Abstract: Efficacy of Ofatumumab in Treatment-Naive, First-Switch and Late-Switch Patients: Insights from the Alithios Open-Label Extension Study (2022 Annual Meeting of the Consortium of Multiple Sclerosis Centers)

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Efficacy of Ofatumumab in Treatment-Naive, First-Switch and Late-Switch Patients: Insights from the Alithios Open-Label Extension Study

Thursday, June 2, 2022

Prince George's Exhibit Hall (Gaylord National Resort & Convention Center)

Jeffrey A Cohen, Dr. , Department of Neurology, Mellen MS Center, Neurological Institute, Cleveland Clinic, Cleveland, OH

Ralf Gold, MD , Department of Neurology, St Josef-Hospital, Ruhr-University Bochum, Bochum, Germany

Jerome De Seze, Dr. , University Hospital of Strasbourg, Strasbourg, France

Derrick S Robertson, MD , Multiple Sclerosis Division, Department of Neurology, University of South Florida, Tampa, FL

Heinz Wiendl, MD, MPH , University of Muenster, Muenster, Germany

Sibyl Wray, MD , Hope Neurology MS center, Knoxville, TN

Francesco Sacca, MD , NSRO Department, University “Federico II” of Naples, Naples, Italy

Amin Azmon, PhD , Novartis Pharma A.G., Basel, Switzerland

Miriam King, BA (Hons) , Novartis Pharma A.G., Basel, Switzerland

Simone Fantaccini, MD , Novartis Pharma A.G., Basel, Switzerland

Ronald Zielman, MD, PhD , Novartis Pharma B.V., Amsterdam, Netherlands

Ludwig Kappos, MD , Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB) and MS Center, Departments of Head, Spine and Neuromedicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University of Basel, Basel, Switzerland

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Background:

Ofatumumab (OMB), a fully human anti-CD20 monoclonal antibody, reduced annualized relapse rate (ARR), MRI lesion activity, and delayed disability worsening versus teriflunomide (TER) in relapsing multiple sclerosis (RMS) patients who were treatment-naive (TN) or previously treated (PT) with disease-modifying therapies (DMTs) in the Phase 3 ASCLEPIOS I/II trials. All patients entering the ALITHIOS extension study were switched to open-label OMB allowing further insights into OMB efficacy in TN/PT patients and after first and late DMT switch.

Objectives:

To compare clinical and MRI outcomes in patients initiating OMB early versus switching to OMB after one or multiple previous DMTs in the ASCLEPIOS I/II and ALITHIOS studies.

Methods:

Outcomes from ASCLEPIOS I/II (ARR, time-to-6-month confirmed disability worsening [6mCDW], number of Gd+T1 lesions, and annualized T2 lesion rate) for TN and PT patients are presented here. Further analyses to be presented at the congress will compare these outcomes in ASCLEPIOS (up to 30 months treatment) with outcomes over 18 months in ALITHIOS (i.e., post-switch to open-label OMB; data cut-off: 25-Sep-2021) in the following four groups: 1) Early TN: TN patients randomized to OMB in ASCLEPIOS I/II and continued OMB in ALITHIOS); 2) First switch: TN patients randomized to TER in ASCLEPIOS I/II and switched to OMB in ALITHIOS; 3) Late switch: patients PT with ≥1 DMTs, randomized to TER in ASCLEPIOS I/II and switched to OMB in ALITHIOS ; 4) PT-Longer term: patients who were PT, randomized to OMB in ASCLEPIOS I/II and continued OMB in ALITHIOS.

Results:

In ASCLEPIOS I/II, 1882 patients were randomized and OMB versus TER reduced the ARR by 51% and 53% in the TN (n=749) and PT (n=1133) subgroups, respectively. For 6mCDW, the risk reductions were 36% and 28%; new/enlarging T2 lesions were reduced by 83% and 85%, respectively. Gd+ T1 lesions were reduced by 95% across both subgroups. These findings were in line with the overall ASCLEPIOS I/II population. The analysis from ALITHIOS will be based on the 1367/1882 (72.6%) patients who entered open-label extension study.

Conclusions:

OMB shows consistent efficacy in patients who were TN or switched from other DMTs. Further insights from ALITHIOS on efficacy outcomes following the initiation of OMB early versus first and late switch will be presented at the congress.

8385 Efficacy of Ofatumumab in Treatment-Naive, First-Switch and Late-Switch Patients: Insights from the Alithios Open-Label Extension Study

8385
Efficacy of Ofatumumab in Treatment-Naive, First-Switch and Late-Switch Patients: Insights from the Alithios Open-Label Extension Study