Contributions
Abstract: P680
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Objective: To assess real-world efficacy and discontinuation of dimethyl fumarate (DMF) and fingolimod (FTY) over 24 months in relapsing-remitting multiple sclerosis (RRMS) patients.
Background: DMF and FTY are approved oral disease modifying therapies (DMT) for relapsing MS. Our previous 12-month comparative study showed comparable clinical efficacy in RRMS patients, but DMF patients discontinued DMT earlier and had higher likelihood of gadolinium-enhancing (GdE) lesions compared to FTY.
Methods: 293 DMF-treated and 215 FTY-treated RRMS patients completed 24-month follow-up in a large academic MS center. Discontinuation rates and measures of disease activity were assessed using propensity score (PS) weighting. Covariates used in the PS model included demographics and baseline clinical and MRI characteristics within 12 months of respective DMT initiation. The primary outcome was on-treatment annualized relapse rate (ARR). Secondary outcome measures included the proportion of patients who discontinued therapy, time to first relapse and discontinuation, and proportion with new MRI lesions defined as new T2-weighted and/or GdE lesions.
Results: PS weighting showed excellent covariate balance. By 24 months, the proportion of patients who discontinued therapy was high (DMF = 43.3%; FTY = 32.6%), largely driven by intolerability (of all patients with discontinuation: DMF = 59.8%; FTY = 44.3%). Overall, the proportion with relapses was low (DMF = 17.9%; FTY = 17.7%). DMF-treated patients demonstrated increased likelihood of discontinuation [OR = 1.85, 95% CI (1.16, 2.95)] that was commonly due to adverse effects [OR = 2.29, 95% CI (1.28, 4.09)] and occurred earlier compared to FTY [HR = 1.71, 95% CI (1.29, 2.26)]. DMF- and FTY-treated patients had comparable ARR [rate ratio = 1.33, 95% CI (0.52, 3.43)], time to first relapse [HR = 1.27, 95% CI (0.84, 1.92)], and MRI disease activity [OR = 1.37, 95% CI (0.75, 2.50)]. The 12-month treatment effect difference in new GdE lesions among DMF-treated patients was not seen in our 24-month experience [OR = 1.69, 95% CI (0.75, 3.84)].
Conclusions: RRMS patients treated with DMF and FTY were equally likely to develop clinical relapses and new MRI disease activity including GdE lesions by 24 months. DMF had higher likelihood of early discontinuation due to intolerability compared to FTY.
Disclosure:
Dr. Carrie Hersh has received speaking and consulting fees from Genzyme and TEVA; Grants- Genentech and Biogen Idec.
Miss Anasua Bandyopadhyay has nothing to disclose.
Dr. Sam Cohn has nothing to disclose.
Ms. Claire Hara-Cleaver has received consulting fees from Biogen Idec, TEVA, EMD Serono, Acorda, Novartis, and Genzyme.
Dr. Robert Bermel has received consulting fees from Biogen Idec, Novartis, TEVA, Genzyme, Questcor; Grants/grants pending- Biogen Idec and Novartis.
Dr. Robert Fox has received consulting fees from Biogen Idec, MedDay, Novartis, Questcor, TEVA, and Xeonport; Grants-Novartis.
Dr. Jeffrey Cohen has received personal compensation for consulting for Adamas, Celgene, Mallinckrodt, Merck, and Novartis, and as a Co-Editor of Multiple Sclerosis Journal - Experimental, Translational and Clinical.
Dr. Daniel Ontaneda has received consulting fees from Biogen, Genentech, and Novartis. Grants/research support- NIH, NMSS, Genzyme, Novartis, and Genentech.
Abstract: P680
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Objective: To assess real-world efficacy and discontinuation of dimethyl fumarate (DMF) and fingolimod (FTY) over 24 months in relapsing-remitting multiple sclerosis (RRMS) patients.
Background: DMF and FTY are approved oral disease modifying therapies (DMT) for relapsing MS. Our previous 12-month comparative study showed comparable clinical efficacy in RRMS patients, but DMF patients discontinued DMT earlier and had higher likelihood of gadolinium-enhancing (GdE) lesions compared to FTY.
Methods: 293 DMF-treated and 215 FTY-treated RRMS patients completed 24-month follow-up in a large academic MS center. Discontinuation rates and measures of disease activity were assessed using propensity score (PS) weighting. Covariates used in the PS model included demographics and baseline clinical and MRI characteristics within 12 months of respective DMT initiation. The primary outcome was on-treatment annualized relapse rate (ARR). Secondary outcome measures included the proportion of patients who discontinued therapy, time to first relapse and discontinuation, and proportion with new MRI lesions defined as new T2-weighted and/or GdE lesions.
Results: PS weighting showed excellent covariate balance. By 24 months, the proportion of patients who discontinued therapy was high (DMF = 43.3%; FTY = 32.6%), largely driven by intolerability (of all patients with discontinuation: DMF = 59.8%; FTY = 44.3%). Overall, the proportion with relapses was low (DMF = 17.9%; FTY = 17.7%). DMF-treated patients demonstrated increased likelihood of discontinuation [OR = 1.85, 95% CI (1.16, 2.95)] that was commonly due to adverse effects [OR = 2.29, 95% CI (1.28, 4.09)] and occurred earlier compared to FTY [HR = 1.71, 95% CI (1.29, 2.26)]. DMF- and FTY-treated patients had comparable ARR [rate ratio = 1.33, 95% CI (0.52, 3.43)], time to first relapse [HR = 1.27, 95% CI (0.84, 1.92)], and MRI disease activity [OR = 1.37, 95% CI (0.75, 2.50)]. The 12-month treatment effect difference in new GdE lesions among DMF-treated patients was not seen in our 24-month experience [OR = 1.69, 95% CI (0.75, 3.84)].
Conclusions: RRMS patients treated with DMF and FTY were equally likely to develop clinical relapses and new MRI disease activity including GdE lesions by 24 months. DMF had higher likelihood of early discontinuation due to intolerability compared to FTY.
Disclosure:
Dr. Carrie Hersh has received speaking and consulting fees from Genzyme and TEVA; Grants- Genentech and Biogen Idec.
Miss Anasua Bandyopadhyay has nothing to disclose.
Dr. Sam Cohn has nothing to disclose.
Ms. Claire Hara-Cleaver has received consulting fees from Biogen Idec, TEVA, EMD Serono, Acorda, Novartis, and Genzyme.
Dr. Robert Bermel has received consulting fees from Biogen Idec, Novartis, TEVA, Genzyme, Questcor; Grants/grants pending- Biogen Idec and Novartis.
Dr. Robert Fox has received consulting fees from Biogen Idec, MedDay, Novartis, Questcor, TEVA, and Xeonport; Grants-Novartis.
Dr. Jeffrey Cohen has received personal compensation for consulting for Adamas, Celgene, Mallinckrodt, Merck, and Novartis, and as a Co-Editor of Multiple Sclerosis Journal - Experimental, Translational and Clinical.
Dr. Daniel Ontaneda has received consulting fees from Biogen, Genentech, and Novartis. Grants/research support- NIH, NMSS, Genzyme, Novartis, and Genentech.