Siponimod (BAF312) for the treatment of secondary progressive multiple sclerosis: Design of the phase 3 EXPAND trial

Kappos, Ludwig; Bar‐Or, Amit; Cree, Bruce A.C.; Fox, R. H.; Giovannoni, Gavin; Gold, Ralf; Vermersch, P.; Lam, Elaine T.; Pohlmann, Harald; Wallström, Erik

doi:10.1016/j.msard.2014.09.185

Cited by 36 publications

(38 citation statements)

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“…Patient attrition may also hinder conclusive statements, as sample sizes may be insufficient to evaluate safety signals, which typically require large numbers of patients in observational studies and disease registries. The 2-mg dose of siponimod has been selected for phase 3 trials in secondary progressive MS. 12 This dose group had the highest attrition at the end of the BOLD extension (25/49; 51%). Because no statistical tests were applied, any observed trends in response across siponimod doses cannot be confirmed as dose-response associations.…”

mentioning

confidence: 88%

Perspectives on Safety and Efficacy—The BOLD Phase 2 Extension Study of Siponimod in Relapsing-Remitting Multiple Sclerosis

Hammond

2016

JAMA Neurol

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confidence: 88%

Perspectives on Safety and Efficacy—The BOLD Phase 2 Extension Study of Siponimod in Relapsing-Remitting Multiple Sclerosis

Hammond

2016

JAMA Neurol

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“…In an adaptive dose-ranging phase II trial in patients with RRMS, siponimod was shown to reduce brain MRI lesions and relapses by up to 80 % (vs placebo) [126]. A phase III trial of siponimod in patients with SPMS is currently in underway (NCT01665144) [127].…”

Section: Siponimodmentioning

confidence: 99%

Therapeutic Advances and Future Prospects in Progressive Forms of Multiple Sclerosis

2016

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Identifying effective therapies for the treatment of progressive forms of multiple sclerosis (MS) is a highly relevant priority and one of the greatest challenges for the global MS community. Better understanding of the mechanisms involved in progression of the disease, novel trial designs, drug repurposing strategies, and new models of collaboration may assist in identifying effective therapies. In this review, we discuss various therapies under study in phase II or III trials, including antioxidants (idebenone); tyrosine kinase inhibitors ( m a s i t i n i b ) ; s p h i n g o s i n e r e c e p t o r m o d u l a t o r s (siponimod); monoclonal antibodies (anti-leucine-rich repeat and immunoglobulin-like domain containing neurite outgrowth inhibitor receptor-interacting protein-1, natalizumab, ocrelizumab, intrathecal rituximab); hematopoetic stem cell therapy; statins and other possible neuroprotective agents (amiloride, riluzole, fluoxetine, oxcarbazepine); lithium; phosphodiesterase inhibitors (ibudilast); hormone-based therapies (adrenocorticotrophic hormone and erythropoietin); T-cell receptor peptide vaccine (NeuroVax); autologous T-cell immunotherapy (Tcelna); MIS416 (a microparticulate immune response modifier); dopamine antagonists (domperidone); and nutritional supplements, including lipoic acid, biotin, and sunphenon epigallocatechin-3-gallate (green tea extract). Given ongoing and planned clinical trial initiatives, and the largest ever focus of the global research community on progressive MS, future prospects for developing targeted therapeutics aimed at reducing disability in progressive forms of MS appear promising.

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“…A phase III trial of Ocrelizumab in patients with PPMS (ORATORIO) was designed (NCT01194570) [102]. Patients were required to have an elevated IgG index, two or more oligoclonal bands, an EDSS of 3.0 to 6.5, and an age of 18 to 55 years.…”

Section: Therapeutic Advances and Future Prospects In Progressive mentioning

confidence: 99%

A Personalized Approach in Progressive Multiple Sclerosis: The Current Status of Disease Modifying Therapies (DMTs) and Future Perspectives

D’Amico

Patti

Zanghì

et al. 2016

IJMS

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Using the term of progressive multiple sclerosis (PMS), we considered a combined population of persons with secondary progressive MS (SPMS) and primary progressive MS (PPMS). These forms of MS cannot be challenged with efficacy by the licensed therapy. In the last years, several measures of risk estimation were developed for predicting clinical course in MS, but none is specific for the PMS forms. Personalized medicine is a therapeutic approach, based on identifying what might be the best therapy for an individual patient, taking into account the risk profile. We need to achieve more accurate estimates of useful predictors in PMS, including unconventional and qualitative markers which are not yet currently available or practicable routine diagnostics. The evaluation of an individual patient is based on the profile of disease activity.Within the neurology field, PMS is one of the fastest-moving going into the future.

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Siponimod (BAF312) for the treatment of secondary progressive multiple sclerosis: Design of the phase 3 EXPAND trial

Cited by 36 publications

References 0 publications

Perspectives on Safety and Efficacy—The BOLD Phase 2 Extension Study of Siponimod in Relapsing-Remitting Multiple Sclerosis

Perspectives on Safety and Efficacy—The BOLD Phase 2 Extension Study of Siponimod in Relapsing-Remitting Multiple Sclerosis

Therapeutic Advances and Future Prospects in Progressive Forms of Multiple Sclerosis

A Personalized Approach in Progressive Multiple Sclerosis: The Current Status of Disease Modifying Therapies (DMTs) and Future Perspectives

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