GLACIER: An open-label, randomized, multicenter study to assess the safety and tolerability of glatiramer acetate 40mg three-times weekly versus 20mg daily in patients with relapsing-remitting multiple sclerosis

Wolinsky, Jerry S.; Børresen, T; Dietrich, Dennis W.; Wynn, Daniel; Sidi, Yechezkel; Steinerman, Joshua R.; Knappertz, Volker; Kolodny, Scott

doi:10.1016/j.msard.2015.06.005

Cited by 58 publications

(50 citation statements)

References 14 publications

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“…Both formulations of GA appear equivalent from the safety standpoint [64,91,94]. In the GALA study AEs associated with administration of GA 40 mg/mL three times a week were found to be consistent with the known safety profile of GA 20 mg/mL once daily.…”

Section: Safetymentioning

confidence: 81%

“…On the same lines, the GLACIER study, in which patients were asked to report the personal experience of shifting from the 20 mg/mL once daily dose to the 40 mg/ mL three times weekly dose, demonstrated a favourable convenience profile and patient satisfaction when converting from the once-daily formulation [94].…”

Section: Three Times Weekly Formulationmentioning

confidence: 98%

“…Importantly, in the GLA-CIER study [94], three times weekly GA was found to be better tolerated than the once-daily formulation in terms of injection-related adverse events (IRAEs): the adjusted mean annualized rate of IRAEs was reduced by 50 % in patients receiving the new formulation (35.3 events per year vs. 70.4 events per year, respectively; p = 0.0006), while the rate of moderate/severe events was reduced by 60 % (0.9 events per year vs. 2.2 events per year, respectively; p = 0.0021). Furthermore, treatment convenience, as measured by the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) convenience subscale, was improved for patients switching from GA 20 mg/ mL once daily to the three times weekly formulation [94]. Recently, results from the extension phase of the GLACIER study confirm the safety profile of the 40 mg/ mL three times weekly formulation, in terms of both IRAEs and convenience [113].…”

Section: Tolerabilitymentioning

confidence: 99%

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The heritage of glatiramer acetate and its use in multiple sclerosis

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Amato

Bertolotto

et al. 2016

Mult Scler Demyelinating Disord

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Multiple sclerosis (MS) is a chronic and progressively debilitating disease of the central nervous system. Treatment of MS involves disease-modifying therapies (DMTs) to reduce the incidence of relapses and prevent disease progression. Glatiramer acetate (Copaxone®) was the first of the currently approved DMTs to be tested in human subjects, and it is still considered a standard choice for first-line treatment. The mechanism of action of glatiramer acetate appears to be relatively complex and has not been completely elucidated, but it is likely that it involves both immunomodulating and neuroprotective properties. The efficacy of glatiramer acetate 20 mg/mL once daily as first-line treatment in relapsingremitting MS is well established, with ample evidence of efficacy from both placebo-controlled and active-comparator controlled clinical trials as well as real-world studies. There is also a considerable body of evidence indicating that the efficacy of glatiramer acetate is maintained in the long term. Clinical trial and real-world data have also consistently shown glatiramer acetate to be safe and well tolerated. Notably, glatiramer acetate has a good safety profile in women planning a pregnancy, and is not associated with foetal toxicity. Until recently, glatiramer acetate was only approved as 20 mg/mL once daily, but a new formulation with less frequent administration, 40 mg/mL three times weekly, has been developed and is now approved in many countries, including Italy. This review examines the mechanism of action, clinical efficacy, safety and tolerability of glatiramer acetate to provide suggestions for optimizing the use of this drug in the current MS therapeutic scenario.

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Section: Safetymentioning

confidence: 81%

Section: Three Times Weekly Formulationmentioning

confidence: 98%

Section: Tolerabilitymentioning

confidence: 99%

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The heritage of glatiramer acetate and its use in multiple sclerosis

Comı

Amato

Bertolotto

et al. 2016

Mult Scler Demyelinating Disord

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“…С целью подтвердить безопасность и продемонстриро-вать лучшую переносимость глатирамера ацетата при перехо-де с использования его в дозе 20 мг ежедневно на дозу 40 мг 3 раза в неделю было проведено исследование GLACIER [17]. До включения в это исследование пациенты получали препарат в дозе 20 мг ежедневно в среднем 6 мес.…”

Section: о б з о р ыunclassified

Glatiramer Acetate Is a First-Line Dual-Action Drug for the Treatment of Relapsing-Remitting Multiple Sclerosis

Shmidt

2016

RJTAO

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Glatiramer acetate is a first-line dual-action drug for the treatment of relapsing-remitting multiple sclerosis Shmidt T.E. Department of Nervous System Diseases and Neurosurgery, I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia, Moscow, Russia 11, Rossolimo St., Moscow 119021 Multiple sclerosis (MS) is the most common and potentially disabling disease of the central nervous system in young people. Not only inflammatory, but also neurodegenerative processes are involved in the pathogenesis of MS. The use of MS-modifying drugs (MSMDs) has led to a substantial reduction in the frequency of MS exacerbations and to the slower development of irreversible neurological deficit. Glatiramer acetate is one of the MSMDs of first choice and has a dual (anti-inflammatory and neuroprotective) action. The drug has proven to be effec

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“…1 The condition is managed in part with disease-modifying therapies that lessen the frequency of clinical relapses and curtail the formation of new lesions noted on magnetic resonance imaging (MRI). Glatiramer acetate (GA) is a frequently prescribed therapy for relapsing forms of MS. 2 Herein I report the case of a recently diagnosed patient with relapsing-remitting MS who developed recurrent serum sickness with exposure to GA after having been receiving treatment for 5 months.…”

mentioning

confidence: 99%

Case Report: Glatiramer Acetate–Induced Serum Sickness

Ferguson¹

2017

International Journal of MS Care

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Multiple sclerosis (MS) is a central nervous system demyelinating disease with a prevalence of approximately 400,000 individuals in the United States. Glatiramer acetate is a frequently prescribed diseasemodifying therapy used for the management of relapsing forms of the disease. A 40-year-old woman with relapsing-remitting MS presented with symptomatic concerns of vomiting, fever, diffuse rash, joint and low back pain, and distal lower-limb paresthesia and was subsequently admitted to the hospital for investigation and treatment. She was discharged initially after conservative management with intravenous methylprednisolone and diphenhydramine. She was restarted on glatiramer acetate 3 weeks later and required rehospitalization for similar symptoms 3 days after resumption of the disease-modifying therapy and was diagnosed as having serum sickness. Int J MS Care. 2017;19:263-264. Multiple sclerosis (MS) is a central nervous system demyelinating disease with a prevalence of approximately 400,000 affected individuals in the United States.1 The condition is managed in part with disease-modifying therapies that lessen the frequency of clinical relapses and curtail the formation of new lesions noted on magnetic resonance imaging (MRI). Glatiramer acetate (GA) is a frequently prescribed therapy for relapsing forms of MS. 2Herein I report the case of a recently diagnosed patient with relapsing-remitting MS who developed recurrent serum sickness with exposure to GA after having been receiving treatment for 5 months. The patient's first, and only, disease-modifying therapy was GA 40 mg subcutaneously three times weekly. Her relapsingremitting MS diagnosis was established based on clinical symptoms of recurrent optic neuritis as well as right-sided sensory impairment. Initial neuroimaging with MRI demonstrated gadolinium enhancement of the optic nerve in the setting of nonenhancing T2 hyperintensities in the subcortical white matter and in the cervical spine at the level of C5. Institutional review board approval was provided by the Office for Human Research Protections, Marshall University (Huntington, WV), and the patient provided written consent for this report. Case ReportA 40-year-old woman with relapsing-remitting MS presented to the local emergency department with symptoms of acute vomiting, fever, diffuse rash, joint and mild low back pain, and distal lower-limb paresthesia and was admitted for investigation. Physical examination findings were remarkable for new petechial rash and chronic monocular visual decrement and right afferent pupillary defect. She noted arthralgia on joint manipulation, but no obvious deformity or joint abnormalities were observed. During the first hospitalization she was treated with intravenous methylprednisolone and diphenhydramine for symptom mitigation of the rash and pruritus. Laboratory analysis showed mild pancytopenia. Hepatitis panel, peripheral blood smear, cyclic citrullinated peptide, erythrocyte sedimentation rate, C-reactive protein, cytomegalovirus, HIV, and EpsteinBarr viru...

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GLACIER: An open-label, randomized, multicenter study to assess the safety and tolerability of glatiramer acetate 40mg three-times weekly versus 20mg daily in patients with relapsing-remitting multiple sclerosis

Abstract: NCT01874145 available at clinicaltrial.gov.

Cited by 58 publications

References 14 publications

The heritage of glatiramer acetate and its use in multiple sclerosis

The heritage of glatiramer acetate and its use in multiple sclerosis

Glatiramer Acetate Is a First-Line Dual-Action Drug for the Treatment of Relapsing-Remitting Multiple Sclerosis

Case Report: Glatiramer Acetate–Induced Serum Sickness

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