Contributions
Abstract: P616
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Objectives: Aim of this study is to confirm post-marketing Teriflunomide (TFU) efficacy and safety profile, and to identify predictors of response to TFU.
Materials and methods: We enrolled all patients receiving TFU in ten northern Italy MS centres. Patients were prospectively followed, collecting demographic and clinical data as well as laboratory assessment abnormalities.
Results: We enrolled 550 patients (66% F) (mean age: 46,2 + 9,8 years; mean disease duration: 14 + 9,8 years). Mean Annualized Relapse Rate (ARR) in the two years before TFU was 0,38 + 0,4; median baseline EDSS was 2 (range 0-6,5).
112/550 patients were treatment naïve or quitted Disease Modifying Drugs (DMDs) more than 12 months before TFU start, 380/550 switched to TFU from injective DMDs (72% for loss of tolerability, 28% for inefficacy), 58/550 switched to TFU after a second line therapy for loss of tolerability or safety reasons. Mean follow up was 13 + 9 months.
82,7% of the patients are relapse-free at follow-up. Mean ARR at follow-up is 0,2 + 0,7. Predictors of relapse-free status are: lower baseline ARR (HR 2,6, 95% CI: 1,6-4,1; p < 0,001), use of TFU as first therapy or switch to TFU for lack of tolerability of previous DMD (HR 2,4; 95% CI: 1,3-4,6; p = 0,04) and lower number of previous therapies (HR 0,7; 95% CI: 0,9-0,4; p = 0.04). In 87,4 % of the patients switching to TFU for loss of tolerability on injective DMDs, ARR remained stable or improved compared to baseline.
Most frequent adverse events (AEs) were diarrhoea or other gastrointestinal side effects (20,2%) and hair thinning (11,3%); Three severe AEs were reported (one Pancreatitis, one Acute Coronary Syndrome and one Glioblastoma). Most frequent laboratory testing abnormalities were lymphopenia (in 5,9% of the patients) and increase in liver function markers (in 5,1% of the patients).
105/555 patients stopped TFU after a mean of 7,6 + 6 months: causes of stop were AEs (65%) and disease activity (35%). Predictors of TFU interruption were higher baseline ARR (HR 2,1, 95% CI: 1,2-3,6; p < 0,003) and switch to TFU after a second line therapy (HR 1,7, 95% CI: 1,3-2,2; p < 0,03).
Discussion and conclusion: Even with the limitations of an open label study, our data confirm the efficacy and tolerability profile of TFU, especially as a first-line agent or alternative to injectable therapies for a better tolerability.
Disclosure:
PA received honoraria for advisory and speaking activities by Biogen, Merck Serono, Novartis, Sanofi Genzyme and TEVA
GM received congress and travel expense compensations from Bayer Schering, Biogen-Idec, Genzyme, Merk Serono, Novartis, Sanofi- Aventis, Teva.
MLR received travel expenses from Biogen, Novartis and Teva.
SM has nothing to disclose
RC has nothing to disclose
LM received honoraria for speaking from Sanofi Aventis, Merck Serono and Biogen Idec in the last two years
VTC acted as an Advisory Board member of Biogen Idec and Novartis, and received funding for traveling and honoraria for speaking or writing from Teva, Novartis, Genzyme, Almirall. She received support for research project by Almirall.
CZ received honoraria for speaking and advisory board from: novartis, teva, sanofi, biogen, bayer, merck.
CC has nothing to disclose
BF has nothing to disclose
RB has served on scientific advisory boards for Biogen Idec and Almirall; has received funding for travel and speaker honoraria from Sanofi-Aventis, Genzyme, Biogen Idec , Bayer Schering, Teva Neurosciences, Merck Serono, Almirall, and Novartis; received research support from Merck Serono, Biogen Idec, Teva Neurosciences, Bayer Schering, Novartis, Sanofi-Aventis.
AB received honoraria for serving in the scientific advisory boards of Almirall, Bayer, Biogen, Genzyme with approval by the Director of AOU San Luigi University Hospital and received speaker honoraria from Biogen, Genzyme, Novartis, TEVA; his institution has received grant support from Bayer, Biogen, Merck, Novartis, TEVA from the Italian Multiple Sclerosis Society, Fondazione Ricerca Biomedica ONLUS and San Luigi ONLUS
PP received honoraria from biogen serono novartis teva genzyme for lectures or advisory board
MR received travel reimbursment and fees for lectures/presentations from Teva, Genzyme-Sanofi, Almirall, Biogen
SR acted as an Advisory Board member of Biogen Idec, Bayer Schering, Merck Serono, Teva, Novartis and Genzyme, and received funding for traveling and honoraria for speaking or writing from Biogen Idec, Merck Serono, Teva, Novartis, Bayer Schering, Genzyme, Almirall. She received support for research project by Teva, Merck Serono and Bayer Schering and is involved as principal investigator in clinical trials for Teva and Roche.
PC received travel support for scientific congresses and speaking honoraria from: Almirall, Biogen, Genzyme, Merck Serono, Novartis and Teva
MRR reports speaking fees and/or travel expenses from Merck, Biogen, Teva Pharmaceutical and Novartis
MZ serves on scientific advisory boards for Merck Serono, Teva, Sanofi Aventis, Almirall and Biogen; has received speaker honoraria from Teva, Sanofi Aventis, Biogen, Merck Serono, Novartis, and Sanofi Aventis.
GC serves on scientific advisory boards for Bayer Schering Pharma, Merck Serono, Teva, Sanofi Aventis, Novartis and Biogen-Idec; has received speaker honoraria from Teva, Sanofi Aventis, Serono Sumposia International Foundation, Biogen-Idec, Merck Serono, Novartis, Bayer Schering and Sanofi Aventis.
AG serves on scientific advisory boards or as a consultant for Merck Serono, Novartis, Genzyme, Biogen Idec, Teva; received honoraria for speaking form Merck Serono, Serono Symposia International Foundation, Biogen Idec, Allmirall, Genzyme, Teva, and Novartis
Abstract: P616
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Objectives: Aim of this study is to confirm post-marketing Teriflunomide (TFU) efficacy and safety profile, and to identify predictors of response to TFU.
Materials and methods: We enrolled all patients receiving TFU in ten northern Italy MS centres. Patients were prospectively followed, collecting demographic and clinical data as well as laboratory assessment abnormalities.
Results: We enrolled 550 patients (66% F) (mean age: 46,2 + 9,8 years; mean disease duration: 14 + 9,8 years). Mean Annualized Relapse Rate (ARR) in the two years before TFU was 0,38 + 0,4; median baseline EDSS was 2 (range 0-6,5).
112/550 patients were treatment naïve or quitted Disease Modifying Drugs (DMDs) more than 12 months before TFU start, 380/550 switched to TFU from injective DMDs (72% for loss of tolerability, 28% for inefficacy), 58/550 switched to TFU after a second line therapy for loss of tolerability or safety reasons. Mean follow up was 13 + 9 months.
82,7% of the patients are relapse-free at follow-up. Mean ARR at follow-up is 0,2 + 0,7. Predictors of relapse-free status are: lower baseline ARR (HR 2,6, 95% CI: 1,6-4,1; p < 0,001), use of TFU as first therapy or switch to TFU for lack of tolerability of previous DMD (HR 2,4; 95% CI: 1,3-4,6; p = 0,04) and lower number of previous therapies (HR 0,7; 95% CI: 0,9-0,4; p = 0.04). In 87,4 % of the patients switching to TFU for loss of tolerability on injective DMDs, ARR remained stable or improved compared to baseline.
Most frequent adverse events (AEs) were diarrhoea or other gastrointestinal side effects (20,2%) and hair thinning (11,3%); Three severe AEs were reported (one Pancreatitis, one Acute Coronary Syndrome and one Glioblastoma). Most frequent laboratory testing abnormalities were lymphopenia (in 5,9% of the patients) and increase in liver function markers (in 5,1% of the patients).
105/555 patients stopped TFU after a mean of 7,6 + 6 months: causes of stop were AEs (65%) and disease activity (35%). Predictors of TFU interruption were higher baseline ARR (HR 2,1, 95% CI: 1,2-3,6; p < 0,003) and switch to TFU after a second line therapy (HR 1,7, 95% CI: 1,3-2,2; p < 0,03).
Discussion and conclusion: Even with the limitations of an open label study, our data confirm the efficacy and tolerability profile of TFU, especially as a first-line agent or alternative to injectable therapies for a better tolerability.
Disclosure:
PA received honoraria for advisory and speaking activities by Biogen, Merck Serono, Novartis, Sanofi Genzyme and TEVA
GM received congress and travel expense compensations from Bayer Schering, Biogen-Idec, Genzyme, Merk Serono, Novartis, Sanofi- Aventis, Teva.
MLR received travel expenses from Biogen, Novartis and Teva.
SM has nothing to disclose
RC has nothing to disclose
LM received honoraria for speaking from Sanofi Aventis, Merck Serono and Biogen Idec in the last two years
VTC acted as an Advisory Board member of Biogen Idec and Novartis, and received funding for traveling and honoraria for speaking or writing from Teva, Novartis, Genzyme, Almirall. She received support for research project by Almirall.
CZ received honoraria for speaking and advisory board from: novartis, teva, sanofi, biogen, bayer, merck.
CC has nothing to disclose
BF has nothing to disclose
RB has served on scientific advisory boards for Biogen Idec and Almirall; has received funding for travel and speaker honoraria from Sanofi-Aventis, Genzyme, Biogen Idec , Bayer Schering, Teva Neurosciences, Merck Serono, Almirall, and Novartis; received research support from Merck Serono, Biogen Idec, Teva Neurosciences, Bayer Schering, Novartis, Sanofi-Aventis.
AB received honoraria for serving in the scientific advisory boards of Almirall, Bayer, Biogen, Genzyme with approval by the Director of AOU San Luigi University Hospital and received speaker honoraria from Biogen, Genzyme, Novartis, TEVA; his institution has received grant support from Bayer, Biogen, Merck, Novartis, TEVA from the Italian Multiple Sclerosis Society, Fondazione Ricerca Biomedica ONLUS and San Luigi ONLUS
PP received honoraria from biogen serono novartis teva genzyme for lectures or advisory board
MR received travel reimbursment and fees for lectures/presentations from Teva, Genzyme-Sanofi, Almirall, Biogen
SR acted as an Advisory Board member of Biogen Idec, Bayer Schering, Merck Serono, Teva, Novartis and Genzyme, and received funding for traveling and honoraria for speaking or writing from Biogen Idec, Merck Serono, Teva, Novartis, Bayer Schering, Genzyme, Almirall. She received support for research project by Teva, Merck Serono and Bayer Schering and is involved as principal investigator in clinical trials for Teva and Roche.
PC received travel support for scientific congresses and speaking honoraria from: Almirall, Biogen, Genzyme, Merck Serono, Novartis and Teva
MRR reports speaking fees and/or travel expenses from Merck, Biogen, Teva Pharmaceutical and Novartis
MZ serves on scientific advisory boards for Merck Serono, Teva, Sanofi Aventis, Almirall and Biogen; has received speaker honoraria from Teva, Sanofi Aventis, Biogen, Merck Serono, Novartis, and Sanofi Aventis.
GC serves on scientific advisory boards for Bayer Schering Pharma, Merck Serono, Teva, Sanofi Aventis, Novartis and Biogen-Idec; has received speaker honoraria from Teva, Sanofi Aventis, Serono Sumposia International Foundation, Biogen-Idec, Merck Serono, Novartis, Bayer Schering and Sanofi Aventis.
AG serves on scientific advisory boards or as a consultant for Merck Serono, Novartis, Genzyme, Biogen Idec, Teva; received honoraria for speaking form Merck Serono, Serono Symposia International Foundation, Biogen Idec, Allmirall, Genzyme, Teva, and Novartis