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5. Oral interferon beta-1a in relapsing-remitting multiple sclerosis: A double-blind randomized study

Author

Polman, C., Barkhof, F., Kappos, L., Pozzilli, C., Sandbrink, R., Dahlke, F., Jakobs, P., Lorenz, A., Hern, J., Coleman, R., Soelberg Srensen, P., Hartung, H. P., Fredrikson, S., Selmaj, K., Pelletier, J., D'Hooghe, M. B., Comi, G., Hohfeld, R., Gold, R., Panelius, M., Ruutiainen, J., Clanet, M., de Vos, M., Jonker, M., van Ijken, T., Jansen, E., van Schijndel, R., Karas, G., Wagner, K., Ghazi, M., Kurth, D., Sauerbrey, K., Tries, E., McFarland, H. F., Miller, D. H., Montalban, X., Petkau, J., Neurology, Radiology and nuclear medicine, and VU University medical center

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Placebo-controlled study, Administration, Oral, Physical examination, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Multiple Sclerosis, Relapsing-Remitting, Randomized controlled trial, Adjuvants, Immunologic, Double-Blind Method, law, Internal medicine, medicine, Humans, 030212 general & internal medicine, medicine.diagnostic_test, business.industry, Multiple sclerosis, Interferon beta-1a, Interferon-beta, Middle Aged, medicine.disease, Surgery, Clinical trial, Treatment Outcome, Neurology, Tolerability, Female, Neurology (clinical), business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Background: Interferon beta (IFNB) is available in parenter al formulations for treatment of multiple sclerosis (MS). The purpo se of this study was to evaluate safety, tolerability and effects on MRI lesions of three different doses of oral IFNB-1a compared with placebo over six months in relapsing-remitting (RR) MS patients. Methods: In this multicenter, double-blind randomized trial, RR -MS patients received 0.06, 0.6 or 6 million international units (MIU) IFNB-1a or placebo every other day for up to six months. G adolinium DTPA enhanced brain MRI scans were performed at screening and monthly during treatment. The primary variable was the cumulative number of newly active lesions. Secondary variables included volume of enhancing lesions on T1-weighted images each month and lesion volume on T2-weighted images at months three and six. Safety measures included adverse events, laboratory variables, vital signs, ECG, physical examination, EDSS and number of relapses. Neopterin was measured in 21 patients and neutralizing antibodies in 24 patients. Results: O f 194 screened patients, 173 were randomized (42-44 patients per group) in 15 centers. Median cumulative numbers of newly active lesions over six months were 4.0 in the placebo and 0.6 MIU groups, compared with 7.5 and 9.0 in the 0.06 and 6 MIU groups (no significant differences). Secondary efficacy endpoints showed small and inconsistent differences between groups. A dverse events showed no notable group differences. A pproximately two-thirds of patients in each group remained relapse free. No patients showed neutralizing antibodies. Neopterin levels were comparable between groups. Conclusion: O ral IFNB-1a showed neither beneficial effects in RRMS nor any systemic biological effects. Treatment was safe and well tolerated.

Published
2003

6. PRISMS-4: Long-term efficacy of interferon-beta-1a in relapsing MS

Author

Francis, G, Hughes, R, King, J, Mitchell, P, Joubert, J, McLeod, J, Parker, G, Pollard, J, Sindic, CJM, Duprez, T, Medaer, R, Broeckx, J, Vanroose, E, Carton, H, Wilms, G, Rice, G, Ebers, G, Lee, DH, Freedman, M, Nelson, R, Rabinovitch, H, Christie, S, Avruch, L, Oger, J, Paty, DW, Li, D, Wikstrom, J, Salonen, OLM, Panelius, M, Eralinna, J, Sonninen, P, Rieckmann, P, Hahn, D, Flachenecker, P, Hartung, HP, Uitdehaag, B, Bertelsmann, FW, Barkhof, F, Hommes, OR, Jongen, PJH, Van Doorn, PA, Tanghe, HLG, Sandberg-Wollheim, M, Larsson, EM, Lonntoft, M, Sallerfors, S, Kappos, L, Lienert, C, Radu, EW, Chofflon, M, Roth, S, Castillo, V, Schwieger, AF, Hughes, RAC, Clews, AM, Bingham, JB, Barnes, D, Clifton, AG, Stoy, N, Bates, D, Coulthard, A, Blumhardt, LD, Evans, SM, Jaspan, T, Palace, J, Newsom-Davis, JM, Byrne, JV, Quaghebeur, G, Li, DKB, Zhao, GJ, Riddehough, A, Rhodes, B, Grp, PRISMSS, and Anal, UBCMSMRI

Subjects
Neurology (clinical)
Published
2001

7. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group

Author

Ebers, GC, Rice, G, Lesaux, J, Paty, D, Oger, J, Li, DKB, Beall, S, Devonshire, V, Hashimoto, S, Hooge, J, Kastrukoff, L, Krieger, C, Mezei, M, Seland, P, Vorobeychi, G, Morrison, W, Nelson, J, Freedman, MS, Chrisie, S, Nelson, R, Rabinovitch, H, Freedman, C, Hartung, HP, Rieckmann, P, Archelos, J, Jung, S, Weilbach, F, Flachenecke, P, Sauer, J, Hommes, O, Jongen, P, Brouwer, S, McLeod, J, Pollard, J, Ng, R, Sandberg-Wollheim, M, Kallen, K, Nilsson, P, Ekberg, R, Lundgren, A, Jadback, G, Wikstrom, J, Multanen, J, Valjakka, M, Carton, H, Lissoir, F, Declerq, I, Vieren, M, Peeters, E, Dubois, B, Dekeersmaeker, E, Van Herle, A, Hughes, RAC, Sharrack, B, Soudain, S, Panelius, M, Eralinna, J, Soilu-Hanninen, M, Murto, S, Medaer, R, Broeckx, J, Vanroose, E, Bogaers, A, Blumhardt, LD, Edwards, S, Liu, C, Orpe, V, Barnes, D, Schwartz, M, Stoy, N, Harraghy, C, Bertelsmann, F, Uitdehaag, B, Nasseri, K, Chofflon, M, Roth, S, Kappos, L, Huber, S, Bellaiche, Y, Senn, C, King, J, Jubert, J, Whitten, S, Newsom-Davis, JM, Palace, J, Lee, M, Evangelou, N, Pinto, A, Cavey, A, Sindic, CJM, Monteyne, P, Verougstraete, D, Van Doorn, PA, Moll, W, Visser, L, Willems, M, Martina, I, Buljevac, D, Loman, L, Bates, D, Pandit, D, Irving, J, Rhodes, B, Riddehough, A, Zhao, GJ, Wang, X, Cheng, Y, Ammoury, N, Dupont, F, Galazka, A, Hyde, R, Olson, M, Pernin, MO, Abdul-Ahad, AK, Noseworthy, J, Borden, E, O'Brien, P, Wolinsky, J, and Grp, PRISMSS

Abstract

BACKGROUND: Previous trials of interferon beta in multiple sclerosis (MS) have shown efficacy, but the degree of clinical benefit remains uncertain, and the optimum dose is not known. We undertook a double-blind, placebo-controlled study in relapsing/remitting MS to investigate the effects of subcutaneous interferon beta-1a. METHODS: 560 patients with Kurtzke expanded disability status scale (EDSS) scores of 0-5.0, from 22 centres in nine countries, were randomly assigned subcutaneous recombinant interferon beta-1a 22 microg (n=189), or 44 microg (n=184), or placebo (n=187) three times a week for 2 years. Neurological examinations were done every 3 months. All patients had MRI twice yearly and 205 had monthly scans in the first 9 months of treatment. Analysis was by intention to treat. FINDINGS: Clinical data on 533 (95%) patients were available at 2 years. The relapse rate was significantly lower at 1 and 2 years with both doses of interferon beta-1a than with placebo (mean number per patient 1.82 for 22 microg group, 1.73 for 44 microg group vs 2.56 for placebo group: risk reductions 27% [95% CI 14-39] and 33 [21-44]). Time to first relapse was prolonged by 3 and 5 months in the 22 microg and 44 microg groups respectively, and the proportion of relapse-free patients was significantly increased (p

Published
1998

24. Intrathecal antibody synthesis to virus antigens in multiple sclerosis.

Author

Salmi, A., Reunanen, M., Ilonen, J., and Panelius, M.

Subjects
VIRUSES, ANTIGENS, IMMUNOGLOBULINS, MULTIPLE sclerosis, VIRUS diseases, HERPESVIRUS diseases, RUBELLA
Abstract

Intrathecal antibody synthesis against 17 common viruses and Mycoplasma pneumoniae lipid antigen was measured in 30 multiple sclerosis patients and 30 patients with other neurological diseases. Antibody synthesis was found against all of the antigens in at least a few of the MS patients. The highest number of patients had intrathecal synthesis of antibodies to measles, rubella and paramyxo type viruses and the lowest frequency was against M. pneumoniae, herpes simplex virus, adenovirus and cytomegalovirus antigens. Simultaneous antibody synthesis occurred against 1-11 different antigens in these patients. When the summation of different antibody specificities synthesized intrathecally was compared to the CSF-IgG Index, which measures the intrathecal immunoglobulin G synthesis, a fairly close correlation was found. The control patients had occasional antibody synthesis but generally only against one single virus antigen. The intrathecal antibody synthesis against viruses did not correlate to the disability of the MS patients. The intrathecal antibody synthesis was not different in younger and older patients or patients with shorter or longer disease duration, suggesting that events leading to intrathecal antibody synthesis may occur relatively early in life in these patients. When presence of Dw2 antigen was compared to different specificities of intrathecally synthesized immunoglobulins, only measles virus antibody synthesis showed correlation. [ABSTRACT FROM AUTHOR]

Published
1983

33. Stapedius Reflex and Brainstem Auditory Evoked Responses in Multiple Sclerosis Patients

Author

Grenman, R., Lang, H., Panelius, M., Salmivalli, A., Laine, H., and Rintamaki, J.

Abstract

The stapedius reflex (SR), its adaptation and the brain-stem auditory evoked potential (ABR) were recorded in a group of 53 multiple sclerosis patients. All cases were classified as definite according to Schumacher's criteria, and their grade of disability in Hyllested's system was 1-4: no cases of the gravest (grades 5 and 6) disability were included in the series. The peripheral hearing (puretone audiogram and speech threshold) was normal in 44 and slightly impaired in 8 cases. SR was abnormal in 6 (11%) and borderline in 11 (21%), whereas the ABR was considered abnormal in 21 (40%) patients. Deviant SR and ABR findings had only slight or no correlation to clinical data. Intercorrelation between SR and ABR abnormality was better but not implicit and a few cases with deviant ABR showed normal SR: The frequency of abnormal and borderline SR findings was clearly higher in bilateral than in unilateral ABR abnormality. Subclassification of ABR into an upper and a lower type of pathology did not correlate with SR abnormality.

Published
1974
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34. Involvement of the central nervous system in acute, uncomplicated measles virus infection

Author

Hänninen, P, Arstila, P, Lang, H, Salmi, A, and Panelius, M

Abstract

A prospective study on acute, uncomplicated measles infection was carried out in 59 patients hospitalized for an ordinary measles infection. A clinical and serological diagnosis of an acute measles infection was made in all cases. Serial serum and cerebrospinal fluid (CSF) specimens were taken two to five times from each patient and tested for pleocytosis, albumin, and measles-specific antibodies. Pleocytosis was found in 18 patients (30%), usually shortly after the onset of rash. Nine patients had antibodies against measles virus in their CSF. Six of them seemed to have damage to the blood-brain barrier, but in two cases there was a very high serum antibody titer with a normal serum/CSF ratio. One patient had a local antibody production against measles virus in the central nervous system. Conventional electroencephalography (EEG) was recorded on 22 children, and a separate, quantitative EEG study with two to six consecutive recordings was also performed on a group of nine patients. Moderate or strong slowing of background EEG activity was found in 50% of the patients. In the consecutive recordings, the changes culminated a few days after the onset of rash. No correlation seemed to exist between the changes in the CSF and the age of the patient, on the one hand, and slowing of the EEG, on the other.

Published
1980
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35. Stapedius Reflex and Brainstem Auditory Evoked Responses in Multiple Sclerosis Patients

Author

Grénman, R., Lang, H., Panelius, M., Salmivalli, A., Laine, H., and Rintamäki, J.

Abstract

The stapedius reflex (SR), its adaptation and the brain-stem auditory evoked potential (ABR) were recorded in a group of 53 multiple sclerosis patients. All cases were classified as definite according to Schumacher's criteria, and their grade of disability in Hyllested's system was 1-4: no cases of the gravest (grades 5 and 6) disability were included in the series. The peripheral hearing (puretone audiogram and speech threshold) was normal in 44 and slightly impaired in 8 cases. SR was abnormal in 6 (11%) and borderline in 11 (21%), whereas the ABR was considered abnormal in 21 (40%) patients. Deviant SR and ABR findings had only slight or no correlation to clinical data. Intercorrelation between SR and ABR abnormality was better but not implicit and a few cases with deviant ABR showed normal SR: The frequency of abnormal and borderline SR findings was clearly higher in bilateral than in unilateral ABR abnormality. Subclassification of ABR into an upper and a lower type of pathology did not correlate with SR abnormality.

Published
1984
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38. Measles Virus Antibody in Cerebrospinal Fluids from Patients with Multiple Sclerosis.

Author

Salmi, A. A., Panelius, M., Halonen, P., Rinne, U. K., and Penttinen, K.

Abstract

A strong measles-specific gel precipitation reaction was found in the cerebrospinal fluid (C.S.F.) of two patients with multiple sclerosis (M.S.) (total of 15 tested). The serum and C.S.F. specimens from these two patients were tested for measles antibody by six assay methods. The results were compared with those obtained from serum and C.S.F. specimens of a patient with subacute sclerosing panencephalitis (S.S.P.E.). The gel precipitation line produced by the C.S.F. from the M.S. patients was identical with one of the three lines produced by the C.S.F. from the S.S.P.E. patient. The main antigenic component responsible for measles antibody appearing in the C.S.F. of the S.S.P.E. patient and the M.S. patients was also electrophoretically similar, and the corresponding antibody was associated with IgG. The serum/C.S.F. antibody titre ratios with the various assay methods used suggest that the C.S.F. antibodies are mainly to other than envelope components of measles virus. No complement-fixing antibody against 27 other viruses or was found in the C.S.F. of the two M.S. patients. [ABSTRACT FROM PUBLISHER]

Published
1972
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