Early High Efficacy treatment verses escalation from a lower efficacy agents was one of the James Lind Alliance top 10 prioritises from 2013 adopted by the MS Society
The trial was adopted and at ECTRIMS 2025 we hear about the demographics of the DELIVER-ms TRIAL. People were randomised to escalation of high efficacy treatment. BartsMS could not take part in the studyy because they typically did not start people on lower efficacy treatment and so they did not have equipoise to offer people this trial. If you look at what treatments people are taking in different places it is evident that where you live/which site you are treated at will impact the type of treatment you get. Is this your choice or are people gaslighted by their neuros/nurses to steer them to take this or that agent?
In the Abstract it suggests the Americans and Different from the British as they go for high efficacy treatment straight from the off
Abstract Number: 1149/P1624 Abstract Number: 1149/P1624 Baseline characteristics of the Baseline characteristics of the Determining the Effectiveness earLy Intensive Versus Escalation approaches for the treatment of Relapsing-remitting MS (DELIVER-MS) trial cohort trial cohort.
Emma Tallantyre et al.
Introduction: There is growing support for high-efficacy Disease Modifying Therapy (DMT) in treatment-naive people with relapsing remitting multiple sclerosis (RRMS), stemming from observational, real-world studies suggesting more favourable long-term disability outcomes. However, for many reasons, an Escalation (ESC) approach to DMT remains a commonly preferred option (Says Who?). A randomized trial is needed to establish the comparative effectiveness and safety of early highly effective (EHT) and ESC (Do we could we need a trial or could we use real World evidence).
Objectives/Aims: We describe characteristics of the baseline DELIVER-MS cohort. Methods: Methods: DELIVER-MS (NCT03535298) is a pragmatic randomized controlled trial (RCT) with a parallel observational study (OBS) comparing the clinical and radiological outcomes of people with early RRMS according to whether they received ESC or EHT as their initial DMT algorithm. The primary outcome is brain volume loss from baseline to 36 months. Participants who declined the randomized study were asked to provide a reason, allowing more than one reason per participant…..Regression was used to examine the adjusted associations between baseline characteristics and: 1) participation in the RCT vs. OBS study, and 2) selection of EHT vs. ESC (within the OBS cohort).
Results: 816 people with RRMS were enrolled (modified intent to treat population: 393 in RCT and 374 in OBS cohort). EHT and ESC groups in the RCT were well balanced for demographic and clinical characteristics. People declined to randomize due to preference for a particular DMT (85%), efficacy concerns (20%), safety concerns (9%). Those entering the RCT had a higher white matter fraction on brain MRI (0.360 [0.022] versus 0.356 [0.024], p=0.009) than those entering the OBS cohort and were significantly less likely to randomize during prevaccine era of the COVID-19 pandemic (p<0.001). Overall, 125 (33%) of those entering the observational study chose ESC and 249 (67%) chose EHT. Prescribing practice differed significantly between US and UK sites with greater EHT use in the US (63% vs 37%, p<0.001). Regarding DMT selection, patients choosing ESC often cited safety concerns, while those opting for EHT were more frequently motivated by efficacy. The other factors predicting EHT commencement in the OBS cohort was higher educational attainment (p<0.001).
Conclusion: Our data demonstrate ongoing clinical equipoise between Escalation and High Efficacy approaches and support the ongoing need for an RCT to address whether all people with MS require first-line high-efficacy DMT.
Here is the view from our friends across the chanel or is it the channel
Early use of anti-CD20 versus escalation strategy in multiple sclerosis: a real-word mono-centric study in a French University Hospital Pauline Buissonniere et al.
Introduction: Accumulative data suggest the benefit of early use of high-efficacy therapies (HET) in relapsing-remitting multiple sclerosis (RR-MS) for reducing inflammatory activity and disability progression. Objectives/Aims: The aim of this study was to compare the effectiveness of early introduction of HET with anti-CD20 monoclonal antibodies versus a therapeutic escalation strategy at Bordeaux University Hospital.
Methods: This is a retrospective monocentric study using the local EDMUS database. RR-MS patients receiving anti-CD20 treatment (Rituximab, Ocrelizumab or Ofatumumab) and followed for at least two years were classified into the therapeutic escalation (ESC) group if they received at least one platform treatment before anti-CD20 or into the Early Intensive Treatment (EIT) group if HET with anti-CD20 was their first-line treatment….The primary outcome was EDSS at two years of treatment. Secondary outcomes were EDSS at the last follow-up, annualized-relapse rate (AAR) at 2 years, and the risk of reaching EDSS 3 and EDSS 6.
Results: 319 patients met ongoing diagnostic criteria for RR-MS and were treated by anti-CD20 for at least 2 years, 217 patients were included in the ESC group and 102 in the EIT group. Mean follow-up duration was 15.7 years in the ESC and 5.5 in EIT group. Mean time on anti-CD20 was 12.3 years in ESC and 2.2 in EIT. In ESC, patients received in average 2.7 DMT before anti-CD20. The PS matching procedure on age, sex, clinical and MRI activity, EDSS and time to first DMT retained 116 patients in the ESC group and 85 in the EIT group. At anti-CD20 initiation, median EDSS was 2, mean ARR was 1.3 in both PS matched arms. EDSS at 2 years was linearly associated with time to first anti-CD20. The median EDSS at 2 years and at last follow-up were lower in EIT than in ESC group (for both 1.5 in EIT group and 2.5 in ESC group, p= 0.001). ARR at 2 years was lower in EIT group (0.09 vs 0.3, p 0.008). There was no difference in relative risk of reaching irreversible EDSS 3 or 6, but events were rare.
Conclusion: In the absence of recommendations on the therapeutic sequence and results of randomized control trials, this study provides additional real word data supporting the impact of early initiation of high-efficacy treatment with anti-CD20 on long-term neurological disability in RR-MS.
Source: multiple-sclerosis-research.org