The Experts below are selected from a list of 8274 Experts worldwide ranked by ideXlab platform
Claudio Gobbi - One of the best experts on this subject based on the ideXlab platform.
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Recurrent Nicolau syndrome associated with subcutaneous Glatiramer acetate injection—a case report
BMC Neurology, 2015Co-Authors: Chiara Zecca, Roland Blum, Carlo Mainetti, Claudio GobbiAbstract:Background Glatiramer acetate is worldwide used as first line treatment in relapsing remitting multiple sclerosis. Local skin reactions associated with Glatiramer acetate are common, however, only isolated cases of severe local injection site reactions known as Nicolau Syndrome have been reported so far. Case presentation We describe the case of a recurrent Nicolau Syndrome occurred during longstanding Glatiramer acetate treatment in a woman with multiple sclerosis. The haemorrhagic patch necrotized and was treated locally as a deep second degree burn with excision of dead skin tissue and was healed. Treatment with Glatiramer acetate was definitely suspended. Conclusions GA injections can be complicated by isolated or recurrent Nicolau Syndrome, a potentially life-threatening condition of which neurologists should be aware.
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recurrent nicolau syndrome associated with subcutaneous Glatiramer acetate injection a case report
BMC Neurology, 2015Co-Authors: Chiara Zecca, Roland Blum, Carlo Mainetti, Claudio GobbiAbstract:Background Glatiramer acetate is worldwide used as first line treatment in relapsing remitting multiple sclerosis. Local skin reactions associated with Glatiramer acetate are common, however, only isolated cases of severe local injection site reactions known as Nicolau Syndrome have been reported so far.
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Two decades of subcutaneous Glatiramer acetate injection: current role of the standard dose, and new high-dose low-frequency Glatiramer acetate in relapsing–remitting multiple sclerosis treatment
Patient preference and adherence, 2014Co-Authors: Matteo Caporro, Claudio Gobbi, Giulio Disanto, Chiara ZeccaAbstract:Glatiramer acetate, a synthetic amino acid polymer analog of myelin basic protein, is one of the first approved drugs for the treatment of relapsing–remitting multiple sclerosis. Several clinical trials have shown consistent and sustained efficacy of Glatiramer acetate 20 mg subcutaneously daily in reducing relapses and new demyelinating lesions on magnetic resonance imaging in patients with relapsing–remitting multiple sclerosis, as well as comparable efficacy to high-dose interferon beta. Some preclinical and clinical data suggest a neuroprotective role for Glatiramer acetate in multiple sclerosis. Glatiramer acetate is associated with a relatively favorable side-effect profile, and importantly this was confirmed also during long-term use. Glatiramer acetate is the only multiple sclerosis treatment compound that has gained the US Food and Drug Administration pregnancy category B. All these data support its current use as a first-line treatment option for patients with clinical isolated syndrome or relapsing–remitting multiple sclerosis. More recent data have shown that high-dose Glatiramer acetate (ie, 40 mg) given three times weekly is effective, safe, and well tolerated in the treatment of relapsing–remitting multiple sclerosis, prompting the approval of this dosage in the US in early 2014. This high-dose, lower-frequency Glatiramer acetate might represent a new, more convenient regimen of administration, and this might enhance patients’ adherence to the treatment, crucial for optimal disease control.
Chiara Zecca - One of the best experts on this subject based on the ideXlab platform.
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Recurrent Nicolau syndrome associated with subcutaneous Glatiramer acetate injection—a case report
BMC Neurology, 2015Co-Authors: Chiara Zecca, Roland Blum, Carlo Mainetti, Claudio GobbiAbstract:Background Glatiramer acetate is worldwide used as first line treatment in relapsing remitting multiple sclerosis. Local skin reactions associated with Glatiramer acetate are common, however, only isolated cases of severe local injection site reactions known as Nicolau Syndrome have been reported so far. Case presentation We describe the case of a recurrent Nicolau Syndrome occurred during longstanding Glatiramer acetate treatment in a woman with multiple sclerosis. The haemorrhagic patch necrotized and was treated locally as a deep second degree burn with excision of dead skin tissue and was healed. Treatment with Glatiramer acetate was definitely suspended. Conclusions GA injections can be complicated by isolated or recurrent Nicolau Syndrome, a potentially life-threatening condition of which neurologists should be aware.
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recurrent nicolau syndrome associated with subcutaneous Glatiramer acetate injection a case report
BMC Neurology, 2015Co-Authors: Chiara Zecca, Roland Blum, Carlo Mainetti, Claudio GobbiAbstract:Background Glatiramer acetate is worldwide used as first line treatment in relapsing remitting multiple sclerosis. Local skin reactions associated with Glatiramer acetate are common, however, only isolated cases of severe local injection site reactions known as Nicolau Syndrome have been reported so far.
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Two decades of subcutaneous Glatiramer acetate injection: current role of the standard dose, and new high-dose low-frequency Glatiramer acetate in relapsing–remitting multiple sclerosis treatment
Patient preference and adherence, 2014Co-Authors: Matteo Caporro, Claudio Gobbi, Giulio Disanto, Chiara ZeccaAbstract:Glatiramer acetate, a synthetic amino acid polymer analog of myelin basic protein, is one of the first approved drugs for the treatment of relapsing–remitting multiple sclerosis. Several clinical trials have shown consistent and sustained efficacy of Glatiramer acetate 20 mg subcutaneously daily in reducing relapses and new demyelinating lesions on magnetic resonance imaging in patients with relapsing–remitting multiple sclerosis, as well as comparable efficacy to high-dose interferon beta. Some preclinical and clinical data suggest a neuroprotective role for Glatiramer acetate in multiple sclerosis. Glatiramer acetate is associated with a relatively favorable side-effect profile, and importantly this was confirmed also during long-term use. Glatiramer acetate is the only multiple sclerosis treatment compound that has gained the US Food and Drug Administration pregnancy category B. All these data support its current use as a first-line treatment option for patients with clinical isolated syndrome or relapsing–remitting multiple sclerosis. More recent data have shown that high-dose Glatiramer acetate (ie, 40 mg) given three times weekly is effective, safe, and well tolerated in the treatment of relapsing–remitting multiple sclerosis, prompting the approval of this dosage in the US in early 2014. This high-dose, lower-frequency Glatiramer acetate might represent a new, more convenient regimen of administration, and this might enhance patients’ adherence to the treatment, crucial for optimal disease control.
Tjalf Ziemssen - One of the best experts on this subject based on the ideXlab platform.
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Effects of Glatiramer acetate on fatigue and days of absence from work in first-time treated relapsing-remitting multiple sclerosis
Health and quality of life outcomes, 2008Co-Authors: Tjalf Ziemssen, Josef Hoffman, Rainer Apfel, Simone KernAbstract:Objectives Treatment of multiple sclerosis patients with Glatiramer acetate has been demonstrated a beneficial effect on disease activity. The objective of this prospective naturalistic study was to evaluate the impact of Glatiramer acetate on fatigue and work absenteeism.
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Effects of Glatiramer acetate on fatigue and days of absence from work in first-time treated relapsing-remitting multiple sclerosis
Health and quality of life outcomes, 2008Co-Authors: Tjalf Ziemssen, Josef Hoffman, Rainer Apfel, Simone KernAbstract:Objectives: Treatment of multiple sclerosis patients with Glatiramer acetate has been demonstrated a beneficial effect on disease activity. The objective of this prospective naturalistic study was to evaluate the impact of Glatiramer acetate on fatigue and work absenteeism. Methods: 291 treatment-naive patients with relapsing remitting multiple sclerosis were included and treated with Glatiramer acetate for twelve months. Relapse rates, disability, fatigue symptoms, days of absence from work and adverse events were monitored. Fatigue was measured with the MFIS scale and with a visual analogue scale. Results: Total MFIS scores decreased by 7.6 ± 16.4 from 34.6 to 27.0 (p ≤ 0.001). Significant reductions were observed on all three subscales of the MFIS. Fatigue symptoms, assessed using a visual analogue scale, decreased by 1.04 ± 2.88 cm from 4.47 cm to 3.43 cm (p ≤ 0.001). The proportion of patients absent from work at least once was reduced by a factor of two from 65.1% to 30.1% (p ≤ 0.001). Tolerance to treatment was rated as very good or good in 78.3% of patients. Adverse effects, most frequently local injection site reactions, were reported in 15.1% of patients. Conclusion: Treatment with Glatiramer acetate was associated with a significant improvement in fatigue symptoms and a marked reduction in absence from work. Treatment was well-tolerated. Such benefits are of relevance to overall patient well-being.
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Glatiramer acetate: mechanisms of action in multiple sclerosis.
Autoimmunity reviews, 2007Co-Authors: Wiebke Schrempf, Tjalf ZiemssenAbstract:Glatiramer acetate (GA) is a mixture of synthetic polypeptides composed of four amino acids resembling myelin basic protein (MBP). GA has been shown to be effective in preventing and suppressing experimental autoimmune encephalomyelitis (EAE), the animal model of multiple sclerosis. It was tested in several clinical studies and approved for the immunomodulatory treatment of relapsing-type MS in 1996. Glatiramer acetate demonstrates a strong promiscuous binding to major histocompatibility complex molecules and inhibits the T cell response to several myelin antigens. In addition, it was shown to act as a T cell receptor antagonist for the 82-100 MBP epitope. Glatiramer acetate treatment causes in vivo changes of the frequency, cytokine secretion pattern and effector function of GA-specific T cells. It was shown to induce GA-specific regulatory CD4(+) and CD8(+) T cells and a TH1-TH2 shift with consecutively increased secretion of antiinflammatory cytokines. GA-specific TH2 cells are able to migrate across the blood-brain barrier and cause in situ bystander suppression of autoaggressive TH1 T cells. In addition Glatiramer acetate was demonstrated to influence antigen presenting cells (APC) such as monocytes and dendritic cells. Furthermore secretion of neurotrophic factors with potential neuroprotective effects was shown.
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Risk-Benefit Assessment of Glatiramer Acetate in Multiple Sclerosis
Drug Safety, 2001Co-Authors: Tjalf Ziemssen, Oliver Neuhaus, Reinhard HohlfeldAbstract:Glatiramer acetate, formerly known as copolymer 1, is a mixture of synthetic polypeptides composed of four amino acids. Glatiramer acetate has been shown to be effective in preventing and suppressing experimental autoimmune encephalitis (EAE), the animal model of multiple sclerosis (MS). Therefore it was tested in several clinical studies, where it was found to slow the progression of disability and to reduce the relapse rate and the magnetic resonance imaging (MRI)—defined disease activity and burden in relapsing-remitting MS. As a daily standard dose, 20mg of Glatiramer acetate is injected subcutaneously. After injection, Glatiramer acetate undergoes rapid degradation to amino acids and shorter peptides; so it is not possible to measure any systemic plasma concentrations or excretion rates. Two major mechanisms have been proposed to explain the effects of Glatiramer acetate in EAE and MS: the induction of Glatiramer acetate-reactive T helper 2 (Th2)-like regulatory suppressive cells and the interference with T cell activation as an altered peptide ligand. The most common adverse effects were mild injection site reactions (erythema, inflammation and induration). The most remarkable adverse event is the acute and transient immediate postinjection reaction manifested by flushing, chest tightness, palpitations and dyspnoea. Other reported adverse effects are transient chest pain and lymphadenopathy. Antibodies to Glatiramer acetate induced during treatment do not interfere with its clinical effects. In several controlled clinical studies, Glatiramer acetate has been shown to provide consistent, reproducible clinical benefits in the target population of patients with relapsing-remitting MS. The safety profile and risk-benefit ratio are excellent. Overall, Glatiramer acetate is very well tolerated and has an excellent risk-benefit profile in patients with relapsing-remitting MS.
Simone Kern - One of the best experts on this subject based on the ideXlab platform.
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Effects of Glatiramer acetate on fatigue and days of absence from work in first-time treated relapsing-remitting multiple sclerosis
Health and quality of life outcomes, 2008Co-Authors: Tjalf Ziemssen, Josef Hoffman, Rainer Apfel, Simone KernAbstract:Objectives: Treatment of multiple sclerosis patients with Glatiramer acetate has been demonstrated a beneficial effect on disease activity. The objective of this prospective naturalistic study was to evaluate the impact of Glatiramer acetate on fatigue and work absenteeism. Methods: 291 treatment-naive patients with relapsing remitting multiple sclerosis were included and treated with Glatiramer acetate for twelve months. Relapse rates, disability, fatigue symptoms, days of absence from work and adverse events were monitored. Fatigue was measured with the MFIS scale and with a visual analogue scale. Results: Total MFIS scores decreased by 7.6 ± 16.4 from 34.6 to 27.0 (p ≤ 0.001). Significant reductions were observed on all three subscales of the MFIS. Fatigue symptoms, assessed using a visual analogue scale, decreased by 1.04 ± 2.88 cm from 4.47 cm to 3.43 cm (p ≤ 0.001). The proportion of patients absent from work at least once was reduced by a factor of two from 65.1% to 30.1% (p ≤ 0.001). Tolerance to treatment was rated as very good or good in 78.3% of patients. Adverse effects, most frequently local injection site reactions, were reported in 15.1% of patients. Conclusion: Treatment with Glatiramer acetate was associated with a significant improvement in fatigue symptoms and a marked reduction in absence from work. Treatment was well-tolerated. Such benefits are of relevance to overall patient well-being.
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Effects of Glatiramer acetate on fatigue and days of absence from work in first-time treated relapsing-remitting multiple sclerosis
Health and quality of life outcomes, 2008Co-Authors: Tjalf Ziemssen, Josef Hoffman, Rainer Apfel, Simone KernAbstract:Objectives Treatment of multiple sclerosis patients with Glatiramer acetate has been demonstrated a beneficial effect on disease activity. The objective of this prospective naturalistic study was to evaluate the impact of Glatiramer acetate on fatigue and work absenteeism.
Maria Giovanna Marrosu - One of the best experts on this subject based on the ideXlab platform.
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fingolimod versus interferon beta Glatiramer acetate after natalizumab suspension in multiple sclerosis
Brain, 2015Co-Authors: Pietro Iaffaldano, Angelo Ghezzi, Giuseppe Lucisano, Carlo Pozzilli, Vincenzo Brescia Morra, Enrico Millefiorini, Francesco Patti, Alessandra Lugaresi, G B Zimatore, Maria Giovanna MarrosuAbstract:The comparative effectiveness of fingolimod versus interferon beta/Glatiramer acetate was assessed in a multicentre, observational, prospectively acquired cohort study including 613 patients with relapsing multiple sclerosis discontinuing natalizumab in the Italian iMedWeb registry. First, after natalizumab suspension, the relapse risk during the untreated wash-out period and during the course of switch therapies was estimated through Poisson regression analyses in separated models. During the wash-out period an increased risk of relapses was found in patients with a higher number of relapses before natalizumab treatment (incidence rate ratio = 1.31, P = 0.0014) and in patients discontinuing natalizumab due to lack of efficacy (incidence rate ratio = 2.33, P = 0.0288), patient's choice (incidence rate ratio = 2.18, P = 0.0064) and adverse events (incidence rate ratio = 2.09, P = 0.0084). The strongest independent factors influencing the relapse risk after the start of switch therapies were a wash-out duration longer than 3 months (incidence rate ratio = 1.78, P < 0.0001), the number of relapses experienced during and before natalizumab treatment (incidence rate ratio = 1.61, P < 0.0001; incidence rate ratio = 1.13, P = 0.0118, respectively) and the presence of comorbidities (incidence rate ratio = 1.4, P = 0.0097). Switching to fingolimod was associated with a 64% reduction of the adjusted-risk for relapse in comparison with switching to interferon beta/Glatiramer acetate (incidence rate ratio = 0.36, P < 0.0001). Secondly, patients who switched to fingolimod or to interferon beta/Glatiramer acetate were propensity score-matched on a 1-to-1 basis at the switching date. In the propensity score-matched sample a Poisson model showed a significant lower incidence of relapses in patients treated with fingolimod in comparison with those treated with interferon beta/Glatiramer acetate (incidence rate ratio = 0.52, P = 0.0003) during a 12-month follow-up. The cumulative probability of a first relapse after the treatment switch was significantly lower in patients receiving fingolimod than in those receiving interferon beta/Glatiramer acetate (P = 0.028). The robustness of this result was also confirmed by sensitivity analyses in subgroups with different wash-out durations (less or more than 3 months). Time to 3-month confirmed disability progression was not significantly different between the two groups (Hazard ratio = 0.58; P = 0.1931). Our results indicate a superiority of fingolimod in comparison to interferon beta/Glatiramer acetate in controlling disease reactivation after natalizumab discontinuation in the real life setting.
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fingolimod versus interferon beta Glatiramer acetate after natalizumab suspension in multiple sclerosis
Brain, 2015Co-Authors: Pietro Iaffaldano, Angelo Ghezzi, Giuseppe Lucisano, Carlo Pozzilli, Enrico Millefiorini, Francesco Patti, Alessandra Lugaresi, G B Zimatore, Vincenzo Morra, Maria Giovanna MarrosuAbstract:The comparative effectiveness of fingolimod versus interferon beta/Glatiramer acetate was assessed in a multicentre, observational, prospectively acquired cohort study including 613 patients with relapsing multiple sclerosis discontinuing natalizumab in the Italian iMedWeb registry. First, after natalizumab suspension, the relapse risk during the untreated wash-out period and during the course of switch therapies was estimated through Poisson regression analyses in separated models. During the wash-out period an increased risk of relapses was found in patients with a higher number of relapses before natalizumab treatment (incidence rate ratio = 1.31, P = 0.0014) and in patients discontinuing natalizumab due to lack of efficacy (incidence rate ratio = 2.33, P = 0.0288), patient’s choice (incidence rate ratio = 2.18, P = 0.0064) and adverse events (incidence rate ratio = 2.09, P = 0.0084). The strongest independent factors influencing the relapse risk after the start of switch therapies were a wash-out duration longer than 3 months (incidence rate ratio = 1.78, P < 0.0001), the number of relapses experienced during and before natalizumab treatment (incidence rate ratio = 1.61, P < 0.0001; incidence rate ratio = 1.13, P = 0.0118, respectively) and the presence of comorbidities (incidence rate ratio = 1.4, P = 0.0097). Switching to fingolimod was associated with a 64% reduction of the adjusted-risk for relapse in comparison with switching to interferon beta/Glatiramer acetate (incidence rate ratio = 0.36, P < 0.0001). Secondly, patients who switched to fingolimod or to interferon beta/Glatiramer acetate were propensity score-matched on a 1-to-1 basis at the switching date. In the propensity score-matched sample a Poisson model showed a significant lower incidence of relapses in patients treated with fingolimod in comparison with those treated with interferon beta/Glatiramer acetate (incidence rate ratio = 0.52, P = 0.0003) during a 12-month follow-up. The cumulative probability of a first relapse after the treatment switch was significantly lower in patients receiving fingolimod than in those receiving interferon beta/Glatiramer acetate ( P = 0.028). The robustness of this result was also confirmed by sensitivity analyses in subgroups with different wash-out durations (less or more than 3 months). Time to 3-month confirmed disability progression was not significantly different between the two groups (Hazard ratio = 0.58; P = 0.1931). Our results indicate a superiority of fingolimod in comparison to interferon beta/Glatiramer acetate in controlling disease reactivation after natalizumab discontinuation in the real life setting. * Abbreviations : BRACE : Betaferon®, Betaseron®, Rebif®, Avonex®, Copaxone® or Extavia® EDSS : Expanded Disability Status Scale IFNβ : interferon beta IRR : incidence rate ratio