Effects of severe spasticity treatment with intrathecal Baclofen in multiple sclerosis patients: Long term follow-up

Background: Intrathecal Baclofen is available to treat severe generalized spasticity in Multiple Sclerosis (MS) unresponsive to oral drug delivery. Objective: The aims of this study were to investigate the effects and the drug dosage of intrathecal Baclofen in a selected population of MS patients, affected by severe spasticity at long term follow-up. Methods: A prospective cohort study of 14 MS patients is presented. Spasticity and pain were periodically assessed and the Baclofen dosage was adjusted. Results: The initial Baclofen dosage was 136.2 ± 109.3 μg, then it was increased at 12 months to 228.6 ± 179.2 μg (p < 0.05). The subsequent dose adjustments did not result in significant changes up to 76 months. Spasticity on the lower limbs decreased significantly from pre-implantation assessment (median: 3.5, IQR: 3.0-4.0) to 12 months evaluation (median: 0.5, IQR: 0.0-2.0) (p < 0.001); no further decrease was observed after 24 months (median: 0.5, IQR: 0.0-1.5); when pain was present, it decreased. Some effects on cerebellar symptoms were observed. Botulinum toxin injections were used with intrathecal Baclofen therapy. Conclusions: A reduced spasticity and pain was observed after the intrathecal Baclofen infusion for at least 76 months. To obtain these results a dosage adjustment was needed only in the first year after the implantation