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3. Minimal manifestation status and prednisone withdrawal in the MGTX trial

Author

Lee, I., Kuo, H.C., Aban, I.B., Cutter, G.R., McPherson, T., Kaminski, H.J., Sussman, J., Strobel, P., Oger, J., Cea, G., Heckmann, J.M., Evoli, A., Nix, W., Ciafaloni, E., Antonini, G., Witoonpanich, R., King, J.O., Beydoun, S.R., Chalk, C.H., Barboi, A.C., Amato, A.A., Shaibani, A.I., Katirji, B., Lecky, B.R.F., Buckley, C., Vincent, A., Dias-Tosta, E., Yoshikawa, H., Waddington-Cruz, M., Pulley, M.T., Rivner, M.H., Kostera-Pruszczyk, A., Pascuzzi, R.M., Jackson, C.E., Verschuuren, J.J.G., Massey, J.M., Kissel, J.T., Werneck, L.C., Benatar, M., Barohn, R.J., Tandan, R., Mozaffar, T., Conwit, R., Minisman, G., Sonett, J.R., Wolfe, G.I., and MGTX Study Grp

Subjects
Male, medicine.medical_treatment, Azathioprine, law.invention, 0302 clinical medicine, Randomized controlled trial, Prednisone, law, Medicine, Single-Blind Method, 030212 general & internal medicine, Young adult, Middle Aged, Thymectomy, Combined Modality Therapy, Substance Withdrawal Syndrome, 3. Good health, Settore MED/26 - NEUROLOGIA, 6.1 Pharmaceuticals, Anesthesia, adolescent, adult, animals, combined modality therapy, female, humans, immunosuppressive agents, male, middle aged, myasthenia gravis, prednisone, rats, single-blind method, substance withdrawal syndrome, thymoma, thymus neoplasms, young adult, thymectomy, Cognitive Sciences, Female, Immunosuppressive Agents, medicine.drug, Adult, Thymoma, Adolescent, Clinical Trials and Supportive Activities, Clinical Sciences, MGTX study group, Autoimmune Disease, Article, Young Adult, 03 medical and health sciences, Rare Diseases, Clinical Research, Myasthenia Gravis, Post-hoc analysis, Animals, Humans, Neurology & Neurosurgery, business.industry, Neurosciences, Evaluation of treatments and therapeutic interventions, Thymus Neoplasms, medicine.disease, Myasthenia gravis, Rats, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

ObjectiveTo examine whether sustained minimal manifestation status (MMS) with complete withdrawal of prednisone is better achieved in thymectomized patients with myasthenia gravis (MG).MethodsThis study is a post hoc analysis of data from a randomized trial of thymectomy in MG (Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy [MGTX]). MGTX was a multicenter, randomized, rater-blinded 3-year trial that was followed by a voluntary 2-year extension for patients with acetylcholine receptor (AChR) antibody–positive MG without thymoma. Patients were randomized 1:1 to thymectomy plus prednisone vs prednisone alone. Participants were age 18–65 years at enrollment with disease duration less than 5 years. All patients received oral prednisone titrated up to 100 mg on alternate days until they achieved MMS, which prompted a standardized prednisone taper as long as MMS was maintained. The achievement rate of sustained MMS (no symptoms of MG for 6 months) with complete withdrawal of prednisone was compared between the thymectomy plus prednisone and prednisone alone groups.ResultsPatients with MG in the thymectomy plus prednisone group achieved sustained MMS with complete withdrawal of prednisone more frequently (64% vs 38%) and quickly compared to the prednisone alone group (median time 30 months vs no median time achieved, p < 0.001) over the 5-year study period. Prednisone-associated adverse symptoms were more frequent in the prednisone alone group and distress level increased with higher doses of prednisone.ConclusionsThymectomy benefits patients with MG by increasing the likelihood of achieving sustained MMS with complete withdrawal of prednisone.Clinicaltrials.gov identifierNCT00294658.Classification of evidenceThis study provides Class II evidence that for patients with generalized MG with AChR antibody, those receiving thymectomy plus prednisone are more likely to attain sustained MMS and complete prednisone withdrawal than those on prednisone alone.

Published
2020

4. (Title Page to) Atlas Universel, Par M. Robert Geographe ordinaire du Roy, et Par M. Robert De Vaugondy son fils Geographe ord. du Roy, et de S. M. Polonoise, Duc de Lorraine et de Bar, et Associe de L'Academie Royale des Sciences et belles Lettres de Nancy, Avec Privilege Du Roy, 1757. A Paris, Chez Les Auteurs ,Quay de l'Horloge du Palais, Boudet Libraire Imprimeur du Roi, rue St. Jacques. Grave par Ch. Baquoy. J. Oger Scripsit.

Author

Robert de Vaugondy, Gilles, 1688-1766, Baquoy, Ch., Oger, J., and Robert de Vaugondy, Didier, 1723-1786

Subjects
Paris, World
Abstract

1st edition, with five postal maps added, as issued. With the list of subscribers and the extra postal maps of England, France, Germany, Italy and Spain. The French postal map is dated 1758. All five were added after the printed list of maps was printed, but are mentioned by Vaugondy in the preface, so they may have been an afterthought. An owner has added their titles to the printed list of maps, in ms. Engraved title page, Advertisement, and Geographical essay giving the sources of the maps. This atlas was reissued until 1799 (Phillips), with later issues having a map of the United States. In original half leather patterned paper covered boards with spine reading "Nouvel Atlas De Mrs. Robert." One of the first atlases based on scientific surveys, in the tradition of D'Anville and De L'Isle. Outline color., Phillips, 619 (1757/1758); Pedley. Belle et utile, p. 227; Fordham, Studies in Cartobibligraphy p. 165.

Published
1757

5. (Covers to) Atlas Universel, Par M. Robert Geographe ordinaire du Roy, et Par M. Robert De Vaugondy son fils Geographe ord. du Roy, et de S. M. Polonoise, Duc de Lorraine et de Bar, et Associe de L'Academie Royale des Sciences et belles Lettres de Nancy, Avec Privilege Du Roy, 1757. A Paris, Chez Les Auteurs ,Quay de l'Horloge du Palais, Boudet Libraire Imprimeur du Roi, rue St. Jacques. Grave par Ch. Baquoy. J. Oger Scripsit.

Author

Robert de Vaugondy, Gilles, 1688-1766, Baquoy, Ch., Oger, J., and Robert de Vaugondy, Didier, 1723-1786

Subjects
Paris
Abstract

1st edition, with five postal maps added, as issued. With the list of subscribers and the extra postal maps of England, France, Germany, Italy and Spain. The French postal map is dated 1758. All five were added after the printed list of maps was printed, but are mentioned by Vaugondy in the preface, so they may have been an afterthought. An owner has added their titles to the printed list of maps, in ms. Engraved title page, Advertisement, and Geographical essay giving the sources of the maps. This atlas was reissued until 1799 (Phillips), with later issues having a map of the United States. In original half leather patterned paper covered boards with spine reading "Nouvel Atlas De Mrs. Robert." One of the first atlases based on scientific surveys, in the tradition of D'Anville and De L'Isle. Outline color., Phillips, 619 (1757/1758); Pedley. Belle et utile, p. 227; Fordham, Studies in Cartobibligraphy p. 165.

Published
1757

9. Epidemiological evidence for a hereditary contribution to myasthenia gravis: A retrospective cohort study of patients from North America

Author

Green, J. D., Barohn, R. J., Bartoccion, E., Benatar, M., Blackmore, D., Chaudhry, V., Chopra, M., Corse, A., Dimachkie, M. M., Evoli Stampanoni-B, Amelia, Florence, J., Freimer, M., Howard, J. F., Jiwa, T., Kaminski, H. J., Kissel, J. T., Koopman, W. J., Lipscomb, B., Maestri, M., Marino, Mariapaola, Massey, J. M., Mcvey, A., Mezei, M. M., Muppidi, S., Nicolle, M. W., Oger, J., Pascuzzi, R. M., Pasnoor, M., Pestronk, A., Provenzano, Carlo, Ricciardi, R., Richman, D. P., Rowin, J., Sanders, D. B., Siddiqi, Z., Soloway, A., Wolfe, G. I., Wulf, C., Drachman, D. B., Traynor, B. J., Evoli A. (ORCID:0000-0003-0282-8787), Marino M. (ORCID:0000-0001-9155-6378), Provenzano C. (ORCID:0000-0001-5476-5517), Green, J. D., Barohn, R. J., Bartoccion, E., Benatar, M., Blackmore, D., Chaudhry, V., Chopra, M., Corse, A., Dimachkie, M. M., Evoli Stampanoni-B, Amelia, Florence, J., Freimer, M., Howard, J. F., Jiwa, T., Kaminski, H. J., Kissel, J. T., Koopman, W. J., Lipscomb, B., Maestri, M., Marino, Mariapaola, Massey, J. M., Mcvey, A., Mezei, M. M., Muppidi, S., Nicolle, M. W., Oger, J., Pascuzzi, R. M., Pasnoor, M., Pestronk, A., Provenzano, Carlo, Ricciardi, R., Richman, D. P., Rowin, J., Sanders, D. B., Siddiqi, Z., Soloway, A., Wolfe, G. I., Wulf, C., Drachman, D. B., Traynor, B. J., Evoli A. (ORCID:0000-0003-0282-8787), Marino M. (ORCID:0000-0001-9155-6378), and Provenzano C. (ORCID:0000-0001-5476-5517)

Abstract

Objectives To approximate the rate of familial myasthenia gravis and the coexistence of other autoimmune disorders in the patients and their families. Design Retrospective cohort study. Setting Clinics across North America. Participants The study included 1032 patients diagnosed with acetylcholine receptor antibody (AChR)-positive myasthenia gravis. Methods Phenotype information of 1032 patients diagnosed with AChR-positive myasthenia gravis was obtained from clinics at 14 centres across North America between January 2010 and January 2011. A critical review of the epidemiological literature on the familial rate of myasthenia gravis was also performed. Results Among 1032 patients, 58 (5.6%) reported a family history of myasthenia gravis. A history of autoimmune diseases was present in 26.6% of patients and in 28.4% of their family members. Discussion The familial rate of myasthenia gravis was higher than would be expected for a sporadic disease. Furthermore, a high proportion of patients had a personal or family history of autoimmune disease. Taken together, these findings suggest a genetic contribution to the pathogenesis of myasthenia gravis.

Published
2020

11. Water content and myelin water fraction in multiple sclerosis; A T.sub.2 relaxation study

Author

Laule, C., Vavasour, I. M., Moore, G. R. W., Oger, J., Li, D. K. B., Paty, D. W., and MacKay, A. L.

Subjects
Magnetic resonance imaging -- Usage, Multiple sclerosis -- Research, Multiple sclerosis -- Complications and side effects, Myelin proteins -- Research, Water -- Research, Health
Abstract

Byline: C. Laule (1), I. M. Vavasour (2), G. R. W. Moore (3), J. Oger (4), D. K. B. Li (2), D. W. Paty (4), A. L. MacKay (1,2) Keywords: multiple sclerosis; brain; myelin; magnetic resonance imaging; normal appearing white matter Abstract: Abstract. Background: Measurements of the T.sub.2 decay curve provide estimates of total water content and myelin water fraction in white matter in-vivo, which may help in understanding the pathological progression of multiple sclerosis (MS). Methods: Thirty-three MS patients (24 relapsing remitting, 8 secondary progressive, 1 primary progressive) and 18 controls underwent MR examinations. T.sub.2 relaxation data were acquired using a 32-echo measurement. All controls and 18 of the 33 MS patients were scanned in the transverse plane through the genu and splenium of the corpus callosum. Five white matter and 6 grey matter structures were outlined in each of these subjects. The remaining 15 MS patients were scanned in other transverse planes. A total of 189 lesions were outlined in the MS patients. Water content and myelin water fraction were calculated for all regions of interest and all lesions. Results: The normal appearing white matter (NAWM) water content was, on average, 2.2% greater than that from controls, with significant differences occurring in the posterior internal capsules, genu and splenium of the corpus callosum, minor forceps and major forceps (p &lt 0.0006). On average, MS lesions had 6.3% higher water content than contralateral NAWM (p &lt 0.0001). Myelin water fraction was 16% lower in NAWM than for controls, with significant differences in the major and minor forceps, internal capsules, and splenium (p &lt 0.05). The myelin water fraction of MS lesions averaged 52 % that of NAWM. Conclusions: NAWM in MS has a higher water content and lower myelin water fraction than control white matter. The cause of the myelin water fraction decrease in NAWM could potentially be due to either diffuse edema, inflammation, demyelination or any combination of these features. We present a simple model which suggests that myelin loss is the dominant feature of NAWM pathology. Author Affiliation: (1) Dept. of Physics &amp Astronomy, Magnetic Resonance Imaging, University of British Columbia Hospital, 2211 Wesbrook Mall, Vancouver, BC, V6T 2B5, Canada (2) Dept. of Radiology, Magnetic Resonance Imaging, University of British Columbia Hospital, Vancouver, Canada (3) Dept. of Pathology &amp Laboratory Medicine, Magnetic Resonance Imaging, University of British Columbia Hospital, Vancouver, Canada (4) Multiple Sclerosis Clinic and Dept. of Medicine, Magnetic Resonance Imaging, University of British Columbia Hospital, Vancouver, Canada Article History: Registration Date: 01/01/2004 Received Date: 02/04/2003 Accepted Date: 06/10/2003

Published
2004

12. A sensitive radioimmunoprecipitation assay for assessing the clinical relevance of antibodies to IFN β

Author

Lawrence, N, Oger, J, Aziz, T, Palace, J, and Vincent, A

Subjects
Interferon beta -- Testing -- Methods, Assaying -- Methods -- Evaluation, Viral antibodies -- Testing -- Methods, Radioimmunoassay -- Evaluation -- Methods, Antibodies -- Testing -- Methods, Health, Psychology and mental health, Testing, Evaluation, Methods
Abstract

Background: Some multiple sclerosis (MS) patients treated with interferon beta (IFN β) develop antibodies to the drug. Neutralising antibody (NAB) assays for IFN β are expensive and the clinical relevance [...]

Published
2003

22. Informing Medication Discontinuation Decisions among Older Adults with Relapsing-Onset Multiple Sclerosis.

Author

Schwehr, Natalie A., Kuntz, Karen M., Enns, Eva A., Shippee, Nathan D., Kingwell, Elaine, Tremlett, Helen, Carpenter, Adam F., Butler, Mary, The BeAMS Study group, Shirani, A., Zhao, Y., Evans, C., van der Kop, M. L., Gustafson, G., Petkau, J., and Oger, J.

Subjects
DRUGS, MULTIPLE sclerosis, PATIENT compliance, DISEASE relapse, TREATMENT effectiveness, QUALITY-adjusted life years, DESCRIPTIVE statistics, OLD age
Abstract

Background: For older adults with relapsing-onset multiple sclerosis (MS), limited information is available to inform if, or when, disease-modifying drugs (DMDs) may be safely discontinued. Objective: The aim of this study was to project the outcomes of DMD discontinuation among older adults with relapsing-onset MS. Methods: We projected the 10-year outcomes of discontinuation of a DMD (interferon-β, fingolimod, or natalizumab) among older adults (aged 55 or 70 years) who were relapse-free for 5 or more years and had not reached an Expanded Disability Status Scale (EDSS) score of 6. Outcomes included the percentage of people who had at least one relapse or reached EDSS 6, and quality-adjusted life-years (QALYs), which incorporated both relapses and disability. We used a simulation modeling approach. With increased age, relapses decreased and the effectiveness of DMDs for disability outcomes also decreased. Results: We found lower projected benefits for DMD continuation at 70 years of age than at 55 years of age. Compared with discontinuation, the projected benefit of DMD continuation ranged from 0.007 to 0.017 QALYs at 55 years of age and dropped to 0.002–0.006 at 70 years of age. The annual projected benefits of DMD continuation (0.1–3.0 quality-adjusted life-days) were very low compared with typical patient preferences regarding treatment burden. Conclusion: The benefits of DMDs may not be substantial among older adults with relapsing-onset MS. Direct clinical evidence remains limited and the decision of whether to discontinue a DMD should also take into account patient preferences. It is important to gain a better understanding of how age-related changes in the trajectory of relapsing-onset MS affect treatment effectiveness among older adults. [ABSTRACT FROM AUTHOR]

Published
2020
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24. Randomized Trial of Thymectomy in Myasthenia Gravis

Author

Wolfe, Gi, Kaminski, Hj, Aban, Ib, Minisman, G, Kuo, Hc, Marx, A, Ströbel, P, Mazia, C, Oger, J, Cea, Jg, Heckmann, Jm, Evoli, A, Nix, W, Ciafaloni, E, Antonini, G, Witoonpanich, R, King, Jo, Beydoun, Sr, Chalk, Ch, Barboi, Ac, Amato, Aa, Shaibani, Ai, Katirji, B, Lecky, Br, Buckley, C, Vincent, A, Dias Tosta, E, Yoshikawa, H, Waddington Cruz, M, Pulley, Mt, Rivner, Mh, Kostera Pruszczyk, A, Pascuzzi, Rm, Jackson, Ce, Garcia Ramos GS, Verschuuren, Jj, Massey, Jm, Kissel, Jt, Werneck, Lc, Benatar, M, Barohn, Rj, Tandan, R, Mozaffar, T, Conwit, R, Odenkirchen, J, Sonett, Jr, 3rd, Jaretzki A., Newsom Davis, J, Cutter, Gr, MGTX study group including Cutter GR, Feese, M, Saluto, V, Rosenberg, M, Alvarez, V, Rey, L, King, J, Butzkueven, H, Goldblatt, J, Carey, J, Pollard, J, Reddel, S, Handel, N, Mccaughan, B, Pallot, L, Novis, R, Boasquevisque, C, Morato Fernandez, R, Ximenes, M, Werneck, L, Scola, R, Soltoski, P, Chalk, C, Moore, F, Mulder, D, Wadup, L, Mezei, M, Evans, K, Jiwa, T, Schaffar, A, White, C, Toth, C, Gelfand, G, Wood, S, Pringle, E, Zwicker, J, Maziak, D, Shamji, F, Sundaresan, S, Seely, A, Cea, G, Verdugo, R, Aguayo, A, Jander, S, Zickler, P, Klein, M, Weis, Ca, Melms, A, Bischof, F, Aebert, H, Ziemer, G, Thümler, B, Wilhem Schwenkmezger, T, Mayer, E, Schalke, B, Pöschel, P, Hieber, G, Wiebe, K, Clemenzi, A, Ceschin, V, Rendina, E, Venuta, F, Morino, S, Bucci, E, Durelli, Luca, Tavella, A, Clerico, Marinella, Contessa, G, Borasio, P, Servidei, S, Granone, P, Mantegazza, R, Berta, E, Novellino, L, Spinelli, L, Motomura, M, Matsuo, H, Nagayasu, T, Takamori, M, Oda, M, Matsumoto, I, Furukawa, Y, Noto, D, Motozaki, Y, Iwasa, K, Yanase, D, Ramos, Gg, Cacho, B, de la Garza, L, Lipowska, M, Kwiecinski, H, Potulska Chromik, A, Orlowski, T, Silva, A, Feijo, M, Freitas, A, Heckmann, J, Frost, A, Pan, El, Tucker, L, Rossouw, J, Drummond, F, Illa, I, Diaz, J, Leon, C, Yeh, Jh, Chiu, Hc, Hsieh, Ys, Tunlayadechanont, S, Attanavanich, S, Verschuuren, J, Straathof, C, Titulaer, M, Versteegh, M, Pels, A, Krum, Y, Leite, M, Hilton Jones, D, Ratnatunga, C, Farrugia, Me, Petty, R, Overell, J, Kirk, A, Gibson, A, Mcdermott, C, Hopkinson, D, Lecky, B, Watling, D, Marshall, D, Saminaden, S, Davies, D, Dougan, C, Sathasivam, S, Page, R, Sussman, J, Ealing, J, Krysiak, P, Amato, A, Salajegheh, M, Jaklitsch, M, Roe, K, Ashizawa, T, Smith, Rg, Zwischenberg, J, Stanton, P, Barboi, A, Jaradeh, S, Tisol, W, Gasparri, M, Haasler, G, Yellick, M, Dennis, C, Barohn, R, Pasnoor, M, Dimachkie, M, Mcvey, A, Gronseth, G, Dick, A, Kramer, J, Currence, M, Herbelin, L, Belsh, J, Li, G, Langenfeld, J, Mertz, Ma, Harrison, T, Force, S, Usher, S, Beydoun, S, Lin, F, Demeester, S, Akhter, S, Malekniazi, A, Avenido, G, Crum, B, Milone, M, Cassivi, S, Fisher, J, Heatwole, C, Watson, T, Hilbert, J, Smirnow, A, Distad, B, Weiss, M, Wood, D, Haug, J, Ernstoff, R, Cao, J, Chmielewski, G, Welsh, R, Duris, R, Gutmann, L, Pawar, G, Graeber, Gm, Altemus, P, Nance, C, Jackson, C, Grogan, P, Calhoon, J, Kittrell, P, Myers, D, Kaminski, H, Hayat, G, Naunheim, K, Eller, S, Holzemer, E, Alshekhlee, A, Robke, J, Karlinchak, B, Katz, J, Miller, R, Roan, R, Forshew, D, Kissel, J, Elsheikh, B, Ross, P, Chelnick, S, Lewis, R, Acsadi, A, Baciewicz, F, Masse, S, Massey, J, Juel, V, Onaitis, M, Lowe, J, Lipscomb, B, Thai, G, Milliken, J, Martin, V, Karayan, R, Muley, S, Parry, G, Shumway, S, Oh, S, Claussen, G, Lu, L, Cerfolio, R, Young, A, Morgan, M, Pascuzzi, R, Kincaid, J, Kesler, K, Guingrich, S, Michaels, A, Phillips, L, Burns, T, Jones, D, Fischer, C, Pulley, M, Berger, A, D'Agostino, H, Smith, L, Rivner, M, Pruitt, J, Landolfo, K, Hillman, D, Shaibani, A, Sermas, A, Ruel, R, Ismail, F, Sivak, M, Goldstein, M, Camunas, J, Bratton, J, Panitch, H, Leavitt, B, Jones, M, Wolfe, G, Muppidi, S, Vernino, S, Nations, S, Meyer, D, and Gorham, N.

Subjects
Male, medicine, medicine.medical_treatment, 030204 cardiovascular system & hematology, Medical and Health Sciences, Severity of Illness Index, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Prednisone, Adolescent, Adult, Aged, Combined Modality Therapy, Female, Glucocorticoids, Hospitalization, Humans, Middle Aged, Myasthenia Gravis, Single-Blind Method, Treatment Outcome, Young Adult, Thymectomy, Medicine (all), Young adult, MGTX Study Group, General Medicine, Settore MED/26 - NEUROLOGIA, 6.1 Pharmaceuticals, medicine.drug, medicine.medical_specialty, Clinical Trials and Supportive Activities, Autoimmune Disease, 03 medical and health sciences, Rare Diseases, Clinical Research, General & Internal Medicine, Internal medicine, Severity of illness, business.industry, Neurosciences, Evaluation of treatments and therapeutic interventions, Retrospective cohort study, medicine.disease, Myasthenia gravis, Surgery, Clinical research, adolescent, adult, aged, combined modality therapy, female, glucocorticoids, hospitalization, humans, male, middle aged, myasthenia gravis, prednisone, severity of Illness index, single-blind method, treatment outcome, young adult, thymectomy, business, 030217 neurology & neurosurgery
Abstract

BackgroundThymectomy has been a mainstay in the treatment of myasthenia gravis, but there is no conclusive evidence of its benefit. We conducted a multicenter, randomized trial comparing thymectomy plus prednisone with prednisone alone.MethodsWe compared extended transsternal thymectomy plus alternate-day prednisone with alternate-day prednisone alone. Patients 18 to 65 years of age who had generalized nonthymomatous myasthenia gravis with a disease duration of less than 5 years were included if they had Myasthenia Gravis Foundation of America clinical class II to IV disease (on a scale from I to V, with higher classes indicating more severe disease) and elevated circulating concentrations of acetylcholine-receptor antibody. The primary outcomes were the time-weighted average Quantitative Myasthenia Gravis score (on a scale from 0 to 39, with higher scores indicating more severe disease) over a 3-year period, as assessed by means of blinded rating, and the time-weighted average required dose of prednisone over a 3-year period.ResultsA total of 126 patients underwent randomization between 2006 and 2012 at 36 sites. Patients who underwent thymectomy had a lower time-weighted average Quantitative Myasthenia Gravis score over a 3-year period than those who received prednisone alone (6.15 vs. 8.99, P

Published
2016

31. Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis

Author

Paul, O'Connor, Wolinsky, Jerry S., Christian, Confavreux, Giancarlo, Comi, Ludwig, Kappos, Olsson, Tomas P., Hadj, Benzerdjeb, Philippe, Truffinet, Lin, Wang, Aaron, Miller, Temso Trial Group Reingold, Freedman Ms S., Cutter, G., Antel, J., Barkhof, F., Maddrey, W., Ravnborg, M., Schenker, S., O'Connor, P., Wolinsky, J. S., Confavreux, C., Comi, G., Kappos, L., Olsson, T. P., Miller, A., Freedman, Mark S., Narayana, P. A., Nelson, F., Vainrub, I., Datta, S., He, R., Gates, B., Ton, K., Wamil, B., Truffinet, P., Igau, B., Nicolas, V., Notelet, L., Payrard, S., Wijnand, P., Devore, S., H. H., Li, Osho, T., Wang, L., Wei, L., Dukovic, D., Ling, Y., Benzerdjeb, H., Mednikova, Z., Trabelsi, N., Musset, M., Merrill, D., Turpault, S., Williams, B., Nortmeyer, H., Kirst, E., Witthaus, E., Chen, S., Maida, E., Auff, E., Fazekas, F., Berger, T., Bhan, V., Bouchard, J. P., Duquette, P., Freedman, M., Grand'Maison, F., Kremenchutzky, M., Bourque, C., Marrie, R. A., Melanson, M., Patry, D., Oger, J., Stefanelli, M., Jacques, F., Venegas, P., Miranda, M., Barrientos, N., Tenhamm, E., Gloger, S., Rohde, G., Mares, J., Frederiksen, J., Stenager, E., Haldre, S., Gross Paju, K., Elovaara, I., Sumelahti, M. L., Erälinna, J. P., Farkkila, M., Harno, H., Reunanen, M., Jolma, T., Camu, W., Clavelou, P., Magy, L., Debouverie, M., Edan, G., Lebrun Frenay, C., Moreau, T., Pelletier, J., Roullet, E., Alamowitch, S., Clanet, M., Hautecoeur, P., Damier, P., Rumbach, L., Chan, A., Schimrigk, S., Haas, J., Lensch, E., Diener, H., Limmroth, V., Anders, D., Berghoff, M., Oschmann, P., Stangel, M., Frese, A., Kiefer, R., Marziniak, M., Zettl, U., Stark, E., Jendroska, K., Reifschneider, G., Amato, M. P., Cosi, V., Gallo, P., Gasperini, Claudio, Ghezzi, A., Trojano, M., Pozzilli, Carlo, Montanari, E., Zwanikken, C. P., Jongen, P. J., Van Munster, E. T., Hupperts, R. M., Anten, B., Sanders, E. A., Celius, E., Hovdal, H., Krogseth, S. B., Kozubski, W., Kwiecinski, H., Czlonkowska, A., Stelmasiak, Z., Selmaj, K., Hasiec, T., Fryze, W., Drozdowski, W., Kochanowicz, J., Cunha, L., De Sa, J., Sena, A. H., Odinak, M., Skoromets, A., Gusev, E., Boiko, A., Lashch, N., Stolyarov, I., Belova, A., Malkova, N., Doronin, B., Yakupov, E., Brundin, L., Hillert, J., Karabudak, R., Irkec, C., Idiman, E., Turan, O., Efendi, H., Gedizlioglu, M., Buchakchyyska, N., Goloborodko, A., Ipatov, A., Kobets, S., Lebedynets, V., Moskovko, S., Sanotskyy, Y., Smolanka, V., Yavorskaya, V., Bates, D., Evangelou, N., Hawkins, C., Mclean, B., O'Riordan, J., Price, S., Turner, B., Barnes, D., Zajicek, J., Honeycutt, W., Khan, O., Spikol, L., Stevens, J., Klinische Neurowetenschappen, and RS: MHeNs School for Mental Health and Neuroscience

Subjects
medicine.medical_specialty, biology, Nausea, business.industry, Incidence (epidemiology), Placebo-controlled study, General Medicine, Placebo, Gastroenterology, Surgery, chemistry.chemical_compound, Alanine transaminase, chemistry, Internal medicine, Relative risk, Teriflunomide, medicine, biology.protein, medicine.symptom, business, Leflunomide, medicine.drug
Abstract

Teriflunomide reduced the annualized relapse rate (0.54 for placebo vs. 0.37 for teri flunomide at either 7 or 14 mg), with relative risk reductions of 31.2% and 31.5%, respectively (P

Published
2011

32. Randomized trial of thymectomy in myasthenia gravis

Author

Wolfe, G. I., Kaminski, H. J., Aban, I. B., Minisman, G., Kuo, H. -C., Marx, A., Ströbel, P., Mazia, C., Oger, J., Cea, J. G., Heckmann, J. M., Evoli Stampanoni-B, Amelia, Nix, W., Ciafaloni, E., Antonini, G., Witoonpanich, R., King, J. O., Beydoun, S. R., Chalk, C. H., Barboi, A. C., Amato, A. A., Shaibani, A. I., Katirji, B., Lecky, B. R. F., Buckley, C., Vincent, A., Dias-Tosta, E., Yoshikawa, H., Waddington-Cruz, M., Pulley, M. T., Rivner, M. H., Kostera-Pruszczyk, A., Pascuzzi, R. M., Jackson, C. E., Garcia Ramos, G. S., Verschuuren, J. J. G. M., Massey, J. M., Kissel, J. T., Werneck, L. C., Benatar, M., Barohn, R. J., Tandan, R., Mozaffar, T., Conwit, R., Odenkirchen, J., Sonett, J. R., Jaretzki, A., Newsom-Davis, J., Cutter, G. R., Evoli, A. (ORCID:0000-0003-0282-8787), Wolfe, G. I., Kaminski, H. J., Aban, I. B., Minisman, G., Kuo, H. -C., Marx, A., Ströbel, P., Mazia, C., Oger, J., Cea, J. G., Heckmann, J. M., Evoli Stampanoni-B, Amelia, Nix, W., Ciafaloni, E., Antonini, G., Witoonpanich, R., King, J. O., Beydoun, S. R., Chalk, C. H., Barboi, A. C., Amato, A. A., Shaibani, A. I., Katirji, B., Lecky, B. R. F., Buckley, C., Vincent, A., Dias-Tosta, E., Yoshikawa, H., Waddington-Cruz, M., Pulley, M. T., Rivner, M. H., Kostera-Pruszczyk, A., Pascuzzi, R. M., Jackson, C. E., Garcia Ramos, G. S., Verschuuren, J. J. G. M., Massey, J. M., Kissel, J. T., Werneck, L. C., Benatar, M., Barohn, R. J., Tandan, R., Mozaffar, T., Conwit, R., Odenkirchen, J., Sonett, J. R., Jaretzki, A., Newsom-Davis, J., Cutter, G. R., and Evoli, A. (ORCID:0000-0003-0282-8787)

Abstract

BACKGROUND: Thymectomy has been a mainstay in the treatment of myasthenia gravis, but there is no conclusive evidence of its benefit. We conducted a multicenter, randomized trial comparing thymectomy plus prednisone with prednisone alone. METHODS: We compared extended transsternal thymectomy plus alternate-day prednisone with alternate-day prednisone alone. Patients 18 to 65 years of age who had generalized nonthymomatous myasthenia gravis with a disease duration of less than 5 years were included if they had Myasthenia Gravis Foundation of America clinical class II to IV disease (on a scale from I to V, with higher classes indicating more severe disease) and elevated circulating concentrations of acetylcholine-receptor antibody. The primary outcomes were the time-weighted average Quantitative Myasthenia Gravis score (on a scale from 0 to 39, with higher scores indicating more severe disease) over a 3-year period, as assessed by means of blinded rating, and the time-weighted average required dose of prednisone over a 3-year period. RESULTS: A total of 126 patients underwent randomization between 2006 and 2012 at 36 sites. Patients who underwent thymectomy had a lower time-weighted average Quantitative Myasthenia Gravis score over a 3-year period than those who received prednisone alone (6.15 vs. 8.99, P<0.001); patients in the thymectomy group also had a lower average requirement for alternate-day prednisone (44 mg vs. 60 mg, P<0.001). Fewer patients in the thymectomy group than in the prednisone-only group required immunosuppression with azathioprine (17% vs. 48%, P<0.001) or were hospitalized for exacerbations (9% vs. 37%, P<0.001). The number of patients with treatment-associated complications did not differ significantly between groups (P=0.73), but patients in the thymectomy group had fewer treatment-associated symptoms related to immunosuppressive medications (P<0.001) and lower distress levels related to symptoms (P=0.003). CONCLUSIONS: Thymectomy improved cl

Published
2016

33. Randomized trial of thymectomy in myasthenia gravis

Author

Wolfe, G. I, Kaminski, H. J., Aban, I. B., Minisman, G., Kuo, H. C., Marx, A., Ströbel, P., Mazia, C., Oger, J., Cea, J. G., Heckmann, J. M., Evoli Stampanoni-B, Amelia, Nix, W., Ciafaloni, E., Antonini, G., Witoonpanich, R., King, J. O., Beydoun, S. R., Chalk, C. H., Barboi, A. C., Amato, A. A., Shaibani, A. I., Katirji, B., Lecky, B. R. F., Buckley, C., Vincent, A., Dias Tosta, E., Yoshikawa, H., Waddington Cruz, M., Pulley, M. T., Rivner, M. H., Kostera Pruszczyk, A., Pascuzzi, R. M., Jackson, C. E., Garcia Ramos, G. S., Verschuuren, J. J. G. M., Massey, J. M., Kissel, J. T., Werneck, L. C., Benatar, M., Barohn, R. J., Tandan, R., Mozaffar, T., Conwit, R., Odenkirchen, J., Sonett, J. R., Jaretzki, A., Newsom Davis, J., Cutter, G. R., Evoli, Amelia (ORCID:0000-0003-0282-8787), Wolfe, G. I, Kaminski, H. J., Aban, I. B., Minisman, G., Kuo, H. C., Marx, A., Ströbel, P., Mazia, C., Oger, J., Cea, J. G., Heckmann, J. M., Evoli Stampanoni-B, Amelia, Nix, W., Ciafaloni, E., Antonini, G., Witoonpanich, R., King, J. O., Beydoun, S. R., Chalk, C. H., Barboi, A. C., Amato, A. A., Shaibani, A. I., Katirji, B., Lecky, B. R. F., Buckley, C., Vincent, A., Dias Tosta, E., Yoshikawa, H., Waddington Cruz, M., Pulley, M. T., Rivner, M. H., Kostera Pruszczyk, A., Pascuzzi, R. M., Jackson, C. E., Garcia Ramos, G. S., Verschuuren, J. J. G. M., Massey, J. M., Kissel, J. T., Werneck, L. C., Benatar, M., Barohn, R. J., Tandan, R., Mozaffar, T., Conwit, R., Odenkirchen, J., Sonett, J. R., Jaretzki, A., Newsom Davis, J., Cutter, G. R., and Evoli, Amelia (ORCID:0000-0003-0282-8787)

Abstract

BACKGROUND: Thymectomy has been a mainstay in the treatment of myasthenia gravis, but there is no conclusive evidence of its benefit. We conducted a multicenter, randomized trial comparing thymectomy plus prednisone with prednisone alone. METHODS: We compared extended transsternal thymectomy plus alternate-day prednisone with alternate-day prednisone alone. Patients 18 to 65 years of age who had generalized nonthymomatous myasthenia gravis with a disease duration of less than 5 years were included if they had Myasthenia Gravis Foundation of America clinical class II to IV disease (on a scale from I to V, with higher classes indicating more severe disease) and elevated circulating concentrations of acetylcholine-receptor antibody. The primary outcomes were the time-weighted average Quantitative Myasthenia Gravis score (on a scale from 0 to 39, with higher scores indicating more severe disease) over a 3-year period, as assessed by means of blinded rating, and the time-weighted average required dose of prednisone over a 3-year period. RESULTS: A total of 126 patients underwent randomization between 2006 and 2012 at 36 sites. Patients who underwent thymectomy had a lower time-weighted average Quantitative Myasthenia Gravis score over a 3-year period than those who received prednisone alone (6.15 vs. 8.99, P<0.001); patients in the thymectomy group also had a lower average requirement for alternate-day prednisone (44 mg vs. 60 mg, P<0.001). Fewer patients in the thymectomy group than in the prednisone-only group required immunosuppression with azathioprine (17% vs. 48%, P<0.001) or were hospitalized for exacerbations (9% vs. 37%, P<0.001). The number of patients with treatment-associated complications did not differ significantly between groups (P=0.73), but patients in the thymectomy group had fewer treatment-associated symptoms related to immunosuppressive medications (P<0.001) and lower distress levels related to symptoms (P=0.003). CONCLUSIONS: Thymectomy improved cl

Published
2016

34. A Genome-wide Association Study of Myasthenia Gravis

Author

Renton, Ae, Pliner, Ha, Provenzano, Carlo, Evoli, Amelia, Ricciardi, R, Nalls, Ma, Marangi, Giuseppe, Abramzon, Y, Arepalli, S, Chong, S, Hernandez, Dg, Johnson, Jo, Bartoccioni, Emanuela, Scuderi, Flavia, Maestri, M, Gibbs, Jr, Errichiello, E, Chiò, A, Restagno, G, Sabatelli, Mario, Macek, M, Scholz, Sw, Corse, A, Chaudhry, V, Benatar, M, Barohn, Rj, Mcvey, A, Pasnoor, M, Dimachkie, Mm, Rowin, J, Kissel, J, Freimer, M, Kaminski, Hj, Sanders, Db, Lipscomb, B, Massey, Jm, Chopra, M, Howard, Jf, Koopman, Wj, Nicolle, Mw, Pascuzzi, Rm, Pestronk, A, Wulf, C, Florence, J, Blackmore, D, Soloway, A, Siddiqi, Z, Muppidi, S, Wolfe, G, Richman, D, Mezei, Mm, Jiwa, T, Oger, J, Drachman, Db, Traynor, Bj, Provenzano, Carlo (ORCID:0000-0001-5476-5517), Evoli, Amelia (ORCID:0000-0003-0282-8787), Marangi, Giuseppe (ORCID:0000-0002-6898-8882), Bartoccioni, Emanuela (ORCID:0000-0002-4434-8661), Sabatelli, Mario (ORCID:0000-0001-6635-4985), Renton, Ae, Pliner, Ha, Provenzano, Carlo, Evoli, Amelia, Ricciardi, R, Nalls, Ma, Marangi, Giuseppe, Abramzon, Y, Arepalli, S, Chong, S, Hernandez, Dg, Johnson, Jo, Bartoccioni, Emanuela, Scuderi, Flavia, Maestri, M, Gibbs, Jr, Errichiello, E, Chiò, A, Restagno, G, Sabatelli, Mario, Macek, M, Scholz, Sw, Corse, A, Chaudhry, V, Benatar, M, Barohn, Rj, Mcvey, A, Pasnoor, M, Dimachkie, Mm, Rowin, J, Kissel, J, Freimer, M, Kaminski, Hj, Sanders, Db, Lipscomb, B, Massey, Jm, Chopra, M, Howard, Jf, Koopman, Wj, Nicolle, Mw, Pascuzzi, Rm, Pestronk, A, Wulf, C, Florence, J, Blackmore, D, Soloway, A, Siddiqi, Z, Muppidi, S, Wolfe, G, Richman, D, Mezei, Mm, Jiwa, T, Oger, J, Drachman, Db, Traynor, Bj, Provenzano, Carlo (ORCID:0000-0001-5476-5517), Evoli, Amelia (ORCID:0000-0003-0282-8787), Marangi, Giuseppe (ORCID:0000-0002-6898-8882), Bartoccioni, Emanuela (ORCID:0000-0002-4434-8661), and Sabatelli, Mario (ORCID:0000-0001-6635-4985)

Abstract

Myasthenia gravis is a chronic, autoimmune, neuromuscular disease characterized by fluctuating weakness of voluntary muscle groups. Although genetic factors are known to play a role in this neuroimmunological condition, the genetic etiology underlying myasthenia gravis is not well understood.

Published
2015

35. Magnetic resonance imaging outcomes from a phase III trial of teriflunomide

Author

Wolinsky, Js, Narayana, Pa, Nelson, F, Datta, S, O'Connor, P, Confavreux, C, Comi, G, Kappos, L, Olsson, Tp, Truffinet, P, Wang, L, Miller, A, Freedman MSMaida, E, Auff, E, Fazekas, F, Berger, T, Bhan, V, Bouchard, Jp, Duquette, P, Freedman, M, Grand'Maison, F, Kremenchutzky, M, Bourque, C, Marrie, Ra, Melanson, M, Patry, D, Oger, J, Stefanelli, M, Jacques, F, Venegas, P, Miranda, M, Barrientos, N, Tenhamm, E, Gloger, S, Rohde, G, Mares, J, Frederiksen, J, Stenager, E, Haldre, S, Gross Paju, K, Elovaara, I, Sumelahti, Ml, Erälinna, Jp, Färkkilä, M, Harno, H, Reunanen, M, Jolma, T, Camu, W, Clavelou, P, Magy, L, Debouverie, M, Edan, G, Lebrun Frenay, C, Moreau, T, Pelletier, J, Roullet, E, Alamowitch, S, Clanet, M, Hautecoeur, P, Damier, P, Rumbach, L, Chan, A, Schimrigk, S, Haas, J, Lensch, E, Diener, H, Limmroth, V, Anders, D, Berghoff, M, Oschmann, P, Stangel, M, Frese, A, Kiefer, R, Marziniak, M, Zettl, U, Stark, E, Jendroska, K, Reifschneider, G, Amato, Mp, Cosi, V, Gallo, Paolo, Gasperini, C, Ghezzi, A, Trojano, M, Pozzilli, C, Montanari, E, Zwanikken, Cp, Jongen, Pj, Centrum, Ms, Van Munster ET, Hupperts, Rm, Anten, B, Sanders, Ea, Celius, E, Hovdal, H, Krogseth, Sb, Kozubski, W, Kwiecinski, H, Czlonkowska, A, Stelmasiak, Z, Selmaj, K, Hasiec, T, Fryze, W, Drozdowski, W, Kochanowicz, J, Cunha, L, De Sá, J, Harrington Sena, A, Odinak, M, Skoromets, A, Gusev, E, Boiko, A, Lashch, N, Stolyarov, I, Belova, A, Malkova, N, Doronin, B, Yakupov, E, Brundin, L, Hillert, J, Karabudak, R, Irkec, C, Idiman, E, Turan, O, Efendi, H, Gedizlioglu, M, Buchakchyyska, N, Goloborodko, A, Ipatov, A, Kobets, S, Lebedynets, V, Moskovko, S, Yushchenko, Oi, Sanotskyy, Y, Smolanka, V, Yavorskaya, V, Bates, D, Evangelou, N, Hawkins, C, Mclean, B, O'Riordan, J, Price, S, Turner, B, Barnes, D, Zajicek, J, Honeycutt, W, Khan, O, Spikol, L, and Stevens, J.

Published
2013

36. LETTERS.

Author

SCANLON, GENE, ABACK, J. R., REIMERS, FREDERICK H., BACON, MILTON E., DILLON, HELEN R., LEANE, EDWIN, BLANCHARD, R. K., ERJAVEC, DON, HUDSON, ROBERT G., PATTERSON, A. H., MOAG, OGER J., MICHAEL, JOHN D., MACQUEENEY, VINCENT P., JONES, ED, SHAW, EDWARD S., REACH, JAMES, CURTIS, CHARLES E., MIKOLIZA, VIVIAN, SENSON, CHARLES D., and WAGNER, GINNY

Subjects
LETTERS to the editor, MILITARY personnel, VOCABULARY, GEOGRAPHIC names
Abstract

Several letters to the editor are presented in response to articles in 1957 issues including one on brave troops in the October 7 issue, one on the name of Little Rock, Arkansas, and one on the definition of faubus as intransitive in the October 7 issue.

Published
1957

38. Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis

Author

O'Connor, P, Wolinsky, Js, Confavreux, C, Comi, G, Kappos, L, Olsson, Tp, Benzerdjeb, H, Truffinet, P, Wang, L, Miller, A, Freedman, Ms, Reingold, S, Cutter, G, Antel, J, Barkhof, F, Maddrey, W, Ravnborg, M, Schenker, S, Narayana, Pa, Nelson, F, Vainrub, I, Datta, S, He, R, Gates, B, Ton, K, Wamil, B, Igau, B, Nicolas, V, Notelet, L, Payrard, S, Wijnand, P, Devore, S, Li, Hh, Osho, T, Wei, L, Dukovic, D, Ling, Y, Mednikova, Z, Trabelsi, N, Musset, M, Merrill, D, Turpault, S, Williams, B, Nortmeyer, H, Kirst, E, Witthaus, E, Chen, S, Maida, E, Auff, E, Fazekas, F, Berger, T, Bhan, V, Bouchard, Jp, Duquette, P, Grand'Maison, F, Kremenchutzky, M, Bourque, C, Marrie, Ra, Melanson, M, Patry, D, Oger, J, Stefanelli, M, Jacques, F, Venegas, P, Miranda, M, Barrientos, N, Tenhamm, E, Gloger, S, Rohde, G, Mares, J, Frederiksen, J, Stenager, E, Haldre, S, Gross Paju, K, Elovaara, I, Sumelahti, Ml, Erälinna, Jp, Färkkilä, M, Harno, H, Reunanen, M, Jolma, T, Camu, W, Clavelou, P, Magy, L, Debouverie, M, Edan, G, Lebrun Frenay, C, Moreau, T, Pelletier, J, Roullet, E, Alamowitch, S, Clanet, M, Hautecoeur, P, Damier, P, Rumbach, L, Chan, A, Schimrigk, S, Haas, J, Lensch, E, Diener, H, Limmroth, V, Anders, D, Berghoff, M, Oschmann, P, Stangel, M, Frese, A, Kiefer, R, Marziniak, M, Zettl, U, Stark, E, Jendroska, K, Reifschneider, G, Amato, Mp, Cosi, V, Gallo, Paolo, Gasperini, C, Ghezzi, A, Trojano, M, Pozzilli, C, Montanari, E, Zwanikken, Cp, Jongen, Pj, Van Munster ET, Hupperts, Rm, Anten, B, Sanders, Ea, Celius, E, Hovdal, H, Krogseth, Sb, Kozubski, W, Kwiecinski, H, Czlonkowska, A, Stelmasiak, Z, Selmaj, K, Hasiec, T, Fryze, W, Drozdowski, W, Kochanowicz, J, Cunha, L, De Sá, J, Sena, Ah, Odinak, M, Skoromets, A, Gusev, E, Boiko, A, Lashch, N, Stolyarov, I, Belova, A, Malkova, N, Doronin, B, Yakupov, E, Brundin, L, Hillert, J, Karabudak, R, Irkec, C, Idiman, E, Turan, O, Efendi, H, Gedizlioglu, M, Buchakchyyska, N, Goloborodko, A, Ipatov, A, Kobets, S, Lebedynets, V, Moskovko, S, Sanotskyy, Y, Smolanka, V, Yavorskaya, V, Bates, D, Evangelou, N, Hawkins, C, Mclean, B, O'Riordan, J, Price, S, Turner, B, Barnes, D, Zajicek, J, Honeycutt, W, Khan, O, Spikol, L, and Stevens, J.

Published
2011

40. Phase II study of oral fingolimod (FTY720) in multiple sclerosis: 3-year results

Author

Comi, G, O'Connor, P, Montalban, X, Antel, J, Radue, Ew, Karlsson, G, Pohlmann, H, Aradhye, S, Kappos, L, Easton, Jd, Kesselring, J, Weinshenker, Bg, Laupacis, A, Zarbin, M, Calandra, T, Temkin, N, Dimarco, J, Hudson, Ld, Durcan, L, Bar Or, A, Duquette, P, Bernier, G, Freedman, M, Maclean, H, Costello, F, Gray, Ta, Hohol, M, Devonshire, V, Oger, J, Hashimoto, S, Sørensen, Ps, Datta, P, Faber Rod JC, Frederiksen, J, Knudsen, S, Petrenaite, V, Färkkila, M, Harno, H, Halavaara, J, Elovaara, I, Kuusisto, H, Palmio, J, Airas, L, Kaasinen, V, Laaksonen, M, Vermersch, P, Pelletier, J, Feuillet, L, Suchet, L, Mauch, E, Gunser, C, Oberbeck, K, Rieckmann, P, Buttmann, M, Klein, M, Ghezzi, A, Zaffaroni, M, Baldini, S, Mancardi, G, Cioli, F, Capello, E, Rodegher, M, Radaelli, M, Pozzilli, C, Onesti, Emanuela, Romano, Silvia, Czlonkowska, A, Litwin, T, Darda Ledzion, L, Kwiecinski, H, Golebiowski, M, Podlecka, A, Cunha, L, Sousa, L, Matias, F, Pedrosa, R, Almeida, M, Pena, Je, de Sá, J, Ferreira, J, Rosa, M, Arbizu, T, Carmona, O, Casado, V, Tintore, M, Pelayo, R, Arroyo, R, Bartolome, M, De las Heras, V, Casanova, B, Bosca, I, Fernandez, O, Leon, A, Romero, F, Izquierdo, G, Gamero, M, Garcia, Jm, Kuhle, J, Mehling, M, Achtnichts, L, Goebels, N, Skulina, C, Waskoenig, J, Bates, D, Nichols, P, Bendfeldt, K, de Vera, A, Gruenbauer, W., Ben Dahan, David, Centre de résonance magnétique biologique et médicale (CRMBM), Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), and Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Oral, Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Time Factors, Adolescent, Phases of clinical research, Administration, Oral, Kaplan-Meier Estimate, Relapsing-Remitting, administration /&/ dosage/adverse effects, Placebo, law.invention, Pulmonary function testing, 03 medical and health sciences, Disability Evaluation, Young Adult, 0302 clinical medicine, Multiple Sclerosis, Relapsing-Remitting, Randomized controlled trial, law, Sphingosine, Internal medicine, Fingolimod Hydrochloride, administration /&/ dosage/adverse effects/analogs /&/ derivatives, medicine, Humans, Adverse effect, business.industry, Fingolimod, Magnetic Resonance Imaging, diagnosis/drug therapy/pathology, Administration, Oral, Adolescent, Adult, Disability Evaluation, Female, Humans, Immunosuppressive Agents, administration /&/ dosage/adverse effects, Kaplan-Meier Estimate, Magnetic Resonance Imaging, Male, Multiple Sclerosis, diagnosis/drug therapy/pathology, Propylene Glycols, administration /&/ dosage/adverse effects, Sphingosine, administration /&/ dosage/adverse effects/analogs /&/ derivatives, Time Factors, Treatment Outcome, Young Adult, 3. Good health, Surgery, Clinical trial, Treatment Outcome, Neurology, Propylene Glycols, 030220 oncology & carcinogenesis, Female, Neurology (clinical), business, 030217 neurology & neurosurgery, Immunosuppressive Agents, medicine.drug
Abstract

In a 6-month, placebo-controlled trial, oral fingolimod (FTY720) 1.25 or 5.0 mg, once daily, significantly reduced MRI inflammatory activity and annualized relapse rate compared with placebo in patients with relapsing multiple sclerosis (MS). The objectives were to monitor the 36-month, interim efficacy and safety results of the ongoing extension of this study. In the extension (months 7—36), placebo-treated patients were re-randomized to either dose of fingolimod; fingolimod-treated patients continued at the same dose. During months 15—24, all patients receiving fingolimod 5.0 mg switched to 1.25 mg. Of the 250 patients who entered the extension study, 173 (69%) continued to month 36. Most patients were free from gadolinium-enhanced lesions (88—89%) or new T2 lesions (70—78%) at month 36. Patients receiving continuous fingolimod treatment had sustained low annualized relapse rates of 0.20—0.21, and 68—73% remained relapse-free at month 36. Over 36 months, nasopharyngitis (34%), headache (30%), fatigue (19%) and influenza (18%) were the most commonly reported adverse events. Pulmonary function remained stable and blood pressure was stable after an initial increase (3—5 mmHg) during the first 6 months of fingolimod treatment; serious adverse events included infections and skin cancer. The low MRI and clinical disease activity at 6 months were maintained at 36 months with fingolimod, which was generally well tolerated by most patients. The efficacy and safety of oral fingolimod are being further evaluated in a large phase III MS study programme.

Published
2010

41. Health-related quality of life in multiple sclerosis: Effects of natalizumab

Author

Rudick, R. A., Miller, D., Hass, S., Hutchinson, M, Calabresi, P. A., Confavreux, C., Galetta, S. L., Giovannoni, G., Havrdova, E., Kappos, L., Lublin, F. D., Miller, D. H., O'Connor, P. W., Phillips, J. T., Polman, C. H., Radue, Ew, Stuart, W. H., Wajgt, A., Weinstock Guttman, B., Wynn, D. R., Lynn, F., Panzara, M. A., Affirm, Macdonell, SENTINEL Investigators including: R., Hughes, A., Taylor, I., Lee, Y. C., Ma, H., King, J., Kilpatrick, T., Butzkueven, H., Marriott, M., Pollard, J., Spring, P., Spies, J., Barnett, M., Dehaene, I., Vanopdenbosch, L., D’Hooghe, M., Van Zandijcke, M., Derijck, O., Seeldrayers, P., Jacquy, J., Piette, T., De Cock, C., Medaer, R., Soors, P., Vanroose, E., Vanderhoven, L., Nagels, G., Dubois, B., Deville, M. C., D’Haene, R., Jacques, F., Hallé, D., Gagnon, S., Likavcan, E., Murray, T. J., Bhan, V., Mackelvey, R., Maxner, C. E., Christie, S., Giaccone, R., Guzman, D. A., Melanson, M., Esfahani, F., Gomori, A. J., Nagaria, M. H., Grand’Maison, F., Berger, L., Nasreddine, Z., Duplessis, M., Brunet, D., Jackson, A., Pari, G., O’Connor, P., Gray, T., Hohol, M., Marchetti, P., Lee, L., Murray, B., Sahlas, J., Perry, J., Devonshire, V., Hooge, J., Hashimoto, S., Oger, J., Smyth, P., Rice, G., Kremenchutzky, M., Stourac, P., Kadanka, Z., Benesova, Y., Niedermayerova, I., Meluzinova, E., Marusic, P., M, Bojar, Zarubova, K., Houzvicková, E., Piková, J., Talab, R., Faculty, Hospital Olomouc, Olomouc, B. Muchova, Urbánek, K, Kettnerova, Z., Mares, J., Otruba, P., Zapletalová, O., Hradilek, P., Ddolezil, D. Dolezil, Woznicova, I., Höfer, R., Ambler J. Fiedler, Z. Ambler J. Fiedler, Sucha, J., Matousek, V., Rektor, I., Dufek, M., Mikulik, R., Mastik, J., Tyrlikova, I., General, Teaching Hospital, Prague, E. Havrdová, Horakova, D., Kalistová, H., Týblová, M., Ehler, E., Novotná, A., Geier, P., Soelberg Sorensen, P., Ravnborg, M., Petersen, B., Blinkenberg, M., Färkkilä, M., Harno, H., Kallela, M., Häppölä, O., Elovaara, I., Kuusisto, H., Ukkonen, M., Peltola, J., Palmio, J., Pelletier, J., Feuillet, L., Suchet, L., Dalecky, A., Tammam, D., Edan, G., Le Page, E., Mérienne, M., Yaouanq, J., Clanet, M., Mekies, C., Azais Vuillemin, C., Senard, A., Lau, G., Steinmetz, G., Warter V. Wolff, J. Warter V. Wolff, Fleury, M., Tranchant, C., Stark, E., Buckpesch Heberer, U., Henn, K. 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W., Fernandez Fernandez, : O., León, A., Romero, F., Alonso, A., Tamayo, J., Montalban, X., Nos, C., Pelayo, R., Tellez, N., Rio, J., Tintore, M., Arbizu, T., Romero, L., Moral, E., Martinez, S., Kappos, : L., Wilmes, S., Karabudak, : R., Kurne, A., Erdem, S., Siva, A., Atamer, A., Bilgili, F., Topcular, B., Giovannoni, : G., Lava, : N., Murnane, M., Dentinger, M., Zimmerman, E., Reiss, M., Gupta, V., Scott, T., Brillman, J., Kunschner, L., Wright, D., Perel, A., Babu, A., Rivera, V., Killian, J., Hutton, G., Lai, E., Picone, M., Cadivid, D., Kamin, S., Shanawani, M., Gauthier, S., Morgan, A., Buckle, G., Margolin, D., Kwen, P. L., Garg, N., Munschauer, F., Khatri, B., Rassouli, M., Saxena, V., Ahmed, A., Turner, A., Fox, E., Couch, C., Tyler, R., Horvit, A., Fodor, P., Humphries, S., Wynn, D., Nagar, C., O’Brien, D., Allen, N., Turel, A., Friedenberg, S., Carlson, J., Hosey, J., Crayton, H., Richert, J., Tornatore, C., Sirdofsky, M., Greenstein, J., Shpigel, Y., Mandel, S., Adbelhak, T., Schmerler, M., Zadikoff, C., Rorick, M., Reed, R., Elias, S., Feit, H., Angus, E., Sripathi, N., Herbert, J., Kiprovski, K., Qu, X., Del Bene, M., Mattson, D., Hingtgen, C., Fleck, J., Horak, H., Javerbaum, J., Elmore, R., Garcia, E., Tasch, E., Gruener, G., Celesia, G., Chawla, J., Miller, A., Drexler, E., Keilson, M., Wolintz, R., Drasby, E., Muscat, P., Belden, J., Sullivan, R., Cohen, J., Stone, L., Marrie, R. A., Fox, R., Hughes, B., Babikian, P., Jacoby, M., Doro, J., Puricelli, M., Boudoris, W., Pierce, R., Eggenberger, E., Birbeck, G., Martin, J., Kaufman, D., Stuart, W., English, J. B., Stuart, D. S., Gilbert, R. W., Kaufman, M., Putman, S., Diedrich, A., Follmer, R., Pelletier, D., Waubant, E., Cree, B., Genain, C., Goodin, D., Patwa, H., Rizo, M., Kitaj, M., Blevins, J., Smith, T., Mcgee, F., Honeycutt, W., Brown, M., Isa, A., Nieves Quinones, D., Krupp, L., Smiroldo, J., Zarif, M., Perkins, C., Sumner, A., Fisher, A., Gutierrez, A., Jacoby, R., Svoboda, S., Dorn, D., Groeschel, A., Steingo, B., Kishner, R., Cohen, B., Melen, O., Simuni, T., Zee, P., Cohan, S., Yerby, M., Hendin, B., Levine, T., Tamm, H., Travis, L. H., Freedman, S. M., Tim, R., Ferrell, W., Stefoski, D., Stevens, S., Katsamakis, G., Topel, J., Ko, M., Gelber, D., Fortin, C., Green, B., Logan, W., Carpenter, D., Temple, L., Sadiq, S., Sylvester, A., Sim, G., Mihai, C., Vertino, M., Jubelt, B., Mejico, L., Riskind, P., Cabo, A., Paskavitz, J., Moonis, M., Bashir J. Brockington, K. Bashir J. Brockington, Nicholas, A., Slaughter, R., Archer S. Harik, R. Archer S. Harik, Haddad, N., Pippenger, M. A., Van den Noort, S., Thai, G., Olek, M., Demetriou, M., Shin, R., Calabresi, P., Rus, H., Bever, C., Johnson, K., Sherbert, R., Herndon, R., Uschmann, H., Chandler, A., Markowitz, C., Jacobs, D., Balcer, L., Mitchell, G., Chakravorty, S., Heyman, R., Stauber, Z., Goodman, A., Segal, B., Schwid, S., Samkoff, L., Levin, M., Jacewicz, M., Menkes, D., Pulsinelli, W., Frohman, E., Racke, M., Hawker, K., Ulrich, R., Panitch, H., Hamill, R., Tandon, R., Dulaney, E., Simnad, V., Miller, J., Wooten, G. F., Harrison, M., Doherty, M., Wundes, A., Distad, J., Kachuck, N., Berkovich, R., Burnett, M., Sahai, S., Bandari, D., Weiner, L., Storey, J. R., Beesley, B., Hart, D., Moses, H., Sriram, S., Fang, J., O’Duffy, A., Kita, M., Taylor, L., Elliott, M., Roberts, J., Jeffery, D., Maxwell, S., Lefkowitz, D., Kumar, S., Sinclair, M., Radue, E. W., de Vera, A., Bacelar, O., and Kuster, P.

Subjects
Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Visual analogue scale, Health Status, Population, Pain, Comorbidity, Placebo, Antibodies, law.invention, Natalizumab, Randomized controlled trial, Quality of life, Double-Blind Method, law, Internal medicine, Surveys and Questionnaires, Monoclonal, medicine, Prevalence, Humans, Longitudinal Studies, education, Humanized, education.field_of_study, Expanded Disability Status Scale, Neuroscience (all), business.industry, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Female, Patient Satisfaction, Treatment Outcome, United States, Quality of Life, Multiple sclerosis, medicine.disease, Neurology, Physical therapy, Neurology (clinical), business, medicine.drug
Abstract

Objective To report the relationship between disease activity and health-related quality of life (HRQoL) in relapsing multiple sclerosis, and the impact of natalizumab. Methods HRQoL data were available from 2,113 multiple sclerosis patients in natalizumab clinical studies. In the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM) study, patients received natalizumab 300mg (n = 627) or placebo (n = 315); in the Safety and Efficacy of Natalizumab in Combination with Interferon Beta-1a in Patients with Relapsing Remitting Multiple Sclerosis (SENTINEL) study, patients received interferon beta-1a (IFN-β-1a) plus natalizumab 300mg (n = 589), or IFN-β-1a plus placebo (n = 582). The Short Form-36 (SF-36) and a subject global assessment visual analog scale were administered at baseline and weeks 24, 52, and 104. Prespecified analyses included changes from baseline to week 104 in SF-36 and visual analog scale scores. Odds ratios for clinically meaningful improvement or worsening on the SF-36 Physical Component Summary (PCS) and Mental Component Summary were calculated. Results Mean baseline SF-36 scores were significantly less than the general US population and correlated with Expanded Disability Status Scale scores, sustained disability progression, relapse number, and increased volume of brain magnetic resonance imaging lesions. Natalizumab significantly improved SF-36 PCS and Mental Component Summary scores at week 104 in AFFIRM. PCS changes were significantly improved by week 24 and at all subsequent time points. Natalizumab-treated patients in both studies were more likely to experience clinically important improvement and less likely to experience clinically important deterioration on the SF-36 PCS. The visual analog scale also showed significantly improved HRQoL with natalizumab. Interpretation HRQoL was impaired in relapsing multiple sclerosis patients, correlated with severity of disease as measured by neurological ratings or magnetic resonance imaging, and improved significantly with natalizumab. Ann Neurol 2007

Published
2007

42. Proposal for diagnostic criteria of tropical spastic paraparesis/HTLV-I- associated myelopathy (TSP/HAM)

Author

De Castro-Costa, CM, Araújo, AQC, Barreto, MM, Takayanagui, OM, Sohler, MP, Da Silva, ELM, De Paula, SMB, Ishak, R, Ribas, JGR, Rovirosa, LC, Carton, H, Gotuzzo, E, Hall, WW, Montano, S, Murphy, EL, Oger, J, Remondegui, C, and Taylor, GP

Subjects
immune system diseases, virus diseases
Abstract

After the first description of TSP/HAM in 1985 and the elaboration of WHO's diagnostic criteria in 1988, the experience of the professionals in this field has increased so that a critical reappraisal of these diagnostic guidelines was considered timely. Brazilian neurologists and observers from other countries met recently to discuss and propose a modified model for diagnosing TSP/HAM with levels of ascertainment as definite, probable, and possible, according to myelopathic symptoms, serological findings, and/or detection of HTLV-IDNA and exclusion of other disorders. © Mary Ann Liebert, Inc.

Published
2006

43. Interferons in relapsing remitting multiple sclerosis [1] (multiple letters)

Author

Goodin, D. S., Kappos, L., Kesselring, J., Paty, D., Arnason, B., Li, D., Traboulsee, A., Freedman, M., King, J., Oger, J., Sharief, M., Hartung, H. -P., Filippini, G., Munari, L., Ebers, G. C., D'Amico, R., Rice, G. P. A., Rudick, R. A., Cookfair, D. L., Griffin, J., Hauser, S., Piantadosi, S., Kolar, O. J., Bauerle, J. A., and Lee, H.

Published
2003

45. International consensus statement on the use of disease-modifying agents in multiple sclerosis

Author

Freedman*, Ms, 1, Blumhardt2, Ld, Brochet3, B., Comi4, G., Noseworthy5, Jh, Sandberg Wollheim6, M., Soelberg Sørensen 7and the Paris Workshop This consensus statement was endorsed by: LD Blumhardt, P., Brochet, B., Comi, G., Correale, J., Cristiano, E., Fernandez, O., Freedman, Ms, Stfm, Frequin, Gallo, Paolo, Garcia Merino, A., Gebeily, S., Heesen, C., King, J., Kristoferitsch, W., Kyritsis, Ap, Lander, R., Leite, I., Pck, Li, Lublin, Fd, Macias, Ma, Miller, A., Milonas, I., Noseworthy, Jh, Oger, J., Bkc, Ong, Pedrosa, R., Po ̈hlau, D., Pollard, Jd, Pozzilli, C., Reder, At, Rieckmann, P., Roullet, E., Sandberg Wollheim, M., Schlesinger, A., Siva, A., Soelberg Sørensen, P., Trojano, M., Vollmer, T., Wolinsky, Js, and Zettl, U.

Published
2002

46. P.042 Could Live Cell-Based Assay increase the acetylcholine receptor autoantibodies seropositivity in patients with clinical suspicion of myasthenia gravis?

Author

Kumar, P, Kaur, N, Mousavi, A, Kihara, E, Aziz, T, Cruz, A, Oger, J, and Frykman, H

Abstract

Background: AChR antibodies (Abs) in Myasthnia Gravis (MG) are detected in approximately 50% of ocular and 85% of generalized MG by the current gold standard radioimmunoprecipitation assay (RIPA). Recently, fixed and lived Cell-Based assays (L-CBA) are developed. We clinically validated our in-house L-CBA in detecting AChR Ab in clinically suspected MG patients. Methods: Between January 2020 and April 2022, we assayed 10167 sera for AChR Ab by RIPA. We also assayed 4349 of AChR Ab seronegative sera of the above suspected MG samples for anti-MuSK Ab by RIPA. Then 1228 sera of double seronegative and/or borderline AChR Ab was assessed by L-CBA for AChR Ab. For clinical validation, we obtained clinical information on 36 seropositive cases for AChR Ab by L-CBA. Results: We found additional eighty-four cases seropositive for AChR Ab by L-CBA. The clinical information was obtained for 36 cases and based on their final diagnosis, twenty had generalized MG, thirteen had ocular MG, 2 not yet diagnosed and 1 case was of not-MG. Conclusions: The L- CBA has demonstrated improved sensitivity and higher diagnostics performance than RIPA. The L-CBA allowed improved clinical diagnosis and increased seropositivity (by 7%) in clinically suspected MG patients who were earlier seronegative/borderline for AChR Ab by RIPA.

Published
2023
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47. Potassium channel antibodies in two patients with reversible limbic encephalitis

Author

Buckley, C, Oger, J, Clover, L, Tüzün, E, Carpenter, K, Jackson, M, and Vincent, A

Abstract

Limbic encephalitis (LE) is often associated with lung, thymic, or testicular tumours and antibodies to Hu, CV2, or Ma2 (Ta) antigens. In these cases, it generally has a poor prognosis. Here we describe two patients with symptoms of LE, negative for typical paraneoplastic antibodies, in whom antibodies to voltage-gated potassium channels (VGKC) were detected retrospectively in serial serum samples. Patient 1 had a thymoma recurrence, but in patient 2 no tumour has been detected in the years following presentation. Plasma exchange was effective in reducing VGKC antibody levels, with substantial improvement in mental symptoms in patient 1. In patient 2, the VGKC antibodies fell spontaneously over two years, with almost complete recovery of mental function. Although neither patient had obvious neuromyotonia at presentation, both showed excessive secretions. We suggest that patients with limbic symptoms and excessive secretions should be tested for VGKC antibodies, and, if they are present, prompt and effective immunosuppressive treatment should be considered.

Published
2001

48. 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

49. 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

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