Contributions
Abstract: P1154
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Objective: To investigate the safety and efficacy of rituximab as rescue therapy in relapsing-remitting multiple sclerosis (RRMS) patients with persistent activity despite second lines treatment.
Methods: In this retrospective observational monocenter study, we collected data of 18 RRMS patients with persistent disease activity despite second-line therapy (fingolimod, natalizumab, mitoxantrone, cyclophosphamide) who received rituximab as rescue therapy. Disease activity on second line therapy was confirmed by a persistent inflammatory activity on MRI. Outcome data were collected from the medical charts and French MS register (EDMUS).
Results: After a wash-out period (median: 44 days, range 21 - 189), two patients received 4 IV dose of 375mg/m2 rituximab, and 16 patients received 2 IV dose 1000mg rituximab 2 weeks apart. After introduction, all patients were treated with 1000mg rituximab every 6 months. The median follow-up was 1 year (Range 0,53 - 1,56). Before switching for rituximab, all patients had MRI inflammatory activity: 12 out of 18 patients showed contrast-enhancing lesions (CELs) and 15 out of 18 patients showed an increase number of T2 lesion on MRI. The first MRI after the switch (median time: 5,42 month, range 2,47 - 9,83) demonstrated at least one CEL in only 2 out of 18 patients (1 and 2 CELs) (p = 0.0002) and an increase number of T2 lesion in 3 out of 18 patients (respectively 1, 2, and 2 new lesions). None of 10 patients who had performed a second MRI (median time: 10.32 month, range 6.21 - 17.79) showed inflammatory activity. The median Expanded Disability Status Scale (EDSS) before rituximab was 4.75 (Range 1,5 - 6,5) and was down to 4.25 (Range 0 - 6,5)) at the last clinical evaluation (p = 0.016). The mean annualized relapse rate (ARR) during rituximab, significantly decreased to 0.15 (SD = 0.34), compared to ARR on the last year before rituximab (1.61) (SD 1.53, p< 0.001) and ARR since the beginning of the disease (1.00) (SD 0.83, p< 0.001) and 16 adverse events (AEs) were collected during treatment in 7 patients: 4 AEs grade ≥ 3 (2 infections and 2 cytopenias). No case of death or multifocal leukoencephalopathy was recorded.
Conclusion: For patient with active RRMS despite second-line treatments, a switch to rituximab is associated with a dramatic reduction of clinical and radiological disease activity. The safety was good and similar to previous studies.
Disclosure:
P.Durozard : Nothing to disclose
A.Maarouf : Nothing to disclose
A.Rico : Nothing to disclose
C.Boutière : Nothing to disclose
B.Audoin : Nothing to disclose
J.Pelletier : Nothing to disclose
Abstract: P1154
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Objective: To investigate the safety and efficacy of rituximab as rescue therapy in relapsing-remitting multiple sclerosis (RRMS) patients with persistent activity despite second lines treatment.
Methods: In this retrospective observational monocenter study, we collected data of 18 RRMS patients with persistent disease activity despite second-line therapy (fingolimod, natalizumab, mitoxantrone, cyclophosphamide) who received rituximab as rescue therapy. Disease activity on second line therapy was confirmed by a persistent inflammatory activity on MRI. Outcome data were collected from the medical charts and French MS register (EDMUS).
Results: After a wash-out period (median: 44 days, range 21 - 189), two patients received 4 IV dose of 375mg/m2 rituximab, and 16 patients received 2 IV dose 1000mg rituximab 2 weeks apart. After introduction, all patients were treated with 1000mg rituximab every 6 months. The median follow-up was 1 year (Range 0,53 - 1,56). Before switching for rituximab, all patients had MRI inflammatory activity: 12 out of 18 patients showed contrast-enhancing lesions (CELs) and 15 out of 18 patients showed an increase number of T2 lesion on MRI. The first MRI after the switch (median time: 5,42 month, range 2,47 - 9,83) demonstrated at least one CEL in only 2 out of 18 patients (1 and 2 CELs) (p = 0.0002) and an increase number of T2 lesion in 3 out of 18 patients (respectively 1, 2, and 2 new lesions). None of 10 patients who had performed a second MRI (median time: 10.32 month, range 6.21 - 17.79) showed inflammatory activity. The median Expanded Disability Status Scale (EDSS) before rituximab was 4.75 (Range 1,5 - 6,5) and was down to 4.25 (Range 0 - 6,5)) at the last clinical evaluation (p = 0.016). The mean annualized relapse rate (ARR) during rituximab, significantly decreased to 0.15 (SD = 0.34), compared to ARR on the last year before rituximab (1.61) (SD 1.53, p< 0.001) and ARR since the beginning of the disease (1.00) (SD 0.83, p< 0.001) and 16 adverse events (AEs) were collected during treatment in 7 patients: 4 AEs grade ≥ 3 (2 infections and 2 cytopenias). No case of death or multifocal leukoencephalopathy was recorded.
Conclusion: For patient with active RRMS despite second-line treatments, a switch to rituximab is associated with a dramatic reduction of clinical and radiological disease activity. The safety was good and similar to previous studies.
Disclosure:
P.Durozard : Nothing to disclose
A.Maarouf : Nothing to disclose
A.Rico : Nothing to disclose
C.Boutière : Nothing to disclose
B.Audoin : Nothing to disclose
J.Pelletier : Nothing to disclose