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Randomized study combining interferon and glatiramer acetate in multiple sclerosis
Lublin, Fred D; Cofield, Stacey S; Cutter, Gary R; Conwit, Robin; Narayana, Ponnada A; Nelson, Flavia; Salter, Amber R; Gustafson, Tarah; Wolinsky, Jerry S; Agius, M; Bashir, K; Baumhefner, R; Birnbaum, G; Blevins, G; Bomprezzi, R; Boster, A; Brown, T; Burkholder, J; Camac, A; Campagnolo, D; Carter, J; Cohen, B; Cooper, J; Corboy, J; Cross, A; Dewitt, L; Dunn, J; Edwards, K; Eggenberger, E; English, J; Felton, W; Fodor, P; Ford, C; Freedman, M; Galetta, S; Garmany, G; Goodman, A; Gottesman, M; Gottschalk, C; Gruenthal, M; Gudesblatt, M; Hagan, M; Hamill, R; Herbert, J; Holub, R; Honeycutt, W; Hughes, B; Hutton, G; Jacobs, D; Johnson, K; Kasper, L; Kattah, J; Kaufman, M; Keegan, M; Khan, O; Khatri, B; Kita, M; Koffman, B; Lallana, E; Lava, N; Lindsey, J; Loge, P; Lynch, S; McGee, F; Mejico, L; Metz, L; O'Connor, P; Okuda, D; Pandey, K; Panitch, H; Pelletier, D; Preiningerova, J; Rammohan, K; Riley, C; Riskind, P; Rolak, L; Royal, W; Scarberry, S; Schulman, A; Scott, T; Sheppard, C; Sheremata, W; Stone, L; Stuart, W; Sriram, S; Thadani, V; Thomas, F P; Thrower, B; Tullman, M; Turel, A; Vollmer, T; Waldman, S; Weinstock-Guttman, B; Wendt, J; Williams, R; Wynn, D; Yeung, M
OBJECTIVE:A double-blind, randomized, controlled study was undertaken to determine whether combined use of interferon β-1a (IFN) 30 μg intramuscularly weekly and glatiramer acetate (GA) 20 mg daily is more efficacious than either agent alone in relapsing-remitting multiple sclerosis. METHODS:A total of 1,008 participants were randomized and followed until the last participant enrolled completed 3 years. The primary endpoint was reduction in annualized relapse rate utilizing a strict definition of relapse. Secondary outcomes included time to confirmed disability, Multiple Sclerosis Functional Composite (MSFC) score, and magnetic resonance imaging (MRI) metrics. RESULTS:Combination IFN+GA was not superior to the better of the single agents (GA) in risk of relapse. Both the combination therapy and GA were significantly better than IFN in reducing the risk of relapse. The combination was not better than either agent alone in lessening confirmed Expanded Disability Status Scale progression or change in MSFC over 36 months. The combination was superior to either agent alone in reducing new lesion activity and accumulation of total lesion volumes. In a post hoc analysis, combination therapy resulted in a higher proportion of participants attaining disease activity-free status (DAFS) compared to either single arm, driven by the MRI results. INTERPRETATION/CONCLUSIONS:Combining the 2 most commonly prescribed therapies for multiple sclerosis did not produce a significant clinical benefit over 3 years. An effect was seen on some MRI metrics. In a test of comparative efficacy, GA was superior to IFN in reducing the risk of exacerbation. The extension phase for CombiRx will address whether the observed differences in MRI and DAFS findings predict later clinical differences.
PMID: 23424159
ISSN: 1531-8249
CID: 5348012
Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial
Coles, Alasdair J; Twyman, Cary L; Arnold, Douglas L; Cohen, Jeffrey A; Confavreux, Christian; Fox, Edward J; Hartung, Hans-Peter; Havrdova, Eva; Selmaj, Krzysztof W; Weiner, Howard L; Miller, Tamara; Fisher, Elizabeth; Sandbrink, Rupert; Lake, Stephen L; Margolin, David H; Oyuela, Pedro; Panzara, Michael A; Compston, D Alastair S; Panitch, Hillel; Clifford, David; Antel, Jack; Barkhof, Frederik; Snydman, David; DeGroot, Leslie; Cines, Douglas; D'Agostino, Ralph; Greenberg, Benjamin; Krauss, Jörg; Limmroth, Volker; Markowitz, Clyde; Naismith, Robert; Tabby, David; Gupta, Ajay S; Fox, Edward; Glyman, Steven A; Thoits, Timothy K; Sullivan, Herman C; Cascione, Mark C; Rammohan, Kottil W; Gazda, Suzanne K; Wynn, Daniel R; Wray, Sibyl E; Elias, Stanton; Ford, Corey C; Goodman, Andrew; Hughes, Bruce L; Khan, Omar Azhar; Vaishnav, Anand G; Kirzinger, Stephen; Lynch, Sharon G; Mattson, David H; Braley, Tiffany J; Mikol, Daniel D; Krieger, Stephen; Miller, Aaron; Miller, Tamara Ann; Collins, Fort; Riskind, Peter N; Bomprezzi, Roberto; Wingerchuk, Dean M; Steingo, Brian; Cohen, Jeffrey Alan; Crayton, Heidi J; Royal, Walter 3rd; Twyman, Cary L; Cooper, Joanna A; Weiner, Leslie P; Moses, Harold Jr; Agius, Mark A; Bass, Ann Doan-Do; Lallana, Enrico C; Mitchell, Galen W; Krolczyk, Stanley J; Minagar, Alireza; Jubelt, Burk; Evans, Bradley K; Hunter, Samuel F; Rizvi, Syed A; Sheppard, Christopher A; Honeycutt, W M David; Herbert, Joseph; Lathi, Ellen S; Pardo, Gabriel; Ilenson, Lily Jung; Rothstein, Ted L; Thrower, Ben W; Picone, Mary Ann; Kita, Mariko; Grazioli, Erica M; Silliman, Scott L; Giancarlo, Thomas; Gottesman, Malcolm H; Zeid, Nuhad E Abou; Rowe, Vernon D 3rd; Boutwell, Christine M; Schaeffer, John D; LaGanke, Christopher C; Riley, Claire S; Gottschalk, Christopher; Preiningerova, Jana; Edwards, Keith R; Wendt, Jeanette K; Bigley, Kim Jr; Singer, Barry A; Shubin, Richard A; Markovic-Plese, Silva; Jones, Davis E; Clauser, Gary; Freedman, Mark S; Grand'Maison, Francois; Jacques, Francois H; Traboulsee, Anthony L; Brunet, Donald G; Kremenchutzky, Marcelo; Ayotte, Charles; Lava, Neil S; Waldman, Stephen R; Janus, Todd J; Vincent, Stephen Gerard; Gudesblatt, Mark; Rossen, Michael; Stein, Lee S; Machanic, Bennett-Irving; Vollmer, Timothy; Gitt, Jeffrey S; Dunn, Jeffrey; Negroski, Donald; Fletcher, Mark H; Javed, Adil; Frohman, Elliot M; Macdonell, Richard; Owen, John; Paine, Mark A; Boundy, Karyn; Broadley, Simon; Vucic, Steve; Reddel, Stephen; Dreyer, Michael D; Schwartz, Raymond; McCombe, Pamela Ann; Hodgkinson, Suzanne; Tilbery, Charles; Ferreira, Maria Lucia B; Callegaro, Dagoberto; Martins, Marcio Mena Barreto; Villanueva, Jesus Arturo Violante; Caballero, Noemi Santos; Mendoza, Claudia Venzor; Deri, Norma Haydee; Coles, Alasdair; Scolding, Neil James; Giovannoni, Gavin; Sharrack, Basil; Rog, David J; Comi, Giancarlo; Ghezzi, Angelo; Mancardi, Giovanni L; Durelli, Luca; Bertolotto, Antonio; Capra, Ruggero; Pozzilli, Carlo; Marrosu, Maria Giovanna; Hupperts, Raymond M M; van Munster, Erik; Montalbán, Xavier; González, Rafael Arroyo; Ayuso, Guillermo Izquierdo; Fernández, Óscar Fernández; Haya, Carlos; Confavreux, Christian; Vermersch, Patrick; de Seze, Jerome; Moreau, Thibault; Clavelou, Pierre; Lubetzki, Catherine; Clanet, Michel; Debouverie, Marc; Edan, Gilles; Hartung, Hans-Peter; Haas, Judith; Stangel, Martin; Ziemssen, Tjalf; Hemmer, Bernhard; Baum, Karl; Zettl, U Klaus; Herrlinger, U; Köhler, Wolfgang; Ochs, Gunter; Oschmann, Patrick; Tiel-Wilck, Klaus; Tumani, Hayrettin; Urban, Peter P; Lycke, Jan; Svenningsson, Anders; Kovarova, Ivana; Vachova, Marta; Rektor, Ivan; Talab, Radomir; Selmaj, Krzysztof; Stelmasiak, Zbigniew; Kozubski, Wojciech; Dubois, Benedicte D P; Dive, Dominique; Grandfossé, Rue; Sindic, Christian; Vass, Karl; Sørensen, Per Soelberg; Petersen, Thor; Ravnborg, Mads; Achiron, Anat; Dembinsky, Adi Vaknin; Karni, Arnon; Gusev, Evgeny I; Stolyarov, Igor D; Zavalishin, Igor A; Skoromets, Alexander A; Boyko, Alexei N; Belova, Anna N; Malkova, Nadezhda A; Barantsevich, Evgeniy R; Yakupov, Eduard Z; Perfiliev, Semen V; Poverennova, Irina E; Voloshyna, Natalia P; Nehrych, Tetyana I; Kobys, Tetyana O; Habek, Mario; Brinar, Vesna; Trkanjec, Zlatko; Vladić, Anton; Piskać, Spomenka Kidemet; MeÅ¡trovića, Ivana; Antonelli, Licia; Drulović, Jelena; Nadj, ÄŒongor; DinÄić, Evica; TonÄev, Gordana
BACKGROUND:The anti-CD52 monoclonal antibody alemtuzumab reduces disease activity in previously untreated patients with relapsing-remitting multiple sclerosis. We aimed to assess efficacy and safety of alemtuzumab compared with interferon beta 1a in patients who have relapsed despite first-line treatment. METHODS:In our 2 year, rater-masked, randomised controlled phase 3 trial, we enrolled adults aged 18-55 years with relapsing-remitting multiple sclerosis and at least one relapse on interferon beta or glatiramer. Eligible participants were randomly allocated in a 1:2:2 ratio by an interactive voice response system, stratified by site, to receive subcutaneous interferon beta 1a 44 μg, intravenous alemtuzumab 12 mg per day, or intravenous alemtuzumab 24 mg per day. Interferon beta 1a was given three-times per week and alemtuzumab was given once per day for 5 days at baseline and for 3 days at 12 months. The 24 mg per day group was discontinued to aid recruitment, but data are included for safety assessments. Coprimary endpoints were relapse rate and time to 6 month sustained accumulation of disability, comparing alemtuzumab 12 mg and interferon beta 1a in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT00548405. FINDINGS/RESULTS:202 (87%) of 231 patients randomly allocated interferon beta 1a and 426 (98%) of 436 patients randomly allocated alemtuzumab 12 mg were included in the primary analyses. 104 (51%) patients in the interferon beta 1a group relapsed (201 events) compared with 147 (35%) patients in the alemtuzumab group (236 events; rate ratio 0·51 [95% CI 0·39-0·65]; p<0·0001), corresponding to a 49·4% improvement with alemtuzumab. 94 (47%) patients in the interferon beta 1a group were relapse-free at 2 years compared with 278 (65%) patients in the alemtuzumab group (p<0·0001). 40 (20%) patients in the interferon beta 1a group had sustained accumulation of disability compared with 54 (13%) in the alemtuzumab group (hazard ratio 0·58 [95% CI 0·38-0·87]; p=0·008), corresponding to a 42% improvement in the alemtuzumab group. For 435 patients allocated alemtuzumab 12 mg, 393 (90%) had infusion-associated reactions, 334 (77%) had infections (compared with 134 [66%] of 202 patients in the interferon beta 1a group) that were mostly mild-moderate with none fatal, 69 (16%) had thyroid disorders, and three (1%) had immune thrombocytopenia. INTERPRETATION/CONCLUSIONS:For patients with first-line treatment-refractory relapsing-remitting multiple sclerosis, alemtuzumab could be used to reduce relapse rates and sustained accumulation of disability. Suitable risk management strategies allow for early identification of alemtuzumab's main adverse effect of secondary autoimmunity. FUNDING/BACKGROUND:Genzyme (Sanofi) and Bayer Schering Pharma.
PMID: 23122650
ISSN: 1474-547x
CID: 5347992
Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis
Fox, Robert J; Miller, David H; Phillips, J Theodore; Hutchinson, Michael; Havrdova, Eva; Kita, Mariko; Yang, Minhua; Raghupathi, Kartik; Novas, Mark; Sweetser, Marianne T; Viglietta, Vissia; Dawson, Katherine T; Antel, Jack; Ware, James; Polman, Chris; Kowey, Peter R; Chung, Raymond; Bakris, George; Richert, John; Seibert, Burt; Brandes, David; Brassat, David; Cohen, Bruce; Diem, Ricarda; Goldman, Myla; Herndon, Robert; Miller, Aaron; Tumani, Hayrettin; Alfaro-Vidal, Teresa; Crespo, Carolina; Foster, Jo; Hunter, Kelvin; Garcia-Gomez, Almudena; MacManus, David; Miller, David; Santana, Virginia; Tozer, Dan; Kingshott-Wheeler, Claudia; Yousry, Tarek; Kneebone, Christopher; Fedulau, Aliaksandr; Mikhailova, Elena; Likhachev, Sergey; Naumova, Halina; Vande Gaer, Luc; Decoo, Danny; Sindic, Christian; Grgic, Sanja; Sinanovic, Osman; Suljic, Enra Mehmedika; Georgiev, Dimitar; Haralanov, Lyubomir; Ivanova, Sonyia; Minchev, Dimitar; Tournev, Ivailo; Stamenova, Paraskeva; Deleva, Nadezhda; Zahariev, Zahari; Manchev, Ivan; Vacheva, Elena; Bar-Or, Amit; Kremenchutzky, Marcelo; Veloso, Felix; Witt, Norbert; Blevins, Gregg; Parajeles Vindas, Alexander; Vargas Howell, Roberto; Soldo-Butković, Silva; Rudež, Josip; Habek, Mario; Vurdelja, Ranka Baraba; Havrdova, Eva; Doležil, David; Vaclavik, Daniel; Novak, JiÅ™Ã; Gross-Paju, Katrin; Antsov, Katrin; Haldre, Sulev; Palu, Alla; Toomsoo, Toomas; Camu, William; Pelletier, Jean; Labauge, Pierre; Debouverie, Marc; Defer, Gilles; De Seze, Jérôme; Moreau, Thibault; Al Khedr, Abdullatif; Rumbach, Lucien; Daskalovska, Vera; Landefeld, Harald; Masri, Sabine; Schimrigk, Sebastian; Tackenberg, Björn; Eisensehr, Ilonka; Hoffmann, Frank; Kieseier, Bernd; Lüer, Wilfried; Benes, Heike; Paschen, Christine; Derfuß, Tobias; Sailer, Michael; Storch-Hagenlocher, Brigitte; Berthele, Achim; Oschmann, Patrick; Angnstwurm, Klemens; Hohlfeld, Reinhard; Reifschneider, Gerd; Tiel-Wilck, Klaus; Nelles, Gereon; Boldt, Hans-Jürgen; Emrich, Peter; Kallmann, Boris-Alexander; Feneberg, Wolfgang; Christopher, Angelika; Hüntemann, Reinhard; Spiegel-Meixensberger, Mechthild; Thomaides, Thomas; Vlaikidis, Nicholas; Karageorgiou, Clementine; Papathanasopoulos, Panagiotis; Mehndiratta, Man Mohan; Vijayan, Krishnan; Arjundas, Deepak; Srinivasa, Rangasetty; Ghosh, Amitabha; Kulkarni, Rahul Vitthal; Shah, Shalin Dipinkumar; Mukherji, Joy Dev; Nellikunja, Shankara; Behari, Madhuri; Singh, Gagandeep; Ghosh, Pahari; Ichaporia, Nasli Rustom; Sethi, Prahlad Kumar; Mehta, Neeta Abhay; Misra, Usha Kant; Singh, Maneesh Kumar; Khurana, Dheeraj; Salem, Abdu; Sweeney, Bernard; Gilad, Ronit; Shahien, Radi; Paegle, Anita; Punzo, Guillermo; Santos, Jose; Quiñones, Sandra; Macias, Miguel Angel; Estañol, Bruno; Escamilla, Juan; Lopez, Neyla; Renteria, Mariela; Delgado, Cesar; Odainic, Olesea; Groppa, Stanislav; Gavriliuc, Mihail; Timmings, Paul; Drozdowski, Wieslaw; Fryze, Waldemar; Kochanowicz, Jan; Kaminska, Anna; Selmaj, Krzysztof; Wajgt, Andrzej; Kleczkowska, Magdalena; Nowacki, Przemyslaw; Czlonkowska, Anna; Stelmasiak, Zbigniew; Podemski, Ryszard; Dorobek, Malgorzata; Hertmanowska, Hanka; Pierzchala, Krystyna; Zielinski, Tomasz; Szczudlik, Andrzej; Tutaj, Andrzej; Losy, Jacek; Potemkowski, Andrzej; Nyka, Walenty; Kapelusiak-Pielok, Magdalena; Ionescu-Dimancea, Valentin; Balasa, Rodica; Mihancea, Petru; Popescu, Cristian; Protosevici, Liviu Codrut; Vojinovic, Slobodan; Drakulić, Svetlana Miletić; Raicevic, Ranko; Nadj, Congor; TurÄáni, Peter; Kahancová, Edita; Kurca, Egon; Lisý, Lubomir; Montalbán, Xavier; Izquierdo, Guillermo; Arroyo, Rafael; Prieto, Jose Maria; Fernández, Oscar; Oreja-Guevara, Celia; Sanchez Lopez, Fernando; Guijarro, Cristina; Voloshina, Nataliya; Pasyura, Igor; Palamar, Borys; Nehrych, Tetyana; Kobys, Tetyana; Lytvynenko, Nataliya; Goloborodko, Alla; Buchakchyyska, Nataliya; Lebedynets, Volodymyr; Ryabichenko, Tatyana; Kushnir, Grygory; Moskovko, Sergii; Chmyr, Galyna; Forester, Mary; Ayala, Ricardo; Voci, James; Krolczyk, Stanley; Glaun, Braeme; Smith, Robert; Crowell, Giles; Kinkel, Revere Philip; Patel, Malti; Miller, Tamara; Pardo, Gabriel; Asher, Stephen; LaGanke, Christopher; Ayres, Donald; Baker, Matthew; Williams, Mitzi; Sheremata, William; Vasquez, Alberto; Janicki, Mark; Garmany, George Jr; Hull, Richard; Steiner, David; Herbert, Joseph; Edwards, Keith; Fox, Robert; Khatri, Bhupendra; Levin, Michael; Mattson, David; Applebee, Angela; Phillips, Joseph Jr; Picone, Mary Ann; Felton, Warren 3rd; Fox, Edward; Apperson, Michelle; Gold, Scott; Kita, Mariko; Moses, Harold Jr; Shin, Robert; Rinker, John 2nd; Hutton, George; Krupp, Lauren; Fodor, Patricia; Foley, John; Gazda, Suzanne; Honeycutt, William; Mitchell, Galen; Sadiq, Saud; Steingo, Brian; Jacobs, Dina; Freedman, Steven; Weinstock-Guttman, Bianca; Lynch, Sharon; Vaishnav, Anand; Wray, Sibyl; Hunter, Samuel; Luzzio, Christopher; Huddlestone, John; Cohan, Stanley; Chinea, Angel; Giang, Daniel; Shubin, Richard; Negroski, Donald; Perel, Allan; Stein, Michael; Herskowitz, Allan; Warach, Jonathan; Mikol, Daniel; Bomprezzi, Roberto; Eubank, Geoffery; Licht, Jonathan; Sullivan, Herman; Rao, T Hemanth; Newman, Stephen; Silverman, Stuart; Gudesblatt, Mark; Sunter, William Jr; Minagar, Alireza; Rammohan, Kottil; Gottesman, Malcolm; Schaeffer, John; Carlini, Walter; Stein, Lee; Buckler, Richard; Azizi, S Ausim; Bauer, Brendan; Ford, Corey
BACKGROUND:BG-12 (dimethyl fumarate) is in development as an oral treatment for relapsing-remitting multiple sclerosis, which is commonly treated with parenteral agents (interferon or glatiramer acetate). METHODS:In this phase 3, randomized study, we investigated the efficacy and safety of oral BG-12, at a dose of 240 mg two or three times daily, as compared with placebo in patients with relapsing-remitting multiple sclerosis. An active agent, glatiramer acetate, was also included as a reference comparator. The primary end point was the annualized relapse rate over a period of 2 years. The study was not designed to test the superiority or noninferiority of BG-12 versus glatiramer acetate. RESULTS:At 2 years, the annualized relapse rate was significantly lower with twice-daily BG-12 (0.22), thrice-daily BG-12 (0.20), and glatiramer acetate (0.29) than with placebo (0.40) (relative reductions: twice-daily BG-12, 44%, P<0.001; thrice-daily BG-12, 51%, P<0.001; glatiramer acetate, 29%, P=0.01). Reductions in disability progression with twice-daily BG-12, thrice-daily BG-12, and glatiramer acetate versus placebo (21%, 24%, and 7%, respectively) were not significant. As compared with placebo, twice-daily BG-12, thrice-daily BG-12, and glatiramer acetate significantly reduced the numbers of new or enlarging T(2)-weighted hyperintense lesions (all P<0.001) and new T(1)-weighted hypointense lesions (P<0.001, P<0.001, and P=0.002, respectively). In post hoc comparisons of BG-12 versus glatiramer acetate, differences were not significant except for the annualized relapse rate (thrice-daily BG-12), new or enlarging T(2)-weighted hyperintense lesions (both BG-12 doses), and new T(1)-weighted hypointense lesions (thrice-daily BG-12) (nominal P<0.05 for each comparison). Adverse events occurring at a higher incidence with an active treatment than with placebo included flushing and gastrointestinal events (with BG-12) and injection-related events (with glatiramer acetate). There were no malignant neoplasms or opportunistic infections reported with BG-12. Lymphocyte counts decreased with BG-12. CONCLUSIONS:In patients with relapsing-remitting multiple sclerosis, BG-12 (at both doses) and glatiramer acetate significantly reduced relapse rates and improved neuroradiologic outcomes relative to placebo. (Funded by Biogen Idec; CONFIRM ClinicalTrials.gov number, NCT00451451.).
PMID: 22992072
ISSN: 1533-4406
CID: 5347972
Outcomes After Percutaneous Surgery for Patients With Multiple Sclerosis-Related Trigeminal Neuralgia COMMENT [Editorial]
Gottesman, Malcolm H.
ISI:000308074400015
ISSN: 0148-396x
CID: 3486082
An approach to natalizumab hypersensitivity: a case series of induction of tolerance [Case Report]
Camacho-Halili, Marie; George, Roxanne; Gottesman, Malcolm; Davis-Lorton, Mark
Induction of tolerance protocols have been applied successfully to manage allergic reactions to many medications. Hypersensitivity reactions to natalizumab (TYSABRI®) have been recognized as a growing problem. In circumstances where a hypersensitivity reaction to a medication has occurred, but no suitable alternative exists, drug induction of tolerance protocols may be considered. Drug induction of tolerance protocols were performed in three patients with prior hypersensitivity reactions to natalizumab. All three patients tolerated the protocol without adverse reactions, allowing for the safe reintroduction of natalizumab. To conclude, this case series demonstrates success with an induction of tolerance procedure to a highly effective biological agent for multiple sclerosis, in patients with allergic reactions to natalizumab.
PMID: 21177321
ISSN: 1477-0970
CID: 3486142
High-dose cyclophosphamide for moderate to severe refractory multiple sclerosis: 2-year follow-up (investigational new drug No. 65863)
Gladstone, Douglas E; Peyster, Robert; Baron, Edward; Friedman-Urevich, Sharon; Sibony, Patrick; Melville, Patricia; Gottesman, Malcolm
High-dose cyclophosphamide (HDC) is a chemotherapy treatment designed to eradicate autoreative B- and T-cells responsible for lymphocyte-mediated autoimmune illness while sparing the pluripotent blood stem cell of any ill effects. Multiple sclerosis (MS) is the most common inflammatory and demyelinating immune-mediated disorder of the central nervous system in young adults. Patients with moderate to severe, refractory MS, defined as an Expanded Disability Status Scale (EDSS) score of 3.5 or higher after two or more Food and Drug Administration-approved disease-modifying agents, received 200 mg/kg of cyclophosphamide over 4 days. For the next 2 years, quarterly EDSS score evaluations and biannual brain magnetic resonance imaging and neuro-ophthalmologic evaluations were obtained. Fifteen patients were evaluated for clinical response. During follow-up, one patient increased their baseline EDSS score by 1.0. EDSS score stability of decrease was realized in five of seven (71%) patients with relapsing-remitting MS and six of eight (75%) patients with secondary progressive MS. Four patients required additional immunomodulatory treatment after treatment. Treatment response was seen regardless of the baseline presence or absence of contrast lesion activity. HDC can effectively decrease symptoms, stop disease progression, and allow for disability regression in relapsing-remitting MS and secondary progressive MS patients. The most appropriate candidates for HDC, its duration of benefit, and the potential need for prophylactic preventative immune manipulation after HDC all require further investigation.
PMID: 19770795
ISSN: 1536-3686
CID: 3486132
Decrease in Individual Multiple Sclerosis Severity Scores during Follow-Up Period: Analysis of the New York State Multiple Sclerosis Consortium Dataset [Meeting Abstract]
Kister, Ilya; Bacon, Tamar; Chamot, Eric; Cutter, Gary; Bacon, Joshua; Apatoff, Brian; Coyle, Patricia; Goodman, Andrew; Gottesman, Malcolm; Edwards, Keith; Frontera, Alfred; Holub, Richard; Jubelt, Burk; Khan, Mustafa; Krupp, Lauren; Lenihan, Michael; Mihai, Cornelia; Miller, Aaron; Lublin, Fred; Perel, Allan; Snyder, David; Teter, Barbara; Weinstock-Guttman, Bianca; Zivadinov, Robert; Herbert, Joseph
ISI:000288149303353
ISSN: 0028-3878
CID: 2225212
Pregnancy Related to Disability Outcomes for Women with Progressive Multiple Sclerosis [Meeting Abstract]
Teter, Barbara; Apatoff, Brian; Coyle, Patricia; Edwards, Keith; Goodman, Andrew; Gottesman, Malcolm; Granger, Carl; Herbert, Joseph; Jubelt, Burk; Kister, Ilya; Krupp, Lauren; Lenihan, Michael; Miller, Aaron; Perel, Allan; Snyder, David; Tullman, Mark; Zivadinov, Robert; Weinstock-Guttman, Bianca
ISI:000288149303373
ISSN: 0028-3878
CID: 2225802
Capture of Patient-Perceived Negative Mood Traits To Improve Treatment for Patients with Multiple Sclerosis [Meeting Abstract]
Teter, Barbara E; Apatoff, Brian; Coyle, Patricia; Edwards, Keith; Goodman, Andrew; Gottesman, Malcolm; Granger, Carl; Herbert, Joseph; Lawn, Fair; Jubelt, Burk; Kister, Ilya; Krupp, Lauren; Lenihan, Michael; Lublin, Fred; Miller, Aaron; Ostroff, Joseph; Perel, Allan; Snyder, David; Tullman, Mark; Zivadinou, Robert; Weinstock-Guttman, Bianca
ISI:000288149300278
ISSN: 0028-3878
CID: 2226002
Trend towards Lowering of Multiple Sclerosis Severity Scores among More Recent Enrollees into the New York State Multiple Sclerosis Consortium [Meeting Abstract]
Herbert, J; Chamot, E; Bacon, J; Apatoff, B; Blitz, K; Coyle, P; Goodman, A; Gottesman, M; Edwards, K; Frontera, A; Holub, R; Jubelt, B; Khan, M; Krupp, L; Lenihan, M; Lublin, F; Mihai, C; Miller, A; Munschauer, FE; Perel, A; Snyder, D; Teter, B; Tullman, M; Weinstock-Guttman, B; Zivadinov, R; Kister, I
ISI:000275274002119
ISSN: 0028-3878
CID: 111991
