Contributions
Abstract: P723
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Introduction: DMF, a first line oral treatment for RRMS, reduces relapse rate and brain MRI active lesions load. However, its gastrointestinal (g-i) and flushing side can undermine adherence to treatment and can determine up to 5% drop-out rate in the first month of treatment. DMF intake with food has been empirically reported to increase tolerability, however no ad hoc studies are reported in literature.
Objective: To assess the association between DMF-related g-i and flushing side effects, and food patterns in RRMS patients over their first month of treatment.
Methods: A multicenter case-control study on RRMS patients was designed to involve MS referral health structures in Italy. The "case" was defined by the presence of DMF-related side effects; a "control" was a RRMS patient under DMF showing no side effects. Exposure to eating habits before starting DMF was assessed with a short version of a food frequency questionnaire. Risk was measured through crude and adjusted odds ratios (OR) and 95% confidence interval (95%CI), by means of logistic regression. Sex and body mass index (BMI) were collected as covariates.
Results: Sixty-two RRMS patients (21 men, 41 women) were consecutively recruited from seven Italian centres; mean (SD) age was 37.6 (8.7) years in men and 40.3 (10.5) years in women, respectively (p=ns). Flushing (any degree) was reported by 70% of patients and over 60% reported g-i effects (any degree). The latter were reported more frequently in women (27%-36%) vs. men (5%-10%); flu-like syndrome was more prevalent among men (20%) than women (2.4%). A significant inverse association was found between DMF g-i side effects and intake of bread, yoghurt or fruit at breakfast (ORadj=0.04 (95%CI: 0.01-0.36), 0.13 (95%CI: 0.02-0.74), and 0.21 (95%CI: 0.06-0.81, respectively)). Intake of aged cheese in the daily diet was found directly associated with flushing. To the study date 2 drop-outs (3.2%) were registered during the first month after DMF initiation.
Conclusions: We have preliminarily shown that exposure to certain foods and/or dietary patterns may reduce the impact of DMF-related g-i and flushing side effects. Our study highlights the potential of specific dietary regimens to increase RRMS patients" adherence to DMF.
Disclosure: Pugliatti M was member in Advisory Board by Bayer Schering and Genzyme; has received travel or speaker honoraria by Almirall, Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis and Teva Neurosciences.
Vettorazzi C: nothing to disclose.
Della Coletta E: nothing to disclose.
Caniatti LM: nothing to disclose.
Baldi E: nothing to disclose.
Rossi S was member in Advisory Board by Biogen Idec, Bayer Schering, Merck Serono, Teva, Novartis and Genzyme, and received funding for traveling and honoraria for speaking or writing from Biogen Idec, Merck Serono, Teva, Novartis, Bayer Schering, Genzyme, Almirall. She received support for research project by Teva, Merck Serono and Bayer Schering and is involved as principal investigator in clinical trials for Teva and Roche.
Ragonese P: nothing to disclose.
Ferracci F: nothing to disclose.
De Gennaro R: nothing to disclose.
Crociani P has been P.I. in a clinical study by Roche.
Naldi P: nothing to disclose.
Protti A: traveling honoraria from Bayer, Biogen, Merck Serono, Novartis, Teva, Genzyme Aventis.
Abstract: P723
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Introduction: DMF, a first line oral treatment for RRMS, reduces relapse rate and brain MRI active lesions load. However, its gastrointestinal (g-i) and flushing side can undermine adherence to treatment and can determine up to 5% drop-out rate in the first month of treatment. DMF intake with food has been empirically reported to increase tolerability, however no ad hoc studies are reported in literature.
Objective: To assess the association between DMF-related g-i and flushing side effects, and food patterns in RRMS patients over their first month of treatment.
Methods: A multicenter case-control study on RRMS patients was designed to involve MS referral health structures in Italy. The "case" was defined by the presence of DMF-related side effects; a "control" was a RRMS patient under DMF showing no side effects. Exposure to eating habits before starting DMF was assessed with a short version of a food frequency questionnaire. Risk was measured through crude and adjusted odds ratios (OR) and 95% confidence interval (95%CI), by means of logistic regression. Sex and body mass index (BMI) were collected as covariates.
Results: Sixty-two RRMS patients (21 men, 41 women) were consecutively recruited from seven Italian centres; mean (SD) age was 37.6 (8.7) years in men and 40.3 (10.5) years in women, respectively (p=ns). Flushing (any degree) was reported by 70% of patients and over 60% reported g-i effects (any degree). The latter were reported more frequently in women (27%-36%) vs. men (5%-10%); flu-like syndrome was more prevalent among men (20%) than women (2.4%). A significant inverse association was found between DMF g-i side effects and intake of bread, yoghurt or fruit at breakfast (ORadj=0.04 (95%CI: 0.01-0.36), 0.13 (95%CI: 0.02-0.74), and 0.21 (95%CI: 0.06-0.81, respectively)). Intake of aged cheese in the daily diet was found directly associated with flushing. To the study date 2 drop-outs (3.2%) were registered during the first month after DMF initiation.
Conclusions: We have preliminarily shown that exposure to certain foods and/or dietary patterns may reduce the impact of DMF-related g-i and flushing side effects. Our study highlights the potential of specific dietary regimens to increase RRMS patients" adherence to DMF.
Disclosure: Pugliatti M was member in Advisory Board by Bayer Schering and Genzyme; has received travel or speaker honoraria by Almirall, Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis and Teva Neurosciences.
Vettorazzi C: nothing to disclose.
Della Coletta E: nothing to disclose.
Caniatti LM: nothing to disclose.
Baldi E: nothing to disclose.
Rossi S was member in Advisory Board by Biogen Idec, Bayer Schering, Merck Serono, Teva, Novartis and Genzyme, and received funding for traveling and honoraria for speaking or writing from Biogen Idec, Merck Serono, Teva, Novartis, Bayer Schering, Genzyme, Almirall. She received support for research project by Teva, Merck Serono and Bayer Schering and is involved as principal investigator in clinical trials for Teva and Roche.
Ragonese P: nothing to disclose.
Ferracci F: nothing to disclose.
De Gennaro R: nothing to disclose.
Crociani P has been P.I. in a clinical study by Roche.
Naldi P: nothing to disclose.
Protti A: traveling honoraria from Bayer, Biogen, Merck Serono, Novartis, Teva, Genzyme Aventis.