Ocrelizumab

Ocrelizumab
Mass / length primary structure	148.1  kDa
Identifier
External IDs	CAS number : 637334-45-3
Drug information
ATC code	L04 AA36
Drug class	Immunosuppressants

Ocrelizumab (trade name Ocrevus ; manufacturer Roche ) is a humanized monoclonal antibody against the B lymphocyte antigen CD20 and a drug that is used to treat multiple sclerosis (MS) . Ocrelizumab is approved as a drug in the United States for the treatment of both primary progressive MS (PP-MS) and the more common relapsing form of MS (RR-MS) . As part of the Compassionate Use Program (CUP), ocrelizumab has been available to German patients since February 2017 under certain conditions. Since September 28, 2017, ocrelizumab has been approved in Switzerland for the treatment of primary progressive and relapsing forms of MS. The EU approval took place in January 2018.

In two Phase III studies , ocrelizumab was more effective against disease progression than the control interferon .

Adverse effects (side effects)

Ocrelizumab has an immunosuppressive effect . Therefore, undesirable effects can also arise from a change in the body's defenses. These are flu-like side effects, headaches, bone pain, an increased susceptibility to infections and, in individual cases, allergic reactions to the substance.

An increased risk of malignant neoplasms cannot be excluded. In clinical studies, malignant neoplasms were more common with ocrelizumab (6 out of 781 women) than in the control group (none of 668 women) who received interferon beta-1a or placebo. Patients should therefore participate in the recommended breast cancer screening .

In May 2017, a patient developed PML after one month of treatment with ocrelizumab , after having been treated with natalizumab for 3 years .

Mechanism of action (pharmacodynamics)

Ocrelizumab works by blocking B cells and belongs to a group of immunosuppressants . The antibody selectively binds the CD20 antigen , which is found on the surface of B cells. It interacts with the body's immune system to eliminate the CD20 positive B cells that play an important role in MS.

administration

Ocrelizumab is given as an intravenous infusion . The first two infusions must be given two weeks apart. Thereafter, patients receive individual, subsequent infusions every 24 weeks.

History

Ocrelizumab was developed by the Hoffmann-LaRoche subsidiary Genentech and Biogen . Ocrelizumab was originally developed to treat rheumatoid arthritis , but further investigations were stopped after tests resulted in deaths. The study arm for multiple sclerosis, however, was continued. The substance itself is derived from rituximab , which is used in oncological diseases . In the USA, the active ingredient was in the accelerated approval process . Ocrelizumab was approved by the FDA in late March 2017.

Criticism of Roche's pricing policy

The humanized antibody ocrelizumab is a further development of the chimeric antibody rituximab (also an anti-CD20 antibody), which, however, was never approved for multiple sclerosis. With the approval of Ocrevus (ocrelizumab), rituximab can no longer be used off-label . Ocrelizumab costs more than 10 times as much as rituximab (€ 33,000 versus € 3,000). The health systems will therefore have to spend billions of euros more.

Individual evidence

1. ^ ^{A b} Reuters: Roche competes with Merck with MS drugs. In: handelsblatt.com . March 29, 2017. Retrieved March 29, 2017 . 
2. ↑ Celine Müller: Ocrelizumab approved . In: DAZ.online . March 29, 2017 ( deutsche-apotheker-zeitung.de [accessed October 13, 2017]).
3. ^ Ocrelizumab approved by Roche in Switzerland for primary progressive and relapsing multiple sclerosis. 2017 F. Hoffmann-La Roche Ltd, September 28, 2017, accessed November 4, 2017 . 
4. ^ John Miller, Michael Shields: Roche's star MS medicine Ocrevus wins EU approval. In: Reuters. January 12, 2018, accessed January 12, 2018 . 
5. ^ SL Hauser, A. Bar-Or u. a .: Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. In: The New England Journal of Medicine . Volume 376, number 3, 01 2017, pp. 221-234, doi : 10.1056 / NEJMoa1601277 , PMID 28002679 .
6. ↑ HIGHLIGHTS OF PRESCRIBING INFORMATION (USA). Genentech, 2017, accessed March 30, 2017 . 
7. ↑ Reuters: Deadly brain infection in German MS patient prompts Roche investigation. May 24, 2017, accessed November 30, 2017 . 
8. ↑ Jutta Scheiderbauer: Greed eats the brain - reloaded, PML case under Ocrevus. Trier Action Group Multiple Sclerosis, accessed on November 30, 2017 (German). 
9. ↑ rme / aerzteblatt.de: B-cell antibodies effective in multiple sclerosis. (No longer available online.) In: aerzteblatt.de . November 2, 2011, archived from the original on March 30, 2017 ; accessed on March 29, 2017 . Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice.  
10. ↑ Der Nervenarzt 2, 2009, p. 196
11. ↑ Der Nervenarzt 2, 2009, pp. 193, 196
12. ↑ AMSEL eV - regional association of the DMSG: Roche stops tests after deaths . ( amsel.de [accessed October 31, 2016]).
13. ↑ US FDA grants Breakthrough Therapy Designation for Roche's investigational medicine ocrelizumab in primary progressive multiple sclerosis , Roche PM February 17, 2016, accessed February 25, 2016
14. ↑ Tagesschau: http://www.tagesschau.de/wirtschaft/roche-ms-101.html. February 8, 2018, accessed February 8, 2018 . 
15. ↑ Overview of rituximab from the EMA (accessed on February 21, 2018)
16. ↑ Article in the DAZ (accessed on February 21, 2018)
17. ↑ Article in the Apotheken Umschau (accessed on February 21, 2018)

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