A pilot Phase 2 trial (NCT00640328) with a small group of 38 RRMS patients tested different doses of Kesimpta in 2011 for 48 weeks, or just less than one year. The results showed a considerable reduction in the formation of brain plaques — areas where the myelin is stripped off of the nerves — along with lower numbers of autoimmune B-cells. The treatment also appeared to suppress new plaque formation. The researchers published these results in the scientific journal Neurology.
These findings paved the way for a second larger, multicenter, double-blind, placebo-controlled Phase 2 trial (NCT01457924) called MIRROR, which enrolled 232 people with RRMS. The participants were randomly selected to receive one of five treatments: a placebo, 3 mg, 30 mg, or 60 mg of Kesimpta every 12 weeks, or 60 mg of Kesimpta every four weeks. All of the patients continued in the study for 24 weeks and until B-cell depletion (or destruction).
Ofatumumab was able to deplete the B-cells quickly, depending on the dose and regimen, and effectively reduced the formation of new brain plaques relative to the placebo, the results showed. The researchers recorded no new or unexpected safety findings.
Two randomized, double-blind Phase 3 studies, ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231), compared the efficacy and safety of Kesimpta against Aubagio (teriflunomide), an oral MS treatment approved by the FDA. A total of 1,881 adults with RRMS or active SPMS were enrolled in the trials. The participants received either Kesimpta every four weeks or Aubagio once daily.
The study assessed the number of confirmed relapses in 12 months, recorded for up to 2.5 years. The disability worsening showed a risk reduction of 34.4% at three months, and 32.5% at six months with Kesimpta, compared with Aubagio. Disability improvement at six months also showed a favorable trend for Kesimpta, but the results were not statistically significant.
Kesimpta treatment led to a 97.5% relative reduction in the number of T1 lesions in ASCLEPIOS I, and 93.8% in ASCLEPIOS II, relative to Aubagio. These findings led the researchers to conclude that Kesimpta treatment is superior to Aubagio in treating people with relapsing forms of MS.
Notably, it can be administered at home through a patient-friendly autoinjector pen.
Adverse events occurred in 83.6% of patients on ofatumumab, and 84.2% of patients receiving Aubagio. There were no significant differences between the two groups with regard to the rate of infections (2.5% with Kesimpta vs. 1.8% with Aubagio) or malignancies (0.5% with Kesimpta vs. 0.3% with Aubagio).
Ongoing clinical trials
A Phase 3 clinical trial (NCT03650114) is now assessing the long-term safety, tolerability, effectiveness, and health outcomes of Kesimpta in adults who participated in previous studies. These patients are currently being recruited at various locations across the world.
Due to end in January 2028, this trial also includes a sub-study evaluating the antibody response to certain vaccines in eligible MS patients. Because Kesimpta leads to B-cell depletion, it can affect a person’s response to vaccinations. Thus, patients should not receive vaccinations during or shortly after Kesimpta treatment.
Other information
The FDA also approved ofatumumab, under the brand name Arzerra, to treat chronic lymphocytic leukemia. Researchers also are investigating it as a potential treatment for other blood cancers, such as follicular lymphoma.
Last updated: Aug. 21, 2020
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