Ocrelizumab (trade name: Ocrevus) has been approved in Germany since February 2018 for the treatment of multiple sclerosis in adults.
Multiple sclerosis (MS) is a chronic and incurable inflammatory disease of the central nervous system in which the body’s immune system damages nerve pathways in the brain and the spinal cord. This condition can cause abnormal sensations, fatigue, arm and leg pain, partial paralysis, dizziness and trembling.
MS can take on various forms:
- Relapsing-remitting MS (RRMS): This type often comes in episodes, with symptom-free intervals between acute phases. Remitting means that after an episode, the symptoms will go away completely or at least get better. If many attacks occur within a short time, it is referred to as highly active relapsing-remitting MS. Relapsing MS can progress into a phase where symptoms get worse gradually or in bouts, but don't get better again. That is referred to as secondary progressive MS (SPMS).
- Primary progressive MS (PPMS): In this rare type of MS, the symptoms constantly get worse, usually without any distinguishable episodes. The symptoms don't get better again in this form, either.
Ocrelizumab has been approved for the treatment of early stages of relapsing and primary progressive MS. Ocrelizumab slows down damage to the nerve cells by influencing the immune system.
In preparation for treatment with ocrelizumab, patients receive a glucocorticoid and an antihistamine, and sometimes acetaminophen (paracetamol) as well. This is done to relieve possible side effects. Ocrelizumab is then given at a dose of 300 mg as an infusion (IV drip) into a vein. The treatment is repeated after two weeks. The next dose (600 mg) is given about six months later. Afterwards, ocrelizumab is given every six months. The infusion takes between 150 to 210 minutes. During the treatment and for an hour afterwards, the patient should be monitored so that any side effects can be quickly responded to.
Various medications are available for people with RRMS, the main ones being interferon beta and glatiramer acetate. If people with highly active RRMS experience an increase in flare-ups despite having treatment, they can use the drugs alemtuzumab, fingolimod or natalizumab too.
Best supportive care (BSC) is an option for adults with early-stage PPMS. This should be tailored to the patient's individual needs, with the aim of relieving symptoms and improving quality of life.
In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether ocrelizumab has any advantages or disadvantages compared to conventional standard treatments for people with RRMS, highly active RRMS or early-stage PPMS.
IQWiG considered the following groups of patients:
- People with relapsing-remitting MS that remains active and who have or have not had treatment before
- People with highly active relapsing-remitting MS who did not benefit from treatment
- People with early-stage primary progressive MS
This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of this review and the hearings received, the G-BA passed a resolution on the added benefit of ocrelizumab (Ocrevus).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ocrelizumab (multiple sclerosis) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A18-06. April 27, 2018. (IQWiG reports; Volume 619).
IQWiG health information is written with the aim of helping
people understand the advantages and disadvantages of the main treatment options and health
Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.
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