AAN 2017: Update on MS medications – Infusion therapies
American Academy of Neurology annual meeting, Boston MA, 22-28 April 2017
The following is a summary of some of the key results from clinical trials of infusion therapies (administered as a slow drip into a vein) for MS presented at AAN 2017.
Lemtrada: Two clinical trials (CARE-MS I and II) compared Lemtrada to Rebif in people with relapsing-remitting MS, and the long-term results are now available. In CARE-MS I, previously untreated people received one course of treatment, followed by a second course a year later. Two-thirds of study participants didn’t require any further treatment (Arnold and colleagues. AAN 2017; abstract S10.002). Six years after starting treatment, 89% had no relapses, 66% had no inflammatory activity on their brain MRI, and 77% had no worsening of their disability; 1 in 3 saw their level of disability improve (Singer and colleagues. AAN 2017; abstract S24.005).
CARE-MS II was a similar study, but enrolled people who had not responded to a prior therapy. Although these people had more severe MS, the responses were similar to those in CARE-MS I: relapses were uncommon, 65% had no MRI activity, and 72% had no worsening of their disability (Rovira and colleagues. AAN 2017; abstract S12.006; Fox and colleagues. AAN 2017; abstract S24.006)). A total of 43% showed some improvement in their disability.
If you continue to have relapses in the 1-year gap between Lemtrada treatments, does this mean that the medication has failed? In CARE-MS II, 14% of people did have a relapse between their first and second treatments, but they continued with the second course of treatment and did very well (Singer and colleagues. AAN 2017; abstract P5.349). By year 6, 88% had no disability worsening, and 39% had some improvement. So they ended up doing as well as people who were relapse-free in the 1-year gap between treatments.
Ocrevus: This is the latest treatment for MS (and not yet available in some countries), and is administered every 6 months. Two studies (OPERA I and II) were conducted in relapsing-remitting MS, and one study (ORATORIO) in primary-progressive MS. In OPERA I/II, 47-48% of people had no relapses, MRI activity or disability worsening after 96 weeks of treatment (Hauser and colleagues. N Engl J Med 2017;376:221-234). The researchers then looked at the subgroup with early MS, defined as diagnosed with MS no more than 2 years earlier and having received no prior treatment (Havrdova and colleagues. AAN 2017; abstract P4.391). The results were the same: 47-48% had no evidence of disease activity.
The potential side effects with Ocrevus include infections, such as upper respiratory tract infections; the estimated risk of serious infections is 1.3% (Hauser 2017). Herpes virus infections, such as shingles or cold sores, are more common (5.9%). The risk of cancers, such as breast cancer, was reported to be 0.40 per 100 patient-years (i.e. 4 cases per thousand people treated per year). The updated safety results were presented at AAN 2017. The risk of serious infections is now 1.8%; and the risk of malignancies is now 0.44/100 patient-years.
For more on Ocrevus, see FDA approves first treatment for primary-progressive MS, MSology, March 31, 2017.
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