ECTRIMS eLearning

The safety and efficacy of rituximab use in secondary-progressive multiple sclerosis (SPMS) at UMMHC: five years follow up data
Author(s):
I. Berrios Morales
,
I. Berrios Morales
Affiliations:
E. Eleftheriou
,
E. Eleftheriou
Affiliations:
L. Maranda
,
L. Maranda
Affiliations:
C. Ionete
C. Ionete
Affiliations:
ECTRIMS Learn. Berrios Morales I. 09/14/16; 145636; EP1541
Idanis Berrios Morales
Idanis Berrios Morales
Contributions
Abstract

Abstract: EP1541

Type: ePoster

Abstract Category: Therapy - disease modifying - Treatment of progressive MS

Background: Treatment for SPMS is currently challenging. Mitoxantrone is the only FDA-approved drug for treatment of SPMS, and its use is limited by high toxicity. With increasing evidence showing a key role of B-cells and humoral immunity in MS pathogenesis, therapies targeting B-cells have been investigated as promising treatments for MS in the past few years.

Objectives: The goals of our study were to: (1) assess the safety and tolerability of Rituximab in patients with SPMS previously treated with DMT"s, (2) measure the efficacy of Rituximab in delaying progression of disease using Extended Disability Status Scale (EDSS).

Methods: The study was an observational open label study involving one center comparing SPMS patients treated with Rituximab versus controls (SPMS patients treated with other DMT"s) regarding safety, tolerability and progression of disease. Controls included patients with SPMS who were either on a first or second-line treatment. Safety and tolerability were assessed by monitoring the adverse effects to Rituximab, which included urinary tract infections, pulmonary infections, rash, fatigue, serum sickness, and infusion reactions among others. Efficacy in delaying progression of disease was measured by a multivariate survival modeling (Cox"s proportional hazards). In this model, we compared “time to event” data defined as the time needed for EDSS to worsen or improve in each group, while adjusting for patient characteristics such as duration of disease, gender, age, prior treatment and ambulation status.

Results: Patients in the Rituximab group (n=39) had good tolerability of the therapy with only mild to moderate adverse effects, most commonly being urinary tract infection compared to the control group (n=24). EDSS in the Rituximab group increased at a lesser rate than the comparison group (HRa=0.455 [0.232 to 0.894]).

Conclusions: This study demonstrates the possibility of Rituximab as a disease modifying therapy for SPMS due to its good safety profile and ability to reduce disability progression as seen in EDSS measures.

Disclosure: Idanis Berrios Morales MD has no disclosures



Evdokia Eleftheriou MD has no disclosures



Louise Maranda PhD has no disclosures



Carolina Ionete MD, PhD has received research support from Biogen Idec and Genzyme. She has received compensations for consulting and advisory boards from Genzyme and TEVA

Abstract: EP1541

Type: ePoster

Abstract Category: Therapy - disease modifying - Treatment of progressive MS

Background: Treatment for SPMS is currently challenging. Mitoxantrone is the only FDA-approved drug for treatment of SPMS, and its use is limited by high toxicity. With increasing evidence showing a key role of B-cells and humoral immunity in MS pathogenesis, therapies targeting B-cells have been investigated as promising treatments for MS in the past few years.

Objectives: The goals of our study were to: (1) assess the safety and tolerability of Rituximab in patients with SPMS previously treated with DMT"s, (2) measure the efficacy of Rituximab in delaying progression of disease using Extended Disability Status Scale (EDSS).

Methods: The study was an observational open label study involving one center comparing SPMS patients treated with Rituximab versus controls (SPMS patients treated with other DMT"s) regarding safety, tolerability and progression of disease. Controls included patients with SPMS who were either on a first or second-line treatment. Safety and tolerability were assessed by monitoring the adverse effects to Rituximab, which included urinary tract infections, pulmonary infections, rash, fatigue, serum sickness, and infusion reactions among others. Efficacy in delaying progression of disease was measured by a multivariate survival modeling (Cox"s proportional hazards). In this model, we compared “time to event” data defined as the time needed for EDSS to worsen or improve in each group, while adjusting for patient characteristics such as duration of disease, gender, age, prior treatment and ambulation status.

Results: Patients in the Rituximab group (n=39) had good tolerability of the therapy with only mild to moderate adverse effects, most commonly being urinary tract infection compared to the control group (n=24). EDSS in the Rituximab group increased at a lesser rate than the comparison group (HRa=0.455 [0.232 to 0.894]).

Conclusions: This study demonstrates the possibility of Rituximab as a disease modifying therapy for SPMS due to its good safety profile and ability to reduce disability progression as seen in EDSS measures.

Disclosure: Idanis Berrios Morales MD has no disclosures



Evdokia Eleftheriou MD has no disclosures



Louise Maranda PhD has no disclosures



Carolina Ionete MD, PhD has received research support from Biogen Idec and Genzyme. She has received compensations for consulting and advisory boards from Genzyme and TEVA

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