Early predictors of injectable disease modifying drugs suboptimal response based on clinical and radiological data assessment in Polish Multiple Sclerosis patients

Abstract

Background. Prospective database studies can provide useful information regarding 'real-world' outcomes and drug efficacy. Objective. To determine the early predictors of suboptimal treatment responses at two and three years under injectable Disease Modifying Therapy (DMT). Methods. This was a multi-centre prospective database study. Adult patients who started injectable DMTs between January 2008 and June 2013 were included. The follow-up continued until July 2014. Suboptimal treatment responses were defined as: The presence of clinical relapse and/or Expanded Disability Status Score (EDSS) progression and/or newly emerging T2 lesions or/and gadolinium enhancing lesions on magnetic resonance imaging (MRI). The parameters were assessed up to 24 months prior to, and every 12 months during, the treatment. Results. Analysis included 297 MS (multiple sclerosis) patients followed for a mean time of 2.3 ± 1.3 years (range 1-5). Within the three years of observation, the persistence and efficacy with injectable DMTs was high. With increased disability, defined by EDSS ≥ 3, the risk of treatment failure increased up to seven times, OR 7.33 in the second year radiological analysis (CI 95% : 1.69-29.2) p < 0.01, similar to over two times in the second year clinical analysis, with the baseline symptomatic hemiparesis OR 2.75 (CI 95% : 1.06-7.06) p 0.034. A high relapse rate one year prior to treatment adversely influenced the treatment success at three years, OR 3.04 (CI 95% : 1.49-8.43) p < 0.01. Conclusions . Injectable DMTs should not be chosen for treatment initiation in motoric disabled patients (EDSS ≥ 3) with a high grade of clinical activity. These drugs are effective in less active relapsing-remitting (RR) MS patients.