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Diego Centonze - One of the best experts on this subject based on the ideXlab platform.

  • management of Flu Like Syndrome with cetirizine in patients with relapsing remitting multiple sclerosis during therapy with interferon beta results of a randomized cross over placebo controlled pilot study
    PLOS ONE, 2017
    Co-Authors: Doriana Landi, Fabio Buttari, Maria Albanese, Elisa Puma, Fabrizia Monteleone, Laura Boffa, Silvia Rossi, Caterina Motta, Diego Centonze
    Abstract:

    Background Flu-Like Syndrome (FLS) is a common adverse event experienced by patients with relapsing-remitting multiple sclerosis (RRMS) treated with interferon beta (IFNβ). FLS can lead to poor treatment adherence and early IFNβ discontinuation. The involvement of interleukin-6 (IL-6) in the occurrence of FLS has been suggested. We hypothesized that cetirizine, a second-generation histamine H1 receptor antagonist able to reduce the levels of IL-6, might improve IFNβ-induced FLS. Methods We conducted a pilot, cross-over, randomized, placebo-controlled, double-blind study to evaluate the efficacy of cetirizine 10 mg added after each IFNβ injection to the standard of care for FLS (acetaminophen or nonsteroidal anti-inflammatory drugs) on FLS in patients with RRMS treated with IFNβ. Patients were randomized to two treatment sequences: 1) 4-week treatment with placebo added to the standard treatment for FLS, followed by 4-week treatment with cetirizine added to the standard of care, and 2) first addition of cetirizine, then of placebo. The primary efficacy endpoint was the mean change of FLS severity [11-point visual analog scale (VAS)] after 4 weeks of treatment within each sequence. Results Forty-five patients (71.1% female, mean age 39.1 years, mean time from RRMS diagnosis 5.8 years) were randomized to treatment sequences 1 and 2. The differences between cetirizine and placebo in the intensity of FLS were not statistically significant: total mean VAS scores at 4 hours from IFNβ injection were 3.57 and 3.42 for cetirizine and placebo, respectively (difference -0.15; 95% confidence interval: from -0.74 to 0.44; p = 0.6029). The two treatments were similar also with regard to other efficacy measures considered and to the safety/tolerability profile. Conclusions The addition of cetirizine to the standard of care for IFNβ-induced FLS in patients with RRMS does not seem to provide significant benefits compared with placebo. Further effort is required to understand the mechanisms underlying IFNβ-induced FLS. Trial registration EudraCT 2013-001055-12.

  • RESEARCH ARTICLE Less Frequent and Less Severe Flu-Like Syndrome in Interferon Beta-1a Treated Multiple Sclerosis Patients with at Least One Allele Bearing the G>C Polymorphism at Position-174 of the IL-6 Promoter Gene
    2016
    Co-Authors: Diego Bertoli, Federico Serana, Ra Sottini, Cinzia Cordioli, Davide Maimone, Maria Pia Amato, Diego Centonze, Ciro Florio, Elisa Puma, Ruggero Capra
    Abstract:

    One of the most common adverse event of interferon beta (IFNβ) therapy for multiple sclero-sis is Flu-Like Syndrome (FLS), which has been reportedly related to increased levels of cytokines such as interleukin 6 (IL-6) and tumor necrosis factor-alpha (TNF-α). Average cytokine levels can be affected by single nucleotide polymorphism in the gene promoter regions. To investigate whether IL-6-174 G>C and TNF-α-376 G>A polymorphisms could be correlated to the incidence of FLS, and whether an anti-inflammatory/antipyretic therapy may inFluence FLS development, a prospective observational study was performed in 190 treatment naïve, multiple sclerosis patients who started IM IFNβ-1a 30mcg once weekly. The identification ofIL-6-174 G>C and TNF-α-376 G>A polymorphisms was achieved by performing an amplification-refractory mutation system. Serum IL-6 levels were measured using enzyme-linked immunosorbent assay in blood samples taken before therapy and then after the first and last IFNβ-1a injection of the follow-up. FLS-related symptoms were recorded by patients once per week during the first 12 weeks of therapy into a self-reported diary. We found that patients carrying at least one copy of the C allele at position-174 in th

  • less frequent and less severe Flu Like Syndrome in interferon beta 1a treated multiple sclerosis patients with at least one allele bearing the g c polymorphism at position 174 of the il 6 promoter gene
    PLOS ONE, 2015
    Co-Authors: Diego Bertoli, Federico Serana, Cinzia Cordioli, Davide Maimone, Maria Pia Amato, Diego Centonze, Ciro Florio, Elisa Puma, Alessandra Sottini, Ruggero Capra
    Abstract:

    One of the most common adverse event of interferon beta (IFNβ) therapy for multiple sclerosis is Flu-Like Syndrome (FLS), which has been reportedly related to increased levels of cytokines such as interleukin 6 (IL-6) and tumor necrosis factor-alpha (TNF-α). Average cytokine levels can be affected by single nucleotide polymorphism in the gene promoter regions. To investigate whether IL-6 -174 G>C and TNF-α -376 G>A polymorphisms could be correlated to the incidence of FLS, and whether an anti-inflammatory/antipyretic therapy may inFluence FLS development, a prospective observational study was performed in 190 treatment naive, multiple sclerosis patients who started IM IFNβ-1a 30mcg once weekly. The identification of IL-6 -174 G>C and TNF-α -376 G>A polymorphisms was achieved by performing an amplification-refractory mutation system. Serum IL-6 levels were measured using enzyme-linked immunosorbent assay in blood samples taken before therapy and then after the first and last IFNβ-1a injection of the follow-up. FLS-related symptoms were recorded by patients once per week during the first 12 weeks of therapy into a self-reported diary. We found that patients carrying at least one copy of the C allele at position -174 in the promoter of IL-6 gene produced lower levels of IL-6 and were less prone to develop FLS, which was also less severe. On the contrary, the polymorphism of TNF-α had no effect on FLS. Patients taking the first dose of anti-inflammatory/antipyretic therapy in the peri-injection period (within 1 hour) experienced a reduced FLS severity. In conclusion, the study of IL-6 -174 G>C polymorphism would allow the identification of patients lacking the C nucleotide on both alleles who are at risk of a more severe FLS, and may be addressed to a timely and stronger anti-inflammatory/antipyretic therapy for a more effective FLS prevention.

Ruggero Capra - One of the best experts on this subject based on the ideXlab platform.

  • RESEARCH ARTICLE Less Frequent and Less Severe Flu-Like Syndrome in Interferon Beta-1a Treated Multiple Sclerosis Patients with at Least One Allele Bearing the G>C Polymorphism at Position-174 of the IL-6 Promoter Gene
    2016
    Co-Authors: Diego Bertoli, Federico Serana, Ra Sottini, Cinzia Cordioli, Davide Maimone, Maria Pia Amato, Diego Centonze, Ciro Florio, Elisa Puma, Ruggero Capra
    Abstract:

    One of the most common adverse event of interferon beta (IFNβ) therapy for multiple sclero-sis is Flu-Like Syndrome (FLS), which has been reportedly related to increased levels of cytokines such as interleukin 6 (IL-6) and tumor necrosis factor-alpha (TNF-α). Average cytokine levels can be affected by single nucleotide polymorphism in the gene promoter regions. To investigate whether IL-6-174 G>C and TNF-α-376 G>A polymorphisms could be correlated to the incidence of FLS, and whether an anti-inflammatory/antipyretic therapy may inFluence FLS development, a prospective observational study was performed in 190 treatment naïve, multiple sclerosis patients who started IM IFNβ-1a 30mcg once weekly. The identification ofIL-6-174 G>C and TNF-α-376 G>A polymorphisms was achieved by performing an amplification-refractory mutation system. Serum IL-6 levels were measured using enzyme-linked immunosorbent assay in blood samples taken before therapy and then after the first and last IFNβ-1a injection of the follow-up. FLS-related symptoms were recorded by patients once per week during the first 12 weeks of therapy into a self-reported diary. We found that patients carrying at least one copy of the C allele at position-174 in th

  • less frequent and less severe Flu Like Syndrome in interferon beta 1a treated multiple sclerosis patients with at least one allele bearing the g c polymorphism at position 174 of the il 6 promoter gene
    PLOS ONE, 2015
    Co-Authors: Diego Bertoli, Federico Serana, Cinzia Cordioli, Davide Maimone, Maria Pia Amato, Diego Centonze, Ciro Florio, Elisa Puma, Alessandra Sottini, Ruggero Capra
    Abstract:

    One of the most common adverse event of interferon beta (IFNβ) therapy for multiple sclerosis is Flu-Like Syndrome (FLS), which has been reportedly related to increased levels of cytokines such as interleukin 6 (IL-6) and tumor necrosis factor-alpha (TNF-α). Average cytokine levels can be affected by single nucleotide polymorphism in the gene promoter regions. To investigate whether IL-6 -174 G>C and TNF-α -376 G>A polymorphisms could be correlated to the incidence of FLS, and whether an anti-inflammatory/antipyretic therapy may inFluence FLS development, a prospective observational study was performed in 190 treatment naive, multiple sclerosis patients who started IM IFNβ-1a 30mcg once weekly. The identification of IL-6 -174 G>C and TNF-α -376 G>A polymorphisms was achieved by performing an amplification-refractory mutation system. Serum IL-6 levels were measured using enzyme-linked immunosorbent assay in blood samples taken before therapy and then after the first and last IFNβ-1a injection of the follow-up. FLS-related symptoms were recorded by patients once per week during the first 12 weeks of therapy into a self-reported diary. We found that patients carrying at least one copy of the C allele at position -174 in the promoter of IL-6 gene produced lower levels of IL-6 and were less prone to develop FLS, which was also less severe. On the contrary, the polymorphism of TNF-α had no effect on FLS. Patients taking the first dose of anti-inflammatory/antipyretic therapy in the peri-injection period (within 1 hour) experienced a reduced FLS severity. In conclusion, the study of IL-6 -174 G>C polymorphism would allow the identification of patients lacking the C nucleotide on both alleles who are at risk of a more severe FLS, and may be addressed to a timely and stronger anti-inflammatory/antipyretic therapy for a more effective FLS prevention.

Elisa Puma - One of the best experts on this subject based on the ideXlab platform.

  • management of Flu Like Syndrome with cetirizine in patients with relapsing remitting multiple sclerosis during therapy with interferon beta results of a randomized cross over placebo controlled pilot study
    PLOS ONE, 2017
    Co-Authors: Doriana Landi, Fabio Buttari, Maria Albanese, Elisa Puma, Fabrizia Monteleone, Laura Boffa, Silvia Rossi, Caterina Motta, Diego Centonze
    Abstract:

    Background Flu-Like Syndrome (FLS) is a common adverse event experienced by patients with relapsing-remitting multiple sclerosis (RRMS) treated with interferon beta (IFNβ). FLS can lead to poor treatment adherence and early IFNβ discontinuation. The involvement of interleukin-6 (IL-6) in the occurrence of FLS has been suggested. We hypothesized that cetirizine, a second-generation histamine H1 receptor antagonist able to reduce the levels of IL-6, might improve IFNβ-induced FLS. Methods We conducted a pilot, cross-over, randomized, placebo-controlled, double-blind study to evaluate the efficacy of cetirizine 10 mg added after each IFNβ injection to the standard of care for FLS (acetaminophen or nonsteroidal anti-inflammatory drugs) on FLS in patients with RRMS treated with IFNβ. Patients were randomized to two treatment sequences: 1) 4-week treatment with placebo added to the standard treatment for FLS, followed by 4-week treatment with cetirizine added to the standard of care, and 2) first addition of cetirizine, then of placebo. The primary efficacy endpoint was the mean change of FLS severity [11-point visual analog scale (VAS)] after 4 weeks of treatment within each sequence. Results Forty-five patients (71.1% female, mean age 39.1 years, mean time from RRMS diagnosis 5.8 years) were randomized to treatment sequences 1 and 2. The differences between cetirizine and placebo in the intensity of FLS were not statistically significant: total mean VAS scores at 4 hours from IFNβ injection were 3.57 and 3.42 for cetirizine and placebo, respectively (difference -0.15; 95% confidence interval: from -0.74 to 0.44; p = 0.6029). The two treatments were similar also with regard to other efficacy measures considered and to the safety/tolerability profile. Conclusions The addition of cetirizine to the standard of care for IFNβ-induced FLS in patients with RRMS does not seem to provide significant benefits compared with placebo. Further effort is required to understand the mechanisms underlying IFNβ-induced FLS. Trial registration EudraCT 2013-001055-12.

  • RESEARCH ARTICLE Less Frequent and Less Severe Flu-Like Syndrome in Interferon Beta-1a Treated Multiple Sclerosis Patients with at Least One Allele Bearing the G>C Polymorphism at Position-174 of the IL-6 Promoter Gene
    2016
    Co-Authors: Diego Bertoli, Federico Serana, Ra Sottini, Cinzia Cordioli, Davide Maimone, Maria Pia Amato, Diego Centonze, Ciro Florio, Elisa Puma, Ruggero Capra
    Abstract:

    One of the most common adverse event of interferon beta (IFNβ) therapy for multiple sclero-sis is Flu-Like Syndrome (FLS), which has been reportedly related to increased levels of cytokines such as interleukin 6 (IL-6) and tumor necrosis factor-alpha (TNF-α). Average cytokine levels can be affected by single nucleotide polymorphism in the gene promoter regions. To investigate whether IL-6-174 G>C and TNF-α-376 G>A polymorphisms could be correlated to the incidence of FLS, and whether an anti-inflammatory/antipyretic therapy may inFluence FLS development, a prospective observational study was performed in 190 treatment naïve, multiple sclerosis patients who started IM IFNβ-1a 30mcg once weekly. The identification ofIL-6-174 G>C and TNF-α-376 G>A polymorphisms was achieved by performing an amplification-refractory mutation system. Serum IL-6 levels were measured using enzyme-linked immunosorbent assay in blood samples taken before therapy and then after the first and last IFNβ-1a injection of the follow-up. FLS-related symptoms were recorded by patients once per week during the first 12 weeks of therapy into a self-reported diary. We found that patients carrying at least one copy of the C allele at position-174 in th

  • less frequent and less severe Flu Like Syndrome in interferon beta 1a treated multiple sclerosis patients with at least one allele bearing the g c polymorphism at position 174 of the il 6 promoter gene
    PLOS ONE, 2015
    Co-Authors: Diego Bertoli, Federico Serana, Cinzia Cordioli, Davide Maimone, Maria Pia Amato, Diego Centonze, Ciro Florio, Elisa Puma, Alessandra Sottini, Ruggero Capra
    Abstract:

    One of the most common adverse event of interferon beta (IFNβ) therapy for multiple sclerosis is Flu-Like Syndrome (FLS), which has been reportedly related to increased levels of cytokines such as interleukin 6 (IL-6) and tumor necrosis factor-alpha (TNF-α). Average cytokine levels can be affected by single nucleotide polymorphism in the gene promoter regions. To investigate whether IL-6 -174 G>C and TNF-α -376 G>A polymorphisms could be correlated to the incidence of FLS, and whether an anti-inflammatory/antipyretic therapy may inFluence FLS development, a prospective observational study was performed in 190 treatment naive, multiple sclerosis patients who started IM IFNβ-1a 30mcg once weekly. The identification of IL-6 -174 G>C and TNF-α -376 G>A polymorphisms was achieved by performing an amplification-refractory mutation system. Serum IL-6 levels were measured using enzyme-linked immunosorbent assay in blood samples taken before therapy and then after the first and last IFNβ-1a injection of the follow-up. FLS-related symptoms were recorded by patients once per week during the first 12 weeks of therapy into a self-reported diary. We found that patients carrying at least one copy of the C allele at position -174 in the promoter of IL-6 gene produced lower levels of IL-6 and were less prone to develop FLS, which was also less severe. On the contrary, the polymorphism of TNF-α had no effect on FLS. Patients taking the first dose of anti-inflammatory/antipyretic therapy in the peri-injection period (within 1 hour) experienced a reduced FLS severity. In conclusion, the study of IL-6 -174 G>C polymorphism would allow the identification of patients lacking the C nucleotide on both alleles who are at risk of a more severe FLS, and may be addressed to a timely and stronger anti-inflammatory/antipyretic therapy for a more effective FLS prevention.

Diego Bertoli - One of the best experts on this subject based on the ideXlab platform.

  • RESEARCH ARTICLE Less Frequent and Less Severe Flu-Like Syndrome in Interferon Beta-1a Treated Multiple Sclerosis Patients with at Least One Allele Bearing the G>C Polymorphism at Position-174 of the IL-6 Promoter Gene
    2016
    Co-Authors: Diego Bertoli, Federico Serana, Ra Sottini, Cinzia Cordioli, Davide Maimone, Maria Pia Amato, Diego Centonze, Ciro Florio, Elisa Puma, Ruggero Capra
    Abstract:

    One of the most common adverse event of interferon beta (IFNβ) therapy for multiple sclero-sis is Flu-Like Syndrome (FLS), which has been reportedly related to increased levels of cytokines such as interleukin 6 (IL-6) and tumor necrosis factor-alpha (TNF-α). Average cytokine levels can be affected by single nucleotide polymorphism in the gene promoter regions. To investigate whether IL-6-174 G>C and TNF-α-376 G>A polymorphisms could be correlated to the incidence of FLS, and whether an anti-inflammatory/antipyretic therapy may inFluence FLS development, a prospective observational study was performed in 190 treatment naïve, multiple sclerosis patients who started IM IFNβ-1a 30mcg once weekly. The identification ofIL-6-174 G>C and TNF-α-376 G>A polymorphisms was achieved by performing an amplification-refractory mutation system. Serum IL-6 levels were measured using enzyme-linked immunosorbent assay in blood samples taken before therapy and then after the first and last IFNβ-1a injection of the follow-up. FLS-related symptoms were recorded by patients once per week during the first 12 weeks of therapy into a self-reported diary. We found that patients carrying at least one copy of the C allele at position-174 in th

  • less frequent and less severe Flu Like Syndrome in interferon beta 1a treated multiple sclerosis patients with at least one allele bearing the g c polymorphism at position 174 of the il 6 promoter gene
    PLOS ONE, 2015
    Co-Authors: Diego Bertoli, Federico Serana, Cinzia Cordioli, Davide Maimone, Maria Pia Amato, Diego Centonze, Ciro Florio, Elisa Puma, Alessandra Sottini, Ruggero Capra
    Abstract:

    One of the most common adverse event of interferon beta (IFNβ) therapy for multiple sclerosis is Flu-Like Syndrome (FLS), which has been reportedly related to increased levels of cytokines such as interleukin 6 (IL-6) and tumor necrosis factor-alpha (TNF-α). Average cytokine levels can be affected by single nucleotide polymorphism in the gene promoter regions. To investigate whether IL-6 -174 G>C and TNF-α -376 G>A polymorphisms could be correlated to the incidence of FLS, and whether an anti-inflammatory/antipyretic therapy may inFluence FLS development, a prospective observational study was performed in 190 treatment naive, multiple sclerosis patients who started IM IFNβ-1a 30mcg once weekly. The identification of IL-6 -174 G>C and TNF-α -376 G>A polymorphisms was achieved by performing an amplification-refractory mutation system. Serum IL-6 levels were measured using enzyme-linked immunosorbent assay in blood samples taken before therapy and then after the first and last IFNβ-1a injection of the follow-up. FLS-related symptoms were recorded by patients once per week during the first 12 weeks of therapy into a self-reported diary. We found that patients carrying at least one copy of the C allele at position -174 in the promoter of IL-6 gene produced lower levels of IL-6 and were less prone to develop FLS, which was also less severe. On the contrary, the polymorphism of TNF-α had no effect on FLS. Patients taking the first dose of anti-inflammatory/antipyretic therapy in the peri-injection period (within 1 hour) experienced a reduced FLS severity. In conclusion, the study of IL-6 -174 G>C polymorphism would allow the identification of patients lacking the C nucleotide on both alleles who are at risk of a more severe FLS, and may be addressed to a timely and stronger anti-inflammatory/antipyretic therapy for a more effective FLS prevention.

Doriana Landi - One of the best experts on this subject based on the ideXlab platform.

  • management of Flu Like Syndrome with cetirizine in patients with relapsing remitting multiple sclerosis during therapy with interferon beta results of a randomized cross over placebo controlled pilot study
    PLOS ONE, 2017
    Co-Authors: Doriana Landi, Fabio Buttari, Maria Albanese, Elisa Puma, Fabrizia Monteleone, Laura Boffa, Silvia Rossi, Caterina Motta, Diego Centonze
    Abstract:

    Background Flu-Like Syndrome (FLS) is a common adverse event experienced by patients with relapsing-remitting multiple sclerosis (RRMS) treated with interferon beta (IFNβ). FLS can lead to poor treatment adherence and early IFNβ discontinuation. The involvement of interleukin-6 (IL-6) in the occurrence of FLS has been suggested. We hypothesized that cetirizine, a second-generation histamine H1 receptor antagonist able to reduce the levels of IL-6, might improve IFNβ-induced FLS. Methods We conducted a pilot, cross-over, randomized, placebo-controlled, double-blind study to evaluate the efficacy of cetirizine 10 mg added after each IFNβ injection to the standard of care for FLS (acetaminophen or nonsteroidal anti-inflammatory drugs) on FLS in patients with RRMS treated with IFNβ. Patients were randomized to two treatment sequences: 1) 4-week treatment with placebo added to the standard treatment for FLS, followed by 4-week treatment with cetirizine added to the standard of care, and 2) first addition of cetirizine, then of placebo. The primary efficacy endpoint was the mean change of FLS severity [11-point visual analog scale (VAS)] after 4 weeks of treatment within each sequence. Results Forty-five patients (71.1% female, mean age 39.1 years, mean time from RRMS diagnosis 5.8 years) were randomized to treatment sequences 1 and 2. The differences between cetirizine and placebo in the intensity of FLS were not statistically significant: total mean VAS scores at 4 hours from IFNβ injection were 3.57 and 3.42 for cetirizine and placebo, respectively (difference -0.15; 95% confidence interval: from -0.74 to 0.44; p = 0.6029). The two treatments were similar also with regard to other efficacy measures considered and to the safety/tolerability profile. Conclusions The addition of cetirizine to the standard of care for IFNβ-induced FLS in patients with RRMS does not seem to provide significant benefits compared with placebo. Further effort is required to understand the mechanisms underlying IFNβ-induced FLS. Trial registration EudraCT 2013-001055-12.

  • trpv1 polymorphisms and risk of interferon β induced Flu Like Syndrome in patients with relapsing remitting multiple sclerosis
    Journal of Neuroimmunology, 2017
    Co-Authors: Fabio Buttari, Sara Zagaglia, Lorenzo Marciano, Maria Albanese, Doriana Landi, Carolina Gabri Nicoletti, Nicola Biagio Mercuri, Mauro Silvestrini, Leandro Provinciali, Girolama Alessandra Marfia
    Abstract:

    Interferon-β (IFN-β) is often discontinued in RRMS patients due to its most common side effect, the Flu-Like Syndrome (FLS). The mechanisms underlying IFN β-induced FLS symptoms are still unclear. The endocannabinoid system (ECS) is a key regulator of pain and inflammation. Thus we tested the hypothesis that the ECS could be involved in FLS severity by exploring the effect of genetic polymorphisms with functional impact on the ECS, on patient-reported FLS symptoms. GG-carriers of the transient-receptor-potential-vanilloid-1 (TRPV1) single nucleotide polymorphism rs222747 reported greater pain and weakness during FLS. This study suggests that the TRPV1 channel is involved in FLS severity.