Contributions
Abstract: EP1728
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Introduction: Teriflunomide (TER) has been subjected to a special monitoring for hepatic toxicity, as it could be observed in multiple sclerosis (MS) clinical trials (CTs), but it is necessary to investigate what happens in real-world practice, where TER has been used mainly after first-line disease-modifying drugs (DMD)
Objective: To analyze safety and tolerability of TER.
Methods: We retrospectively recorded clinical and biochemical data from MS patients who underwent teriflunomide from 6 Spanish hospitals.
Results: A total of 255 records from MS patients (mean of age= 45.27±11.5 y; 184 females) who initiated TER (mean on-treatment time =13.1±6.7mo) from december 2014 to march 2017, were reviewed. Regarding the MS type, most of them (n=242; 174 females) were classified as relapsing-remiting form, and 13 as progressive active forms (12 SP, 1 PP). Mean disease duration was 10.92±8.5y ; range=0-37y). A total of 171 patients had been previously on at least one DMF (43.13% from IF, 8.23% from GA, 2.74% from NTZ, 3.13% from FTY, and 7.45% from DMF), 37 patients switched to TER because of inefficacy, and 134 patients for intolerance or side effects. A 40.8% of patients on TER experienced some adverse events (AE). Most common AEs were abdominal complaints (23.5%), hair thinning or decreased hair density (16.9%). AEs, leading to discontinuation appeared in 15 patients (6%), mainly diarrhea (n=4; 26.7%). Serious adverse events accounted for 13 patients, included 5 patients with stomatitis (1 herpetic), 1 case with lymphopenia (< 900 cel/mm3), and pregnancy in 2 females. Hepatic toxicity was temporarily observed in 22.7%, being less than 3x normal range in 48.5% of them, and in only one case exceeded x3 normal range. First ALT increase was recorded during the first 3 months for 91.9% of patients.
Conclusions: In real word practice, teriflunomide was generally well tolerated. Hepatic toxicity was mild and temporarilly found in the first 3 months, leading to discontinuation for only one patient (0.4%). These results do not justify the number of blood draws needed for monitoring teriflunomide potential hepatic toxicity.
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 for speaking or advisor from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme.
Hernandez L has received for speaking or advisor honoraria from Biogen Inc., TEVA, Novartis, Sanofi Genzyme.
Perez D has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme.
Solar DM has received honoraria for speaking or advisor from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme, Bayer, and Roche.
Suarez R has received honoraria for speaking or advisor from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme.
FernandezUria D has received honoraria for speaking or advisor from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme, Almirall, Bayer, and 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: EP1728
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Introduction: Teriflunomide (TER) has been subjected to a special monitoring for hepatic toxicity, as it could be observed in multiple sclerosis (MS) clinical trials (CTs), but it is necessary to investigate what happens in real-world practice, where TER has been used mainly after first-line disease-modifying drugs (DMD)
Objective: To analyze safety and tolerability of TER.
Methods: We retrospectively recorded clinical and biochemical data from MS patients who underwent teriflunomide from 6 Spanish hospitals.
Results: A total of 255 records from MS patients (mean of age= 45.27±11.5 y; 184 females) who initiated TER (mean on-treatment time =13.1±6.7mo) from december 2014 to march 2017, were reviewed. Regarding the MS type, most of them (n=242; 174 females) were classified as relapsing-remiting form, and 13 as progressive active forms (12 SP, 1 PP). Mean disease duration was 10.92±8.5y ; range=0-37y). A total of 171 patients had been previously on at least one DMF (43.13% from IF, 8.23% from GA, 2.74% from NTZ, 3.13% from FTY, and 7.45% from DMF), 37 patients switched to TER because of inefficacy, and 134 patients for intolerance or side effects. A 40.8% of patients on TER experienced some adverse events (AE). Most common AEs were abdominal complaints (23.5%), hair thinning or decreased hair density (16.9%). AEs, leading to discontinuation appeared in 15 patients (6%), mainly diarrhea (n=4; 26.7%). Serious adverse events accounted for 13 patients, included 5 patients with stomatitis (1 herpetic), 1 case with lymphopenia (< 900 cel/mm3), and pregnancy in 2 females. Hepatic toxicity was temporarily observed in 22.7%, being less than 3x normal range in 48.5% of them, and in only one case exceeded x3 normal range. First ALT increase was recorded during the first 3 months for 91.9% of patients.
Conclusions: In real word practice, teriflunomide was generally well tolerated. Hepatic toxicity was mild and temporarilly found in the first 3 months, leading to discontinuation for only one patient (0.4%). These results do not justify the number of blood draws needed for monitoring teriflunomide potential hepatic toxicity.
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 for speaking or advisor from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme.
Hernandez L has received for speaking or advisor honoraria from Biogen Inc., TEVA, Novartis, Sanofi Genzyme.
Perez D has received honoraria from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme.
Solar DM has received honoraria for speaking or advisor from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme, Bayer, and Roche.
Suarez R has received honoraria for speaking or advisor from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme.
FernandezUria D has received honoraria for speaking or advisor from Biogen Inc., TEVA, Novartis, Merck, Sanofi Genzyme, Almirall, Bayer, and 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.