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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 evidence of disease activity (NEDA-3) long-term data2,3

9 out of 10 patients taking KESIMPTA® (ofatumumab) achieved NEDA-3* in year 5

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


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


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

  • 6-month CDP

  • Confirmed relapse

  • ≥1 Gd+ T1 lesions

  • ≥1 NE T2 lesions

  • Discontinuation from the study due to either lack of efficacy or death

% 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

  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 04

  2. Analyses of NEDA-3 using a re-baselining approach may more closely reflect the effects of DMTs5

  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 state5


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

“My doctor recommended Kesimpta to help reduce the number of relapses I experience.” – Kristin: mother, real estate agent, Kesimpta patient.

"My doctor recommended KESIMPTA to help reduce the number of relapses I experience."

Kristin: mom, real estate agent, KESIMPTA patient

Real 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.

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References: 1. Kesimpta. Prescribing information. Novartis Pharmaceuticals Corp. 2. Kappos L, Cohen JA, Gold R, et al. Five-year efficacy outcomes of ofatumumab in relapsing MS patients: insights from ALITHIOS open-label extension study. EPR-097. Presented at: 9th Congress of the European Academy of Neurology; July 1-4, 2023; Budapest, Hungary. 3. Data on file. Summary of NEDA-3 components per year. Novartis Pharmaceuticals Corp; East Hanover, NJ. 2023. 4. Data on file. OMB157G (ofatumumab). Statistical overview. Novartis Pharmaceuticals Corp; East Hanover, NJ. December 2019. 5. 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.