#ClinicSpeak & #ThinkHand: famine to a feast

Are there enough progressive patients to go around? #ClinicSpeak #ThinkHand

Since the half-positive natalizumab in SPMS (ASCEND), positive ocrelizumab in PPMS (ORATORIO), and positive siponimod in SPMS (EXPAND) trials there has been an explosion of interest in doing trials in progressive MS. I have recently been engaged in so many discussions with investigators planning investigator-led, or with pharma representatives, planning large-scale phase 3 trials, that I am now concerned that we don't have enough 'clean' patients with advanced MS to recruit for all these trials. Clean refers to the pwMS without a significant prior treatment history or comorbidities that makes them eligible for progressive trials. The screen failure rate for progressive trials is much greater than with relapsing studies. We seem to have gone from a famine to a feast.

The problem will be compounded by indication creep, i.e. extending prescribing from relapsing MS into SPMS and from PPMS into SPMS. I am not surprised by the latter; it is clear that our definition of what is progressive MS, is so nebulous, that it actually encourages indication creep. What can we do about this? I think we should scrap  the artificial definition between relapsing and progressive MS and tell all our patients that regardless of what stage of the disease they think they are in their is the potential for them to have progressive, or more correctly, neurodegenerative pathology already. We should then be targeting this pathology regardless of phase of disease. We should also be extending the window to beyond the mobile phase of the disease and including wheelchair-users in trials. The arguments for the latter are now overwhelming and underpins our #ThinkHand campaign.

Is this good news, or not, for people with more advanced MS?


CoI: multiple

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