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Early predictors of injectable disease modifying drugs suboptimal response based on clinical and radiological data assessment in Polish Multiple Sclerosis patients
Affiliations- Department of Neurology, Military Clinical Hospital No. 10 with Policlinic, ul. Powstańców Warszawy 5, 85-681 Bydgoszcz, Poland
- Department of Neurology, Pomeranian Medical University, Szczecin, Poland
- Department of Neurology, Medical University of Bialystok, Bialystok, Poland
- Department of Neurology, Faculty of Medicine, University of Rzeszów, ul. Lwowska 60, 35-301 Rzeszów, Poland
- Department of Neurology, Medical University of Silesia, Zabrze, Poland
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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.
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.
Keywords
multiple sclerosis, disease modifying treatment, annualised relapse rate, Expanded Disability Status Score, magnetic resonance imaging, RIO score, efficacy
About this articleTitle
Early predictors of injectable disease modifying drugs suboptimal response based on clinical and radiological data assessment in Polish Multiple Sclerosis patients
Journal
Neurologia i Neurochirurgia Polska
Issue
Article type
Research Paper
Pages
131-137
Published online
2019-03-11
Page views
1173
Article views/downloads
952
DOI
Pubmed
Bibliographic record
Neurol Neurochir Pol 2019;53(2):131-137.
Keywords
multiple sclerosis
disease modifying treatment
annualised relapse rate
Expanded Disability Status Score
magnetic resonance imaging
RIO score
efficacy
Authors
Sławomir Wawrzyniak
Dorota Koziarska
Alina Kułakowska
Halina Bartosik-Psujek
Monika Adamczyk-Sowa
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