Abstract: P930
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Introduction: Since approval by medicine agencies, patients treated with teriflunomide (TER) has been checked for liver enzyme ALT increase every 2 weeks for the first 6 months, and afterwards, every 2 months. We had initially observed that ALT elevation ocurred early, in the first 5 weeks for most patients who had ALT elevation.
Objective: To analyzed the evolution of ALT increase, and other adverse events (AE) in MS patients under TER in a 3-year study.
Methods: We retrospectively recorded clinical and biochemical data from 6 hospital of Northern Spain. We use descriptive statistics, and comparisons of categorical variables were performed using Χ2 method.
Results: A total of 327 (235 females; mean of age 46.2±11.2) patients´record were reviewed from December 2014 to March 2018.
A total of 66 (21.85%) patients who were on TER at least for 1 y had ALT elevation; of those having ALT elevation, 44 patients (64%) the increase of ALT was less than 3x upper normal limit (UNL), 22 (33%) between 3x-5x, and only 3(3%) more than 5x UNL, representing less than 1% from the total sample. Most patients had the ALT elevation before the 5th week after TER initiation. Only 3 patients out of 141 who were on TER for more than 2 y had ALT elevation, all of them < 3x UNL.
Other common AEs also were observed. Hair thinning accounted for 20%, gastrointestinal (GID) disturbances 21%, headache 7%, HTA 4% linfopenia 4%, neutropenia 4%, and paresthesias 4% during the first year. Most of these AEs were transient and mild. In those patients who were on TER for more than 2 y, the incidence of AEs significatively decreased, especially hair thinning (p=0.002), ALT elevation (p< 0.001), or GID (p=0.001). We registered only 1 pregnancy exposed to TER.
A total of 49 (20.4%) patients abandoned TER, 45% of them for inefficacy and 41% for AE.
Conclusions: TER is an effective and well tolerated treatment subjected to an strict and unnecessary biochemical control which must be adapted to real-world practice (RWP) having into consideration our and other studies. The security profile of TER in this study did not differ from that of clinical trials and other RWP studies.
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 fromBiogen 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: P930
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Introduction: Since approval by medicine agencies, patients treated with teriflunomide (TER) has been checked for liver enzyme ALT increase every 2 weeks for the first 6 months, and afterwards, every 2 months. We had initially observed that ALT elevation ocurred early, in the first 5 weeks for most patients who had ALT elevation.
Objective: To analyzed the evolution of ALT increase, and other adverse events (AE) in MS patients under TER in a 3-year study.
Methods: We retrospectively recorded clinical and biochemical data from 6 hospital of Northern Spain. We use descriptive statistics, and comparisons of categorical variables were performed using Χ2 method.
Results: A total of 327 (235 females; mean of age 46.2±11.2) patients´record were reviewed from December 2014 to March 2018.
A total of 66 (21.85%) patients who were on TER at least for 1 y had ALT elevation; of those having ALT elevation, 44 patients (64%) the increase of ALT was less than 3x upper normal limit (UNL), 22 (33%) between 3x-5x, and only 3(3%) more than 5x UNL, representing less than 1% from the total sample. Most patients had the ALT elevation before the 5th week after TER initiation. Only 3 patients out of 141 who were on TER for more than 2 y had ALT elevation, all of them < 3x UNL.
Other common AEs also were observed. Hair thinning accounted for 20%, gastrointestinal (GID) disturbances 21%, headache 7%, HTA 4% linfopenia 4%, neutropenia 4%, and paresthesias 4% during the first year. Most of these AEs were transient and mild. In those patients who were on TER for more than 2 y, the incidence of AEs significatively decreased, especially hair thinning (p=0.002), ALT elevation (p< 0.001), or GID (p=0.001). We registered only 1 pregnancy exposed to TER.
A total of 49 (20.4%) patients abandoned TER, 45% of them for inefficacy and 41% for AE.
Conclusions: TER is an effective and well tolerated treatment subjected to an strict and unnecessary biochemical control which must be adapted to real-world practice (RWP) having into consideration our and other studies. The security profile of TER in this study did not differ from that of clinical trials and other RWP studies.
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 fromBiogen 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.