Contributions
Abstract: P1135
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Clinical trials (DEFINE/CONFIRM) demonstrated the efficacy and favorable benefit/risk of dimethyl fumarate (DMF) in patients with relapsing-remitting multiple sclerosis (RRMS). The overall results of the PROTEC study showed that DMF significantly reduced annualized relapse rate (ARR) and improved patient-reported outcomes (PROs).
Objective: Post-hoc subgroup analyses were conducted to describe the impact of DMF on clinical endpoints and PROs over a 12-month period in patients enrolled in France.
Methods: Adult patients (≥18 years) with RRMS and naïve to DMF or second-line RRMS therapies were enrolled in the PROTEC phase-4, open-label, single-arm, international, multicenter study. Patients were treated with DMF 240 mg twice daily (approved dosing regimen). Relapses and adverse events were evaluated at scheduled and unscheduled visits. Among the PROs examined, the Modified Fatigue Impact Scale-5 (MFIS-5) was completed at baseline and 3, 6 and 12 months after DMF initiation.
Results: Overall, 1105 patients fulfilled all selection criteria and received at least one DMF dose; 198 patients were enrolled in France (18%) with a mean age (±SD) of 40.0 (±11.0) years and 76.8% were females. Mean time since RRMS diagnosis was 5.9 (±7.0) years. Mean time since most recent pre-study relapse was 4.3 (±2.8) months. Unadjusted ARRs for the 12-month periods before and after DMF initiation were 0.62 (95% confidence interval [CI]: 0.52,0.72) and 0.22 (95%CI: 0.15,0.31), respectively. The rate ratio (month 12/baseline) was 0.36 (95%CI: 0.25,0.51; p< 0.0001), representing a 64% lower ARR after DMF initiation. Mean MFIS-5 score (higher scores indicate greater fatigue) was 8.6 (±5.1) at baseline and 6.5 (±5.0) at 12 months (mean change: -1.8 ±3.9, n=157; p< 0.0001).
Conclusion: DMF therapy was associated with lower 12-month ARRs and fatigue score in this French subgroup analysis, consistent with findings in the overall study population. Further effectiveness results on eligible patients and safety data will be presented.
Disclosure: The study was funded by Biogen.
Brochet B reports personal fees and non-financial support from Biogen-Idec, grants from Merck-Serono, personal fees and non-financial support from Novartis, personal fees and non-financial support from Genzyme, grants, personal fees and non-financial support from Teva, grants and non-financial support from Bayer, non-financial support from Medday, non-financial support from Actelion, non-financial support from ROCHE, outside the submitted work.
Tourbah A reports consulting and lecturing fees, travel grants and research support from Biogen Idec, Novartis, Medday Pharmaceuticals, Merck Serono, Hoffman LaRoche, Sanofi-Genzyme, Teva.
Castelnovo G reports honoraria and consulting fees from Novartis, Biogen, Teva, Sanofi, Genzyme, Merck-Serono, Merz, Ipsen, Bayer, research supports from Novartis, Merz, Ipsen.
De Seze J reports potential conflict of interest and source of funding with Biogen.
Neau JP reports potential conflict of interest and source of funding with Biogen, Roche, Novartis, Genzyme.
Magy L reports honoraria, housing and travel grants from Biogen Idec, Sanofi Genzyme, Novartis Pharma.
Bourhis Y works at Mapi, subcontractor of Biogen.
Bouzid O works at Biogen France.
Okwuokenye M works at Biogen USA.
Abstract: P1135
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Clinical trials (DEFINE/CONFIRM) demonstrated the efficacy and favorable benefit/risk of dimethyl fumarate (DMF) in patients with relapsing-remitting multiple sclerosis (RRMS). The overall results of the PROTEC study showed that DMF significantly reduced annualized relapse rate (ARR) and improved patient-reported outcomes (PROs).
Objective: Post-hoc subgroup analyses were conducted to describe the impact of DMF on clinical endpoints and PROs over a 12-month period in patients enrolled in France.
Methods: Adult patients (≥18 years) with RRMS and naïve to DMF or second-line RRMS therapies were enrolled in the PROTEC phase-4, open-label, single-arm, international, multicenter study. Patients were treated with DMF 240 mg twice daily (approved dosing regimen). Relapses and adverse events were evaluated at scheduled and unscheduled visits. Among the PROs examined, the Modified Fatigue Impact Scale-5 (MFIS-5) was completed at baseline and 3, 6 and 12 months after DMF initiation.
Results: Overall, 1105 patients fulfilled all selection criteria and received at least one DMF dose; 198 patients were enrolled in France (18%) with a mean age (±SD) of 40.0 (±11.0) years and 76.8% were females. Mean time since RRMS diagnosis was 5.9 (±7.0) years. Mean time since most recent pre-study relapse was 4.3 (±2.8) months. Unadjusted ARRs for the 12-month periods before and after DMF initiation were 0.62 (95% confidence interval [CI]: 0.52,0.72) and 0.22 (95%CI: 0.15,0.31), respectively. The rate ratio (month 12/baseline) was 0.36 (95%CI: 0.25,0.51; p< 0.0001), representing a 64% lower ARR after DMF initiation. Mean MFIS-5 score (higher scores indicate greater fatigue) was 8.6 (±5.1) at baseline and 6.5 (±5.0) at 12 months (mean change: -1.8 ±3.9, n=157; p< 0.0001).
Conclusion: DMF therapy was associated with lower 12-month ARRs and fatigue score in this French subgroup analysis, consistent with findings in the overall study population. Further effectiveness results on eligible patients and safety data will be presented.
Disclosure: The study was funded by Biogen.
Brochet B reports personal fees and non-financial support from Biogen-Idec, grants from Merck-Serono, personal fees and non-financial support from Novartis, personal fees and non-financial support from Genzyme, grants, personal fees and non-financial support from Teva, grants and non-financial support from Bayer, non-financial support from Medday, non-financial support from Actelion, non-financial support from ROCHE, outside the submitted work.
Tourbah A reports consulting and lecturing fees, travel grants and research support from Biogen Idec, Novartis, Medday Pharmaceuticals, Merck Serono, Hoffman LaRoche, Sanofi-Genzyme, Teva.
Castelnovo G reports honoraria and consulting fees from Novartis, Biogen, Teva, Sanofi, Genzyme, Merck-Serono, Merz, Ipsen, Bayer, research supports from Novartis, Merz, Ipsen.
De Seze J reports potential conflict of interest and source of funding with Biogen.
Neau JP reports potential conflict of interest and source of funding with Biogen, Roche, Novartis, Genzyme.
Magy L reports honoraria, housing and travel grants from Biogen Idec, Sanofi Genzyme, Novartis Pharma.
Bourhis Y works at Mapi, subcontractor of Biogen.
Bouzid O works at Biogen France.
Okwuokenye M works at Biogen USA.