BBC News: Multiple sclerosis drug 'a landmark'

[AndyPR]

A drug that alters the immune system has been described as "big news" and a "landmark" in treating multiple sclerosis, doctors and charities say.

Trials, published in the New England Journal of Medicine, suggest the drug can slow damage to the brain in two forms of MS.

Ocrelizumab is the first drug shown to work in the primary progressive form of the disease.

The drug is being reviewed for use in the US and Europe.

MS is caused by a rogue immune system mistaking part of the brain for a hostile invader and attacking it.

It destroys the protective coating that wraps round nerves called the myelin sheath.

The sheath also acts like wire insulation to help electrical signals travel down the nerve.

Damage to the sheath prevents nerves from working correctly and means messages struggle to get from the brain to the body.

This leads to symptoms like having difficulty walking, fatigue and blurred vision.

http://www.bbc.co.uk/news/health-38392548

From Wikipedia https://en.wikipedia.org/wiki/Ocrelizumab

Ocrelizumab is a humanized anti-CD20 monoclonal antibody, hence a CD20 antagonist. It targets mature B lymphocytes[1] and hence is an immunosuppressive drug candidate. It is under development for multiple sclerosis by Hoffmann–La Roche's subsidiary Genentech.
........
Ocrelizumab is a slightly modified version of Biogen/Genentech's existing therapy Rituxan/Rituximab. As Rituxan was approaching FDA approval for treatment of multiple sclerosis, it was simultaneously approaching the end of its patent. To avoid the profit loss of a new treatment that could have been available sooner and eventually in a generic form, Rituxan trials were halted and Ocrelizumab trials quickly began.

Paper in New England Journal of Medicine http://www.nejm.org/doi/full/10.1056/NEJMoa1606468

 

[Cheesus]

Very interesting! I'd like to see some trials in ME.

It is also interesting that Rituximab is reaching the end of its patent, so it might be affordable for people who wouldn't otherwise have been able to access it. Good news all around.

 

[AndyPR]

It is also interesting that Rituximab is reaching the end of its patent, so it might be affordable for people who wouldn't otherwise have been able to access it. Good news all around.

Well, yes and no. For MS, it will be Ocrelizumab licenced as a treatment, not Rituximab, so, unless someone else runs trials to prove that Rituximab is as effective and safe as Ocrelizumab, the high(-er) cost will remain. For ME, if and when Rituximab is proven as a treatment, then yes, hopefully it will be cheaper than it might have been.

 

[trishrhymes]

Fascinating and horribly cynical of a drug company to stop trials on a drug that was about to go off patent and switch to one that's only slightly different that can be patented for years and therefore make the drug company far more money. Nothing to do with benefit to patients.

 

[J.G]

Fascinating and horribly cynical of a drug company to stop trials on a drug that was about to go off patent and switch to one that's only slightly different that can be patented for years and therefore make the drug company far more money. Nothing to do with benefit to patients.

This. Fortunately they did it "quickly", so it's all good! /rolleyes

Hadn't heard of Ocrelizumab before. Good to see the repertoire of immunomodulatory drugs expanding.

 

[Cheesus]

Well, yes and no. For MS, it will be Ocrelizumab licenced as a treatment, not Rituximab, so, unless someone else runs trials to prove that Rituximab is as effective and safe as Ocrelizumab, the high(-er) cost will remain. For ME, if and when Rituximab is proven as a treatment, then yes, hopefully it will be cheaper than it might have been.

I did actually mean it would be affordable for ME patients if/when it becomes available.

 

[Sidereal]

The percentage of patients with 12-week confirmed disability progression was 32.9% with ocrelizumab versus 39.3% with placebo (hazard ratio, 0.76; 95% confidence interval [CI], 0.59 to 0.98; P=0.03). The percentage of patients with 24-week confirmed disability progression was 29.6% with ocrelizumab versus 35.7% with placebo (hazard ratio, 0.75; 95% CI, 0.58 to 0.98; P=0.04). By week 120, performance on the timed 25-foot walk worsened by 38.9% with ocrelizumab versus 55.1% with placebo (P=0.04); the total volume of brain lesions on T2-weighted magnetic resonance imaging (MRI) decreased by 3.4% with ocrelizumab and increased by 7.4% with placebo (P<0.001); and the percentage of brain-volume loss was 0.90% with ocrelizumab versus 1.09% with placebo (P=0.02). There was no significant difference in the change in the Physical Component Summary score of the 36-Item Short-Form Health Survey. Infusion-related reactions, upper respiratory tract infections, and oral herpes infections were more frequent with ocrelizumab than with placebo. Neoplasms occurred in 2.3% of patients who received ocrelizumab and in 0.8% of patients who received placebo; there was no clinically significant difference between groups in the rates of serious adverse events and serious infections.

The results sound rather pathetic and grossly overhyped in the media, sorry. And the side effects including what looks like a trend toward increased cancer seems rather scary and doesn't seem worth it given that the patients felt no better on the expensive new pharma drug than in the placebo group, as evidenced by the fact that their SF-36 scores were the same. If autoimmune diseases were really caused by B cells you'd expect a drug like this to do a lot better.

 

[Cinders66]

I think this might have parallels with ME in that It seems more useful in the RR form than PP and isn't thought to be useful to secondary primary progressive MS where it's an accumulation of damage and interfering with the immune process won't reverse that. Is that why rituximzb and ampligen seem more Useful in shorter Ill, less severe ME ?
Its good pwMS have more treatment options to reduce disability but these somewhat weak results to me highlight the difficulty of treating complex illness and just make me fear how long it's going to take To find treatment for Various stages of ME with a Research effort 20 times less.