, a new study shows.
The drug, which is already approved for the treatment of chronic lymphocytic leukemia, is currently under review for relapsing MS as a once-per-month self-injected therapy that could offer a convenient alternative to DMTs that require in-office infusion.
The new findings are from a pooled analysis from the phase 3 ASCLEPIOS I/II trials of the use of ofatumumab for patients with relapsing MS. There were 927 patients in the ASCLEPIOS I trial and 955 in the ASCLEPIOS II trial. The trials were conducted in 37 countries and involved patients aged 18-55 years.
The late-breaking research was presented at the virtual meeting of the Consortium of Multiple Sclerosis Centers (CMSC).
The studies compared patients who were treated with subcutaneous ofatumumab 20 mg with patients treated with oral teriflunomide 14 mg once daily for up to 30 months. The average duration of follow-up was 18 months.
NEDA-3, commonly used to determine treatment outcomes for patients with relapsing MS, was defined as a composite of having no worsening of disability over a 6-month period (6mCDW), no confirmed MS relapse, no new/enlarging T2 lesions, and no gadolinium-enhancing T1 lesions.
The pooled results showed that the odds of achieving NEDA-3 during the first 12 months were three times greater with ofatumumab than with teriflunomide (47.0% vs. 24.5%; odds ratio [OR], 3.36; P < .001) and were more than eight times greater from months 12 to 24 (87.8% vs. 48.2%; OR, 8.09; P < .001).
In addition, compared with patients who received teriflunomide, a higher proportion of patients who received ofatumumab were free from 6mCDW over 2 years (91.9% vs. 88.9%), as well as from relapses (82.3% vs 69.2%) and lesion activity (54.1% vs. 27.5%).
There was a significantly greater reduction in annualized relapse rate with ofatumumab compared with teriflunomide at all cumulative time intervals, including months 0 to 3 (P = .011), and at all subsequent time intervals from month 0 to 27 (P < .001).
The pooled findings further showed that ofatumumab reduced the mean number of gadolinium-enhancing T1 lesions per scan by 95.9% compared with teriflunomide (P < .001).
“Ofatumumab increased the probability of achieving NEDA-3 and demonstrated superior efficacy vs teriflunomide in patients with relapsing MS,” said the authors, led by Stephen L. Hauser, MD, of the department of neurology, UCSF Weill Institute for Neurosciences, University of California, San Francisco.
Ofatumumab superior in primary, secondary outcomes
As previously reported, subcutaneous ofatumumab also demonstrated superior efficacy over oral teriflunomide in the primary and secondary endpoints in the ASCLEPIOS I/II trials. The annualized relapse rate was reduced by 0.22 in the teriflunomide group, vs 0.11 in the ofatumumab group (50.5% relative reduction; P < .001) in the ASCLEPIOS I trial, and by 0.25 vs. 0.10 (58.5% relative reduction P < .001) in ASCLEPIOS II.
Ofatumumab also reduced the number of gadolinium-enhancing T1 lesions and new or enlarging T2 lesions compared with teriflunomide (all P < .001). It reduced the risk for disability progression by 34.4% over 3 months and by 32.5% over 6 months.
In the studies, the rate of serious infection with ofatumumab was 2.5%, compared with 1.8% with teriflunomide. Rates of malignancies were 0.5% and 0.3%, respectively.
“Ofatumumab demonstrated superior efficacy versus teriflunomide, with an acceptable safety profile, in patients with relapsing MS,” the authors reported.