OCREVUS was proven in 2 large, identical clinical studies over 2 years against REBIF®*, a currently approved treatment for relapsing MS, not a placebo. A placebo is a substance or treatment that has no active medicine.
*REBIF® is a registered trademark of EMD Serono, Inc.
Disability progression is the increase in physical disability that
happens over time for people with MS. How and when it happens is
different for everyone.
†Disability progression was confirmed 3 months after the initial neurological change.
‡Disability progression was also confirmed after 6 months.
How is disability progression measured in clinical studies?
Disability progression is measured using a tool called the Expanded
Disability Status Scale (EDSS). It assesses your functionality or
changes to function in the areas listed below. OCREVUS was not proven
to individually reduce each of these measured endpoints.
- Muscle weakness or difficulty moving limbs
- Tremor or loss of coordination
- Problems with speech, swallowing, or involuntary eye movements
- Numbness or loss of sensations
- Bowel and bladder function
- Visual function - problems with sight
- Cerebral functions - problems with thinking and memory
†Disability improvement was not confirmed after 6 months.
Infusion reactions are a common side effect of OCREVUS, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of OCREVUS for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any reactions. Please visit Safety & Side Effects for more information.
OCREVUS was consistently proven superior at reducing T1 Gd+ lesions|| compared with REBIF across 2 clinical studies.
The average number of T1 Gd+ lesions per MRI was lower for OCREVUS:
Study 1: 0.016 lesions with OCREVUS compared with
0.286 lesions with REBIF
Study 2: 0.021 lesions with OCREVUS compared with 0.416 lesions with REBIF
||A T1 gadolinium-enhancing (Gd+) lesion is a magnetic
resonance imaging (MRI) indicator that highlights active
inflammation has occurred. Active inflammation means that myelin is
being damaged or destroyed. T1 Gd+ lesions are thought to be a sign
of active inflammation.
¶The exact way OCREVUS works is not fully known.
Here are the people included in the study:
- 1656 people (827 received OCREVUS, 829 received REBIF)
- 18–55 years of age
- Average time since diagnosis was about 4 years
- Had experienced ≥2 relapses in last 2 years, or ≥1 relapse in last year
- Had T1 gadolinium-enhancing (Gd+) lesions and/or T2 hyperintense lesions
Why this is important:
- Studied in a large number of people with relapsing MS
- Studied in a range of people with MS
- Studied in people who had active disease