Contributions
Abstract: P1179
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Dimethyl fumerate (DF) is a first line oral therapy for relapsing remitting multiple sclerosis (RRMS). This retrospective study aims to determine the MRI and relapse outcomes within one year after initiation of DF in a real world clinical setting.
Methods: The Calgary MS Clinic manages over 1,800 disease modifying therapy (DMT) patients. Data from all patients with RRMS who initiated DF between July 1, 2013 and December 31, 2014 were included. DMT use is carefully tracked and clinic processes ensure that patients starting a new DMT are offered a brain MRI 6-12 months after DMT initiation and that an annual follow-up is arranged. Patients may phone MS clinic nurses to discuss DMT tolerance and clinical symptoms. Suspected relapses are confirmed at an expedited or routine clinic visit with an MS Clinic neurologist. Demographic, clinical, MRI and relapse information are collected prospectively in a clinic database. We reviewed patient electronic medical records to assure reported relapses were not missed.
Results: This analysis included 170 patients. At treatment initiation mean age was 42.5 years, 75% were women, median disease duration was 11.3 years, median EDSS was 2, and 24% were treatment naïve. Most patients (147, 86%) had a clinic visit at one year (>46 weeks after initiating DF); 23 (14%) patients were assessed earlier (22 at 34-46 weeks and one at 29 weeks). One patient discontinued treatment at 5 days and had no follow-up. Within one year, DF was discontinued by 32 (19%) patients; median time to discontinuation was 4.8 months (range: 0.2-11.9).Among 150/170 (88%) patients on DF for at least 6 months, 133/150 (89%) had a follow-up MRI scan with gadolinium 6-12 months after starting DF. Median time to MRI was 8.7 months (range: 5.5-11.9). Gadolinium-enhancing lesions were detected on 16/133 (12%) MRI scans. At one year, 12 confirmed relapses occurred in 10 (6%) patients; median time to first relapse was 4.4 months (range: 0.2-10.9); 3 relapses occurred at 0-3 months, 6 relapses at 3-6 months, 1 relapse at 6-9 months, and 2 relapses at 9-12 months after starting DF. The annualized on-treatment relapse rate was 0.08 (95% CI: 0.04-0.14).
Conclusions: One year treatment with DF in a real world clinical setting is associated with low risk of relapses and gadolinium enhancing MRI lesions. The one-year discontinuation rate of 19%, however, is higher than we have previously reported for glatiramer acetate (12%) or interferon beta (16%).
Disclosure: Yaser Al Malik: nothing to disclose.
Jamie Greenfield: nothing to disclose.
Luanne Metz: nothing to disclose.
Abstract: P1179
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Dimethyl fumerate (DF) is a first line oral therapy for relapsing remitting multiple sclerosis (RRMS). This retrospective study aims to determine the MRI and relapse outcomes within one year after initiation of DF in a real world clinical setting.
Methods: The Calgary MS Clinic manages over 1,800 disease modifying therapy (DMT) patients. Data from all patients with RRMS who initiated DF between July 1, 2013 and December 31, 2014 were included. DMT use is carefully tracked and clinic processes ensure that patients starting a new DMT are offered a brain MRI 6-12 months after DMT initiation and that an annual follow-up is arranged. Patients may phone MS clinic nurses to discuss DMT tolerance and clinical symptoms. Suspected relapses are confirmed at an expedited or routine clinic visit with an MS Clinic neurologist. Demographic, clinical, MRI and relapse information are collected prospectively in a clinic database. We reviewed patient electronic medical records to assure reported relapses were not missed.
Results: This analysis included 170 patients. At treatment initiation mean age was 42.5 years, 75% were women, median disease duration was 11.3 years, median EDSS was 2, and 24% were treatment naïve. Most patients (147, 86%) had a clinic visit at one year (>46 weeks after initiating DF); 23 (14%) patients were assessed earlier (22 at 34-46 weeks and one at 29 weeks). One patient discontinued treatment at 5 days and had no follow-up. Within one year, DF was discontinued by 32 (19%) patients; median time to discontinuation was 4.8 months (range: 0.2-11.9).Among 150/170 (88%) patients on DF for at least 6 months, 133/150 (89%) had a follow-up MRI scan with gadolinium 6-12 months after starting DF. Median time to MRI was 8.7 months (range: 5.5-11.9). Gadolinium-enhancing lesions were detected on 16/133 (12%) MRI scans. At one year, 12 confirmed relapses occurred in 10 (6%) patients; median time to first relapse was 4.4 months (range: 0.2-10.9); 3 relapses occurred at 0-3 months, 6 relapses at 3-6 months, 1 relapse at 6-9 months, and 2 relapses at 9-12 months after starting DF. The annualized on-treatment relapse rate was 0.08 (95% CI: 0.04-0.14).
Conclusions: One year treatment with DF in a real world clinical setting is associated with low risk of relapses and gadolinium enhancing MRI lesions. The one-year discontinuation rate of 19%, however, is higher than we have previously reported for glatiramer acetate (12%) or interferon beta (16%).
Disclosure: Yaser Al Malik: nothing to disclose.
Jamie Greenfield: nothing to disclose.
Luanne Metz: nothing to disclose.