Multiple sclerosis (MS) significantly affects the quality of life (QoL), interfering with a patient's ability to work, pursue leisurely activities, and execute daily life tasks (Pashazadeh Kan et al., 2022). Although different studies have investigated QoL in MS patients, results may vary across regions, cultures, and health care systems (Jongen, 2017; Pashazadeh Kan et al., 2022; Rudick and Miller, 2008; Ysrraelit et al., 2017). QoL is also affected by treatment implemented to control and avoid disease progression in MS (Jongen, 2017; Kidd et al., 2017; Rojas et al., 2022b). Regarding the treatment, most patients require multiple clinic visits and treatments – pharmacological, physical therapy, cognitive neurorehabilitation – to manage the disease, avoid disability and maintain their QoL (Jongen, 2017; Pashazadeh Kan et al., 2022; Rojas et al., 2022b). All these needs further increase the burden of the treatment (BOT) of affected patients (Arroyo et al., 2017; Pashazadeh Kan et al., 2022; Rojas et al., 2022b; Wilson et al., 2015). Some MS treatments involve self-administered injections or infusions, which can be extremely challenging for some patients to carry out (Arroyo et al., 2017; Pashazadeh Kan et al., 2022; Rojas et al., 2022b; Wilson et al., 2015; Ysrraelit et al., 2017, 2019). Despite some studies evaluated the role of the BOT in MS patients, scarce data exist in our region (Rojas et al., 2022b).

Early high efficacy therapy (HET) has been the main treatment strategies adopted in MS in recent years showing a significant decrease in disease progression versus a more conservative approach like an escalation approach or even no treatment (Brown et al., 2019; He et al., 2020; Kalincik et al., 2017; Ontaneda et al., 2019; Rojas et al., 2022a). Early HET strategy refers to starting early on high-efficacy immunosuppressant agents to control the disease (Brown et al., 2019; He et al., 2020). Its advocates argue that the risk profile of some highly efficacious drugs is not materially worse than less efficacious treatments. On the other side, the escalation strategy refers to starting treatment in newly diagnosed patients with less potent, but relatively safe agents and eventually moving on to more potent drugs in case of disease activity (Ontaneda et al., 2019). The benefit of early HET was postulated not only in a clinical benefit as well as in term of a patient reported outcomes (PRO) benefit and a societal benefit, however, these outcomes were not completely evaluated in our region (Brown et al., 2019; He et al., 2020; Ontaneda et al., 2019). Local data generation focused on the QoL and BOT of early HET and escalation therapies would be extremely useful as local factors such as access to treatments and to neurological and clinical controls could have an impact on these important factors beyond MS activity and disability progression (Rojas et al., 2021, 2022a).

Considering the previous, the objective of this study was to describe and compare the burden of treatment (BOT) and the quality of life (QoL) in early HET vs. escalation therapy in RRMS patients included in RelevarEM, the Argentinean registry of MS (RelevarEM, NCT 03,375,177).