Patient and treatment characteristics and safety outcomes of patients with relapsing-remitting multiple sclerosis treated with natalizumab in Greece: Results from the multicenter, 5-year prospective observational study 'TOPICS greece'.

BACKGROUND: Natalizumab is a highly efficacious treatment for relapsing-remitting multiple sclerosis (RRMS). OBJECTIVE: To assess the real-world long-term safety of natalizumab in RRMS. METHODS: This multicenter, 5-year prospective observational study, included adults with RRMS newly initiated on natalizumab as per the approved product label in the routine care in Greece. Safety was evaluated by collecting serious adverse events (SAEs) following study enrollment. RESULTS: Between 19-Apr-2012 and 18-Dec-2014, 304 eligible patients (median age at natalizumab initiation: 38.0 years; median disease duration: 6.2 years) were enrolled by 20 hospital-based neurologists. Over a median treatment duration period of 58.7 months, 50.7% of the patients discontinued natalizumab, mainly due to anti-JCV antibody detection (59.1%). The adverse event treatment discontinuation rate was 5.2%. The SAE incidence rate during the safety data collection period (median: 48.7 months) was 4.6%. The most common SAEs were infections (1.0%), including 2 cases (0.7%) of progressive multifocal leukoencephalopathy (PML), and no other opportunistic infections. PML diagnoses occurred 6.2-6.7 years after natalizumab initiation, and approximately 2 years after first detection of anti-JCV antibody for both patients. The incidence rate of malignancies was 0.7%. CONCLUSION: In real-world settings in Greece, natalizumab displayed an acceptable safety profile, with no new safety signals emerging.

Superficial siderosis due to a lumbar ependymoma mimicking adult-onset spinocerebellar ataxia.

Superficial siderosis (SS), as a result of chronic subarachnoid haemorrhage and haemosiderin deposition on the leptomeninges and subpial layers of the brain, cerebellum and spinal cord, can cause ataxia, pyramidal tract lesions and hearing deficits. In cases with not pronounced hearing impairment adult-onset spinocerebellar ataxia can be considered as a differential diagnostic alternative. We report a similar case where the diagnosis of SS was established by means of gradient echo MRI sequences 5 years after symptom onset. A bleeding lumbar ependymoma was identified as a source of haemorrhage. Surgical tumor resection stopped any further disease progression. Our report underlines that clinicians should be aware of the clinical features and diagnostic pitfalls of SS. Time of diagnosis and neurosurgical intervention can essentially influence the patients' prognosis.

Autoimmune cholangitis presented as fever of unknown origin.

Autoimmune cholangitis is a rare chronic cholestatic liver disease. Fever of unknown origin is defined as a temperature higher than 38.3 degrees C that lasts for more than 3 weeks with no obvious source despite appropriate investigation. We describe the case of a 62-year-old woman who presented with fever, fatigue and weight loss. The serum biochemical study showed an increase in alkaline phosphatase and gamma-glutamyl transpeptidase levels. Antinuclear, antimitochondrial, anti-smooth-muscle antibodies and antibodies against the cytoplasm of neutrophils were negative. Liver biopsy was compatible with autoimmune cholangitis. The patient was successfully treated with methylprednisolone and ursodeoxycholic acid. We describe here a rare case of fever as preceding and leading symptom of autoimmune cholangitis.