Health care situation of patients with relapsing-remitting multiple sclerosis receiving immunomodulatory therapy: a retrospective survey of more than 9000 German patients with MS.

BACKGROUND AND PURPOSE: First-line immunomodulatory treatment with interferon-beta or glatiramer acetate is accepted as effective basic therapy in patients with relapsing-remitting multiple sclerosis (RRMS). However, a considerable portion of patients does not benefit from treatment. METHOD: To test basic immunomodulatory treatment under real-life conditions, we retrospectively analyzed clinical and subclinical disease activity within the last 12 months in a cohort of 9916 patients with RRMS, of which 7896 patients were receiving immunomodulatory treatment. In addition, factors associated with treating physicians' consideration of a switch of current treatment were assessed. RESULTS: The majority of treated patients (approximately 66%) experienced no relapse during the last 12 months. However, in line with common clinical study findings, about one-third (approximately 34%) of patients had relapses. When MRI data were taken into account, approximately one-quarter (24%) of patients would qualify for therapy escalation to monoclonal antibody natalizumab. Relapse rate in the preceding year (the year directly prior to the start of retrospective data collection) was strongly associated with considering a switch of current treatment. In addition, therapy switch was more often considered in younger patients. The relationship between MRI findings in the absence of clinical symptoms and consideration of a treatment switch was not as clear. CONCLUSIONS: This analysis confirms that disease progression occurs in a considerable proportion of patients with RRMS. These patients should be considered for therapy escalation.

Quality of life in 1000 patients with early relapsing-remitting multiple sclerosis.

BACKGROUND AND PURPOSE: To examine the quality of life (QoL) in a large cohort of untreated patients with relapsing-remitting multiple sclerosis (RRMS) and to investigate the impact of intramuscular (IM) interferon beta-1a (IFNbeta-1a) treatment. METHODS: Prospective, observational, open-label, multicentre study conducted in Germany. Untreated patients with RRMS who initiated treatment with IM IFNbeta-1a were included and followed for 12 months. QoL was measured using the EQ-5D questionnaire. Clinical response was assessed by relapse rate and disability (Expanded Disability Status Scale; EDSS). RESULTS: A total of 1157 patients were included [mean age 37.6 years, median disease duration 13 months, mean relapse rate 1.7 (95%CI: 1.58-1.73), median EDSS score 2.0]. Relapse rate was reduced to 0.6 at 12 months (95%CI: 0.51-0.69, P < 0.0001). EDSS did not change significantly. At baseline, QoL was considerably lower in MS patients compared with the general German population, but was improved after treatment initiation [utilities of EQ-5D: 0.77 (95%CI: 0.75-0.78) vs. 0.75 (95%CI: 0.74-0.76) at baseline, 95%CI for difference: 0.01-0.03, P = 0.0046]. Higher disease activity and inability to work were negative predictors of QoL. 14.7% of patients were incapable of working for MS-related reasons. CONCLUSIONS: Quality of life is considerably impaired in early stages of MS. Treatment initiation with IM IFNbeta attenuates MS disease activity and improves QoL. Inability to work early during the disease is a major challenge for the social security systems.