TagOcrelizumab

Participating in Oratorio-Hand?

At the recent ORATORIO-HAND investigators’ meetings in Barcelona and Athens, several investigators’ made the point that it may be hard to retain people with PPMS in this trial because ocrelizumab has already been licensed to treat MS. I said YES and NO.  For one a lot of neurologists, HCPs and payers don’t think the original ORATORIO trial was positive. They think the trial was driven by the 25%...

De novo PML on ocrelizumab

In my career as a neurologist, I have seen three patients who developed PML (progressive multifocal leukoencephalopathy) without any apparent risk factors apart from being old. They were all over 70. Prior to the HIV epidemic, about 1 in 10 patients with PML did not have an obvious underlying risk factor except for age or immunosenescence of the elderly.  Immunosenescence is the term...

the HYPE study

It is clear that many MSers on continuous anti-CD20 therapy are concerned about the risk of developing hypogammaglobulinaemia and subsequent infections. Yesterday, I spoke to several neurologists at the O’HAND investigators meeting in Barcelona who informed me that they are considering giving their ocrelizumab-treated patients hyperimmune globulin replacement therapy (HYPE-Ig-RT) when they...

O’HAND

I am very excited and proud to be attending and speaking at the first European Oratoria-HAND, or O’Hand, study investigator meeting in Barcelona. With Chariot-MS, the O’HAND study is the culmination of more than 4 years of work and campaigning for Barts-MS.  However, our #ThinkHand campaign will only be considered a true success if we get a positive outcome from one of our studies and a DMT...

For English PPMSers

“I love deadlines. I like the whooshing sound they make as they fly by” Douglas Adams, Hitchhikers Guide to the Galaxy. There is one deadline that happened quitely earlier this month. NHS England turned on the blueteq form ocrelizumab treatment for PPMSers living in England; they did at the last possible timepoint dictated by the law. The good news is that the requirements for someone...

OVO Study

Finally, after a week or more of thinking and contemplation my opinion about the ofatumumab vs. teriflunomide trial data (ASCLEPIOS I and II); another of my ECTRIMS highlights.  The result of the ASCLEPIOS I and II are not unexpected and in line with the treatment effects of anti-CD20 therapies with some caveats.  Novartis summary: Both ASCLEPIOS I and II studies met their primary endpoints in...

JCV index and the effect of DMTs

JCV STRATIFY (anti-JCV antibody) test has been utilized for more than decade to de-risk natalizumab treatment and other DMTs for risk of PML (Progressive Multifocal Leukoencephalopathy). Cases of PML have occurred predominantly in natalizumab, but less commonly with fingolimod (Gilenya), dimethylfumerate (Tecfidera) and rituximab. A high JCV antibody index value indicates that the risk of...

Derisking anti-CD20 therapy

An important highlight of ECTRIMS this year was the data on the safety of the anti-CD20 therapies as a class. It is clear that prolonged, and sustained, B-cell depletion is not safe. Hypogammaglobulinaemia will become a problem with the risk of both common and opportunistic infections.  Stephen Hauser presented the 7-year ocrelizumab safety data and there is a clear uptick in infections in...

All for one and one for all

“All for one and one for all”- The Musketeers FACTS Fact 1 – Siponimod (Novartis Pharmaceuticals) trialed for SPMS, but the FDA label sits as Clinically isolated syndrome (the first clinical episode), Relapsing-remitting MS, and active Secondary progressive MS. Fact 2 – Ocrelizumab (Genentech, Roche Pharmaceuticals) trialed for RRMS/PPMS; the latter has been shown to be...

Results time

It is time to set in stone our #CrowdThink competition results. We had over 110 responses; thank you. If you want to know more about the rationale behind this competition you need to read my post on the DODO trial and the post explaining the rationale behind the COMPETITION. Study 1: Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis (OPTIMUM). The Crowd has predicted that...

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