Citation

Laroni A, Gandoglia I, Solaro C, Ribizzi G, Tassinari T, Pizzorno M, Parodi S, Baldassarre G, Rilla MT, Venturi S, Capello E, Sormani MP, Uccelli A, Mancardi GL. BMC Neurol. 2014; 14(1).

Copyright

(Copyright © 2014, Holtzbrinck Springer Nature Publishing Group - BMC)

DOI

10.1186/1471-2377-14-103

PMID

unavailable

Abstract

BACKGROUND: Optimal patient selection would improve the risk-benefit ratio of natalizumab treatment for relapsing-remitting multiple sclerosis (RR MS). Clinical features of subjects responding to natalizumab have not been univocally recognized.

METHODS: Longitudinal data on RR MS patients treated with natalizumab in Liguria, Italy are reported. Predictors of relapse occurrence and disability improvement were analyzed with a logistic regression method in subjects treated for one year (N = 62). A new score, called " Better EDSS Trend (BET)" , was devised to describe the impact of the treatment on disability. Changes in annualized relapse rate (ARR) and Expanded Disability Status Scale (EDSS) after one and two years and proportion of disease-free patients were evaluated.

RESULTS: Previous EDSS worsening plus ARR ≥ 2 increased the risk of relapse during the treatment [Odds Ratio (OR) 4.12, P = 0.04], but this was not associated with an increase in disability at one year. EDSS 3.0-3.5 or high disease activity were associated with neurological improvement in the first year of treatment (respectively OR 5.78, P = 0.05 and OR 4.80, P = 0.05). Positive BET score, i.e. improvement in the disability trend, was observed in 40.3% of patients, and correlated with high ARR in the year before treatment (OR 1.69, P = 0.03).

CONCLUSION: Subjects with EDSS 3.0-3.5 and those with very active disease in the year before treatment are most likely to improve in neurological function under natalizumab. A relapse in the first year of treatment is associated to high pre-treatment disease activity; however, since the occurrence of a relapse did not have a negative impact on clinical improvement at one year, we suggest that it should not lead to treatment discontinuation. We propose BET as an additional endpoint of treatment response in MS. © 2014 Laroni et al.; licensee BioMed Central Ltd.

Language: en

Keywords

Humans; Adult; Female; Male; Middle Aged; adult; disability; human; Research Design; Disability Evaluation; female; male; Young Adult; Cohort Studies; bipolar disorder; Longitudinal Studies; Multiple sclerosis; suicide attempt; longitudinal study; Predictive Value of Tests; Recurrence; fatigue; Patient Selection; article; major clinical study; clinical feature; headache; middle aged; recurrent disease; methodology; follow up; cohort analysis; recurrence risk; correlation analysis; Natalizumab; patient selection; multiple sclerosis; disease duration; immunosuppressive agent; treatment response; disease activity; Immunosuppressive Agents; natalizumab; Expanded Disability Status Scale; monoclonal antibody; young adult; Neuropharmacology; musculoskeletal pain; Multiple Sclerosis, Relapsing-Remitting; predictive value; Antibodies, Monoclonal, Humanized; Clinical neurology; pityriasis rosea