Safety of long-term intrathecal methotrexate in progressive forms of MS.

Autor: Stark JW; International Multiple Sclerosis Management Practice, New York, NY, USA., Josephs L; Tisch Multiple Sclerosis Research Center of New York, New York, NY, USA., Dulak D; Tisch Multiple Sclerosis Research Center of New York, New York, NY, USA., Clague M; Tisch Multiple Sclerosis Research Center of New York, New York, NY, USA., Sadiq SA; International Multiple Sclerosis Management Practice and Tisch Multiple Sclerosis Research Center of New York, 521 West 57th St., 4th floor, New York, NY 10019, USA.
Jazyk: angličtina
Zdroj: Therapeutic advances in neurological disorders [Ther Adv Neurol Disord] 2019 Dec 03; Vol. 12, pp. 1756286419892360. Date of Electronic Publication: 2019 Dec 03 (Print Publication: 2019).
DOI: 10.1177/1756286419892360
Abstrakt: Background: There are few treatment options for multiple sclerosis (MS) patients with advanced disability [expanded disability status scale (EDSS) ⩾ 6.0]. In 2010, we reported initial results of using intrathecal methotrexate (ITMTX) in patients with progressive MS. We now report on long-term use of ITMTX. We performed a retrospective chart analysis of patients who have had 18 or more treatments to establish the ongoing safety and tolerability of ITMTX. Thus, the objective of this study was to establish the safety and tolerability of long-term therapy with (ITMTX) in patients with treatment-resistant, progressive forms of MS.
Methods: We studied 83 patients (67 secondary and 16 primary progressive) who received ITMTX 12.5 mg every 8-11 weeks for 3-10 years (range: 18-57 treatments). All patients were evaluated neurologically, and their EDSS was assessed at every treatment. In addition, all adverse events, frequency of infections, and any hospitalizations, were noted.
Results: There were no deaths, hospitalizations, or other serious adverse effects related to ITMTX. Headaches occurred at least once in 12% of patients, and transient fatigue occurred in 53% of patients. As determined by EDSS, there was no significant change from baseline status to post-treatment scores in both primary progressive MS (PPMS) and secondary progressive (SPMS) patients.
Conclusions: Pulsed ITMTX was well tolerated for up to 10 years in PPMS patients with no serious adverse effects. Although this was an open-label, retrospective analysis, and efficacy could not be studied, there was evidence of disease stabilization in many patients receiving ITMTX. It appears that long-term ITMTX is a safe therapeutic option in advanced progressive MS.
Competing Interests: Conflict of interest statement: The authors declare that there is no conflict of interest.
(© The Author(s), 2019.)
Databáze: MEDLINE