Contributions
Abstract: P657
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Dimethyl fumarate (DMF) and fingolimod (FTY) are increasingly used as first line disease modifying therapies for relapsing forms of multiple sclerosis (MS) in the United States. Previous observational studies of large cohorts of DMF and FTY patients in clinical practice showed comparable efficacy but somewhat different discontinuation rates. Direct comparisons in treatment naïve subjects are limited.
Objective: To assess efficacy and discontinuation of first line and second line DMF and FTY in clinical practice at 12 months.
Design and methods: A total of 775 patients treated with DMF (1st line n= 38; 2nd line n= 420) and FTY (1st line n= 17; 2nd line n= 300) were identified from a single large academic MS center within the first year of respective DMT approval. Measures of disease activity and discontinuation were assessed using chi-square unadjusted comparisons and propensity score adjustment. Outcomes included proportions of patients with relapses, MRI activity, and discontinuation within 12 months of DMT initiation.
Results: Patients treated with first line DMF and FTY overall showed excellent on-treatment disease control with low proportions with relapses (DMF 12.5%, FTY 11.8%; p>0.5), new T2-weighted lesions (DMF 12.5%, FTY 6.7%, p>0.5), and gadolinium-enhancing (GdE) lesions (DMF 6.3%, FTY 0%; p>0.5). Second line groups showed similar results with low proportions with relapses (DMF 14.1%, FTY 11.3%; p>0.3), new T2-weighted lesions (DMF 18.2%, FTY 13.1%; p>0.1), and GdE lesions (DMF 10.1%, FTY 6.9%; p>0.2). Among first line DMF and FTY patients, there were comparable proportions with relapses [OR= 1.07, 95% CI (0.18, 6.54)], new T2 lesions [OR= 2.0, 95% CI (0.20, 4.62)], and discontinuation [OR= 1.75, 95% CI (0.18, 3.13)]. Similar results were seen in patients treated with DMF and FTY as second line. 32% of patients discontinued first line DMF compared to 23% of FTY patients. 33% of patients discontinued second line DMF compared to 25% of FTY patients. The most frequent cause of discontinuation was adverse effects for both DMF (1st line, 100%; 2nd line, 77%) and FTY (1st line, 75%; 2nd line, 71%).
Discussion: This analysis demonstrates no significant difference in disease activity between first line DMF and FTY at 12 months in clinical practice, similar to that observed in second line use. As expected, tolerability issues were the most common cause for discontinuation in DMF and FTY as both first and second line treatment.
Disclosure:
Dr. Carrie Hersh is supported by National Multiple Sclerosis Society Sylvia Lawry Physician Fellowship Award.
Dr. Samuel Cohn - there is no conflict of interest.
Ms. Claire Hara-Cleaver has received consulting or speaking fees from Biogen Idec, TEVA, EMD Serono, Acorda, Novartis, and Genzyme.
Dr. Robert Bermel has received consulting or speaking fees from Biogen Idec, Novartis, TEVA, Genzyme, and Questcor.
Dr. Robert Fox has received consulting fees from Biogen Idec, MedDay, Novartis, Questcor, TEVA, and Xeonport.
Dr. Jeffrey Cohen has received consulting fees from Biogen Idec, EMD Serono, Genzyme, Novartis, Receptos, Synthon, TEVA, and Vaccinex.
Dr. Daniel Ontaneda is supported by KL2 TR000440/TR/NCATS NIH Grant.
Abstract: P657
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Dimethyl fumarate (DMF) and fingolimod (FTY) are increasingly used as first line disease modifying therapies for relapsing forms of multiple sclerosis (MS) in the United States. Previous observational studies of large cohorts of DMF and FTY patients in clinical practice showed comparable efficacy but somewhat different discontinuation rates. Direct comparisons in treatment naïve subjects are limited.
Objective: To assess efficacy and discontinuation of first line and second line DMF and FTY in clinical practice at 12 months.
Design and methods: A total of 775 patients treated with DMF (1st line n= 38; 2nd line n= 420) and FTY (1st line n= 17; 2nd line n= 300) were identified from a single large academic MS center within the first year of respective DMT approval. Measures of disease activity and discontinuation were assessed using chi-square unadjusted comparisons and propensity score adjustment. Outcomes included proportions of patients with relapses, MRI activity, and discontinuation within 12 months of DMT initiation.
Results: Patients treated with first line DMF and FTY overall showed excellent on-treatment disease control with low proportions with relapses (DMF 12.5%, FTY 11.8%; p>0.5), new T2-weighted lesions (DMF 12.5%, FTY 6.7%, p>0.5), and gadolinium-enhancing (GdE) lesions (DMF 6.3%, FTY 0%; p>0.5). Second line groups showed similar results with low proportions with relapses (DMF 14.1%, FTY 11.3%; p>0.3), new T2-weighted lesions (DMF 18.2%, FTY 13.1%; p>0.1), and GdE lesions (DMF 10.1%, FTY 6.9%; p>0.2). Among first line DMF and FTY patients, there were comparable proportions with relapses [OR= 1.07, 95% CI (0.18, 6.54)], new T2 lesions [OR= 2.0, 95% CI (0.20, 4.62)], and discontinuation [OR= 1.75, 95% CI (0.18, 3.13)]. Similar results were seen in patients treated with DMF and FTY as second line. 32% of patients discontinued first line DMF compared to 23% of FTY patients. 33% of patients discontinued second line DMF compared to 25% of FTY patients. The most frequent cause of discontinuation was adverse effects for both DMF (1st line, 100%; 2nd line, 77%) and FTY (1st line, 75%; 2nd line, 71%).
Discussion: This analysis demonstrates no significant difference in disease activity between first line DMF and FTY at 12 months in clinical practice, similar to that observed in second line use. As expected, tolerability issues were the most common cause for discontinuation in DMF and FTY as both first and second line treatment.
Disclosure:
Dr. Carrie Hersh is supported by National Multiple Sclerosis Society Sylvia Lawry Physician Fellowship Award.
Dr. Samuel Cohn - there is no conflict of interest.
Ms. Claire Hara-Cleaver has received consulting or speaking fees from Biogen Idec, TEVA, EMD Serono, Acorda, Novartis, and Genzyme.
Dr. Robert Bermel has received consulting or speaking fees from Biogen Idec, Novartis, TEVA, Genzyme, and Questcor.
Dr. Robert Fox has received consulting fees from Biogen Idec, MedDay, Novartis, Questcor, TEVA, and Xeonport.
Dr. Jeffrey Cohen has received consulting fees from Biogen Idec, EMD Serono, Genzyme, Novartis, Receptos, Synthon, TEVA, and Vaccinex.
Dr. Daniel Ontaneda is supported by KL2 TR000440/TR/NCATS NIH Grant.