie, 0-12 months and 12-24 months), patients who achieved NEDA-3 experienced no
- 6-month CDP
- Confirmed relapse
- ≥1 Gd+ T1 lesions
- ≥1 T2 lesions
- Discontinuation from the study drug due to either lack of efficacy or death
% Achieving NEDA-3
Calculated as n/N, where n is the number of patients who achieved NEDA-3 and N is the total number of patients in the treatment group.2
Re-baselining After Year 1
- 1. For the year 2 (12-24 month) analysis, all components of NEDA-3 were re-baselined, meaning outcomes were recalculated relative to the month 12 baseline vs month 03
- 2. Analyses of NEDA-3 using a re-baselining approach may more closely reflect the effects of DMTs4
- 3. Re-baselining is utilized to reflect a truer representation of a DMT's steady state of efficacy unconfounded by any initial disease activity carried over from baseline and recent prebaseline disease state4
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.3
reduce the number of relapses I experience.
Kristin: mom, real estate agent, KESIMPTA patient†
†Actual KESIMPTA patient who was compensated for their time. Individual results may vary.
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VISIT COVERMYMEDS®ARR=annualized relapse rate; CDP=confirmed disability progression; CI=confidence interval; DMT=disease-modifying therapy; Gd+=gadolinium-enhancing; K-M=Kaplan-Meier; MOA=mechanism of action; MS=multiple sclerosis.
References: 1. Hauser SL, Bar-Or A, Cohen JA, et al. Ofatumumab vs teriflunomide in relapsing multiple sclerosis: analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOS I and II trials. LB62. Poster presented at: 6th Congress of the European Academy of Neurology; May 23-26, 2020;Virtual. 2. Data on file. OMB157G (ofatumumab). Summary of clinical efficacy in relapsing multiple sclerosis. Novartis Pharmaceuticals Corp; East Hanover, NJ. December 2019. 3. Data on file. OMB157G (ofatumumab) OMB157G 5.3.5.3. Statistical overview. Novartis Pharmaceuticals Corp; East Hanover, NJ. December 2019. 4. Giovannoni G, Turner B, Gnanapavan S, Offiah C, Schmierer K, Marta M. Is it time to target no evident disease activity (NEDA) in multiple sclerosis? Mult Scler Relat Disord. 2015;4(4):329-333.