Barts-MS rose-tinted-odometer: ★★★★
Gray & White MRI Friday #808080
When we interrogated a large number of pwSPMS we discovered that what really determines if you have active vs. inactive SPMS is how frequently you have an MRI scan. The more frequently you get scanned the more likely your team are to find new MRI lesions. If you rely on having a clinical relapse you may wait a long time. For example, after 2 years of no relapse and no MRI activity, disease activity returned in >50% of previously inactive pwSPMS. However, in 4 out of 5 cases this was driven by MRI activity and not by having a relapse.
Based on the observation that many pwSPMS have reduced MRI monitoring this decreases the chances of detecting and potentially treating and preventing disease activity in pwSPMS.
For those of you who have been told you have inactive SPMS and are ineligible for treatment, you need to ask has my MS been looked at in enough detail?
Giovannoni et al. MRI activity versus relapses as markers of disease activity in SPMS: Data from real world and pivotal clinical studies. ECTRIMS2021 P001.
Introduction: Secondary progressive multiple sclerosis (SPMS) is often categorised as active (aSPMS) or non-active (naSPMS) based on the evidence of disease activity (relapses and/or magnetic resonance imaging [MRI] activity).
Objectives: To evaluate the contribution of MRI activity and relapses in defining disease activity in SPMS patients by analysing real-world data from Adelphi real-world MS Disease Specific Programme (Adelphi MS DSP) and to understand whether aSPMS and naSPMS are mutually exclusive groups based on data from the Phase 3 EXPAND study.
Methods: Adelphi MS DSP was a non-interventional, multinational real-world study consisting of 37,318 MS patients that includes 3580 patients with SPMS who were surveyed between 2011–2019. Patients were categorised into aSPMS (≥1 new lesion on the most recent MRI and/or ≥1 relapse in the last 12 months) and naSPMS groups. In the EXPAND study, disease activity (aSPMS) was defined as presence of relapses in the 2 years prior to screening and with/without ≥1 gadolinium-enhancing (Gd+) T1 lesion at baseline. Demographics, MRI and relapse status were analysed descriptively.
Results: Patients with SPMS from the Adelphi MS DSP were categorised as aSPMS (n=1889) and naSPMS (n=665). Disease activity (aSPMS) was defined on the basis of MRI lesions (59.1%), relapse status (12.6%), and both MRI and relapse (28.3%). In the past 12 months, aSPMS (vs naSPMS) patients had a lower mean Expanded Disability Status Scale score (4.6 vs 5.2), a higher proportion of patients undergoing MRI (87.7% vs 58.7%), and more MRIs per patient (1.24 vs 0.87). A greater proportion of naSPMS (vs aSPMS) patients were without treatment (45.1% vs 23.4%). In EXPAND, 52.6% of patients (n/N=866/1645) who had no relapse in the 2 years prior to screening and no Gd+ T1 lesions at baseline were categorised under naSPMS; of these naSPMS patients who were on placebo, 52.7% experienced on-study relapse and/or MRI activity: MRI (41.8%), relapses (4.6%), and both MRI and relapse (9.2%).
Conclusions: In both real-world and clinical studies, MRI activity appears to be a more sensitive measure of disease activity versus relapses. Even after 2 years of no relapse and no MRI activity at baseline, disease activity returned in >50% of previously ‘non-active’ patients on placebo in EXPAND. Further, reduced MRI monitoring in ‘naSPMS’ patients in the real world is a concern, which decreases the chance to detect and treat any new disease activity in these patients.
Some pointed out to me yesterday that they thought it was quite cool that I was P001; I think they were drawing an analogy to 007, but let’s not go there 😉
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General Disclaimer: Please note that the opinions expressed here are those of Professor Giovannoni and do not necessarily reflect the positions of the Barts and The London School of Medicine and Dentistry nor Barts Health NHS Trust and are not meant to be interpreted as personal clinical advice.
With regards to active vs inactive RRMS, is MRI activity enough to label it as active? Looking at the NHS algorithm it seems to suggest that a new lesion isn’t enough, there needs to be a clinical relapse in the previous two years.
Currently treatment-naive. My last relapse was 3 years ago. The last two scans have shown new lesions but all sub-clinical. I’m concerned I’m not eligible for any treatment at the moment
I have SPMS and have not had any MRIs for 7 years
Are you saying that if an MRI showed changes, despite no obvious relapses , that treatments might be possible ?
I thought there was no approved treatment for SPMS .
If the latter is the case there seems no point in doing anything ?
Yes, siponimod is licensed for active SPMS defined clinically (relapses) or on MRI (new T2 or enlarging T2 or Gd-enhancing lesions) in the last 2-3 years. The latter timing is debatable, but the 2-3 year window is a pragmatic definition.
Thank you ..I wonder is it available for older patients ..I am 73 !
Was there any data on the age of these patients?
I have not seen a neurologist or MS nurse since July 2012 – we’ve had 3 Olympic games since the neuro team in Taunton were interested in seeing me!
At my last appointment the neurologist told me that I was now SPMS & things were pretty much staying the same so there wasn’t any point in me going for check-ups. He finished by looking at the busy waiting room & saying “as you can see, it’s really busy, so we need to make sure we see the people who we can help”!
I am so envious when I read of MS folk who have the luxury of seeing neurologists/MS nurses…you definitely do not want to live in Somerset – nobody is interested here.
This has been known (that MRIs are superior to picking up both overt, acute and sub-acute changes that are NOT discernible clinically) for quite sometime so why are we returning to this debate ? Given that MRIs are perhaps x 10 more sensitive, the more you do the more you are likely to pick up BUT it comes with a cost and of course, depending on whether GAD is used or not, bring in an extra wrinkle. Right ?
There were studies done in the past about x 2 GAD dose, if not x 3 dosing and so forth. How about delaying after GAD admn ? A 5 min delay is NOT the same as 30, is it ?