Contributions
Abstract: P790
Type: Poster
Abstract Category: Therapy - disease modifying - 32 Others
Background: Patients with relapsing-remitting multiple sclerosis (RRMS) who switch between multiple disease-modifying therapies (DMTs) accumulate disease activity due to suboptimal treatment response, and become increasingly difficult to treat. Early disease control with high-efficacy DMTs may reduce disease burden in the short and long term.
Objective: To compare the effect of fingolimod in RRMS patients who switched from first-line oral DMTs (oDMTs) vs patients who switched directly from injectable DMTs (iDMTs) using data from two independent real-world observational studies, PASSAGE (USA and Europe) and PANGAEA 2.0 (Germany).
Methods: In the present analysis, patients were divided into two cohorts: patients who switched to fingolimod 0.5 mg from dimethyl fumarate or teriflunomide (oDMT cohort; PASSAGE N=157, PANGAEA 2.0 N=72) and those who received fingolimod as their first therapy or after iDMTs (iDMT cohort; PASSAGE N=3484, PANGAEA 2.0 N=270). The annualised relapse rate (ARR) was recorded at months (M)12 and 24.
Results: In the PASSAGE study, patients in the oDMT cohort had a higher ARR at baseline (BL; the year before the switch to fingolimod) vs the iDMT cohort (1.45 vs 1.15, p=0.0006). At M12, fingolimod treatment resulted in an overall ARR reduction to 0.30 in the oDMT cohort and 0.26 in the iDMT cohort that was constant at M24. When compared by their number of prior DMTs, patients whose first therapy was an oDMT had a higher BL ARR compared with those starting fingolimod as their first therapy (1.34 vs 1.02, p=non-significant). Increasingly higher BL ARR were observed in the oDMT cohort patients who had received two DMTs (ARR=1.47) or three DMTs (ARR=1.53). Fingolimod treatment reduced the ARR at M12 and 24. Similarly, in the PANGAEA 2.0 study, patients in the oDMT cohort had a higher BL ARR vs the iDMT cohort (1.59 vs 1.29, p=0.02). Although fingolimod treatment reduced the ARR at M12 in both cohorts, it was higher in the oDMT than in the iDMT cohort (0.19 vs 0.10, p=0.01). The BL ARR in the oDMT cohort increased with the number of failed DMTs prior to the fingolimod switch (two DMTs, 1.58; three DMTs, 1.86) and was reduced with fingolimod treatment at M12 (two DMTs, 0.18; three DMTs, 0.21).
Conclusions: Fingolimod treatment is an effective option to control disease activity in patients who switched from other oDMTs. Patients exposed to multiple oDMTs showed higher ARR. Early switch to fingolimod results in better relapse control within 1 year of initiation.
Disclosure: Funding source: This study was funded by Novartis Pharma AG.
Tjalf Ziemssen has received personal compensation for participating on advisory boards, trial steering committees and data and safety monitoring committees, as well as for scientific talks and project support from: Bayer HealthCare, Biogen, Elan, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, Synthon and Teva.
Kathrin Ringwald is an employee of DATAMAP GmbH.
Stanley Cohan has received speaking honoraria, served on steering committees or advisory boards and has received research support from Biogen, Novartis, SanofiGenzyme, Roche, Acorda, Opexa, MedDay and Mallinckrodt.
Diego Silva, Jennie Medin and Christian Cornelissen are employees of Novartis.
Abstract: P790
Type: Poster
Abstract Category: Therapy - disease modifying - 32 Others
Background: Patients with relapsing-remitting multiple sclerosis (RRMS) who switch between multiple disease-modifying therapies (DMTs) accumulate disease activity due to suboptimal treatment response, and become increasingly difficult to treat. Early disease control with high-efficacy DMTs may reduce disease burden in the short and long term.
Objective: To compare the effect of fingolimod in RRMS patients who switched from first-line oral DMTs (oDMTs) vs patients who switched directly from injectable DMTs (iDMTs) using data from two independent real-world observational studies, PASSAGE (USA and Europe) and PANGAEA 2.0 (Germany).
Methods: In the present analysis, patients were divided into two cohorts: patients who switched to fingolimod 0.5 mg from dimethyl fumarate or teriflunomide (oDMT cohort; PASSAGE N=157, PANGAEA 2.0 N=72) and those who received fingolimod as their first therapy or after iDMTs (iDMT cohort; PASSAGE N=3484, PANGAEA 2.0 N=270). The annualised relapse rate (ARR) was recorded at months (M)12 and 24.
Results: In the PASSAGE study, patients in the oDMT cohort had a higher ARR at baseline (BL; the year before the switch to fingolimod) vs the iDMT cohort (1.45 vs 1.15, p=0.0006). At M12, fingolimod treatment resulted in an overall ARR reduction to 0.30 in the oDMT cohort and 0.26 in the iDMT cohort that was constant at M24. When compared by their number of prior DMTs, patients whose first therapy was an oDMT had a higher BL ARR compared with those starting fingolimod as their first therapy (1.34 vs 1.02, p=non-significant). Increasingly higher BL ARR were observed in the oDMT cohort patients who had received two DMTs (ARR=1.47) or three DMTs (ARR=1.53). Fingolimod treatment reduced the ARR at M12 and 24. Similarly, in the PANGAEA 2.0 study, patients in the oDMT cohort had a higher BL ARR vs the iDMT cohort (1.59 vs 1.29, p=0.02). Although fingolimod treatment reduced the ARR at M12 in both cohorts, it was higher in the oDMT than in the iDMT cohort (0.19 vs 0.10, p=0.01). The BL ARR in the oDMT cohort increased with the number of failed DMTs prior to the fingolimod switch (two DMTs, 1.58; three DMTs, 1.86) and was reduced with fingolimod treatment at M12 (two DMTs, 0.18; three DMTs, 0.21).
Conclusions: Fingolimod treatment is an effective option to control disease activity in patients who switched from other oDMTs. Patients exposed to multiple oDMTs showed higher ARR. Early switch to fingolimod results in better relapse control within 1 year of initiation.
Disclosure: Funding source: This study was funded by Novartis Pharma AG.
Tjalf Ziemssen has received personal compensation for participating on advisory boards, trial steering committees and data and safety monitoring committees, as well as for scientific talks and project support from: Bayer HealthCare, Biogen, Elan, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, Synthon and Teva.
Kathrin Ringwald is an employee of DATAMAP GmbH.
Stanley Cohan has received speaking honoraria, served on steering committees or advisory boards and has received research support from Biogen, Novartis, SanofiGenzyme, Roche, Acorda, Opexa, MedDay and Mallinckrodt.
Diego Silva, Jennie Medin and Christian Cornelissen are employees of Novartis.