Contributions
Abstract: EP1661
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Introduction: Fingolimod is an oral daily treatment approved for Relapsing Remitting Multiple Sclerosis (RRMS). Lymphopenia or elevated liver enzymes are the main persistent side effects and the reasons to clinicians propose a reduced dose rather than discontinuation of fingolimod. However, current data on the effectiveness of less frequent dosing regimens are scarce and contradictory.
Objectives: To investigate if the fingolimod effectiveness is maintained with reduction in dosing frequency.
Methods: Unicentric, retrospective and observational study at a tertiary Multiple Sclerosis Center. Using our local clinical database (iMed® software), we identified RRMS patients taking reduced dose (nondaily) of fingolimod for at least 6 months. Propensity score-based matching was performed to select patients taking daily dose of fingolimod with comparable baseline characteristics: age, sex, disease duration, annualized relapse rate (ARR) and Expanded Disability Status Scale (EDSS).
Results: We retained 36 patients in each group (reduced dose vs. daily dose of fingolimod) after propensity score matching, with similar baseline characteristics. Lymphopenia was the main reason for switching to reduced fingolimod dose (88.9%), followed by liver function abnormalities (11.1%). Treatment with natalizumab before fingolimod was inversely associated with risk of reducing dose (OR 0.253, 95% confidence interval= 0.08-0.807, p=0.016), while age, disease duration, lymphocyte count before fingolimod, baseline EDSS and ARR were not significant predictors. Before reducing dose, patients took daily fingolimod during 18.5 ±16.01 months. One patient on reduced dose (2.8%) suspended fingolimod and 6 (16.7%) returned to the daily dose; the other patients remain in the alternative scheme for 23.07 ±8.04 months.
The clinical disease activity was similar between patients taking daily dose compared with reduced dose: mean ARR 0.4 vs. 0.3 (p=0.247); median EDSS 2.0 vs. 2.0 (p=0.687); proportion of patients with EDSS increase 9.1% vs. 16.7% (p=0.481). Fingolimod in reduced dose was overall well tolerated and was associated with an increase in the mean lymphocyte count (0.36/mm3 before reducing dose vs. 0.65/mm3 after reducing dose, p=0.009).
Conclusion: These data suggest that the effectiveness of fingolimod is maintained despite the reduction of the dose, allowing to minimize the most common adverse events. These findings warrant further confirmation, ideally with randomized clinical trials.
Disclosure: All the authors: nothing to disclose.
Abstract: EP1661
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Introduction: Fingolimod is an oral daily treatment approved for Relapsing Remitting Multiple Sclerosis (RRMS). Lymphopenia or elevated liver enzymes are the main persistent side effects and the reasons to clinicians propose a reduced dose rather than discontinuation of fingolimod. However, current data on the effectiveness of less frequent dosing regimens are scarce and contradictory.
Objectives: To investigate if the fingolimod effectiveness is maintained with reduction in dosing frequency.
Methods: Unicentric, retrospective and observational study at a tertiary Multiple Sclerosis Center. Using our local clinical database (iMed® software), we identified RRMS patients taking reduced dose (nondaily) of fingolimod for at least 6 months. Propensity score-based matching was performed to select patients taking daily dose of fingolimod with comparable baseline characteristics: age, sex, disease duration, annualized relapse rate (ARR) and Expanded Disability Status Scale (EDSS).
Results: We retained 36 patients in each group (reduced dose vs. daily dose of fingolimod) after propensity score matching, with similar baseline characteristics. Lymphopenia was the main reason for switching to reduced fingolimod dose (88.9%), followed by liver function abnormalities (11.1%). Treatment with natalizumab before fingolimod was inversely associated with risk of reducing dose (OR 0.253, 95% confidence interval= 0.08-0.807, p=0.016), while age, disease duration, lymphocyte count before fingolimod, baseline EDSS and ARR were not significant predictors. Before reducing dose, patients took daily fingolimod during 18.5 ±16.01 months. One patient on reduced dose (2.8%) suspended fingolimod and 6 (16.7%) returned to the daily dose; the other patients remain in the alternative scheme for 23.07 ±8.04 months.
The clinical disease activity was similar between patients taking daily dose compared with reduced dose: mean ARR 0.4 vs. 0.3 (p=0.247); median EDSS 2.0 vs. 2.0 (p=0.687); proportion of patients with EDSS increase 9.1% vs. 16.7% (p=0.481). Fingolimod in reduced dose was overall well tolerated and was associated with an increase in the mean lymphocyte count (0.36/mm3 before reducing dose vs. 0.65/mm3 after reducing dose, p=0.009).
Conclusion: These data suggest that the effectiveness of fingolimod is maintained despite the reduction of the dose, allowing to minimize the most common adverse events. These findings warrant further confirmation, ideally with randomized clinical trials.
Disclosure: All the authors: nothing to disclose.