Apr 16, 2021
  • Kesimpta reduced the risk of disability progression independent of relapse activity (PIRA) by up to almost 60% vs first-line teriflunomide in a subgroup of newly diagnosed, treatment-naïve patients with relapsing forms of multiple sclerosis (RMS) according to new post hoc data from the Phase III ASCLEPIOS trials, further supporting Kesimpta as a first-choice treatment option for adults with RMS1

  • More than 50% of confirmed disability worsening events in newly diagnosed, treatment-naïve RMS patients were PIRA, an emerging endpoint used in MS trials to measure disability worsening independent of relapses, indicating that disease progression starts early1

  • Emerging open-label extension study data from the ALITHIOS trial showed that with this targeted B-cell therapy, precisely delivered through subcutaneous administration, mean serum IgM/IgG levels remained within the reference ranges over a three-year period to December 20202

Basel, April 16, 2021 — Novartis announced today new post hoc data from the Phase III ASCLEPIOS trials showing Kesimpta® (ofatumumab) reduced the risk of disability progression independent of relapse activity (PIRA) at three and six months vs teriflunomide in a subgroup of newly diagnosed, treatment-naïve patients with relapsing forms of multiple sclerosis (RMS)1. These data, to be presented at the American Academy of Neurology (AAN) Annual Meeting being held virtually on April 17-22, 2021, further support Kesimpta as a first-choice treatment option for adults with RMS.

“This PIRA analysis shows more than half of the disability worsening events experienced by patients with early RMS were occurring regardless of whether they experienced relapses,” said Jacqueline A. Nicholas, MD, MPH, System Chief Neuroimmunology & MS, OhioHealth MS Center, Riverside Methodist Hospital, Columbus, Ohio. “Kesimpta reduced this risk of progression by up to almost 60% versus teriflunomide, reinforcing the importance of early intervention with high-efficacy treatment to address underlying disease progression before irreversible damage occurs.”

“Evidence shows that progression occurs in people living with MS in the early stages of disease. This reinforces the need to treat early with a first-choice treatment like Kesimpta, which combines powerful efficacy with a favorable safety profile and can be self-administered at home,” said Estelle Vester-Blokland, Global Head Neuroscience Medical Affairs, Novartis Pharmaceuticals. “We are dedicated to advancing the scientific understanding of underlying progression so that we can ultimately improve the quality of life for people living with this chronic disease.”

All abstracts will be published in the journal Neurology following the meeting.

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About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

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  1. Kappos L, Montalban X, Coyle P, et al. Ofatumumab reduces disability progression independent of relapse activity in patients with relapsing multiple sclerosis. ePoster presentation at Virtual AAN Meeting; April 2021.
  2. Cross AH, Delgado S, Habek M, et al. Characteristics and outcome of COVID-19 in patients with relapsing multiple sclerosis receiving ofatumumab. ePoster presentation at Virtual AAN Meeting; April 2021.

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