Achieving no evidence of disease activity-3 in highly active multiple sclerosis patients treated with cladribine and monoclonal antibodies

Background We aimed to determine the proportion of highly active multiple sclerosis patients under high-efficacy therapies (HETs) achieve no evidence of disease activity-3 (NEDA-3) at 1 and 2 years, and to identify factors associated with failing to meet no evidence of disease activity 3 at 2 years. Methods This retrospective cohort study based on Argentina Multiple Sclerosis patient registry (RelevarEM), includes highly active multiple sclerosis patients who received HETs. Results In total, 254 (78.51%) achieved NEDA-3 at year 1 and 220 (68.12%) achieved NEDA-3 at year 2. Patients who achieved NEDA-3 at 2 years had a shorter duration of multiple sclerosis (p < 0.01) and a shorter time between first treatment and current treatment (p = 0.01). Early high-efficacy strategy patients reached NEDA-3 more frequently (p < 0.01). Being a naïve patient (odds ratio: 3.78, 95% confidence interval 1.50–9.86, p < 0.01) was an independent predictor to reach NEDA-3 at 2 years. No association was found between type of HETs and NEDA-3 at 2 years when adjusted for potential confounders (odds ratio: 1.73; 95% confidence interval 0.51–6.06, p 0.57). Conclusion We found a high proportion of patients who achieved NEDA-3 at 1 and 2 years. Early high-efficacy strategy patients had a higher probability of achieving NEDA-3 at 2 years.

[1]  E. Cristiano,et al.  Effectiveness and Safety of Early High-Efficacy Versus Escalation Therapy in Relapsing-Remitting Multiple Sclerosis in Argentina , 2022, Clinical neuropharmacology.

[2]  K. Alstadhaug,et al.  Effectiveness of Natalizumab in Achieving No Evidence of Disease Activity (NEDA-3)—Data From a Local Norwegian Cohort , 2021, Frontiers in Neurology.

[3]  P. Vermersch,et al.  Durability of no evidence of disease activity-3 (NEDA-3) in patients receiving cladribine tablets: The CLARITY extension study , 2021, Multiple sclerosis.

[4]  D. Centonze,et al.  Expert opinion on the use of cladribine tablets in clinical practice , 2020, Therapeutic advances in neurological disorders.

[5]  C. Gasperini,et al.  Induction Versus Escalation in Multiple Sclerosis: A 10-Year Real World Study , 2020, Neurotherapeutics.

[6]  J. Correale,et al.  Barriers to access and utilization of multiple sclerosis care services in a large cohort of Latin American patients , 2020, Multiple sclerosis.

[7]  A. Carrá,et al.  Access and unmet needs to multiple sclerosis care in a cohort of Argentinean patients. , 2019, Multiple sclerosis and related disorders.

[8]  J. Correale,et al.  The Argentinean multiple sclerosis registry (RelevarEM): Methodological aspects and directions. , 2019, Multiple sclerosis and related disorders.

[9]  V. Tomassini,et al.  Clinical Outcomes of Escalation vs Early Intensive Disease-Modifying Therapy in Patients With Multiple Sclerosis , 2019, JAMA neurology.

[10]  J. Lechner-Scott,et al.  Association of Initial Disease-Modifying Therapy With Later Conversion to Secondary Progressive Multiple Sclerosis , 2019, JAMA.

[11]  T. Berger,et al.  ‘No evidence of disease activity’ – is it an appropriate surrogate in multiple sclerosis? , 2018, European journal of neurology.

[12]  L. Kappos,et al.  Comparative analysis of natalizumab versus fingolimod as second-line treatment in relapsing–remitting multiple sclerosis , 2018, Multiple sclerosis.

[13]  David H. Miller,et al.  Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria , 2017, The Lancet Neurology.

[14]  E. Havrdová,et al.  “No evident disease activity”: The use of combined assessments in the management of patients with multiple sclerosis , 2017, Multiple sclerosis.

[15]  G. Comi,et al.  Evolving concepts in the treatment of relapsing multiple sclerosis , 2017, The Lancet.

[16]  K. Schmierer,et al.  Is it time to target no evident disease activity (NEDA) in multiple sclerosis? , 2015, Multiple sclerosis and related disorders.

[17]  H. Weiner,et al.  Evaluation of no evidence of disease activity in a 7-year longitudinal multiple sclerosis cohort. , 2015, JAMA neurology.

[18]  M. Filippi,et al.  Guidelines from The Italian Neurological and Neuroradiological Societies for the use of magnetic resonance imaging in daily life clinical practice of multiple sclerosis patients , 2013, Neurological Sciences.

[19]  G. Comi,et al.  Freedom from disease activity in multiple sclerosis , 2010, Neurology.

[20]  R Core Team,et al.  R: A language and environment for statistical computing. , 2014 .

[21]  F. Lublin Disease activity free status in MS. , 2012, Multiple sclerosis and related disorders.