Contributions
Abstract: P1152
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Dimethyl fumarate (DMF) was recently approved for treating patients with relapsing remitting multiple sclerosis (RRMS) based on two phase III clinical trials demonstrating its efficacy. This prompts the need to obtain real world data comparing DMF with other first line immunotherapies.
Methods: By retrospective analysis of medical records at two German MS centres, 644 RRMS patients treated with DMF were identified. All were included in a safety analysis and a subgroup of patients with available efficacy data during previous MS therapies (n=352) was further analysed for annualised relapse rate and disability progression assessed by the Expanded Disability Status Scale.
Results: In the overall population studied, DMF reduced annualised relapse rate and disability progression by 33%. Patients who had been switched from interferons or glatiramer acetate to DMF benefited more, whereas those pretreated with more potent immunotherapies did not respond as well. In contrast, the subgroup of patients with no disease activity prior to DMF worsened, revealing an increase in annualised relapse rate and disability progression. Interestingly, patients with a lymphocyte count ≥2000/µl after 0.52 years (mean, SD 0.2) of DMF treatment did not benefit compared to those with lower lymphocyte counts. In total, 22.2% of the patients withdrew from DMF due to side effects with gastrointestinal discomfort (12.7%) and lymphopenia (5.3%) as most frequently reported reasons.
Conclusion: Our study corroborates that DMF is an overall safe and effective drug reducing relapse rate as well as disability progression in RRMS patients. Further prospective studies are warranted to establish additional parameters predicting DMF response, especially in patients switching from other first line medications.
Disclosure:
A Miclea reports no disclosures.
R Hoepner received research and travel grants from Novartis and Biogen Idec.
V Leussink received speaker"s and board honoraria from Biogen and Novartis as well as scientific grant support from Novartis.
H-P Hartung has received honoraria for consulting and speaking at symposia from Bayer Schering Pharma, Biogen Idec, GeNeuro, Genzyme, MedImmune, Merck Serono, Novartis, Octapharma, Opexa, Roche, Teva, and Sanofi-Aventis, with approval by the rector of Heinrich Heine University.
R Gold received speaker"s and board honoraria from Biogen Idec, Baxter, Bayer Schering, Chugai Pharmaceuticals, Merck Serono, Novartis, Roche, Sanofi-Aventis, Talecris and TEVA. He also received scientific grant support from Biogen Idec, Bayer Schering, Genzyme, Merck Serono and TEVA.
Funding: No funding.
Abstract: P1152
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Dimethyl fumarate (DMF) was recently approved for treating patients with relapsing remitting multiple sclerosis (RRMS) based on two phase III clinical trials demonstrating its efficacy. This prompts the need to obtain real world data comparing DMF with other first line immunotherapies.
Methods: By retrospective analysis of medical records at two German MS centres, 644 RRMS patients treated with DMF were identified. All were included in a safety analysis and a subgroup of patients with available efficacy data during previous MS therapies (n=352) was further analysed for annualised relapse rate and disability progression assessed by the Expanded Disability Status Scale.
Results: In the overall population studied, DMF reduced annualised relapse rate and disability progression by 33%. Patients who had been switched from interferons or glatiramer acetate to DMF benefited more, whereas those pretreated with more potent immunotherapies did not respond as well. In contrast, the subgroup of patients with no disease activity prior to DMF worsened, revealing an increase in annualised relapse rate and disability progression. Interestingly, patients with a lymphocyte count ≥2000/µl after 0.52 years (mean, SD 0.2) of DMF treatment did not benefit compared to those with lower lymphocyte counts. In total, 22.2% of the patients withdrew from DMF due to side effects with gastrointestinal discomfort (12.7%) and lymphopenia (5.3%) as most frequently reported reasons.
Conclusion: Our study corroborates that DMF is an overall safe and effective drug reducing relapse rate as well as disability progression in RRMS patients. Further prospective studies are warranted to establish additional parameters predicting DMF response, especially in patients switching from other first line medications.
Disclosure:
A Miclea reports no disclosures.
R Hoepner received research and travel grants from Novartis and Biogen Idec.
V Leussink received speaker"s and board honoraria from Biogen and Novartis as well as scientific grant support from Novartis.
H-P Hartung has received honoraria for consulting and speaking at symposia from Bayer Schering Pharma, Biogen Idec, GeNeuro, Genzyme, MedImmune, Merck Serono, Novartis, Octapharma, Opexa, Roche, Teva, and Sanofi-Aventis, with approval by the rector of Heinrich Heine University.
R Gold received speaker"s and board honoraria from Biogen Idec, Baxter, Bayer Schering, Chugai Pharmaceuticals, Merck Serono, Novartis, Roche, Sanofi-Aventis, Talecris and TEVA. He also received scientific grant support from Biogen Idec, Bayer Schering, Genzyme, Merck Serono and TEVA.
Funding: No funding.