Tagofatumumab

My position on anti-CD20 therapies has been criticised, why?

Barts-MS rose-tinted-odometer: ★★★★★ I have recently been criticised by a colleague for supporting the DODO (double-dose ocrelizumab study) and the ADIOS (adaptive dosing ocrelizumab study) studies. How you can I on the one hand support more ocrelizumab and on the other hand suggest reducing the dose in the longterm. I responded that it is all about timing and how you use anti–CD20...

#MSCOVID19: getting ready for the vaccine

Informing patients about their potential coronavirus risks associated with anti-CD20 therapy is complicated and resulting in our patients being given different advice depending on who they see. The reason for this is that we don’t have the direct evidence to be able to dissect out why people on anti-CD20 therapy are at higher risk of COVID-19 and at higher risk of being admitted to hospital with...

The tortoise has finally arrived

The FDA has just approved ofatumumab for patients with relapsing MS. See Novartis’ press release below. Ofatumumab delivers powerful efficacy with a favorable safety profile and can be self-administered at home, addressing significant unmet needs for people living with relapsing forms of multiple sclerosis (RMS)1 Approval based on two Phase III ASCLEPIOS studies demonstrating significant...

A false sense of security?

Just catching up with my reading. Whilst I was away on holiday the ASCLEPIOS I and II trials was published in the New England Journal of Medicine.  There is little doubt that ofatumumab is superior to teriflunomide when it comes to suppressing focal inflammation, i.e. relapses, MRI activity and peripheral blood neurofilament levels. However, ofatumumab’s effectiveness against teriflunomide on the...

#MSCOVID19: summertime

To me three swallows make a summer; one from Sweden, a second from Iran and now a third from Italy. I have little doubt more will emerge soon. A few weeks’ ago I explained that having asymmetrical information is never a good thing. Tragically I have known about the data published yesterday on the Lancet’s pre-publication archive for several weeks. The new data shows that ocrelizumab-treated...

#MSCOVID19: an anti-CD20 backpedal

Science is not a religion and hence scientific advice, unlike beliefs, change as new evidence emerges. When the COVID-19 pandemic started we had to formulate advice on DMT use and their impact on SARS-CoV-2 infection and COVID-19 based on scientific principles and evidence of other viral infections. I created a table to summarise my opinions and as evidence has emerged I have updated the table...

#MSCOVID19 Anti-CD20 therapies and vaccines

Have we optimised the dose of anti-CD20 therapies to target the real MS or smouldering MS, i.e. disease progression independent of relapse activity (PIRA)? I did an iWiMS webinar on Wednesday covering anti-CD20 therapies and the risk of COVID-19 and severe COVID-19. I covered vaccine responses and how to be vaccine-ready or vaccine responsive to a future SARS-CoV-2 vaccine if you are on an anti...

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...

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...

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...

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