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252. Theme 13 Clinical management and support.

Author

Crook, Ashley, Hogden, Anne, Mumford, Virginia, Blair, Ian P., Williams, Kelly L., Rowe, Dominic B., Fell, Rosie, moura Campos, Cecilia Helena, Cruz, Fabiana Theodoro, Leico Oda, Adriana, O'Brien, Mary R., Oliver, David, Aoun, Samar, Mc Dermott, Christopher J., Kirton, Jennifer, Pearson, Emma, Lucia, Diana, McCombe, Pamela A., Henderson, Robert D., and Steyn, Frederik J.

Subjects
SOCIAL surveys, CAREER development
Abstract

2017; The 28th International Symposium on ALS/MND. 32 Costello J. (2012) Preserving legacy: A guide to Message Banking a patient's voice. A phase 1 study to evaluate bioequivalence between BHV-0223 40 mg zydis sublingual formulation and riluzole 50mg oral tablet in healthy volunteers. A phase 1 study to evaluate bioequivalence between BHV-0223 40 mg zydis sublingual formulation and riluzole 50mg oral tablet in healthy volunteers. https://www.biohavenpharma.com/sites/default/files/documents/bvh-0223-bioequivalence-aanem-2018.pdf. [Extracted from the article]

Published
2019
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253. Association of Initial Disease-Modifying Therapy With Later Conversion to Secondary Progressive Multiple Sclerosis.

Author

Brown, J. William L., Coles, Alasdair, Horakova, Dana, Havrdova, Eva, Izquierdo, Guillermo, Prat, Alexandre, Girard, Marc, Duquette, Pierre, Trojano, Maria, Lugaresi, Alessandra, Bergamaschi, Roberto, Grammond, Pierre, Alroughani, Raed, Hupperts, Raymond, McCombe, Pamela, Van Pesch, Vincent, Sola, Patrizia, Ferraro, Diana, Grand'Maison, Francois, and Terzi, Murat

Subjects
MULTIPLE sclerosis treatment, THERAPEUTICS research, DISEASE progression, DISEASE relapse, FINGOLIMOD, NATALIZUMAB, ALEMTUZUMAB, IMMUNOLOGICAL adjuvants, THERAPEUTIC use of interferons, IMMUNOSUPPRESSIVE agents, COMPARATIVE studies, LONGITUDINAL method, RESEARCH methodology, MEDICAL care, MEDICAL cooperation, MULTIPLE sclerosis, PATIENTS, RESEARCH, RESEARCH funding, EVALUATION research, THERAPEUTICS
Abstract

Importance: Within 2 decades of onset, 80% of untreated patients with relapsing-remitting multiple sclerosis (MS) convert to a phase of irreversible disability accrual termed secondary progressive MS. The association between disease-modifying treatments (DMTs), and this conversion has rarely been studied and never using a validated definition.Objective: To determine the association between the use, the type of, and the timing of DMTs with the risk of conversion to secondary progressive MS diagnosed with a validated definition.Design, Setting, and Participants: Cohort study with prospective data from 68 neurology centers in 21 countries examining patients with relapsing-remitting MS commencing DMTs (or clinical monitoring) between 1988-2012 with minimum 4 years' follow-up.Exposures: The use, type, and timing of the following DMTs: interferon beta, glatiramer acetate, fingolimod, natalizumab, or alemtuzumab. After propensity-score matching, 1555 patients were included (last follow-up, February 14, 2017).Main Outcome and Measure: Conversion to objectively defined secondary progressive MS.Results: Of the 1555 patients, 1123 were female (mean baseline age, 35 years [SD, 10]). Patients initially treated with glatiramer acetate or interferon beta had a lower hazard of conversion to secondary progressive MS than matched untreated patients (HR, 0.71; 95% CI, 0.61-0.81; P < .001; 5-year absolute risk, 12% [49 of 407] vs 27% [58 of 213]; median follow-up, 7.6 years [IQR, 5.8-9.6]), as did fingolimod (HR, 0.37; 95% CI, 0.22-0.62; P < .001; 5-year absolute risk, 7% [6 of 85] vs 32% [56 of 174]; median follow-up, 4.5 years [IQR, 4.3-5.1]); natalizumab (HR, 0.61; 95% CI, 0.43-0.86; P = .005; 5-year absolute risk, 19% [16 of 82] vs 38% [62 of 164]; median follow-up, 4.9 years [IQR, 4.4-5.8]); and alemtuzumab (HR, 0.52; 95% CI, 0.32-0.85; P = .009; 5-year absolute risk, 10% [4 of 44] vs 25% [23 of 92]; median follow-up, 7.4 years [IQR, 6.0-8.6]). Initial treatment with fingolimod, alemtuzumab, or natalizumab was associated with a lower risk of conversion than initial treatment with glatiramer acetate or interferon beta (HR, 0.66; 95% CI, 0.44-0.99; P = .046); 5-year absolute risk, 7% [16 of 235] vs 12% [46 of 380]; median follow-up, 5.8 years [IQR, 4.7-8.0]). The probability of conversion was lower when glatiramer acetate or interferon beta was started within 5 years of disease onset vs later (HR, 0.77; 95% CI, 0.61-0.98; P = .03; 5-year absolute risk, 3% [4 of 120] vs 6% [2 of 38]; median follow-up, 13.4 years [IQR, 11-18.1]). When glatiramer acetate or interferon beta were escalated to fingolimod, alemtuzumab, or natalizumab within 5 years vs later, the HR was 0.76 (95% CI, 0.66-0.88; P < .001; 5-year absolute risk, 8% [25 of 307] vs 14% [46 of 331], median follow-up, 5.3 years [IQR], 4.6-6.1).Conclusions and Relevance: Among patients with relapsing-remitting MS, initial treatment with fingolimod, alemtuzumab, or natalizumab was associated with a lower risk of conversion to secondary progressive MS vs initial treatment with glatiramer acetate or interferon beta. These findings, considered along with these therapies' risks, may help inform decisions about DMT selection. [ABSTRACT FROM AUTHOR]

Published
2019
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254. Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis

Author

Kalincik, Tomas, Horakova, Dana, Spelman, Tim, Jokubaitis, Vilija, Trojano, Maria, Lugaresi, Alessandra, Izquierdo, Guillermo, Rozsa, Csilla, Grammond, Pierre, Alroughani, Raed, Duquette, Pierre, Girard, Marc, Pucci, Eugenio, Lechner-Scott, Jeannette, Slee, Mark, Fernandez-Bolanos, Ricardo, Grand'Maison, Francois, Hupperts, Raymond, Verheul, Freek, Hodgkinson, Suzanne, Oreja-Guevara, Celia, Spitaleri, Daniele, Barnett, Michael, Terzi, Murat, Bergamaschi, Roberto, McCombe, Pamela, Sanchez-Menoyo, Jose, Simo, Magdolna, Csepany, Tunde, Rum, Gabor, Boz, Cavit, Havrdova, Eva, Butzkueven, Helmut, MUMC+: MA Med Staf Spec Neurologie (9), Klinische Neurowetenschappen, and RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience

Subjects
Adult, Male, Fingolimod Hydrochloride, Natalizumab, Orvostudományok, Middle Aged, Klinikai orvostudományok, Antibodies, Monoclonal, Humanized, Severity of Illness Index, Disability Evaluation, Multiple Sclerosis, Relapsing-Remitting, Treatment Outcome, Propylene Glycols, Recurrence, Sphingosine, Disease Progression, Humans, Female, Registries, Immunosuppressive Agents
Abstract

In patients suffering multiple sclerosis activity despite treatment with interferon β or glatiramer acetate, clinicians often switch therapy to either natalizumab or fingolimod. However, no studies have directly compared the outcomes of switching to either of these agents.Using MSBase, a large international, observational, prospectively acquired cohort study, we identified patients with relapsing-remitting multiple sclerosis experiencing relapses or disability progression within the 6 months immediately preceding switch to either natalizumab or fingolimod. Quasi-randomization with propensity score-based matching was used to select subpopulations with comparable baseline characteristics. Relapse and disability outcomes were compared in paired, pairwise-censored analyses.Of the 792 included patients, 578 patients were matched (natalizumab, n = 407; fingolimod, n = 171). Mean on-study follow-up was 12 months. The annualized relapse rates decreased from 1.5 to 0.2 on natalizumab and from 1.3 to 0.4 on fingolimod, with 50% relative postswitch difference in relapse hazard (p = 0.002). A 2.8 times higher rate of sustained disability regression was observed after the switch to natalizumab in comparison to fingolimod (p 0.001). No difference in the rate of sustained disability progression events was observed between the groups. The change in overall disability burden (quantified as area under the disability-time curve) differed between natalizumab and fingolimod (-0.12 vs 0.04 per year, respectively, p 0.001).This study suggests that in active multiple sclerosis during treatment with injectable disease-modifying therapies, switching to natalizumab is more effective than switching to fingolimod in reducing relapse rate and short-term disability burden.

Published
2014

256. Identification and outcomes of clinical phenotypes in amyotrophic lateral sclerosis/motor neuron disease: Australian National Motor Neuron Disease observational cohort

Author

Talman, Paul, primary, Duong, Thi, additional, Vucic, Steve, additional, Mathers, Susan, additional, Venkatesh, Svetha, additional, Henderson, Robert, additional, Rowe, Dominic, additional, Schultz, David, additional, Edis, Robert, additional, Needham, Merrilee, additional, Macdonnell, Richard, additional, McCombe, Pamela, additional, Birks, Carol, additional, and Kiernan, Matthew, additional

Published
2016
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257. Prospectively tracking disease course and treatment changes in Neuromyelitis Optica using NMOBase, a global online registry. (P5.307)

Author

Kister, Ilya, primary, Bacon, Tamar, additional, Shaygannejad, Vahid, additional, Hor, Jyh Yung, additional, Alroughani, Raed, additional, Haas, Shannon, additional, Terzi, Murat, additional, Boz, Cavit, additional, Olascoaga, Javier, additional, McCombe, Pamela, additional, Fragoso, Yara, additional, Lugaresi, Alessandra, additional, Sola, Patrizia, additional, Vucic, Steve, additional, Pucci, Eugenio, additional, Al-Harbi, Talal, additional, Sajedi, Seyed Aidin, additional, Rojas, Juan Ignacio, additional, Patrucco, Liliana, additional, Cristiano, Edgardo, additional, Suarez, Jose Alberto, additional, Tsolaki, Magdalini, additional, Taylor, Bruce, additional, Iuliano, Gerardo, additional, Devranis, Paschalis, additional, Marriott, Mark, additional, and Butzkueven, Helmut, additional

Published
2016
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261. A new era in the treatment of multiple sclerosis

Author

Broadley, Simon A, primary, Barnett, Michael H, additional, Boggild, Mike, additional, Brew, Bruce J, additional, Butzkueven, Helmut, additional, Heard, Robert, additional, Hodgkinson, Suzanne, additional, Kermode, Allan G, additional, Lechner‐Scott, Jeannette, additional, Macdonell, Richard AL, additional, Marriott, Mark, additional, Mason, Deborah F, additional, Parratt, John, additional, Reddel, Stephen W, additional, Shaw, Cameron P, additional, Slee, Mark, additional, Spies, Judith M, additional, Taylor, Bruce V, additional, Carroll, William M, additional, Kilpatrick, Trevor J, additional, King, John, additional, McCombe, Pamela A, additional, Pollard, John D, additional, and Willoughby, Ernest, additional

Published
2015
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262. Comparison of first-line fingolimod efficacy compared with first-line interferon-beta or glatiramer therapy in MS patients with active disease using propensity-matched registry data (P3.247)

Author

Spelman, Tim, primary, Bergvall, Niklas, additional, Izquierdo, Guillermo, additional, Alroughani, Raed, additional, McCombe, Pamela, additional, Fernández Bolaños, Ricardo, additional, Horakova, Dana, additional, Havrdova, Eva, additional, Oreja-Guevara, Celia, additional, Lechner-Scott, Jeannette, additional, Slee, Mark, additional, Trojano, Maria, additional, and Butzkueven, Helmut, additional

Published
2015
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266. 28.

Author

Devine, Matthew, primary, Kiernan, Matthew, additional, Pannek, Kerstin, additional, Rose, Stephen, additional, McCombe, Pamela, additional, and Henderson, Robert, additional

Published
2014
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267. 80.

Author

Sheikh, Nabeel, primary, McCombe, Pamela, additional, and Blum, Stefan, additional

Published
2014
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268. 18.

Author

Blum, Stefan, primary, Csurhes, Peter, additional, Reddel, Stephen, additional, Spies, Judy, additional, and McCombe, Pamela, additional

Published
2014
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270. Patient with ALS with a novel TBK1 mutation, widespread brain involvement, behaviour changes and metabolic dysfunction.

Author

Mccombe, Pamela A., Shyuan T. Ngo, Cong Guo, Christine, Fazlollahi, Amir, Bollmann, Saskia, Liting Wang, Xintao Hu, Barth, Markus, Salvado, Olivier, Davis, Mark, Ceslis, Amelia, Robinson, Gail, Henderson, Robert D., Steyn, Frederik J., Ngo, Shyuan T, Guo, Christine Cong, Wang, Liting, and Hu, Xintao

Subjects
AMYOTROPHIC lateral sclerosis, LEAN body mass, BRAIN, BRAIN metabolism, COMPARATIVE studies, NEUROPSYCHOLOGICAL tests, RESEARCH methodology, MEDICAL cooperation, GENETIC mutation, RESEARCH, TRANSFERASES, EVALUATION research
Published
2019
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277. Targeted assessment of lower motor neuron burden is associated with survival in amyotrophic lateral sclerosis.

Author

Devine, Matthew S., Ballard, Emma, O'Rourke, Peter, Kiernan, Matthew C., Mccombe, Pamela A., and Henderson, Robert D.

Subjects
MOTOR neuron diseases, AMYOTROPHIC lateral sclerosis, NONINVASIVE ventilation, UNIVARIATE analysis, BIOMARKERS
Abstract

Estimating survival in amyotrophic lateral sclerosis (ALS) is challenging due to heterogeneity in clinical features of disease and a lack of suitable markers that predict survival. Our aim was to determine whether scoring of upper or lower motor neuron weakness is associated with survival. With this objective, 161 ALS subjects were recruited from two tertiary referral centres. Scoring of upper (UMN) and lower motor neuron (LMN) signs was performed, in addition to a brief questionnaire. Subjects were then followed until the censorship date. Univariate analysis was performed to identify variables associated with survival to either non-invasive ventilation (NIV) or death, which were then further characterized using Cox regression. Results showed that factors associated with reduced survival included older age, bulbar and respiratory involvement and shorter diagnostic delay (allp < 0.05). Whole body LMN score was strongly associated with time to NIV or death (p ≤0.001) whereas UMN scores were poorly associated with survival. In conclusion, our results suggest that, early in disease assessment and in the context of other factors (age, bulbar, respiratory status), the burden of LMN weakness provides an accurate estimate of outcome. Such a scoring system could predict prognosis, and thereby aid in selection of patients for clinical trials. [ABSTRACT FROM PUBLISHER]

Published
2016
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286. 63. Immune response in acute ischaemic stroke

Author

Badve, Monica S., primary, Yan, J., additional, Hull, R., additional, Henderson, Robert, additional, O’Sullivan, John D., additional, Read, Stephen J., additional, Wong, Andrew A., additional, and McCombe, Pamela, additional

Published
2010
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294. Clinical features and impact of myasthenia gravis disease in Australian patients.

Author

Blum, Stefan, Lee, David, Gillis, David, McEniery, David F., Reddel, Stephen, and McCombe, Pamela

Abstract

We performed a community-based survey of 165 Australian patients with a physician-confirmed diagnosis of myasthenia gravis (MG). MG is an autoimmune disease of the neuromuscular junction causing fatiguable muscle weakness. Patients with early onset MG (<40 years of age) were more frequently female (22 males, 60 females) whereas patients with late onset MG (>40 years of age) were more frequently male (50 males, 28 females; p < 0.001). Triggering and exacerbating factors included physical and emotional stress, infections, surgery or trauma, seasonal changes and medications. The co-occurrence of other immune-related diseases was reported by 54% of patients. The median MG quality of life (QOL) score was 92 (range: 24–186). The factor most strongly associated with poor QOL was depression. Only 40.6% of patients were working at the time of the survey and of these, almost half had required sick leave due to MG in the past 12 months. A further 39.4% had stopped work due to MG and 19.4% having to change occupation. Full-time or part-time care was required by 29% of patients and government financial support was received by 52.7%. [ABSTRACT FROM AUTHOR]

Published
2015
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