Tagalemtuzumab

Unaccountable

The European Union and its Institutions have been heavily criticised as part of the Brexit debate as been undemocratic and unaccountable to the man or woman on the street. However, it is only when their decisions impact on you, or your patients, that you realise that these critics have a valid point.  Last week the European Medicine Agency’s safety committee (PRAC or Pharmacovigilance Risk...

Are IRTs ahead of their time?

I am beginning to think that immune reconstitution therapies or IRTs are ahead of their time. Many neurologists, people with MS (pwMS), payers – particularly fee-for-service insurance companies – and the regulators are unable to get their heads around how these agents work. In addition, a few recent review articles, written by colleagues, cast doubt on this treatment strategy and the...

The Phoenix

Like a phoenix rising from the ashes for the third or fourth time, alemtuzumab is given yet another life. I am sure many neurologists and people living with MS will be grateful, but I don’t agree with its positioning. EMA’s safety committee or PRAC has handcuffed alemtuzumab and is restricting it for adults with relapsing-remitting multiple sclerosis that is highly active despite adequate...

Your race in MS

Race, ethnicity, creed – all architectural descriptors, some complex, others less so, depending on your perspective. When it comes to illnesses however, you are largely referencing race (the inheritance of your DNA) and ethnicity (the branch of race that your DNA occupies). We may be different in a number of ways, but our illnesses are a great equalizer. There is no such thing as race...

Short- or long-sighted

I saw three patients 9-and-half-years after starting treatment with alemtuzumab as first-line therapy, yesterday. It was a remarkable experience. Only one of the three patients had needed a third cycle of alemtuzumab. All are in long-term remission; i.e. flat-lining on the EDSS, relapse-free and with no MRI activity (NEDA-3). Their EDSS scores yesterday were 1.0, 1.5 and 2.0. All of them are...

Real Life

After my #1 highlight #ECTRIMS2019 post, I was sent an email by Antoinio Scalafari, a like-minded colleague, to remind me of their real-life data at Imperial College on alemtuzumab in clinical practice. It mirrors the trial experience and needs a platform for discussion (see below). In parallel, I heard via the MS grapevine that the MS community does not appreciate me questioning the ethics of...

Open letter to the EMA

Just back from ECTRIMS 2019 in Stockholm. My highlight was the alemtuzumab 8-year longterm extension data; the brain volume data is quite extraordinary (figure 5). In short, apart from HSCT, there is nothing that comes close to alemtuzumab in radically slowing-down or preventing end-organ damage. Comi et al. Alemtuzumab improves clinical and MRI disease activity outcomes, including slowing of...

Thyroid disease with Alemtuzumab – risk mitigation

There is a popular old saying in English – “forewarned is forearmed”. Prior knowledge that something is going to happen offers tactical advantage, whether you’re at war or simply everyday life. The difficulty, however, is that more often than not we are transfixed by the detail of the matter, resulting in numerous avenues of investigation in the process, some of which are...

AAN 2019 posters #2

Well, here is part deux of the 2019 AAN posters; a veritable smorgasbord of hidden gems on Market St in Philadelphia. 1. Effect of Ibudilast on Neurofilament light chain in Progressive MS Analysis from a Phase II Trial. Fox et al. Cleveland Clinic.Previous results from the SPRINT-MS study that used 80-100mg/day of Ibudilast, showed slowing of the progression in brain atrophy (i.e. volume loss) by...

Jetlag

Just arrived back from the AAN 2019 in Philadelphia. Jetlagged, which is why I am writing this at 2 am in the morning. As always the AAN is more a meeting of meetings or networking in academic lingo. These meetings have allowed us to progress several of our ideas including (1) DrK’s #MSAttack study with natalizumab, (2) to think more deeply about our proposed ADIOS Trial (adaptive dosing...

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