Contributions
Abstract: P1238
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: After the ample development study of Teriflunomide (TER), real-world practice (RWP) studies have been scarcely published. In those available studies, TER has been indicated for patients having basal characteristics quite different from that of pivotal studies (older and more disabled patients), yielding poorer results than expected from clinical trials.
Objective: To analyze the efficacy and tolerability of TER with respect to previous disease modifiyng therapy in RWP.
Methods: We retrospectively recorded clinical and radiological data from 6 hospitals of Northern Spain. Descriptive statistics and comparisons were made using Wilcoxon test for numerical variables, and χ2 for categorical variables under alfa=0.05. Logistic regression models were applied correcting for confounder variables.
Results: A total of 327 patients´ records (mean of age=46.2±11.2y; mean of disease duration 9.6±8.3y) who were on TER from December 2014 to March 2018 (235 females) were reviewed. MS types were classified as relapsing-remitting (n=311; 95.1%), and 16 as progressive forms. A total of 303 patients were at least 1y on TER, 168 2y, and 19 3y on treatment. Most patients (n=215, 65.7%) had been on at least one DMT (median=1.0). Switches were mainly for intolerance or adverse events (AE; 65%) or inefficacy (21%). Annual relapse rate (ARR) was significatively reduced in 303 patients completing at least 1y on treatment (basal ARR=0.80±0.7; 1y ARR=0.21±0.5; p< 0.0001), 2ndy ARR=0.17±0.4 (n=168; p < 0.0001),and 3rdy ARR=0.11±0.4 (n=19;p< 0.05.We observed no differences for TER response after 12, and 24 mo by previous treatment (basal ARR=1.12±0.5, 1st y ARR=0.29±0.6, and 2nd y ARR=0.11±0.3 for naïve patients; and basal ARR=0.63±0.7, 1st y ARR=0.17±0.4, and 2nd y ARR=0.20±0.5 for switchers). These effects were independent of age, sex, and disease duration. Minor, not significant changes were observed for EDSS for the 1st y (mean=1.90±1.0), 2nd y (mean=2.15±1.5), and 3rd y (mean=2.29±1.5) on treatment.
MRI scans (basal n=306) showed significant decrease of T1Gd+ lesion (p< 0.05) after each year of treatment. A total of 49 (20.40%) patients abandoned TER along this period, 45% of them for inefficacy, and 41% for AE.
Conclusions: In RWP, TER has a consistent profile of sustained efficacy, high persitence rate and security. TER was even effective in those patients who switched from other DMT, switched either for inefficiency or intolerance.
Disclosure: Villafani J has received honoraria for speaking from Biogen Inc., TEVA, Novartis,
Merck, Sanofi Genzyme, Roche.
Peña J, has received honoraria for speaking from Biogen Inc., TEVA, Novartis, Merck, Sanofi
Genzyme.
Oliva P has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme, Roche
Ares A has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme.
Hernandez L has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme.
Perez D has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme.
Solar DM has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme, Roche
Suarez R has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme.
Fernandez-Uria D has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme, Roche.
Lara L has nothing to disclose
Quintanilla GQ for speaking from Novartis and Sanofi Genzyme.
Rodriguez E has received honoraria from Sanofi Genzyme.
Oterino A has received honoraria for speaking from Biogen Inc., TEVA, Almirall, MSD Novartis, Sanofi Genzyme, Roche, Allergan.
Abstract: P1238
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: After the ample development study of Teriflunomide (TER), real-world practice (RWP) studies have been scarcely published. In those available studies, TER has been indicated for patients having basal characteristics quite different from that of pivotal studies (older and more disabled patients), yielding poorer results than expected from clinical trials.
Objective: To analyze the efficacy and tolerability of TER with respect to previous disease modifiyng therapy in RWP.
Methods: We retrospectively recorded clinical and radiological data from 6 hospitals of Northern Spain. Descriptive statistics and comparisons were made using Wilcoxon test for numerical variables, and χ2 for categorical variables under alfa=0.05. Logistic regression models were applied correcting for confounder variables.
Results: A total of 327 patients´ records (mean of age=46.2±11.2y; mean of disease duration 9.6±8.3y) who were on TER from December 2014 to March 2018 (235 females) were reviewed. MS types were classified as relapsing-remitting (n=311; 95.1%), and 16 as progressive forms. A total of 303 patients were at least 1y on TER, 168 2y, and 19 3y on treatment. Most patients (n=215, 65.7%) had been on at least one DMT (median=1.0). Switches were mainly for intolerance or adverse events (AE; 65%) or inefficacy (21%). Annual relapse rate (ARR) was significatively reduced in 303 patients completing at least 1y on treatment (basal ARR=0.80±0.7; 1y ARR=0.21±0.5; p< 0.0001), 2ndy ARR=0.17±0.4 (n=168; p < 0.0001),and 3rdy ARR=0.11±0.4 (n=19;p< 0.05.We observed no differences for TER response after 12, and 24 mo by previous treatment (basal ARR=1.12±0.5, 1st y ARR=0.29±0.6, and 2nd y ARR=0.11±0.3 for naïve patients; and basal ARR=0.63±0.7, 1st y ARR=0.17±0.4, and 2nd y ARR=0.20±0.5 for switchers). These effects were independent of age, sex, and disease duration. Minor, not significant changes were observed for EDSS for the 1st y (mean=1.90±1.0), 2nd y (mean=2.15±1.5), and 3rd y (mean=2.29±1.5) on treatment.
MRI scans (basal n=306) showed significant decrease of T1Gd+ lesion (p< 0.05) after each year of treatment. A total of 49 (20.40%) patients abandoned TER along this period, 45% of them for inefficacy, and 41% for AE.
Conclusions: In RWP, TER has a consistent profile of sustained efficacy, high persitence rate and security. TER was even effective in those patients who switched from other DMT, switched either for inefficiency or intolerance.
Disclosure: Villafani J has received honoraria for speaking from Biogen Inc., TEVA, Novartis,
Merck, Sanofi Genzyme, Roche.
Peña J, has received honoraria for speaking from Biogen Inc., TEVA, Novartis, Merck, Sanofi
Genzyme.
Oliva P has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme, Roche
Ares A has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme.
Hernandez L has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme.
Perez D has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme.
Solar DM has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme, Roche
Suarez R has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme.
Fernandez-Uria D has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme, Roche.
Lara L has nothing to disclose
Quintanilla GQ for speaking from Novartis and Sanofi Genzyme.
Rodriguez E has received honoraria from Sanofi Genzyme.
Oterino A has received honoraria for speaking from Biogen Inc., TEVA, Almirall, MSD Novartis, Sanofi Genzyme, Roche, Allergan.