Safety and immunogenicity of a new formulation of interferon beta-1a (Rebif New Formulation) in a Phase IIIb study in patients with relapsing multiple sclerosis: 96-week results.

BACKGROUND: A new formulation of subcutaneous (s.c.) interferon-beta-1a has been developed (Rebif New Formulation, RNF), produced without fetal bovine serum and without human serum albumin as an excipient, with the aim of improving injection tolerability, and reducing immunogenicity. OBJECTIVES: This article reports 96-week analyses of a Phase IIIb, open-label study of the safety and immunogenicity of RNF compared with historical (EVIDENCE study) and recent (REGARD study) data on the original formulation. METHODS: Patients with relapsing multiple sclerosis (McDonald criteria) and an Expanded Disability Status Scale score < 6.0 received RNF, 44 microg s.c. three times weekly. RESULTS: The proportion of neutralizing antibody-positive (NAb+) patients (serum NAb status >or=20 neutralizing units/mL) at week 96 (last observation carried forward; primary endpoint) was 17.4% (exact 95% confidence interval [CI]: 13.0-22.5), compared with 21.4% (95% CI: 17.2-26.2) in the EVIDENCE study, and 27.3% (95% CI: 22.8-32.1) in the REGARD study. The proportion of patients NAb+ at any time during the 96 weeks was 18.9% (95% CI: 14.4-24.2), compared with 27.1% (95% CI: 22.4-32.2) and 33.7% (95% CI: 28.9-38.7), respectively. Most pre-specified categories of adverse events were reported by patients in the RNF study at a similar or lower proportion than in the EVIDENCE and REGARD studies. Injection-site reactions were experienced by fewer patients than in the EVIDENCE and REGARD studies. CONCLUSIONS: RNF has improved overall immunogenicity and safety profiles compared with the original formulation.

The utility of computerized neuropsychological assessment of cognitive dysfunction in patients with relapsing-remitting multiple sclerosis.

Traditional paper-and-pencil neuropsychological batteries used to document cognitive deficits in multiple sclerosis (MS) patients lack timing precision. This makes it difficult to accurately measure psychomotor slowing, a central cognitive symptom of MS. Additionally, traditional batteries lack multiple alternate forms necessary to control for practice effects when assessing cognition over time. Finally such batteries are lengthy and expensive. Computerized neuropsychological batteries address many of these shortcomings. They measure response time more precisely, require less administration time, include alternate forms, and are ideal for rapid screening/triage. Although there are normative data on the reliability and validity of computerized measures, there have been no controlled validation studies with MS patients. The current study was designed to validate a computerized neuropsychological battery (ANAM) for use with relapsing-remitting (RR) MS patients. Prior to initiation of interferon-beta-1a (Avonex) treatment, subjects participated in a neuropsychological evaluation consisting of traditional and computerized measures. Moderate-to-high correlations were found between computerized and traditional measures. Computerized tests accurately predicted performance on key traditional tests. The battery was also concordant with traditional measures in identifying RR MS patients with and without neurocognitive impairment. Findings are discussed with respect to increased accuracy and accessibility of neuropsychological evaluations for MS patients.

Photoassociation of sodium in a Bose-Einstein condensate.

We form ultracold Na2 molecules by single-photon photoassociation of a Bose-Einstein condensate, measuring the photoassociation rate, linewidth, and light shift of the J = 1, v = 135 vibrational level of the A1 Sigma (+)(u) molecular state. The photoassociation rate constant increases linearly with intensity, even where it is predicted that many-body effects might limit the rate. Our observations are in good agreement with a two-body theory having no free parameters.

7S(1/2) ? 9S(1/2) two-photon spectroscopy of trapped francium.

We report on the spectroscopic measurement of the (210)Fr 9S(1/2) energy obtained by two-photon excitation of atoms confined and cooled in a magneto-optic trap. The resonant intermediate level 7P(3/2) is the upper state of the trapping transition. We have measured the energy difference between the 9S(1/2) state and the 7S(1/2) ground state to be 25 671.021 +/- 0.006 cm(-1).

Measurements of 220Rn emanation from rocks.

Alpha-particle and gamma-ray measurements are employed to determine the individual emanation and production rates associated with the thorium radioactive series for thirty-seven rock specimens of approximately 200 cm3 individual volume representing igneous, sedimentary, and metamorphic types. These results are combined to establish 220Rn emanating powers for each of these specimens, and a wide range of values is observed. The generally large 220Rn emanation observed for these specimens strongly indicates that non-tortuous diffusion paths are commonly present in the associated structures, which gives more evidence for the existence of well-connected pore networks at the nanometer level in many of the specimens studied. While the results are qualitatively explainable, they are not predictable in terms of the current macroscopic observables. Since 220Rn and 222Rn emanation rates from rock specimens have previously been found to be comparable in magnitude, the relatively fast determination of 220Rn emanation rates described herein (measurements involving 1-h duration) is in reasonable probability indicative of a comparable 222Rn emanation rate: The employment of 220Rn as a convenient screening tool for potentially high 222Rn emanation sources is indicated.