Michael Lang

Independent Researcher

ZUSAMMENFASSUNG Besonders bei Menschen mit chronischen Erkrankungen, z. B. Multiple Sklerose (MS), stellt die Einhaltung der verordneten Therapie über einen langen Zeitraum eine große Herausforderung dar. Teils alarmierend niedrige Adhärenzraten und ein dadurch geringerer Therapienutzen sind die Folge. Neben einem verbesserten Nebenwirkungsmanageme...

Objective To evaluate the 5-year real-world benefit–risk profile of fingolimod in patients with relapsing–remitting MS (RRMS) in Germany. Methods Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA) is a non-interventional real-world study to prospectively assess the effectiveness and safety of fingolimod in routine clini...

Despite improvements in diagnosis and treatment, multiple sclerosis (MS) is the leading neurological cause of disability in young adults. As a chronic disease, MS requires complex and challenging management. In this context, eHealth has gained an increasing relevance. Here, we aim to summarize beneficial features of a mobile app recently implemente...

Background: Fingolimod (Gilenya®) is approved for adult and pediatric patients with highly active relapsing–remitting multiple sclerosis (RRMS). Objectives: The objective was to describe the effectiveness of fingolimod in young adults compared to older patients in clinical practice. Methods: PANGAEA is the largest prospective, multi-center, non-int...

Background: The risk of progressive multifocal leukoencephalopathy limits the duration over which patients can receive natalizumab before requiring a switch to other therapies such as fingolimod. To date, no studies have assessed the long-term real-world effectiveness and safety of fingolimod following a switch from natalizumab. We aimed to invest...

Objective To assess the long-term real-world benefit–risk profile of fingolimod in patients with relapsing MS in Germany. Methods This analysis used data from the noninterventional real-world study, Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA), to assess prospectively the persistence, effectiveness, and safety of...

Introduction In addition to a wide range of disease-related burdens, patients with multiple sclerosis (MS) are challenged by long-term medication and complex disease management plans, often leading to decreased adherence. Earlier studies have indicated that patient support through intensified communication can positively impact adherence. During re...

Background Natalizumab (NTZ) was the first approved monoclonal antibody for the treatment of relapsing-remitting multiple sclerosis (RRMS). Despite proven and sustained efficacy, its use is limited by the risk of progressive multifocal leukoencephalopathy (PML). Moreover, some patients show ongoing disease activity under NTZ, requiring a switch to...

Background Recent research has convincingly shown that the ability to work mainly depends on the cognitive status in multiple sclerosis (MS). An international committee of experts recommended a brief neuropsychological battery to evaluate cognitive performance in MS. BICAMS comprises three tests, the Symbol Digit Modalities Test (SDMT), the learnin...

UNSTRUCTURED Background: Adherence constitutes a great challenge for disease management, particularly when treating chronically ill patients facing an extensive, complex and long-term therapy. Earlier studies emphasize the relevance of adherence for improving therapy benefits. Besides the positive impact of increased patient support, the use of mob...

The population with multiple sclerosis receiving treatment in clinical practice differs from that in randomized controlled trials (RCTs). An assessment of the real-world benefit-risk profile of therapies is needed. This analysis used data from the large, noninterventional, observational German study Post-Authorization Non-interventional German sAfe...

The safety profile of fingolimod 0.5 mg, approved therapy for relapsing multiple sclerosis, is well established in clinical and real-world studies. As fingolimod is teratogenic in rats, it was considered important to assess the concentrations of fingolimod and its active metabolite, fingolimod-phosphate, in the semen of male patients on treatment a...

Background First dose observation for cardiac effects is required for fingolimod, but recommendations on the extent vary. This study aims to assess cardiac safety of fingolimod first dose. Individual bradyarrhythmic episodes were evaluated to assess the relevance of continuous electrocardiogram (ECG) monitoring. MethodsSTART is an ongoing open-labe...

Purpose: The aim of this study was to evaluate physician adherence to the German Neurological Society guidelines of 2008 regarding initial monotherapy and to determine the cost-of-illness in epilepsy. Methods: This was an observational cohort study using health data routinely collected at 55 outpatient neurology practices throughout Germany (Neu...

Objective The aim was to assess the effects of prolonged release oxycodone/naloxone (OXN PR) on sleep and quality of life (QoL) in patients with severe restless legs syndrome (RLS) refractory to first-line dopaminergic RLS treatment. Methods Sleep and QoL data from a 12-week, randomized, double-blind, placebo-controlled study with subsequent 40-wee...

With the approval of various substances for the immunotherapy of multiple sclerosis (MS), treatment possibilities have improved significantly over the last few years. Indeed, the choice of individually tailored preparations and treatment monitoring for the treating doctor is becoming increasingly more complex. This is particularly applicable for mo...

Although fingolimod is registered in Europe for treatment of relapsing-remitting multiple sclerosis (RRMS) if earlier disease modifying therapy (DMT) has failed, no data regarding its efficacy in this patient group are available. This observational cohort study of the NeuroTransData network includes German RRMS outpatients with failure of earlier t...

Study supported by Sanofi Genzyme. LK: Compensation for serving on scientific advisory boards (Genzyme, Novartis); speaker honoraria/travel support (CSL Behring, Merck Serono, Novartis); research support (Biogen Idec, Novartis). SGM: Received honoraria for lecturing and travel expenses for attending meetings, and has received financial research sup...

Aim: The aim of this study is to assess the effect of switching to rotigotine transdermal patch on severity of restless legs syndrome (RLS) in patients who experienced acute augmentation with previous oral dopaminergics. Methods: In this 13-month observational study, adults with moderate-to-severe RLS and augmentation were switched to rotigotine...

Background So far, clinical studies in primary progressive MS (PPMS) have failed to meet their primary efficacy endpoints. To some extent this might be attributable to the choice of assessments or to the selection of the study population. Objective The aim of this study was to identify outcome influencing factors by analyzing the design and meth...

Die Behandlungsmoglichkeiten der schubformig-remittierenden Multiplen Sklerose (RRMS) haben sich durch den seit Herbst 2013 in Europa zugelassenen Antikorper Alemtuzumab erweitert. Inzwischen liegen erste Erfahrungen mit dem neuen Therapiekonzept vor. Doch wer ist der richtige Patient fur Alemtuzumab? Was ist beim Infusionsmanagement zu beachten? W...

In recent years the approval of new substances has led to a substantial increase in the number of course-modifying immunotherapies available for multiple sclerosis. Therapy conversion therefore represents an increasing challenge. The treatment options sometimes show complex adverse effect profiles and necessitate a long-term and comprehensive monit...

Alemtuzumab, a humanized monoclonal antibody targeting the surface molecule CD52, leads to a rapid depletion of immune cells in the innate and adaptive immune system. In phase 2 and 3 trials in multiple sclerosis (MS), infections have been reported more frequently in alemtuzumab than in interferon beta treated patients. Here we report two patients...

The origin and pathophysiological background of multiple sclerosis (MS)-associated fatigue is poorly understood. There is no unifying concept of its nature and its determinants to date. This paper reviews possible influences of factors determining personality profile on fatigue in MS. Likewise, the role of psychological factors and their interactio...

In 2012, our expert group formulated treatment goals for the immunomodulatory therapy of relapsing-remitting MS (RRMS): the primary aim is the best achievable control of disease activity, as measured by the absence of clinical and MRI-detectable disease activity. Treatment of RRMS should therefore be initiated early with an effective medication. Pr...

Fingolimod, a sphingosine 1-phosphate receptor (S1PR) modulator, is approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). Following treatment initiation, fingolimod activates S1PR at the surface of cardiac myocytes, resulting in transient pulse rate reduction, and in rare cases in atrioventricular conduction blocks. The START...

Objective The aim of the present observational study was to determine the effects of a delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) oromucosal spray (Sativex® spray), brand name Sativex®, indicated for drug-resistant MS spasticity, on the driving ability of treated MS patients.Methods The study was conducted over a period of 4–6 weeks....

Abstract BACKGROUND: Subcutaneous pegylated interferon (peginterferon) beta-1a is being developed for treatment of relapsing multiple sclerosis, with less frequent dosing than currently available first-line injectable treatments. We assessed the safety and efficacy of peginterferon beta-1a after 48 weeks of treatment in the placebo-controlled phase...

Abstract BACKGROUND: Subcutaneous pegylated interferon (peginterferon) beta-1a is being developed for treatment of relapsing multiple sclerosis, with less frequent dosing than currently available first-line injectable treatments. We assessed the safety and efficacy of peginterferon beta-1a after 48 weeks of treatment in the placebo-controlled phase...

Background: Opioids are a potential new treatment for severe restless legs syndrome. We investigated the efficacy and safety of a fixed-dose combination of prolonged release oxycodone-naloxone for patients with severe restless legs syndrome inadequately controlled by previous, mainly dopaminergic, treatment. Methods: This multicentre study consi...

Although Fingolimod is registered as a second-line drug in relapsing-remittend multiple sclerosis (RRMS) in Europe there are no clinical studies available comparing Fingolimod (FTY) and Natalizumab (N). This observational cohort-study used health data routinely collected in outpatient neurology practices throughout Germany completing a treatment pe...

Patients with multiple sclerosis (MS) may change immunomodulatory therapies if efficacy is considered inadequate or if adverse drug reactions occur. Identifying potential candidates for therapy adjustment is an important aspect of treatment optimization. This study aimed to evaluate the safety and efficacy of interferon beta-1a (IFNβ-1a), 44 μg sub...

Supplemental Table. Patient assessment of the injection process in the previous 4 weeks; intent-to-treat population (n = 106)*.

Multiple sclerosis (MS) currently requires long-term treatment with disease-modifying drugs, administered parenterally up to once daily. The need for regular self-injection can be a barrier to treatment for many patients. Autoinjectors can help patients overcome problems or concerns with self-injection and could, therefore, improve treatment adhere...

Interferon beta has been approved for the treatment of multiple sclerosis (MS). It is believed that immunomodulatory rather than antiviral activity of interferon beta is responsible for disease amelioration. The impact of interferon beta on the chemoattraction of immune cells has not been fully addressed. To address the influence of interferon beta...

Long-term efficacy and tolerability data are not yet available for patch formulations of dopamine agonists in restless legs syndrome. Efficacy and safety of rotigotine (0.5-4mg/24h), formulated as a once-daily transdermal system (patch), were investigated in an open extension (SP710) of a preceding 6-week placebo-controlled trial (SP709, 341 random...

Continuous administration of a dopamine agonist could be used to treat patients with restless legs syndrome. Our aim was to investigate the efficacy of transdermal rotigotine in the treatment of idiopathic restless legs syndrome. In this randomised, double-blind, placebo-controlled trial, 458 patients with moderate-to-severe idiopathic restless leg...

A significant proportion of patients with relapsing-remitting multiple sclerosis (MS) discontinue therapy within the first few months, although beneficial effects occur on the longer term only. This study should evaluate whether the patient's support by trained MS-nurses improves adherence. Methods: During the first three months of therapy with int...

Zusammenfassung Einleitung: Ein großer Teil der Patienten mit schubförmiger Multipler Sklerose (MS) bricht die Behandlung mit krankheitsmodifizierenden Medikamenten (DMD) frühzeitig ab. Diese Nichttherapietreue (Nonadhärenz) limitiert den Therapieerfolg und wirkt sich gesundheitsökonomisch nachteilig aus. Ziel der vorliegenden Studie war es zu prüf...

We correlated impaired unimanual motor learning with the lesion site in 53 patients with chronic lesions predominantly of the frontal lobe. The lesions were assessed using computed tomography (CT), then transferred to standard templates of nine slices parallel to the canthomeatal plane and digitized with a raster matrix of 3 mm by 3 mm width. The l...