ECTRIMS eLearning

Determinants of discontinuation of Botulinum Toxin Type A treatment for spasticity in multiple sclerosis
Author(s): ,
L Castelli
Affiliations:
Neurology and Psychiatry, Sapienza University
,
P Latino
Affiliations:
S. Andrea Hospital, Rome, Italy
,
G Taborri
Affiliations:
S. Andrea Hospital, Rome, Italy
,
L Prosperini
Affiliations:
Neurology and Psychiatry, Sapienza University
,
C Pozzilli
Affiliations:
Neurology and Psychiatry, Sapienza University;S. Andrea Hospital, Rome, Italy
M Giovannelli
Affiliations:
S. Andrea Hospital, Rome, Italy
ECTRIMS Learn. Castelli L. 09/15/16; 146626; P786
Letizia Castelli
Letizia Castelli
Contributions
Abstract

Abstract: P786

Type: Poster

Abstract Category: RIMS - Symptoms Management

Background: Botulinum Toxin Type-A (BoNT-A) is a well-established treatment for spasticity due to multiple sclerosis (MS). The advantage of BoNT-A lies in its focal use, long-lasting action (over many weeks), complete reversibility of effect, and additive use in patients with systemic treatment. However, no studies have been performed so far to investigate the long-term treatment persistence (defined as "the duration of time from initiation to discontinuation of therapy”) with BoNT-A treatment.

Objective: To investigate the effect of long-term treatment persistence with BONT-A and determinants of its discontinuation in daily clinical setting.

Methods: We retrospectively collected data of patients with definite MS who started BoNT-A injections and underwent regular routine follow-up visits. Determinants of BoNT-A discontinuation were explored in a time-to-event Cox regression analysis which included as independent variables the following baseline

(i.e. at the beginning of BoNT-A treatment) characteristics: age, MS duration, Expanded Disability Status Scale score, MS phenotype (relapsing-remitting, secondary progressive, primary progressive), Modified Ashworth Scale, neurological picture (monoparesis, hemiparesis, paraparesis, tetraparesis), ongoing disease-modifying treatment, ongoing oral anti-spastic drugs, absence or presence of a stable caregiver, regular rehabilitation (yes or not) and frequency (sessions per week).

Results: From 2002 to 2014 a total of 185 patients started BoNT-A treatment. Of them, data on 121 were considered in our analysis. At follow-up (September 2015), 53 (44%) patients were still on treatment and 68 (56%) patients discontinued the treatment after a median time of 1.2 years (interval: 6 months to 7.4 years). Reasons for discontinuation were loss of efficacy (n=45); logistic problems or barriers to reach the structure (n=16); adverse events (n=7). According to the multivariable time-to-event analysis, the absence of caregiver (HR=0.59, p=0.03) and lack of rehabilitation (HR=0.59, p=0.02) were two independent predictors of discontinuing BoNT-A treatment.

Discussion: Our study confirms the beneficial effect of combining BoNT-A injections with regular rehabilitation on overall response to BoNT-A treatment in people with MS. The absence of caregiver may have a deleterious effect on persistence with treatment, highlighting the crucial role of caregivers for achieving better long-term outcomes in chronic conditions, such as MS.

Disclosure:

LC: consulting fees from Almirall.

PL: nothing to disclose.

GT: nothing to disclose.

LP: consulting fees from Biogen and Novartis; speaker honoriaria from Biogen, Genzyme, Novartis, Teva; research grants from Genzyme.

CP: consulting fees and/or speaker honoraria from Almirall, Biogen, Genzyme, Merck Serono, Novartis, Roche, Teva; research grants from Merck Serono and Novartis.

MG: consulting fees from Allergan and Ipsen.

Abstract: P786

Type: Poster

Abstract Category: RIMS - Symptoms Management

Background: Botulinum Toxin Type-A (BoNT-A) is a well-established treatment for spasticity due to multiple sclerosis (MS). The advantage of BoNT-A lies in its focal use, long-lasting action (over many weeks), complete reversibility of effect, and additive use in patients with systemic treatment. However, no studies have been performed so far to investigate the long-term treatment persistence (defined as "the duration of time from initiation to discontinuation of therapy”) with BoNT-A treatment.

Objective: To investigate the effect of long-term treatment persistence with BONT-A and determinants of its discontinuation in daily clinical setting.

Methods: We retrospectively collected data of patients with definite MS who started BoNT-A injections and underwent regular routine follow-up visits. Determinants of BoNT-A discontinuation were explored in a time-to-event Cox regression analysis which included as independent variables the following baseline

(i.e. at the beginning of BoNT-A treatment) characteristics: age, MS duration, Expanded Disability Status Scale score, MS phenotype (relapsing-remitting, secondary progressive, primary progressive), Modified Ashworth Scale, neurological picture (monoparesis, hemiparesis, paraparesis, tetraparesis), ongoing disease-modifying treatment, ongoing oral anti-spastic drugs, absence or presence of a stable caregiver, regular rehabilitation (yes or not) and frequency (sessions per week).

Results: From 2002 to 2014 a total of 185 patients started BoNT-A treatment. Of them, data on 121 were considered in our analysis. At follow-up (September 2015), 53 (44%) patients were still on treatment and 68 (56%) patients discontinued the treatment after a median time of 1.2 years (interval: 6 months to 7.4 years). Reasons for discontinuation were loss of efficacy (n=45); logistic problems or barriers to reach the structure (n=16); adverse events (n=7). According to the multivariable time-to-event analysis, the absence of caregiver (HR=0.59, p=0.03) and lack of rehabilitation (HR=0.59, p=0.02) were two independent predictors of discontinuing BoNT-A treatment.

Discussion: Our study confirms the beneficial effect of combining BoNT-A injections with regular rehabilitation on overall response to BoNT-A treatment in people with MS. The absence of caregiver may have a deleterious effect on persistence with treatment, highlighting the crucial role of caregivers for achieving better long-term outcomes in chronic conditions, such as MS.

Disclosure:

LC: consulting fees from Almirall.

PL: nothing to disclose.

GT: nothing to disclose.

LP: consulting fees from Biogen and Novartis; speaker honoriaria from Biogen, Genzyme, Novartis, Teva; research grants from Genzyme.

CP: consulting fees and/or speaker honoraria from Almirall, Biogen, Genzyme, Merck Serono, Novartis, Roche, Teva; research grants from Merck Serono and Novartis.

MG: consulting fees from Allergan and Ipsen.

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