Contributions
Abstract: EP1483
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: There are limited data on clinical and patient-reported outcomes (PROs) in relapsing multiple sclerosis (RMS) patients who switched to delayed-release dimethyl fumarate (DMF, also known as gastro-resistant DMF) after suboptimal response to glatiramer acetate (GA).
Objectives: To present 12-month results from RESPOND (NCT01903291), an open-label, single-arm, observational study conducted to evaluate clinical outcomes and PROs in RMS patients who switched from GA to DMF 240 mg twice daily (BID) in the real-world clinical practice.
Methods: Eligibility criteria include age ≥18 years; ongoing treatment with and suboptimal response to GA (eg, suboptimal efficacy, intolerance, or poor adherence) or discontinuation of GA as a result of suboptimal response within 30 days of enrolment; and pre-enrolment decision to initiate DMF treatment. Relapse data were collected from medical records to assess clinical effectiveness over the 12-month study period. PROs (completed prior to and at 6 and 12 months after initiation of DMF treatment) included the Short Form-36 (SF-36), Treatment Satisfaction Questionnaire for Medication (TSQM-14), Modified Fatigue Impact Scale (MFIS-5), and Beck Depression Inventory (BDI-7). Six-month interim results are reported; 12-month results will be presented.
Results: As of 12 June 2015, 333 patients were enrolled and 168 had completed the study. Mean (standard deviation) age of patients in RESPOND was 47.6 (10.9) years, compared with 37.9 (9.2) years in patients treated with DMF 240 mg BID in DEFINE/CONFIRM (integrated analysis). Reasons for discontinuation of the most recent GA included efficacy (51%), tolerability (45%), patient preference (37%), lack of adherence, (5%) and safety (5%). The annualised relapse rate (ARR) reported for the 12 months prior to DMF initiation was 0.40 (95% confidence interval [CI]: 0.33, 0.48) and the ARR 6 months after DMF initiation was 0.13 (95% CI: 0.08, 0.21), representing a 67% lower ARR after DMF initiation
(P< 0.0001). Significant improvements from baseline were observed for SF-36 Physical and Mental Component Summaries (P=0.0118 and P=0.0003, respectively) as well as TSQM-14, MFIS-5, and BDI-7 (all P< 0.005).
Conclusions: The 6-month interim analysis of RESPOND suggests that DMF was associated with lower ARR and improvement on PROs in RMS patients switching to DMF after suboptimal treatment with GA. Results of the 12-month analysis, including safety outcomes, will be presented.
Disclosure: Supported by: Biogen.
Kiren Kresa-Reahl: on the speakers´ bureau of Biogen, Novartis, Teva, Pfizer, EMD/Serono, and Genzyme; research funding from Biogen, Novartis, Mallinkrodt, and Genzyme.
Pavle Repovic: served as a consultant for Biogen, Teva Neuroscience, Questcor, Genzyme/Sanofi Aventis, and Novartis; on the speakers´ bureau of Biogen, Pfizer, EMD Serono, Novartis, and Teva Neuroscience; grant support from Novartis.
Derrick Robertson: served as a consultant for Biogen, Genzyme/Sanofi Aventis, Teva Neuroscience, and Pfizer; on the speakers´ bureau of Biogen, Pfizer, EMD Serono, Genzyme/Sanofi Aventis, Novartis, Teva Neuroscience, Mallinckrodt, and Acorda; grant support from Biogen, Genzyme/Sanofi Aventis, Novartis, Sun Pharma, MedImmune, GlaxoSmithKline, Roche, and Genetech.
Macaulay Okwuokenye: employee of and holds stock/stock options in Biogen.
Leslie Meltzer: employee of and holds stock/stock options in Biogen.
Jason Mendoza: employee of and holds stock/stock options in Biogen.
Abstract: EP1483
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: There are limited data on clinical and patient-reported outcomes (PROs) in relapsing multiple sclerosis (RMS) patients who switched to delayed-release dimethyl fumarate (DMF, also known as gastro-resistant DMF) after suboptimal response to glatiramer acetate (GA).
Objectives: To present 12-month results from RESPOND (NCT01903291), an open-label, single-arm, observational study conducted to evaluate clinical outcomes and PROs in RMS patients who switched from GA to DMF 240 mg twice daily (BID) in the real-world clinical practice.
Methods: Eligibility criteria include age ≥18 years; ongoing treatment with and suboptimal response to GA (eg, suboptimal efficacy, intolerance, or poor adherence) or discontinuation of GA as a result of suboptimal response within 30 days of enrolment; and pre-enrolment decision to initiate DMF treatment. Relapse data were collected from medical records to assess clinical effectiveness over the 12-month study period. PROs (completed prior to and at 6 and 12 months after initiation of DMF treatment) included the Short Form-36 (SF-36), Treatment Satisfaction Questionnaire for Medication (TSQM-14), Modified Fatigue Impact Scale (MFIS-5), and Beck Depression Inventory (BDI-7). Six-month interim results are reported; 12-month results will be presented.
Results: As of 12 June 2015, 333 patients were enrolled and 168 had completed the study. Mean (standard deviation) age of patients in RESPOND was 47.6 (10.9) years, compared with 37.9 (9.2) years in patients treated with DMF 240 mg BID in DEFINE/CONFIRM (integrated analysis). Reasons for discontinuation of the most recent GA included efficacy (51%), tolerability (45%), patient preference (37%), lack of adherence, (5%) and safety (5%). The annualised relapse rate (ARR) reported for the 12 months prior to DMF initiation was 0.40 (95% confidence interval [CI]: 0.33, 0.48) and the ARR 6 months after DMF initiation was 0.13 (95% CI: 0.08, 0.21), representing a 67% lower ARR after DMF initiation
(P< 0.0001). Significant improvements from baseline were observed for SF-36 Physical and Mental Component Summaries (P=0.0118 and P=0.0003, respectively) as well as TSQM-14, MFIS-5, and BDI-7 (all P< 0.005).
Conclusions: The 6-month interim analysis of RESPOND suggests that DMF was associated with lower ARR and improvement on PROs in RMS patients switching to DMF after suboptimal treatment with GA. Results of the 12-month analysis, including safety outcomes, will be presented.
Disclosure: Supported by: Biogen.
Kiren Kresa-Reahl: on the speakers´ bureau of Biogen, Novartis, Teva, Pfizer, EMD/Serono, and Genzyme; research funding from Biogen, Novartis, Mallinkrodt, and Genzyme.
Pavle Repovic: served as a consultant for Biogen, Teva Neuroscience, Questcor, Genzyme/Sanofi Aventis, and Novartis; on the speakers´ bureau of Biogen, Pfizer, EMD Serono, Novartis, and Teva Neuroscience; grant support from Novartis.
Derrick Robertson: served as a consultant for Biogen, Genzyme/Sanofi Aventis, Teva Neuroscience, and Pfizer; on the speakers´ bureau of Biogen, Pfizer, EMD Serono, Genzyme/Sanofi Aventis, Novartis, Teva Neuroscience, Mallinckrodt, and Acorda; grant support from Biogen, Genzyme/Sanofi Aventis, Novartis, Sun Pharma, MedImmune, GlaxoSmithKline, Roche, and Genetech.
Macaulay Okwuokenye: employee of and holds stock/stock options in Biogen.
Leslie Meltzer: employee of and holds stock/stock options in Biogen.
Jason Mendoza: employee of and holds stock/stock options in Biogen.