Contributions
Abstract: EP1681
Type: Poster Sessions
Abstract Category: Therapy - Tools for detecting therapeutic response
Objectives: PEGylated Interferon (PEG) pivotal trials in Multiple Sclerosis (MS) have shown its favourable efficacy and 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 prospectively follow MS patients who started PEG in the two-year span 2015-2016, recording demographic and clinical features and laboratory tests results.
Results: 251 patients (166F) were enrolled from 9 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 21 ± 5.1 months. 178/251 patients reported Adverse Events (AEs): 60% (n=151) complained of flu-like syndrome (FLS) (in 46 cases leading to PEG discontinuation), and 27% of skin reactions. FLS was reported more frequently by patients switching from IFN-1w (74%), compared to patients previously treated with IFN-mw (48%), naïve (61%) or other patients (59%) (p=0.03). Other notable AE included blood test count abnormalities (2%, in 3 cases leading to discontinuation) and elevation in transaminases (3%, 3 leading to discontinuation). 94/251 patients stopped PEG: 65 for AEs, 6 for pregnancy and 23 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 0.31, 95% CI: 0.06-0.86, p = 0.001), 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: Despite the limitations of an open label study, our data seem to confirm the good tolerability profile of PEG. Switching from non-PEGylated IFN to PEG does not seem to affect relapse rate. Persistence in PEG is maximized in patients whose previous IFN regime was of high frequency, suggesting that 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, Roche, Sanofi-Aventis, Teva; received speaker honoraria from Biogen Idec and served on the scientific advisory board for Biogen, 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.
NDR received speaker honoraria from Biogen Idec, Sanofi-Genzyme, Novartis; received funding for participation in advisory board to Novartis and Genzyme-Sanofi and for travel to scientific meetings and congresses from Biogen Idec, Teva, Sanofi-Genzyme, Roche, Almirall and Novartis
VM received honoraria for participation in advisory boards and/or travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi-Genzyme, Roche and Novartis
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.
ST received honoraria for lecturing from Teva and Sanofi-Genzime, for writing from Teva, for participation in advisory boards from Merck and Biogen and for travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi-Genzyme and Novartis.
MR, AMP, ES, MLF, and LA have nothing to disclose
Abstract: EP1681
Type: Poster Sessions
Abstract Category: Therapy - Tools for detecting therapeutic response
Objectives: PEGylated Interferon (PEG) pivotal trials in Multiple Sclerosis (MS) have shown its favourable efficacy and 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 prospectively follow MS patients who started PEG in the two-year span 2015-2016, recording demographic and clinical features and laboratory tests results.
Results: 251 patients (166F) were enrolled from 9 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 21 ± 5.1 months. 178/251 patients reported Adverse Events (AEs): 60% (n=151) complained of flu-like syndrome (FLS) (in 46 cases leading to PEG discontinuation), and 27% of skin reactions. FLS was reported more frequently by patients switching from IFN-1w (74%), compared to patients previously treated with IFN-mw (48%), naïve (61%) or other patients (59%) (p=0.03). Other notable AE included blood test count abnormalities (2%, in 3 cases leading to discontinuation) and elevation in transaminases (3%, 3 leading to discontinuation). 94/251 patients stopped PEG: 65 for AEs, 6 for pregnancy and 23 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 0.31, 95% CI: 0.06-0.86, p = 0.001), 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: Despite the limitations of an open label study, our data seem to confirm the good tolerability profile of PEG. Switching from non-PEGylated IFN to PEG does not seem to affect relapse rate. Persistence in PEG is maximized in patients whose previous IFN regime was of high frequency, suggesting that 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, Roche, Sanofi-Aventis, Teva; received speaker honoraria from Biogen Idec and served on the scientific advisory board for Biogen, 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.
NDR received speaker honoraria from Biogen Idec, Sanofi-Genzyme, Novartis; received funding for participation in advisory board to Novartis and Genzyme-Sanofi and for travel to scientific meetings and congresses from Biogen Idec, Teva, Sanofi-Genzyme, Roche, Almirall and Novartis
VM received honoraria for participation in advisory boards and/or travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi-Genzyme, Roche and Novartis
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.
ST received honoraria for lecturing from Teva and Sanofi-Genzime, for writing from Teva, for participation in advisory boards from Merck and Biogen and for travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi-Genzyme and Novartis.
MR, AMP, ES, MLF, and LA have nothing to disclose