Contributions
Abstract: EP1630
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Objective: Our observational study aimed to evaluate the efficacy and safety of DMF in a real-life setting and analyze factors related to drug response.
Design/Methods: We collected prospectively data for all patients treated with DMF in six MS centers in Campania region Southern Italy) since 2014. Univariate and multivariate analyses were performed to assess relations of baseline parameters with DMF efficacy outcomes.
Results: We collected data for 428 patients (70% female subjects, mean age 39 ±12 years). Proportion of Naïve versus pretreated with other DMTs patients was 166/262, with 90 patients switching to DMF for disease activity and 162 for safety and tolerability issues. Mean treatment exposure to DMF was 589 ±315 days. Mean ARR decreased from 0.24 during the 2 years previous DMF start to 0.09 while on DMF ( p=0.001). Dropped out patients were 83 (19%) after 334±264 days : 33 out of 83 dropped for inefficacy, 32 patients dropped out for tolerability or poor compliance and 8 patients for safety issues. Baseline higher EDSS predicted the drop out for inefficacy ( HR 1.380, CI 1.121, 1.698, p=0.002).
At multivariate analysis, we found that male gender (OR 0.32, CI 0.132 - 0.772, p=0.011) and older age at diagnosis (OR 0.952, CI 0.919-0.986, p=0.006) were protective factors for relapse occurrence. EDSS remained stable in 89% of patients. We divided patients switched to DMF in 2 groups: horizontal switch from another first line therapy or “de-escalation” from a second line therapy. In the first group, 57 out of 80 patients switching for disease activity to DMF, were clinically stable on oral drug, whereas 14 dropped for poor tolerability. In the second group, switching mainly for safety and tolerability issues, disease control was lower than in first group, with higher ARR and proportion of progressing patients (p< 0.0001, X2 test).
Conclusions: We confirm in a real life setting a good efficacy with high persistence of patients on DMF, both for naïve patients and patients switching from other first line DMTs. Male sex and older age at diagnosis are prognostic factors for DMF efficacy, while higher EDSS is a risk factor for poor response to treatment. Safety was reassuring confirming a favorable safety profile for DMF, but tolerability can still be improved.
Disclosure: · Dr. L. Lavorgna received speakers honoraria from Sanofi, Teva, Novartis, Merck, Roche, Bayer, Biogen.
· Dr. L. Sinisi received speakers honoraria from MercK Serono, Biogen, Teva, Novartis, Almirall, Sanofi Genzyme.
· Dr. G.T. Maniscalco has served on advisory boards and/or received travel grants and speaker honoraria from Almirall, Biogen, Merck Serono, Novartis and Teva.
· E. Signoriello received travel funding and speaker honoraria from Biogen, Novartis, Sanofi Genzyme, Bayer, Teva.
· G. Lus received travel funding, research support, speaker honoraria from Biogen, Novartis, Sanofi Genzyme, Bayer, Teva, Almirall, Allergan, Ipsen.
· Marcello Moccia received research grants from MAGNIMS-ECTRIMS and from Merck.
· Antonio Carotenuto received travel funding from Roche and research grants from Almirall
· R. Lanzillo, F. Saccà and V. Brescia Morra received personal fees for public speaking or consultancy from Merck, Novartis, Biogen, Genzyme, Teva and Almirall
· Dr. F.Romano, C.V.Russo, A. De Rosa, M.De Angelis, S. Bonavita, C. Florio and B. Ronga have nothing to disclose.
Abstract: EP1630
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Objective: Our observational study aimed to evaluate the efficacy and safety of DMF in a real-life setting and analyze factors related to drug response.
Design/Methods: We collected prospectively data for all patients treated with DMF in six MS centers in Campania region Southern Italy) since 2014. Univariate and multivariate analyses were performed to assess relations of baseline parameters with DMF efficacy outcomes.
Results: We collected data for 428 patients (70% female subjects, mean age 39 ±12 years). Proportion of Naïve versus pretreated with other DMTs patients was 166/262, with 90 patients switching to DMF for disease activity and 162 for safety and tolerability issues. Mean treatment exposure to DMF was 589 ±315 days. Mean ARR decreased from 0.24 during the 2 years previous DMF start to 0.09 while on DMF ( p=0.001). Dropped out patients were 83 (19%) after 334±264 days : 33 out of 83 dropped for inefficacy, 32 patients dropped out for tolerability or poor compliance and 8 patients for safety issues. Baseline higher EDSS predicted the drop out for inefficacy ( HR 1.380, CI 1.121, 1.698, p=0.002).
At multivariate analysis, we found that male gender (OR 0.32, CI 0.132 - 0.772, p=0.011) and older age at diagnosis (OR 0.952, CI 0.919-0.986, p=0.006) were protective factors for relapse occurrence. EDSS remained stable in 89% of patients. We divided patients switched to DMF in 2 groups: horizontal switch from another first line therapy or “de-escalation” from a second line therapy. In the first group, 57 out of 80 patients switching for disease activity to DMF, were clinically stable on oral drug, whereas 14 dropped for poor tolerability. In the second group, switching mainly for safety and tolerability issues, disease control was lower than in first group, with higher ARR and proportion of progressing patients (p< 0.0001, X2 test).
Conclusions: We confirm in a real life setting a good efficacy with high persistence of patients on DMF, both for naïve patients and patients switching from other first line DMTs. Male sex and older age at diagnosis are prognostic factors for DMF efficacy, while higher EDSS is a risk factor for poor response to treatment. Safety was reassuring confirming a favorable safety profile for DMF, but tolerability can still be improved.
Disclosure: · Dr. L. Lavorgna received speakers honoraria from Sanofi, Teva, Novartis, Merck, Roche, Bayer, Biogen.
· Dr. L. Sinisi received speakers honoraria from MercK Serono, Biogen, Teva, Novartis, Almirall, Sanofi Genzyme.
· Dr. G.T. Maniscalco has served on advisory boards and/or received travel grants and speaker honoraria from Almirall, Biogen, Merck Serono, Novartis and Teva.
· E. Signoriello received travel funding and speaker honoraria from Biogen, Novartis, Sanofi Genzyme, Bayer, Teva.
· G. Lus received travel funding, research support, speaker honoraria from Biogen, Novartis, Sanofi Genzyme, Bayer, Teva, Almirall, Allergan, Ipsen.
· Marcello Moccia received research grants from MAGNIMS-ECTRIMS and from Merck.
· Antonio Carotenuto received travel funding from Roche and research grants from Almirall
· R. Lanzillo, F. Saccà and V. Brescia Morra received personal fees for public speaking or consultancy from Merck, Novartis, Biogen, Genzyme, Teva and Almirall
· Dr. F.Romano, C.V.Russo, A. De Rosa, M.De Angelis, S. Bonavita, C. Florio and B. Ronga have nothing to disclose.