What the trial was testing
The ASCLEPIOS II enrolled 955 patients with multiple sclerosis. The study was sponsored by Novartis and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
People on ofatumumab had 51% fewer relapses per year and 98% fewer new active brain lesions compared to those taking teriflunomide.
New England Journal of Medicine · 2020 · NCT02792231
These findings — that ofatumumab reduced the annualized relapse rate by more than half compared to the standard daily oral treatment — were published in the New England Journal of Medicine and represent the headline result of the study.
Researchers tracked outcomes across 955 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with multiple sclerosis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Ofatumumab (Kesimpta) is now FDA-approved for relapsing MS and available as a monthly self-injection you do at home with a pen device. If you have relapsing MS — especially if a current drug is not controlling relapses well — ask your neurologist whether ofatumumab is a good fit for your situation.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open multiple sclerosis trials
Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis
The aim of the study is to assess the association between bladder sensations progression during bladder filling and severity of Overactive bladder (OAB) in patients with multiple sclerosis.
Cohort Study on Neuroimmune Diseases in the Reproductive Age
Neuroimmune diseases are more prevalent among women of reproductive age. Studies have shown that neuroimmune diseases may impact fertility. Therefore, effective management of neuroimmune diseases during pregnancy is particularly important. This study included a follow-up period of up to five years in patients with pregnancy-associated neuroimmune disorders. Data collected included relapse frequency, symptomatology, imaging findings, treatment regimens, peripheral blood profiles, EDSS scores, and MRI results. In addition, maternal drug concentrations, postpartum relapse rates, and neonatal development were monitored after delivery. Following the successful completion of the five-year follow-up, the research team plans to continue the prospective epidemiological study with ten-year follow-up phases. The aim of this study is to generate detailed clinical data on pregnancy-associated autoimmune diseases and to equip clinicians with evidence-based strategies for optimizing disease management during the reproductive age.