Adherence rates with self-injection encouraging
An additional analysis from the two trials presented virtually in a separate abstract at the CMSC showed greater adherence to the self-administered regimen.
The analysis shows that in the ASCLEPIOS I study, 86.0% patients who were randomly assigned to receive ofatumumab and 77.7% who received teriflunomide completed the study on the assigned study drug. The proportion of patients who received ofatumumab and who discontinued treatment was 14.0%, versus 21.2% for those in the teriflunomide group. The most common reasons for discontinuation were patient/guardian decision (ofatumumab, 4.9%; teriflunomide, 8.2%), adverse event (ofatumumab, 5.2%; teriflunomide, 5.0%), and physician decision (ofatumumab, 2.2%; teriflunomide, 6.5%).
In the ASCLEPIOS II study, the rates were similar in all measures.
“In ASCLEPIOS trials, compliance with home-administered subcutaneous ofatumumab was high, and fewer patients discontinued ofatumumab as compared to teriflunomide,” the authors concluded.
Comparator drug a weak choice?
In commenting on the research, Stephen Kamin, MD, professor, vice chair, and chief of service, department of neurology, New Jersey Medical School, in Newark, noted that a limitation of the ASCLEPIOS trials is the comparison with teriflunomide.
“The comparator drug, teriflunomide, is one of the least effective DMTs, and one that some clinicians, including myself, don’t use,” he said.
Previously, when asked in an interview about the choice of teriflunomide as the comparator, Dr. Hauser noted that considerable discussion had gone into the decision. “The rationale was that we wanted to have a comparator that would be present not only against focal disease activity but also potentially against progression, and we were also able to blind the study successfully,” he said at the time.
Dr. Kamin said that ofatumumab will nevertheless likely represent a welcome addition to the tool kit of treatment options for MS. “Any new drug is helpful in adding to our choices as a general rule,” he said. “Subcutaneous injection does have increased convenience.”
It is not likely that the drug will be a game changer, he added, although the treatment’s efficacy compared with other drugs remains to be seen. “It all depends upon the relative efficacy of ofatumumab versus ocrelizumab or siponimod,” Dr. Kamin said.
“There has been another subcutaneous monoclonal for MS, daclizumab, although this was withdrawn from the market due to severe adverse effects not related to route of administration,” he added.
Dr. Hauser has relationships with Alector, Annexon, Bionure, Molecular Stethoscope, Symbiotix, and F. Hoffmann-La Roche. Dr. Kamin has received research support from Biogen, Novartis and CMSC.
A version of this article originally appeared on Medscape.com.