Objective: To identify predictors of clinical disease activity after treatment change to higher-dose interferon beta-1a in relapsing-remitting multiple sclerosis (MS). Methods: This was a retrospective-prospective observational multicenter study. We enrolled patients with at least one relapse on platform injectable therapy who were changed to 44 μg interferon beta-1a. Our primary endpoint was the clinical disease activity-free (cDAF) status at 6, 12, 18, and 24 months. Secondary endponts included relapse-free status and disability progression-free status at different timepoints. The primary predictor of interest was the monosymptomatic vs. polysymptomatic index relapse, based on the number of affected functional systems from the Kurtzke scale during the last relapse prior to baseline. Other secondary predictors of clinical disease activity were analyzed based on different demographic and relapse characteristics. Kaplan-Meier estimates of the cumulative probability of remaining in cDAF status were performed. The time to clinical disease activity was compared between groups using univariate Kaplan-Meier analysis and multivariate Cox regression. Multivariate analyses were processed in the form of CART (Classification & Regression Trees). Results: A total of 300 patients entered the study; 233 (77.7%) of them completed the 24-month study period and 67 patients (22.3%) terminated early. The proportion of patients in cDAF status was 84.7, 69.5, 57.5, and 54.2% at 6, 12, 18, and 24 months. After 2 years of follow-up, 55.9% of patients remained relapse-free and 87.8% of patients remained disability progression-free. At all timepoints, the polysymptomatic index relapse was the most significant predictor of clinical disease activity of all studied variables. Hazard ratio of cDAF status for patients with monosymptomatic vs. polysymptomatic index relapse was 1.94 (95% CI 1.38-2.73). CART analyses also confirmed the polysymptomatic index relapse being the strongest predictor of clinical disease activity, followed by higher number of pre-baseline relapses with the most significant effect in the monosymptomatic index relapse group. The next strongest predictors of clinical disease activity were cerebellar syndrome as the most disabled Kurtzke functional system for the monosymptomatic relapse group, and age at first MS symptom ≥ 45 for the polysymptomatic relapse group. Conclusions: Patients with a polysymptomatic index relapse and/or higher number of relapses within 2 years prior to baseline are at high risk of clinical disease activity, despite treatment change to higher-dose interferon beta-1a from other platform injectable therapy. Trial registration: State Institute of Drug Control (SUKL), URL: http://www.sukl.eu/modules/nps/index.php?h=study&a=detail&id=958&lang=2, registration number 1205090000.

• Klíčová slova
• disease activity, interferon beta, multiple sclerosis, progression, relapse,
• Publikační typ
• časopisecké články MeSH

Multiple sclerosis (MS) experts in Europe are facing rapidly rising demands of excellence due to the increasing complexity of MS therapy and management. A central European expert board of MS experts met to identify needs and obstacles with respect to raising quality of MS care in central and Eastern European countries. There are substantial variations across countries regarding delivery of care and its cost structure, as well as access to treatment. To date, Eastern European countries are often less able to afford reimbursement of immunomodulatory agents than Western countries. Overall, approximately 40% of working-age patients are not working due to MS. Costs rise steeply with increasing disability; indirect costs constitute the bulk of the financial burden in patients with severe MS. Magnetic resonance imaging (MRI) assessment is meanwhile obligatory as the diagnostic interface in the management of MS patients. Recommended measures directed at improving quality of care include the collection of patient data in registries, enhanced education of healthcare professionals, implementation of national strategies aiming at reducing regional variation, optimization of approval processes, and removal of administrative barriers. Local partnerships with authorities such as those that represent the interests of employees can contribute to leverage the importance of epidemiological data. The need for education extends to (neuro)radiologists who are responsible for reporting MRI findings in expert quality. Dissemination of the Magnetic Resonance Imaging in MS (MAGNIMS) protocol would be an important step in this context. Also, clinical freedom of choice is rated as essential. Physicians should have access to a range of treatment options due to the complexity of disease. Guidelines such as the upcoming EAN-ECTRIMS clinical practice guideline also aim at providing a basis for argumentation in negotiations with national health authorities.

• Klíčová slova
• MS registry, access to treatment, burden of disease, multiple sclerosis, quality of care,
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH