From the Guidelines
Ocrelizumab is the only FDA-approved medication specifically for the treatment of Primary Progressive Multiple Sclerosis (PPMS), as demonstrated by the ORATORIO trial 1. The medication is administered as an intravenous infusion, with the first dose split into two 300mg infusions given two weeks apart, followed by 600mg infusions every six months thereafter. Key points to consider when prescribing ocrelizumab for PPMS include:
- The medication works by targeting CD20-positive B cells, which are believed to contribute to myelin and axonal damage in MS
- Common side effects include infusion reactions, upper respiratory tract infections, and an increased risk of infections
- Patients should undergo screening for hepatitis B virus before starting treatment, as the medication can cause reactivation of this infection
- Patients should be up-to-date on vaccinations before beginning treatment, as live or live-attenuated vaccines are not recommended during therapy The approval of ocrelizumab for PPMS was based on the ORATORIO trial, which demonstrated that the medication could slow disability progression in patients with PPMS 1. While other disease-modifying therapies are available for relapsing forms of MS, ocrelizumab remains the only approved option specifically for the primary progressive form of the disease. It is essential to note that the ORATORIO trial results are based on a specific patient population, and the effectiveness of ocrelizumab may vary depending on individual patient characteristics. However, based on the current evidence, ocrelizumab is the recommended treatment for PPMS, and its use should be considered in the context of a comprehensive treatment plan that includes regular monitoring and management of potential side effects 1.
From the FDA Drug Label
OCREVUS ZUNOVO is indicated for the treatment of: Primary progressive MS, in adults The medication ocrelizumab (IV) is approved for the treatment of Primary Progressive Multiple Sclerosis (PPMS) in adults 2 and 2.
- Key points:
- Ocrelizumab is indicated for the treatment of PPMS
- It is approved for use in adults
- The medication has been shown to significantly lower the annualized relapse rate and the proportion of patients with disability progression confirmed at 12 weeks after onset compared to placebo in patients with PPMS 2.
From the Research
Approved Medications for Primary Progressive Multiple Sclerosis (PPMS)
- Ocrelizumab is the only disease-modifying therapy (DMT) approved for the treatment of PPMS, as stated in 3 and 4.
- It was approved by the Food and Drug Administration (FDA) in March 2017 for use in adults with relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS) 3.
- The European Medicines Agency (EMA) also approved ocrelizumab in November 2017 for people with early PPMS 3.
Comparison with Other Medications
- A real-world observational study compared the effectiveness of rituximab and ocrelizumab in PPMS, finding no differences in time to confirmed disability progression at 3 months (CDW) between the two treatments 5.
- However, it is essential to note that rituximab is not approved for the treatment of PPMS, and its use is off-label 5.
Real-World Evidence and Extended Interval Dosing
- Real-world data support the use of ocrelizumab in a broader PPMS population than in the original randomized controlled trial 4.
- A study on extended interval dosing (EID) of ocrelizumab found that it does not impact MS clinical and radiological outcomes, although it interferes with B-cell dynamics 6.
Other Therapeutic Approaches
- Siponimod, a sphingosine-1-receptor modulator, is under development for secondary-progressive MS, as mentioned in 7.
- The pathomechanisms of progressive MS comprise chronic inflammation, age-dependent accumulation of iron, and neurodegeneration, and potential therapeutic approaches are being explored 7.