Contributions
Abstract: P457
Type: Poster Sessions
Abstract Category: Pathology and pathogenesis of MS - Neurodegeneration
Introduction: Delayed-release dimethyl fumarate (DMF) has demonstrated good efficacy and a favourable benefit-risk profile in patients with relapsing-remitting multiple sclerosis (RRMS) in Phase 3 studies (DEFINE/ CONFIRM).
Objectives: To evaluate the effectiveness of DMF in RRMS patients treated in real-world clinical practice over 2 years, with a focus on cognition, as well as other functional outcomes function.
Methods: This multicentre (24 Italian sites), single arm, open-label study, enrolled 232 patients. Of the 232 patients, 217 were eligible for analysis; 156 patients completed the study. All patients were assessed at baseline and every 12 months thereafter using the Rao's Brief Repeatable Battery (BRB), Stroop test and Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS). Cognitive impairment (CI) was defined as failure in ≥2 out of 10 batteries among the BRB and Stroop test.
Results: Of 167 patients with cognitive data over 2 years, 83 (49.7%) did not develop CI. However, 29% (49/167) patients in the intent-to-treat population exhibited CI at baseline. Of these, 34 patients had cognitive data available at Year 2: among these, 19 (55.9%) did not experience deteriorating CI over 2 years compared to baseline. The unadjusted ARR at Year 1 and Year 2 was 0.265 and 0.19, respectively. The majority of patients were relapse-free (n=175; 80.6%) and had no evidence of disability progression (n=177, 94.1%), as per 6-month sustained EDSS at 2 years Overall, there were significant decreases in total scores on the Modified Fatigue Impact scale, Montgomery and Asberg Depression Rating Scale and Environmental Status Scale over 2 years. There was a significant increase in EQ-5D Health Survey VAS from baseline to each post-baseline visit and over the study period (P< 0.0001). One-hundred-fifty-five (71.4%) out of 217 patients experienced mostly mild to moderate treatment-emergent adverse events, most commonly flushing (41.9%).
Conclusions: These findings suggest that DMF can delay cognitive worsening in RRMS patients. A positive effect on patient reported outcomes, including fatigue, depression, activities of daily living and quality of life was reported.
Disclosure: Supported by: Biogen.
Paola Tortorella: Biogen employee, nothing to disclose.
Benedetta Goretti: “Dr Goretti received honoraria for speaking from Teva and Biogen “
Vincenzo Bresciamorra: Vincenzo Brescia Morra has received funding for travel, speaker honoraria, and research support from Sanofi-Genzyme, Bayer Schering Pharma, Merck Serono, and Biogen.
Paolo Gallo served on scientific advisory boards of Biogen Italy, Merck Serono, Bayer Schering, Sanofi-Aventis, Roche, Teva, Novartis and Almirall; received travel funding and/or speaker honoraria from Biogen Italy, Merck Serono, Sanofi-Aventis, Roche, Teva and Novartis.
Mauro Zaffaroni has received honoraria for consultancy, lecturing or participation in advisory boards, and financial support for attending scientific meetings from Almirall, Biogen Idec, Genzyme, Merck Serono, Novartis, and Teva.
Marco Onofrj:
Eleonora Cocco:
Carlo Pozzilli: scientific advisory boards for Actelion, Biogen, Genzyme, Hoffmann-la Roche ltd, Merck Serono, Novartis, Sanofi, Teva; consulting and/or speaking fees, research support and travel grants from Allergan, Almirall, Biogen, Genzyme, Hoffmann-la Roche ltd, Merck Serono, Novartis, Sanofi and Teva.
Maria Trojano: Maria Trojano has served on scientific Advisory Boards for Biogen, Novartis, Roche and Genzyme; has received speaker honoraria from Biogen Idec, Bayer Schering, Sanofi-Aventis, Merck Serono, Teva,Genzyme, Almirall and Novartis; and has received research grants for her Institution from Biogen Idec, Merck Serono and Novartis.
Valentina Zipoli: Biogen employee, nothing to disclose.
Maria Pia Amato: research grants and honoraria as speaker and member of advisory boards by Biogen, Byer, Merck, Sanofi Genzyme, Teva, Novartis and Roche.
Abstract: P457
Type: Poster Sessions
Abstract Category: Pathology and pathogenesis of MS - Neurodegeneration
Introduction: Delayed-release dimethyl fumarate (DMF) has demonstrated good efficacy and a favourable benefit-risk profile in patients with relapsing-remitting multiple sclerosis (RRMS) in Phase 3 studies (DEFINE/ CONFIRM).
Objectives: To evaluate the effectiveness of DMF in RRMS patients treated in real-world clinical practice over 2 years, with a focus on cognition, as well as other functional outcomes function.
Methods: This multicentre (24 Italian sites), single arm, open-label study, enrolled 232 patients. Of the 232 patients, 217 were eligible for analysis; 156 patients completed the study. All patients were assessed at baseline and every 12 months thereafter using the Rao's Brief Repeatable Battery (BRB), Stroop test and Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS). Cognitive impairment (CI) was defined as failure in ≥2 out of 10 batteries among the BRB and Stroop test.
Results: Of 167 patients with cognitive data over 2 years, 83 (49.7%) did not develop CI. However, 29% (49/167) patients in the intent-to-treat population exhibited CI at baseline. Of these, 34 patients had cognitive data available at Year 2: among these, 19 (55.9%) did not experience deteriorating CI over 2 years compared to baseline. The unadjusted ARR at Year 1 and Year 2 was 0.265 and 0.19, respectively. The majority of patients were relapse-free (n=175; 80.6%) and had no evidence of disability progression (n=177, 94.1%), as per 6-month sustained EDSS at 2 years Overall, there were significant decreases in total scores on the Modified Fatigue Impact scale, Montgomery and Asberg Depression Rating Scale and Environmental Status Scale over 2 years. There was a significant increase in EQ-5D Health Survey VAS from baseline to each post-baseline visit and over the study period (P< 0.0001). One-hundred-fifty-five (71.4%) out of 217 patients experienced mostly mild to moderate treatment-emergent adverse events, most commonly flushing (41.9%).
Conclusions: These findings suggest that DMF can delay cognitive worsening in RRMS patients. A positive effect on patient reported outcomes, including fatigue, depression, activities of daily living and quality of life was reported.
Disclosure: Supported by: Biogen.
Paola Tortorella: Biogen employee, nothing to disclose.
Benedetta Goretti: “Dr Goretti received honoraria for speaking from Teva and Biogen “
Vincenzo Bresciamorra: Vincenzo Brescia Morra has received funding for travel, speaker honoraria, and research support from Sanofi-Genzyme, Bayer Schering Pharma, Merck Serono, and Biogen.
Paolo Gallo served on scientific advisory boards of Biogen Italy, Merck Serono, Bayer Schering, Sanofi-Aventis, Roche, Teva, Novartis and Almirall; received travel funding and/or speaker honoraria from Biogen Italy, Merck Serono, Sanofi-Aventis, Roche, Teva and Novartis.
Mauro Zaffaroni has received honoraria for consultancy, lecturing or participation in advisory boards, and financial support for attending scientific meetings from Almirall, Biogen Idec, Genzyme, Merck Serono, Novartis, and Teva.
Marco Onofrj:
Eleonora Cocco:
Carlo Pozzilli: scientific advisory boards for Actelion, Biogen, Genzyme, Hoffmann-la Roche ltd, Merck Serono, Novartis, Sanofi, Teva; consulting and/or speaking fees, research support and travel grants from Allergan, Almirall, Biogen, Genzyme, Hoffmann-la Roche ltd, Merck Serono, Novartis, Sanofi and Teva.
Maria Trojano: Maria Trojano has served on scientific Advisory Boards for Biogen, Novartis, Roche and Genzyme; has received speaker honoraria from Biogen Idec, Bayer Schering, Sanofi-Aventis, Merck Serono, Teva,Genzyme, Almirall and Novartis; and has received research grants for her Institution from Biogen Idec, Merck Serono and Novartis.
Valentina Zipoli: Biogen employee, nothing to disclose.
Maria Pia Amato: research grants and honoraria as speaker and member of advisory boards by Biogen, Byer, Merck, Sanofi Genzyme, Teva, Novartis and Roche.