Contributions
Abstract: EP1639
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Pegylated-interferon beta-1a (Peg-IFN) is a disease-modifying treatment, proven efficatious in RRMS patients in the ADVANCE phase III trial, with the advantage of low frequency administration. It is available in Italy since the last quarter of 2014.
We aimed to evaluate effectiveness, safety and prescribing patterns of Peg-IFN in a cohort of patients with RRMS.
Methods: Clinical, radiological and laboratory data of RRMS patients under Peg-IFN treatment during the years 2015-2017 were retrospectively collected in 7 centres in Central Italy, following a common database.
Results: Overall 169 patients were eligible for data analysis, 24,3% naive and 75,7% switching from other treatments (91,4% from injectable drugs). The main reason for switching to Peg-IFN was lack of tolerability in 43%, ineffectiveness in 3.1%. Mean disease duration was 8.6 ± 7.6 years, with mean EDSS of 1.3 ± 1.1. The mean follow-up period was 9,8 ± 6,7 months. MRI analysis during follow-up revealed 18,4% of patients with new/enlarging T2-lesions, 13,3% with new Gd-enhancing lesions. Flu-like syndrome was reported by 50,2%, injection-site-reactions by 17,7%, 8,3% had abnormal liver enzymes. The overall discontinuation rate was 33,1%, of which 51,8% for systemic tolerability and 17,9% for ineffectiveness. Switchers to Peg-IFN for “lack of tolerability” with previous treatment (n=73) resulted at higher risk of treatment discontinuation (p=0,038) than switchers for “patient decision/treatment frequency reduction” (n=50) and treatment-naive patients (n=41).
Conclusions: Effectiveness and tolerability of Peg-IFN appeared comparable with the class of drugs. Unlike clinical trials, our analysis showed a prevalent use of PegIFN as replacement therapy for other injectable agents, in older patients with stable disease and mild disability. Switchers to Peg-IFN for tolerability problems with previous treatment were more likely to discontinue Peg-IFN.
Disclosure:
- SH has received consulting fees, speaker honoraria and/or travel grants from Biogen, Genzyme, Teva, CSL Behrig, Zambon. Research grants from Italian Minister of Foreign Affairs.
- GM received travel funding and honoraria for speaking from Almirall, Biogen, Novartis and Sanofi-Genzyme and consultation fee from Kedrion. She is subinvestigator in clinical trials being conducted for Biogen, Merck Serono, Novartis, Roche and Teva.
- SR has received consulting fees from Biogen, Novartis and Merck.
- CD received honoraria for speaking and travel grants from Biogen, Sanofi-Genzyme, Merck Serono
- AC received speaker honoraria from Biogen; travel grants from Biogen, Merck, Sanofi Genzyme, Teva; advisory boards member honoraria from Biogen, Merck, Novartis, Teva.
- FB has served on advisory boards for Teva and Roche and has received travel grants and/or speaker honoraria from Merck Serono, Teva, Biogen, Sanofi-Genzyme and Novartis.
- FC has received travel support from CSL Behring GmbH, Genzyme, Biogen, and Merck Serono.
- LP has received consulting fees from Biogen, Genzyme, Novartis and Roche; speaker honoraria from Almirall, Biogen, Genzyme, Merck Serono, Novartis and Teva; travel grants from Biogen, Genzyme, Novartis and Teva; research grants from the Italian MS Society (Associazione Italiana Sclerosi Multipla) and Genzyme
- SP has received speaker honoraria from Biogen, Novarti, Teva.
Abstract: EP1639
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Pegylated-interferon beta-1a (Peg-IFN) is a disease-modifying treatment, proven efficatious in RRMS patients in the ADVANCE phase III trial, with the advantage of low frequency administration. It is available in Italy since the last quarter of 2014.
We aimed to evaluate effectiveness, safety and prescribing patterns of Peg-IFN in a cohort of patients with RRMS.
Methods: Clinical, radiological and laboratory data of RRMS patients under Peg-IFN treatment during the years 2015-2017 were retrospectively collected in 7 centres in Central Italy, following a common database.
Results: Overall 169 patients were eligible for data analysis, 24,3% naive and 75,7% switching from other treatments (91,4% from injectable drugs). The main reason for switching to Peg-IFN was lack of tolerability in 43%, ineffectiveness in 3.1%. Mean disease duration was 8.6 ± 7.6 years, with mean EDSS of 1.3 ± 1.1. The mean follow-up period was 9,8 ± 6,7 months. MRI analysis during follow-up revealed 18,4% of patients with new/enlarging T2-lesions, 13,3% with new Gd-enhancing lesions. Flu-like syndrome was reported by 50,2%, injection-site-reactions by 17,7%, 8,3% had abnormal liver enzymes. The overall discontinuation rate was 33,1%, of which 51,8% for systemic tolerability and 17,9% for ineffectiveness. Switchers to Peg-IFN for “lack of tolerability” with previous treatment (n=73) resulted at higher risk of treatment discontinuation (p=0,038) than switchers for “patient decision/treatment frequency reduction” (n=50) and treatment-naive patients (n=41).
Conclusions: Effectiveness and tolerability of Peg-IFN appeared comparable with the class of drugs. Unlike clinical trials, our analysis showed a prevalent use of PegIFN as replacement therapy for other injectable agents, in older patients with stable disease and mild disability. Switchers to Peg-IFN for tolerability problems with previous treatment were more likely to discontinue Peg-IFN.
Disclosure:
- SH has received consulting fees, speaker honoraria and/or travel grants from Biogen, Genzyme, Teva, CSL Behrig, Zambon. Research grants from Italian Minister of Foreign Affairs.
- GM received travel funding and honoraria for speaking from Almirall, Biogen, Novartis and Sanofi-Genzyme and consultation fee from Kedrion. She is subinvestigator in clinical trials being conducted for Biogen, Merck Serono, Novartis, Roche and Teva.
- SR has received consulting fees from Biogen, Novartis and Merck.
- CD received honoraria for speaking and travel grants from Biogen, Sanofi-Genzyme, Merck Serono
- AC received speaker honoraria from Biogen; travel grants from Biogen, Merck, Sanofi Genzyme, Teva; advisory boards member honoraria from Biogen, Merck, Novartis, Teva.
- FB has served on advisory boards for Teva and Roche and has received travel grants and/or speaker honoraria from Merck Serono, Teva, Biogen, Sanofi-Genzyme and Novartis.
- FC has received travel support from CSL Behring GmbH, Genzyme, Biogen, and Merck Serono.
- LP has received consulting fees from Biogen, Genzyme, Novartis and Roche; speaker honoraria from Almirall, Biogen, Genzyme, Merck Serono, Novartis and Teva; travel grants from Biogen, Genzyme, Novartis and Teva; research grants from the Italian MS Society (Associazione Italiana Sclerosi Multipla) and Genzyme
- SP has received speaker honoraria from Biogen, Novarti, Teva.