Dose escalation in intrathecal baclofen therapy based on disease etiology: Can an a priori target dose be established? A ten-year follow-up study

J Spinal Cord Med. 2023 Nov 20:1-7. doi: 10.1080/10790268.2023.2266614. Online ahead of print.

Abstract

Context: Intrathecal baclofen (ITB) therapy is administered for severe, persistent spasticity that cannot be addressed by oral medication or other treatments.

Objective: We aimed to evaluate the target dose of ITB for severe, persistent spasticity based on disease etiology.

Methods: Data at baseline (discharge), 1, and 10 years from 102 patients who received ITB therapy between 1985 and 2011 were retrospectively collected. Patients were divided based on disease etiology (cerebral, spinal, or multiple sclerosis [MS]) to evaluate differences in dose requirements. A comprehensive literature review of the dose trends in ITB therapy was conducted.

Results: Patients with cerebral spasticity (n = 62) required the highest dose after discharge (102.66 ± 30.9 µg), 1 (402.29 ± 300.2 µg), and 10 years (578.74 ± 421.2 µg). Patients with spinal spasticity (n = 19) required an average of 82.89 ± 30.7 µg baclofen at discharge, 296.3 ± 224.6 µg after 1 year, and 522.63 ± 425.97 µg after 10 years. Patients with MS-related spasticity (n = 21) had a dose of 82.73 ± 39.3 µg baclofen at discharge, 226.95 ± 193.3 µg after 1 year, and 320.6 ± 261.4 µg after 10 years. The differences among the categories were significant after 1 and 10 years of therapy.

Conclusions: The largest dose escalation occurs within the first year of ITB therapy. Our work provides a guideline for the initial dose setting during the inpatient stay after implantation and potentially expected dosage over the years thereafter, although this must always be adjusted individually.

Keywords: Dose change; Intrathecal baclofen; Intrathecal therapy; Spastic movement disorder; Spasticity; Spinal cord injury.