Novartis presents data at ACTRIMS-ECTRIMS for Kesimpta in newly diagnosed treatment-naïve adults with relapsing multiple sclerosis.

Novartis announced new post hoc data showing the efficacy and safety of Kesimpta (ofatumumab), a targeted B-cell therapy, in patients with relapsing forms of multiple sclerosis (RMS) who are newly diagnosed as well as ongoing safety study findings . These data—presented at the MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting taking place on September 11–13, 2020—further support Kesimpta as a first-choice treatment option for adults with RMS.“These encouraging data show that newly diagnosed and treatment-naïve patients may benefit from lower disease activity when treated with Kesimpta,” said Dr. Amit Bar-Or, University of Pennsylvania. A post hoc analysis from the Phase III ASCLEPIOS I and II trials (n=615) evaluated the efficacy and safety profile of treatment with Kesimpta in a subgroup of patients with early RMS (newly diagnosed and treatment-naïve). Baseline characteristics of the newly diagnosed (within three years before screening), treatment-naïve (no prior disease-modifying therapy use) subgroup were typical of early MS patients (median age and MS duration since diagnosis were 36 and 0.35 years, respectively). The study results showed Kesimpta significantly reduced the annualized relapse rate (ARR) by 50.3% (0.09 vs 0.18) compared with teriflunomide (P<.001). kesimpta significantly reduced the mean number of both gadolinium-enhancing (gd+) t1 lesions by 95.4% (0.02 vs 0.39; p><.001) and new or enlarging t2 lesions by 82.0% (0.86 vs 4.78; p><.001) compared with teriflunomide. kesimpta also showed a relative risk reduction of 38% (p=".065)" in 3-month confirmed disability worsening (cdw) and a significant relative risk reduction of 46% (p=".044)" in 6-month cdw. an additional post hoc analysis presented in the same poster at msvirtual2020 showed that the odds of achieving no evidence of disease activity (neda-3; no relapses, no mri lesions, and no disability worsening combined) with kesimpta versus teriflunomide in the same newly diagnosed, treatment-naïve subgroup were greater than 3-fold higher at the first year (47.0% vs 24.7% of patients; p><.001) and greater than 14-fold higher at the second year of treatment (92.1% vs 46.8% of patients, p><.001). overall, kesimpta had a similar safety profile to teriflunomide. a separate safety analysis (n="1,873)" of the ongoing phase iiib alithios trial reported on the extended exposure of kesimpta in patients with rms . the alithios trial included patients who either continued on kesimpta treatment from the phase iii asclepios trials or the phase ii aplios trial (continuous) or switched from teriflunomide in the asclepios trials to kesimpta (newly-switched). the results showed no new safety signals, highlighting that the safety profile of kesimpta in rms patients remains consistent with data reported in the core studies. “collectively, these data add to the body of evidence that shows kesimpta to be a powerful b-cell therapy with a favorable safety profile for people living with rms, including those who are newly diagnosed or previously treated,” said krishnan ramanathan, neuroscience global program head at novartis. “novartis is committed to reimagining care and bringing innovative treatment options for people living with this disease.” in addition, another analysis of the pooled asclepios trials presented indicated the prognostic value of serum neurofilament light chain (nfl) in assessing future course of disease in rms3 . the value of measuring serum nfl is also supported by findings from the aplios study that demonstrate a clear association of nfl with disease activity, either in the form of new gd+ t1 lesions or relapses.all abstracts will be published in the multiple sclerosis journal following the meeting. in august, the fda approved kesimpta as an injection for subcutaneous use for the treatment of rms, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. kesimpta is the first and only targeted b-cell therapy that can be self-administered once monthly at home via the sensoready® autoinjector pen.>