Superior ARR reductions of up to 58% vs Aubagio

Primary end point: relative reduction in annualized relapses vs Aubagio^® (teriflunomide)^1-3

*Based on ARR primary end point results.

KESIMPTA provided early and continued relapse reduction over the study period^4,5*

Post hoc analysis of pooled data from ASCLEPIOS I and II

Cumulative ARR by time interval

n=total number of patients included in the analysis.
No conclusions can be drawn.

Post hoc study design: ARR by time intervals was analyzed from the pooled pivotal trials. The ARR (95% CI) was estimated separately for each time interval by fitting a negative binomial regression model adjusted for treatment as factor.⁴

*Reduction in ARR seen in the first 3 months and time intervals over 2 years.

Long-term ARR reductions in patients who remained on KESIMPTA and those who switched from Aubagio to KESIMPTA⁶

ALITHIOS study design: ALITHIOS (N=1703) was an open-label, umbrella extension, Phase 3b, single-arm study evaluating long-term (up to 5 years) safety, tolerability, and effectiveness of KESIMPTA (20 mg SC) in subjects with RMS. The study enrolled 1367 RMS patients from the ASCLEPIOS I and II trials who continued KESIMPTA treatment. Of these, 1145 patients were still receiving KESIMPTA at 5 years. A long-term safety analysis was conducted to evaluate IgM/IgG levels and their association with serious infection. 1416 patients were still receiving KESIMPTA at 5 years.^6-10

Limitations: This analysis represents chance findings. The open-label extension study was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. No conclusions of statistical or clinical significance can be drawn.

Near complete suppression of Gd+ T1 and T2 lesion activity^1,11

Profound reduction in active inflammatory Gd+ T1 lesions vs Aubagio

Up to 98% reduction in mean Gd+ T1 lesions per scan^*

Superior reductions in T2 lesions vs Aubagio

Up to 85% reduction in mean NE T2 lesions per year^*

NE, new or enlarging.
Negative binomial regression model.
*At 96 weeks.

Long-term MRI lesion activity in patients who remained on KESIMPTA and those who switched from Aubagio to KESIMPTA⁶

Gd+ T1 lesions over time

NE T2 lesions over time

Limitations: This analysis represents chance findings. The open-label extension study was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. No conclusions of statistical or clinical significance can be drawn.

ARR reduction in recently diagnosed treatment-naïve patients on first-line KESIMPTA vs Aubagio¹²

MRI lesion activity in recently diagnosed treatment-naïve patients on first-line KESIMPTA vs Aubagio¹²

This post hoc study assessed the benefit–risk profile of KESIMPTA vs Aubagio, comprising clinical and MRI data in a subpopulation of recently diagnosed treatment-naïve participants from the combined ASCLEPIOS I and II trial populations.

Post hoc study design: Efficacy and safety data were drawn from the pooled ASCLEPIOS subpopulation of protocol-defined treatment-naïve patients who were within 0.1–2.9 years from diagnosis (median 0.35 and 0.36 years for KESIMPTA and Aubagio patients, respectively). Of the 1882 participants randomly assigned to treatment in ASCLEPIOS I and II, 615 (32.7%) were both recently diagnosed and treatment naïve at baseline (KESIMPTA, 314; Aubagio, 301).

No conclusions can be drawn.

In a prespecified meta-analysis of pooled data from ASCLEPIOS I and II, KESIMPTA reduced the risk of CDP vs Aubagio.^1,11,13

Proportion of patients with 3-month CDP refers to Kaplan-Meier estimates at month 24.

In the extension study, at 5 years^6,14

•  Cumulative 3-month disability progression: KESIMPTA initiators, 21.7%; Aubagio to KESIMPTA switch, 24.8%

• Cumulative 6-month disability progression: KESIMPTA initiators, 18.5%; Aubagio to KESIMPTA switch, 21% 

Limitations: This analysis represents chance findings. The open-label extension study was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. This study is an ongoing trial and the data presented are an interim analysis. No conclusions of statistical or clinical significance can be drawn at 5 years in the extension study.

Disability progression was defined as an increase in EDSS of at least 1.5, 1, or 0.65 points in patients with a baseline EDSS of 0, 1 to 5, or 5.5 or greater, respectively.

Real patient taking KESIMPTA who was compensated for time. Individual results may vary.

ARR, annualized relapse rate; CDP, confirmed disability progression; CI, confidence interval; EDSS, Expanded Disability Status Scale; Gd+, gadolinium-enhancing; IgG, immunoglobulin G; IgM, immunoglobulin M; MOA, mechanism of action; MRI, magnetic resonance imaging; MS, multiple sclerosis; RMS, relapsing multiple sclerosis; SC, subcutaneous.