Contributions
Abstract: EP1793
Type: ePoster
Abstract Category: Therapy - disease modifying - 32 Others
Objectives: PEGylated Interferon (PEG) pivotal trials in Multiple Sclerosis (MS) have shown its efficacy compared to placebo, with a favourable tolerability profile. Aim of this study is to confirm these data in a real-life setting, and understand predictors of good tolerability and persistence in therapy.
Materials and methods: We invited MS centres in Lombardy to collect data from all RR-MS patients receiving PEG, recording demographic and clinical features and laboratory tests results.
Results: 251 patients (166F) were enrolled from 10 MS centres (mean age 42.1 ± 10.6 years (y)), mean disease duration 11.2 ± 7.8 y). Mean ARR in the two y before PEG was 0.2 ± 0.2; median baseline EDSS was 1.5. 31/251 patients were treatment naïve and 94/251 started PEG switching from Interferon (IFN) once a week (IFN-1w), 109/251 switched to PEG from IFN multiple times a week (IFN-mw), while 17/251 switched from other therapies. Mean follow up was 11 ± 3.3 months (mo) (median 11 mo, I and III quartiles: 8-13 mo). 169/251 patients reported Adverse Events (AEs): 55% (n=139) complained of flu-like syndrome (FLS) (in 28 cases leading to PEG discontinuation), and 27% of skin reactions. FLS was reported more frequently by patients switching from IFN-1w (69%), compared to patients previously treated with IFN-mw (43%), naïve (58%) or other patients (53%) (p=0.03). Other notable AE included blood test count abnormalities (7%, one leading to discontinuation) and elevation in transaminases
(3%, one leading to discontinuation). 51/251 patients stopped PEG: 38 for AEs, 5 for pregnancy and 8 for disease activity. 29% of the patients switching from IFN-1w stopped PEG, with respect to patients previously treated with IFN-mw (14%), naïve (6%) or other patients (41%). Predictors of non-persistence in therapy were switching to PEG from IFN-1w (HR 0.15, 95% CI: 0.03-0.76, p = 0.02), but not gender, age, disease duration, baseline EDSS or the number of previous therapies. Among patients switching to PEG from IFN-mw no increase in the relapse rate was observed.
Discussion and conclusion: Even with the limitations of an open label study with a short follow-up, our data seem to confirm the good tolerability profile of PEG. Switching from non-PEGylated IFN to PEG doesn't seem to affect relapse rate. Persistence in PEG is maximized in patients whose previous IFN regime was of high frequency, probably because the benefit of a sharp decrease in the number of injections overwhelms PEG side effects.
Disclosure:
PA received honoraria for lecturing and participation in advisory boards, and/or travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi-Genzyme, Almirall, Roche and Novartis.
GM received support to travel to scientific meetings from Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis, Teva; received speaker honoraria from Biogen Idec and served on the scientific advisory board for Genzyme and Merck Serono.
VTC acted as an Advisory Board member of Novartis and Merck-Serono, received funding for traveling and honoraria for speaking or writing from Teva, Biogen, Genzyme, Merk-Serono and Almirall. She received support for research project by Almirall.
VM served on the scientific advisory board for Merck, Roche e Genzyme-Sanofi
CB served on the scientific advisory board for Merck
DB received honoraria for lecturing and participation in advisory boards, and/or travel expenses for attending congresses and meetings from Merck, Teva, Sanofi-Genzyme, Almirall, and Novartis.
MR, AMP, ES, LMF, LA, and ST have nothing to disclose
Abstract: EP1793
Type: ePoster
Abstract Category: Therapy - disease modifying - 32 Others
Objectives: PEGylated Interferon (PEG) pivotal trials in Multiple Sclerosis (MS) have shown its efficacy compared to placebo, with a favourable tolerability profile. Aim of this study is to confirm these data in a real-life setting, and understand predictors of good tolerability and persistence in therapy.
Materials and methods: We invited MS centres in Lombardy to collect data from all RR-MS patients receiving PEG, recording demographic and clinical features and laboratory tests results.
Results: 251 patients (166F) were enrolled from 10 MS centres (mean age 42.1 ± 10.6 years (y)), mean disease duration 11.2 ± 7.8 y). Mean ARR in the two y before PEG was 0.2 ± 0.2; median baseline EDSS was 1.5. 31/251 patients were treatment naïve and 94/251 started PEG switching from Interferon (IFN) once a week (IFN-1w), 109/251 switched to PEG from IFN multiple times a week (IFN-mw), while 17/251 switched from other therapies. Mean follow up was 11 ± 3.3 months (mo) (median 11 mo, I and III quartiles: 8-13 mo). 169/251 patients reported Adverse Events (AEs): 55% (n=139) complained of flu-like syndrome (FLS) (in 28 cases leading to PEG discontinuation), and 27% of skin reactions. FLS was reported more frequently by patients switching from IFN-1w (69%), compared to patients previously treated with IFN-mw (43%), naïve (58%) or other patients (53%) (p=0.03). Other notable AE included blood test count abnormalities (7%, one leading to discontinuation) and elevation in transaminases
(3%, one leading to discontinuation). 51/251 patients stopped PEG: 38 for AEs, 5 for pregnancy and 8 for disease activity. 29% of the patients switching from IFN-1w stopped PEG, with respect to patients previously treated with IFN-mw (14%), naïve (6%) or other patients (41%). Predictors of non-persistence in therapy were switching to PEG from IFN-1w (HR 0.15, 95% CI: 0.03-0.76, p = 0.02), but not gender, age, disease duration, baseline EDSS or the number of previous therapies. Among patients switching to PEG from IFN-mw no increase in the relapse rate was observed.
Discussion and conclusion: Even with the limitations of an open label study with a short follow-up, our data seem to confirm the good tolerability profile of PEG. Switching from non-PEGylated IFN to PEG doesn't seem to affect relapse rate. Persistence in PEG is maximized in patients whose previous IFN regime was of high frequency, probably because the benefit of a sharp decrease in the number of injections overwhelms PEG side effects.
Disclosure:
PA received honoraria for lecturing and participation in advisory boards, and/or travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi-Genzyme, Almirall, Roche and Novartis.
GM received support to travel to scientific meetings from Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis, Teva; received speaker honoraria from Biogen Idec and served on the scientific advisory board for Genzyme and Merck Serono.
VTC acted as an Advisory Board member of Novartis and Merck-Serono, received funding for traveling and honoraria for speaking or writing from Teva, Biogen, Genzyme, Merk-Serono and Almirall. She received support for research project by Almirall.
VM served on the scientific advisory board for Merck, Roche e Genzyme-Sanofi
CB served on the scientific advisory board for Merck
DB received honoraria for lecturing and participation in advisory boards, and/or travel expenses for attending congresses and meetings from Merck, Teva, Sanofi-Genzyme, Almirall, and Novartis.
MR, AMP, ES, LMF, LA, and ST have nothing to disclose