Author: Gavin Giovannoni

Training the next generation of UK’s MSologists

Tony Blair is famously quoted as saying ‘Education, education, education, …’ and putting education at the centre of New Labour’s manifesto in 1997. However, is it the type or the quality of education that makes the difference and changes the world?






We are trying to change the world of MS treatment.



I have learned that information in itself may pique attention, but it rarely changes behaviour.

I have been very impressed by the feedback we have had from our initial two MS Academies. Healthcare delegates participate in a 3-day course. They then go to a research or service development project or even an audit in relation to MS. The act of going away and doing something active makes delegates think about their MS practice and consider the service(s) they provide for their patients with MS. In other words, the doing induces a change in behaviour and complements the educational element of the course in changing behaviour.

Doing makes a difference!

If you are interested in joining the MS Academy and attending an MS Masterclass please register your interest via the MS Academy website. Please note these courses are open to non-UK clinicians and having HCPs from other countries helps NHS employees. After all aren’t we still European, or even better citizens of the world?




CoI: At present, the Neurology Academy is supported by an unrestricted educational grant from Biogen. Biogen has no input into the design and running of the Academy that is based on the very influential Parkinson’s Disease Academy, which has been running for more than a decade. We are also looking for additional sponsors.  

Have you been involved in shared-decision making?

A recent study published in the British Medical Journal (BMJ) proposes a simple three talk model for shared-decision making in the clinic. 


Have you been involved in a shared-decision making process, or have you simply been told what is best for you? 


Please have your say.




My problem is that in reality, very few MSologists practise shared-decision making. They tend to pay lip service to it. For example, I recently co-chaired a teaching course during which we discussed several case scenarios. The objective was to select an appropriate DMT for the cases presented. The problem is that none of the patients were in the room, so how could we engage them in shared-decision making? In other words, you make a decision for the patient and then you encourage them to agree with you. This is called paternalism. 


The model is simple enough and should be easy to implement:
  1. Team Talk: Let’s work as a team to make a decision that suits you best.
  2. Option Talk: Let’s compare the possible options.
  3. Decision Talk: Tell me what matters most to you for this decision.


Elwyn et al. A three-talk model for shared decision making: multistage consultation process. BMJ 2017;359:j4891


Objectives: To revise an existing three-talk model for learning how to achieve shared decision making, and to consult with relevant stakeholders to update and obtain wider engagement.


Design: Multistage consultation process.


Setting: Key informant group, communities of interest, and survey of clinical specialities.


Participants: 19 key informants, 153 member responses from multiple communities of interest, and 316 responses to an online survey from medically qualified clinicians from six specialities.


Results: After extended consultation over three iterations, we revised the three-talk model by making changes to one talk category, adding the need to elicit patient goals, providing a clear set of tasks for each talk category, and adding suggested scripts to illustrate each step. A new three-talk model of shared decision making is proposed, based on “team talk,” “option talk,” and “decision talk,” to depict a process of collaboration and deliberation. Team talk places emphasis on the need to provide support to patients when they are made aware of choices, and to elicit their goals as a means of guiding decision-making processes. Option talk refers to the task of comparing alternatives, using risk communication principles. Decision talk refers to the task of arriving at decisions that reflect the informed preferences of patients, guided by the experience and expertise of health professionals.


Conclusions: The revised three-talk model of shared decision making depicts conversational steps, initiated by providing support when introducing options, followed by strategies to compare and discuss trade-offs, before deliberation based on informed preferences.

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Latest natalizumab PML risk update

The latest PML risk figures from Biogen. If you are on natalizumab and are JCV seropositive this post is for you.


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Ocrelizumab news: finally two eagles have landed

Landmark decision by the CHMP; ocrelizumab gets licensed for both relapsing and primary progressive MS.






 For all those pwPPMS who have been waiting for a treatment for their disease. Your wait is almost over. After many anxious months, and against the opinion of many naysayers, the CHMP (Committe for Medicinal Products for Human Use) have greenlighted ocrelizumab for the treatment of PPMS in Europe. It is not quite the liberal license of other countries, but it is a start. 


“Ocrevus is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis
(RMS) with active disease defined by clinical or imaging features (see section 5.1). 


Ocrevus is indicated for the treatment of adult patients with early primary progressive multiple
sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features
characteristic of inflammatory activity (see section 5.1).”

 The question I have for Roche is will they take up our #ThinkHand challenge and do a trial in people with more advanced MS, i.e. those who are in wheelchairs? 

 I personally would like to thank all the pwMS who participated in both the relapsing (Opera 1 & 2) and primary progressive (Oratorio) trials; without you we wouldn’t have gotten here. Progressive MS is now a tractable problem, what we now need is combination therapy trials. 



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Will Biogen walk-the-talk and do another natalizumab SPMS trial?

At #MSParis207 I presented a new analysis of the data of the ASCEND trial (natalizumab in SPMS) that shows natalizumab is very effective in protecting upper limb function, and to a lesser extent lower limb function, in people with more advanced MS (majority needing walking aids). 




Will Biogen learn from this analysis and do an ASCEND-2 trial? If they cared about people with more advanced MS they would do this study. I also anticipate that in the future PML will not be a problem; we will have antivirals that will clear the body of JCV and the risk of PML as a complication of natalizumab treatment will become very, very, low. The latter is another reason for doing this study.

YouTube Webinar:
SlideShare slides: 
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Guest post: will the COMBAT-MS study disrupt the MS market?

You may be aware that people living with MS in resource-poor environments are often not treated with disease-modifying therapies. To address this we have been promoting a Barts-MS Essential Off-label list of DMTs. The problem with this list is that it is often not backed by a so-called ‘class 1 evidence’. 

 To address this lack of evidence, trials such as COMBAT-MS are being performed to provide data from real-life practice to support off-label prescribing. We are therefore privileged to have a guest post from the team running the COMBAT-MS trial explaining what the trial is about.




COMBAT-MS STUDY


We keep getting at least one new approved MS disease-modifying drug per year. You might think this would help tailor therapy to individual needs. Unfortunately, this doesn’t really seem to be the case. Patients are switching therapies now more than ever. MS experts can’t seem to agree which drug is the best even for the same types of patients. Treatment practices vary widely, not only across countries but all the way down to regions, clinics and even individual doctors. Perhaps the most important cause of these wide variations in care is the lack of long-term real-world data. 


Loads of money has been invested into randomized clinical trials and they are really important. However, randomized controlled trials don’t give the whole picture. These trials are conducted over a relatively short period of time, in mostly treatment-naive patients who are otherwise healthy and do not want to get pregnant. The drugs are usually compared only to placebo rather than to the other drugs patients have to choose from. These studies also do not consider patient-reported outcomes like quality of life. 

 In the real world, many patients don’t fit this picture. They may have tried other therapies before, have health issues other than MS, want to get pregnant soon and/or (of course) value the impact the drug may have on their quality of life (QoL). Short of a cure, they desire a highly effective treatment, that is reasonably safe and well-tolerated even if they need to take it for decades. Unfortunately, we can´t rely on the pharmaceutical industry to support us in answering these questions. And academic registry-based studies have inherent weaknesses that prevent them from satisfactorily addressing these issues. 

Aside from a prohibitively expense and complex randomized controlled trial, is there a middle way? Yes, perhaps. The US federally-funded Patient-Centered Outcomes Research Institute (PCORI) last year gave a big award to a US-Swedish initiative for a hybrid study between a traditional retrospective cohort and a structured, prospective cohort study. Sweden has a nationwide MS registry which includes >90% of patients and nearly complete information on MS drugs used, physical disability outcomes and the ability to link to national health registries to detect major safety signals. However, much of the other key variables like patient-reported outcomes and MRI data have over 20% missing data, which would make effects of treatments on these outcomes difficult to interpret. Therefore, a prospective trial (COMBAT-MS; clinicaltrials.gov NCT03193866) has recently launched. 

We aim to recruit up to 3,700 MS patients at all of Sweden´s seven university clinics (serving about 50% of the total population) who are starting their first MS therapy or switching therapies. By doing the same structured follow-ups with annual disability scorings, MRIs and patient-reported QoL outcomes the study will generate high quality, real-world long-term efficacy outcomes. This will help us sort out which drugs work or don’t work so well in real-world MS patients. To address safety concerns, we will obtain data from Swedish national healthcare registries, as well as from Kaiser Permanente Southern California. By combining these resources, we will be able to address major risks, such as cancer, as well as transient treatable concerns like recurring bladder infections and bothersome skin rashes. So, which of the approved MS drugs will be the winner? Perhaps none! 

Over the last few years, there has been a dramatic shift in Sweden and Kaiser Permanente toward rituximab. One in two MS patients in Sweden now chooses to start rituximab. The data produced so far show that rituximab beats all approved MS drugs in terms of providing MS patients with an effective, safe and tolerable drug. The fact that rituximab is much cheaper than other MS drugs also makes it an attractive option in resource-limited countries, where access to brand name MS drugs is out of reach for most patients. 


Fredrik Piehl, Annette Langer-Gould, Jessica Smith and Anna Fogdell Hahn on behalf of the COMBAT-MS investigators and steering committee



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Cognition: to measure routinely or not?

At ECTRIMS I gave a short TED-type talk on why I think we need to measure cognition in people with MS in routine clinical practice. Do you agree?



Podcast: 


 The following are my slides and the accompanying script. What are your thoughts on the issue?




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News: daclizumab handcuffed by the EMA

After a second person with early RRMS died from fulminant liver failure whilst being treated with daclizumab the EMA are restricting daclizumab’s use. 



The following statement was released last Friday on the EMA’s website. It is reassuring that the EMA has decided not to withdraw daclizumab product from the market. I still think there will be a group of pwMS who will benefit from the therapy. For example, patients at (1) high-risk of PML transitioning from natalizumab, those with (2) PML post-natalizumab and (3) patients with high-disease activity who don’t want an irreversible therapy nor therapies that cause continuous immunosuppression. The elephant in the room is that in both fatal cases, those who died of liver failure on daclizumab also received concomitant tizanidine. Could tizanidine, or other hepatotoxic drugs, when used in combination with daclizumab, be the problem? I suspect the use of daclizumab will now be so low we won’t be able to answer this question with post-marketing surveillance. 

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage. 27 July 2017.

Zinbryta to be used only in a restricted patient group, with strict liver monitoring

PRAC is recommending further restrictions on the use of the multiple sclerosis medicine Zinbryta (daclizumab) following a review of the medicine’s effects on the liver.

The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta and for up to 6 months after stopping treatment. In clinical trials, 1.7% of patients receiving Zinbryta had a serious liver reaction.

In order to reduce the risks, doctors should now only prescribe Zinbryta for relapsing forms of multiple sclerosis in patients who have had an inadequate response to at least two disease-modifying therapies (DMTs) and cannot be treated with other DMTs.

In addition, doctors should monitor patients’ liver function (ALT, AST and bilirubin) at least once a month as closely as possible before each treatment and continue monitoring them for up to 6 months after treatments have stopped.

If the patient does not comply with monitoring requirements or the response to treatment is inadequate, doctors should consider stopping treatment.

It is recommended that the doctor should stop treatment if a patient has liver enzyme levels over 3 times the normal limit and refer any patients with signs and symptoms of liver damage to a liver specialist.

Patients who test positive for hepatitis B or C infection should also be referred to a specialist.

Zinbryta must not be used in patients with pre-existing liver disease and should not be started in new patients with over 2 times the normal limit of liver enzymes. It is recommended that doctors do not use Zinbryta in patients with other autoimmune conditions.

The PRAC is also recommending that in addition to the current educational material, patients and healthcare professionals in the EU should be given an acknowledgement form. The form will be used to confirm that doctors have discussed the risk with their patients and that the patients understand the importance of monitoring and checking for signs of liver damage.

These recommendations, which strengthen provisional measures introduced in July 2017, will now be sent to EMA’s Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s final opinion.


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Are we on the cusp of a self-monitoring revolution?

Self-monitoring and the socialisation of web-based apps is the revolution waiting to happen in MS care.

The following is my ‘Hot Topics’ talk on web-based PROMS (patient-related outcome measures). The presentation should be self-explanatory but if you have any questions please feel free to ask.


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text-decoration: none;
margin: 5px 2px;
border-radius: 50%;
}

.fa:hover {
opacity: 0.7;
}

.fa-facebook {
background: #3B5998;
color: white;
}

.fa-twitter {
background: #55ACEE;
color: white;
}

.fa-google {
background: #dd4b39;
color: white;
}

.fa-linkedin {
background: #007bb5;
color: white;
}

.fa-youtube {
background: #bb0000;
color: white;
}

.fa-instagram {
background: #125688;
color: white;
}

.fa-pinterest {
background: #cb2027;
color: white;
}

.fa-snapchat-ghost {
background: #fffc00;
color: white;
text-shadow: -1px 0 black, 0 1px black, 1px 0 black, 0 -1px black;
}

.fa-skype {
background: #00aff0;
color: white;
}

.fa-android {
background: #a4c639;
color: white;
}

.fa-dribbble {
background: #ea4c89;
color: white;
}

.fa-medium {
background: #000000;
color: white;
}

.fa-tumblr {
background: #2c4762;
color: white;
}

.fa-vine {
background: #00b489;
color: white;
}

.fa-foursquare {
background: #45bbff;
color: white;
}

.fa-stumbleupon {
background: #eb4924;
color: white;
}

.fa-flickr {
background: #f40083;
color: white;
}

.fa-yahoo {
background: #430297;
color: white;
}

.fa-soundcloud {
background: #ff5500;
color: white;
}

.fa-reddit {
background: #ff5700;
color: white;
}

.fa-rss {
background: #ff6600;
color: white;
}