New data from the ALITHIOS open-label extension study were announced at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which was held in Copenhagen..
These data demonstrate that first-line treatment with ofatumumab for up to six years led to less disability and less disease progression in people with recently diagnosed (≤ 3 years) and treatment-naïve relapsing multiple sclerosis (MRS) (Recently Diagnosed and Treatment NaïveRDTN), compared to those who switched to ofatumumab from teriflunomide therapy.
The phase IIIb OLIKOS study a single arm conducted in the United States also demonstrated that at 12 months all patients with clinically stable Relapsing Multiple Sclerosis who switched from intravenous (IV) anti-CD20 therapy to self-administered ofatumumab did not find new T1 lesions capturing the gadolinium compared to baseline.
“These data demonstrate that people recently diagnosed with relapsing multiple sclerosis who received ofatumumab in the first line had fewer events of worsening of disability and a greater probability of being free from progression – observes Marinella Clerico, Head of SSD Specialist Neurological Pathologies, AOU San Luigi Gonzaga and Associate Professor of the Department of Clinical and Biological Sciences UniTo – Encouraging results that demonstrate how the early adoption of a highly effective therapy brings a significant benefit for the patient, both in terms of disease control and quality of life ”.
“Novartis has been engaged in research and development in neuroinflammatory diseases for more than 80 years. Therapeutic evolution today allows us to be increasingly effective in the treatment of relapsing multiple sclerosis – underlines Paola Coco, Medical Affairs Head of Novartis Italia – But our goal is to obtain increasingly better outcomes and reduce the progression of disability: for this reason we continue to study the efficacy and safety of our molecules in different populations of people affected by this disease and we promote research programs focusing on other targets and innovative platforms.”
Lo studio ALITHIOS
Data from the overall ALITHIOS study population demonstrated that continued use of ofatumumab is associated with numerically fewer confirmed disability worsening events at 6 months (6mCDW) and progression regardless of relapse activity at 6 months ( 6mPIRA) for up to six years, compared to those who switched to ofatumumab from teriflunomide therapy. These benefits appeared most pronounced in the treatment-naive subgroup (RDTN), consisting of people who started ofatumumab as their first treatment within three years of diagnosis.
RDTN patients treated with ofatumumab continuously were more likely to remain confirmed disability-free at 6 months than those switched to ofatumumab from teriflunomide therapy (83.4% vs. 76.3%)
RDTN patients treated with ofatumumab continuously were also more likely to be progression-free regardless of relapse activity at 6 months compared to those switched to ofatumumab from teriflunomide therapy (88.9% vs 83.3% ).
Limitations of the findings include potential bias associated with withdrawing subjects from the study and the open-label nature of the extension study.
No new T1 lesions in patients who switched from intravenous therapy to ofatumumab. The OLIKOS studio
The OLIKOS study, conducted in the United States, analyzed 102 patients with clinically stable RMS who switched from previous intravenous anti-CD20 therapy (99% from ocrelizumab) to ofatumumab. For 84 patients with available MRI results, no new T1 Gd+ lesions were observed at 12 months, the primary endpoint of the study.
Additionally, 98% of patients did not develop new/expanding T2 (NeT2) lesions at 12 months, an exploratory endpoint in the study.
Treatment-emergent adverse events (TEAEs) occurred at a similar frequency to the ASCLEPIOS phase III clinical trials, with no new safety events to report identified. The most commonly reported TEAEs (≥ 10%) were COVID-19, headache, fatigue, and urinary tract infection. Mean serum immunoglobulin G and M (IgG and IgM) levels remained stable for up to 12 months2.
“Our study of patients with relapsing multiple sclerosis who switched from high-efficacy intravenous treatment to self-administered subcutaneous ofatumumab showed a sustained absence of Gd+ T1 lesions for up to one year,” concludes principal investigator Le Hua. , director of clinical operations at the Cleveland Clinic – Ofatumumab is an effective treatment that gives RMS patients the flexibility to self-administer anti-CD20 therapy at home.”