Gary Bloomgren

Anti–JC virus antibody levels in serum or plasma further define risk of natalizumab-associated progressive multifocal leukoencephalopathy

The increased risk of progressive multifocal leukoencephalopathy (PML) with natalizumab treatment is associated with the presence of anti–JC virus (JCV) antibodies. We analyzed whether anti‐JCV antibody levels, measured as index, may further define PML risk in seropositive patients.

Anti‐John Cunnigham virus antibody prevalence in multiple sclerosis patients: Baseline results of STRATIFY‐1

A study was undertaken to define the prevalence of anti‐JC virus (JCV) antibodies in multiple sclerosis (MS) patients and to evaluate the analytical false‐negative rate of a 2‐step anti‐JC virus antibody assay.

Outcome and survival of asymptomatic PML in natalizumab‐treated MS patients

As of 3 September 2013, 399 cases of natalizumab‐associated progressive multifocal leukoencephalopathy (PML) were confirmed in multiple sclerosis (MS) patients. We evaluated outcomes of natalizumab‐treated MS patients who were asymptomatic at PML diagnosis.

Assessment of malignancy risk in patients with multiple sclerosis treated with intramuscular interferon beta-1a: retrospective evaluation using a health insurance claims database and postmarketing surveillance data

Background Intramuscular interferon beta-1a (IFNβ-1a), a multiple sclerosis (MS) therapy that has been commercially available for over a decade, provides a unique opportunity to retrospectively assess postmarketing data for evidence of malignancy risk, compared with relatively limited data available for more recently approved therapies. Postmarketing and claims data were analyzed to determine the risk of malignancy in MS patients treated with intramuscular IFNβ-1a. Materials and methods The cumulative reporting rates of suspected adverse drug reactions coded to malignancy in the intramuscular IFNβ-1a global safety database were compared with malignancy incidence rates in the World Health Organization GLOBOCAN database. In addition, using data from a large US claims database, the cumulative prevalence of malignancy in MS patients treated with intramuscular IFNβ-1a was compared with non-MS population controls, MS patients without intramuscular IFNβ-1a use, and untreated MS patients. Mean follow-up was approximately 3 years for all groups, ie, 3.1 years for the intramuscular IFNβ-1a group (range 0.02–6.0 years), 2.6 years for non-MS population controls (range 0–6.0 years), 2.6 years for the intramuscular IFNβ-1a nonuse group (range 0.01–6.0 years), and 2.4 years for the untreated MS group (range 0.01–6.0 years). Results An estimated 402,250 patients received intramuscular IFNβ-1a during the postmarketing period. Cumulative reporting rates of malignancy in this population were consistent with GLOBOCAN incidence rates observed within the general population. The claims database included 12,894 MS patients who received intramuscular IFNβ-1a. No significant difference in malignancy prevalence was observed in intramuscular IFNβ-1a users compared with other groups. Conclusion Results from this evaluation provide no evidence of an increased risk of malignancy with intramuscular IFNβ-1a use.

Natalizumab Use in Patients With Crohnʼs Disease (CD) and Relapsing Multiple Sclerosis (MS): Updated Utilization and Safety Results: P-129

and complete data is available on 3 subjects who have completed the study. Their baseline PUCAI scores were 30, 35 and 50, which improved to 15, 0 and 40 respectively, at one month after FMT. All the subjects tolerated fecal enemas without leakage. One subject received only 6 oz enemas due to feeling of fullness. No serious adverse events were noted. Symptoms associated with FMT were mild (cramping, fullness, flatulence, bloating, diarrhea and nausea, which did not need treatment) to moderate (fever in one, which responded to antipyretic and anti-histaminic medications). These symptoms were self-limiting and lasted only for the duration of FMT treatment days. CONCLUSION(S): Fecal microbial transplantation as an enema is feasible, well tolerated and can be performed easily in children with UC with minimal training and support. Two of three subjects achieved clinical response by reduction in PUCAI of 15 points or more. One of them had complete resolution of disease activity. More data is anticipated for the Advances in IBD meeting in December. Larger prospective and controlled studies are needed to study clinical efficacy, endoscopic healing and the mechanism of action of FMT.