Journal of Neurology
Abstract Volume 249 Issue 1 (2002) pp 50-56
Carlo Pozzilli (1), Giovanni Antonini (1), Francesca Bagnato (1), Caterina Mainero (1), Valentina Tomassini (1), Emanuela Onesti (1), Roberta Fantozzi (2), Simona Galgani (3), Patrizio Pasqualetti (4), Enrico Millefiorini (1), Maria Spadaro (2), Frank Dahlke (5), Claudio Gasperini (3)
(1) Department of Neurological Sciences, University "La Sapienza", Viale dell'Università 30, 00185, Rome, Italy, Tel.: +39-6-49914716, Fax: +39-6-4457705, E-Mail: firstname.lastname@example.org
(2) Institute of Neurology, University of Rome "La Sapienza", Italy
(3) Department of Neurology, S. Camillo Hospital, Rome, Italy
(4) Centre of Medical Statistics, AFaR-CRCCS Fatebenefratelli Hospital, Isola Tiberina, Rome, Italy
(5) Schering AG, Berlin, Germany
Neutralizing antibodies (NAB) to interferon beta (IFN<beta>) occur in some multiple sclerosis (MS) patients, particularly during the first year of treatment.
The presence of NAB may be associated with an attenuation of the therapeutic effect.
The aim of this study was to compare the frequency of NAB occurrence in patients treated with IFN<beta>-1 b with that in patients treated with IFN<beta>-1 b combined with monthly pulses of intravenous methylprednisolone (MP).
One hundred and sixty-one patients with relapsing-remitting MS were randomized in two treatment arms: 8 MIU of IFN<beta>-1 b subcutaneously injected every other day either alone or in combination with 1000 mg of monthly intravenous MP.
NAB were evaluated at baseline and at months 3, 6, 9, 12 and 15 by the MxA assay in a specialized laboratory.
Positivity was defined as a titer of \geq 20 neutralizing units according to two different definitions:
I) one or more non-consecutive positive samples,
II) at least two consecutive positive samples.
NAB (definition I) were observed in 26.8 % of patients in the IFN<beta>-1 b alone arm and in 12.1 % of patients in the combination therapy arm (p=0.05 by the chi-square test), which corresponds to a relative reduction of 54.9 %, whereas according to definition II, these figures dropped to 22.5 % for the IFN<beta>-1 b alone arm, and 10.6 % for the combination therapy arm (relative reduction 52.9 %, p=0.10, NS).
A higher probability of remaining in the NAB-free status was observed in patients treated with the combination therapy (p=0.031 for definition I and p=0.049 for definition II, by the Wilcoxon-Gehan test).
Methylprednisilone combined with
IFN<beta>-1 b reduces the incidence of neutralizing bodies to interferon-<beta>
during the first year of treatment in MS patients.
© Steinkopff Verlag 2002