1. Clinical baseline factors predict response to natalizumab: their usefulness in patient selection
- Author
-
Antonio Uccelli, Simonetta Venturi, Maria Teresa Rilla, Tiziana Tassinari, Matteo Pizzorno, Maria Pia Sormani, Alice Laroni, Giovanni Luigi Mancardi, Claudio Solaro, Sergio Parodi, Ilaria Gandoglia, Elisabetta Capello, Giovanna Baldassarre, and Giuseppe Ribizzi
- Subjects
Adult ,Male ,medicine.medical_specialty ,Clinical Neurology ,Antibodies, Monoclonal, Humanized ,Logistic regression ,Cohort Studies ,Multiple sclerosis ,Disability Evaluation ,Young Adult ,Multiple Sclerosis, Relapsing-Remitting ,Neuropharmacology ,Natalizumab ,Predictive Value of Tests ,Recurrence ,Internal medicine ,medicine ,Humans ,Longitudinal Studies ,Psychiatry ,Expanded Disability Status Scale ,business.industry ,Patient Selection ,General Medicine ,Odds ratio ,Middle Aged ,medicine.disease ,Discontinuation ,Research Design ,Predictive value of tests ,Female ,Neurology (clinical) ,business ,Immunosuppressive Agents ,Research Article ,medicine.drug ,Cohort study - 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.
- Full Text
- View/download PDF