DMT20
Longer-Term Effects of Ofatumumab on Clinical and MRI Outcomes in Patients with Relapsing Multiple Sclerosis

Thursday, June 2, 2022
Prince George's Exhibit Hall (Gaylord National Resort & Convention Center)
Derrick Robertson, MD , College of Medicine, Neurology, University of South Florida, Tampa, FL
Stephen L Hauser, PhD , UCSF Weill Institute for Neurosciences, University of California, San Francisco, CA
Edward J Fox, MD, PhD , Central Texas Neurology Consultants, University of Texas Medical Branch, Round Rock, TX
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
Jeffrey A Cohen, MD , Mellen MS Center, Cleveland Clinic, Cleveland, OH
Angela Aungst, MPH , Multiple Sclerosis Division Department of Neurology University of South Florida, Florida, FL
Wendy Su, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Ronald Zielman, MD, PhD , Novartis Pharma B.V., Amsterdam, Netherlands
Jing Xi, PhD , China Novartis Institutes For Biomedical Research Co., Ltd., Shanghai, China
Ayan Das Gupta, MSc , Novartis Healthcare Pvt. Ltd., Hyderabad, India
Dee Stoneman, MPharm , Novartis Pharma AG, Basel, Switzerland
PDF


Background:

The Phase 3 ASCLEPIOS I/II trials demonstrated the superiority of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis (RMS) by reducing annualized relapse rate (ARR), suppressing MRI lesion activity and delaying disability worsening, while maintaining a favorable safety profile. Evaluation of the longer-term efficacy of ofatumumab treatment continues to be important.

Objectives:

To assess the longer-term efficacy of ofatumumab treatment for up to 4 years in patients with RMS.

Methods:

This analysis will include cumulative data from patients randomized to ofatumumab/teriflunomide in the ASCLEPIOS I/II trials (core study) and followed up to data cut-off: 25-Sep-2021, the majority patients had entered the ongoing, open-label, ALITHIOS extension study. In ALITHIOS, patients randomized to ofatumumab in the core study continued with ofatumumab treatment (continuous group) and those randomized to teriflunomide in the core study were switched to ofatumumab (switch group). ARR, disability worsening (time-to-3-month/6-month confirmed disability worsening), disability improvement (time-to-6-month confirmed disability improvement), and MRI outcomes (number of Gd+T1 lesions and annualized T2 lesion rate) will be assessed.

Results:

Of 1882 patients randomized in the ASCLEPIOS I/II trials (ofatumumab/teriflunomide: 946/936), 1367 patients enrolled into ALITHIOS (continuous/switch: 690/677; 88.8% ongoing for both groups). Baseline demographics and disease characteristics of the continuous (baseline from core) and switch (baseline from extension) groups include: mean age, ~38 years (continuous), ~40 years (switch); female, ~67% (both groups); mean BMI, ~26 kg/m2 (both groups); mean EDSS, ~2.9 (both groups); treatment-naive patients, 40.8% (continuous) and 38.8% (switch; baseline from core); mean number of Gd+T1 lesions, 1.7 (continuous) and 0.8 (switch); mean volume of T2 lesions, 13.7 cm3 (continuous) and 12.6 cm3 (switch; baseline from core); treatment exposure, 2761.4 PY (continuous) and 1271.1 PY (switch). Updated efficacy results for up to 4 years of ofatumumab treatment will be presented at the congress.

Conclusions:

These analyses will provide further insights on the longer-term effects of continuous ofatumumab treatment for up to 4 years, and the effects of switching from teriflunomide to ofatumumab and providing further evidence to support the benefit/risk profile of ofatumumab.

See more of: Disease-Modifying Therapy
See more of: Posters
<< Previous Abstract | Next Abstract >>