The 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) was held last week from the 13th to the 15th. This event is the largest meeting focused on research on multiple sclerosis (MS). At this event, Bristol Myers Squibb presented updated data from their Phase 3 open-label extension (OLE) of Zeposia, titled DAYBREAK. The data are positive, confirming Zeposia’s long-term safety and efficacy profile.
About the DAYBREAK Trial
Organized to evaluate the long-term safety and efficacy of Zeposia, the Phase 3 DAYBREAK trial is double-blind, randomized, active-controlled, double-dummy, parallel, and held across multiple sites. Participants were taken from the parent trials: RADIANCE, RPC01-1001, and SUNBEAM, with a total of 2,639 patients completing them.
2,494 patients were included in the analysis presented at ECTRIMS, with results including:
- Annualized relapse rate (ARR) of 0.103
- 75% of participants had not experienced a relapse by month 36
- 71% of participants had not experienced a relapse by month 48
- At three months, the confirmed disability progression was seen in 13.9% of patients
- At six months, the confirmed disability progression was seen in 11.4% of patients
- No new safety signals
- 85.9% of participants experienced treatment-emergent adverse events (TEAE)
- 11.9% experienced a serious TEAE
- 3.0% discontinued their participation in the trial due to TEAEs
- The most common adverse events were headaches, upper respiratory tract infections, nasopharyngitis, and lymphopenia
In addition to the data from the DAYBREAK trial, Bristol Myers Squibb will present a number of other abstracts from their clinical trials focusing on MS. The company hopes to stress its commitment to MS patients.
About MS
MS is a neurological disorder that occurs when the protective coating of nerve cells (myelin sheath) breaks down, interrupting communication between the brain and body. This results in symptoms such as weakness, numbness, issues with balance, loss of coordination, and problems with speech, bladder control, and vision. Depending on the form of MS that one has, these symptoms may present in episodes followed by periods of remission (relapsing/remitting MS) or remain consistent (progressive MS).
Medical professionals are unsure as to what exactly causes this disorder, but they suspect that it is an autoimmune disease. This means that the immune system mistakenly attacks the body, in this case, the myelin sheath. While more research must be done, it is most likely that a combination of environmental and genetic factors plays a role. There is no cure for MS, although numerous treatments exist with more currently in development.
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