ClinicSpeak: are you avoiding the Big Issue?

Is it time to stare-down the beast of SPMS? #ClinicSpeak #MSBlog #MSResearch

"Time for a rant; apologies upfront if the following post upsets you."

"We have had so many problems recruiting for the PROXIMUS trial that I beginning to doubt the wisdom of doing the trial. The idea is simple enough; try and add-on neuroprotective drug in early secondary progressive MS (SPMS) to see if it can stop, or at slow down, the neuroaxonal loss that underlies progressive phase of the disease. The primary outcome is neurofilament levels in spinal fluid. As you know neurofilaments are released when axons degenerate and raised levels predict a poor outcome. What we are testing is whether or not a putative neuroprotective drug can reduce neurofilament levels."

"What I have now discovered that many of my fellow healthcare professionals are reluctant to to discuss the PROXIMUS trial with their patients as it means that have to mention the dreaded topic of secondary progressive MS. Why have the conversation if you don't need to? A lot of people with MS who are on DMTs know they are gradually getting worse; they notice their cognition, walking, balance, sphincter function, etc., deteriorating, month-by-month or year-by-year. Why would they want to deny it? Is SPMS such a taboo?"

"I have argued many times before the pathological processes that drive progressive disease are present in the majority of pwMS from the outset. This is why we are starting to measure brain volume changes and CSF neurofilament levels in routine clinical practice; we need objective information to tell people that their MS is progressing despite them not being aware of it. There is no point ignoring the elephant in the room. If want to change the natural history of the progressive phase of this disease then we are going to have to get our heads around diagnosing progressive disease as early as possible. There is no point waiting for the shredder to take you to EDSS 6.0 before you accept you have SPMS. It is better to face-up to the possibility early on so that we can try and do something about it."

"The natalizumab in SPMS trial was negative, simply because the majority of pwMS went into this study with an EDSS of 6.0 (walking stick) or more. The ocrelizumab in PPMS trial was positive because the majority went into the trial with an EDSS of 5.0 or less. The message from these two studies is clear; the earlier you target progressive MS the greater the chances of us doing something about it. So if you are on a DMT and have not had a relapse in the last 6 months and you feel as if you may be getting worse you may be interested in participating in the PROXIMUS trial. How are we going to improve the lot for pwSPMS if don't get the community to wake-up to the fact that progressive MS is something to be discussed and tackled head-on; it is not something to be ignored and denied until it is too late to do something about it."


"For those of  you who have SPMS or PPMS and have already lost leg function, don't get despondent. We are in the process of designing treatment strategies to protect your upper limbs and bulbar function (speech and swallowing). We don't think we should give-up on you simply because MS has affected your walking. We would also encourage Pharma and the Regulators to think again about this; why should we write-off arm function simply because leg function has been lost? When someone loses the ability to walk their arms and hands become their legs. This is why it infuriates me when I seen non-evidence based DMT stopping criteria based on EDDS; i.e. if you get to EDSS 7.0 you have to stop your DMT. What about arm function, what about bulbar function? What people don't realise is that although the natalizumab in SPMS trial was negative it had a major impact on preserving arm function. Surely we should be focusing on that positive? An holistic approach to MS requires us to remove the EDSS blinkers and focus on what is important to pwMS and that is a moving target depending on the stage of the disease (no disability to severe disability)."

CoI: multiple and I am the chief investigator on the PROXIMUS trial

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