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Therapeutic Drug Monitoring: Affecting Factors

Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.

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Intrathecal methotrexate in progressive multiple sclerosis: a phase 1 open-label study with long-term follow-up.

Hadar Kolb1, Yuval Shachaf2, Karin Fainberg1

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Intrathecal methotrexate (ITMTX) shows promise for progressive multiple sclerosis (PMS). This study found ITMTX well-tolerated and effective in stabilizing disability over long-term treatment for many PMS patients.

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Intrathecal treatmentMethotrexatePhase 1 studyProgressive multiple sclerosis

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Area of Science:

  • Neuroscience
  • Immunology
  • Clinical Neurology

Background:

  • Progressive multiple sclerosis (PMS) presents significant treatment challenges.
  • Intrathecal methotrexate (ITMTX) is being investigated as a potential therapy for PMS.

Purpose of the Study:

  • To evaluate the safety, tolerability, and efficacy of ITMTX in PMS patients.
  • To assess short-term (1-year) and long-term outcomes of ITMTX treatment.

Main Methods:

  • A 1-year, open-label, phase 1 study administering ITMTX quarterly.
  • Primary endpoints included changes in EDSS, 25FW, and SDMT.
  • Secondary endpoints involved CSF analysis and MRI; long-term follow-up was retrospective.

Main Results:

  • ITMTX was well-tolerated, with post-lumbar puncture headache as the most common side effect.
  • No significant changes in EDSS, 25FW, SDMT, CSF IgG, or immune cells were observed at 12 months.
  • Long-term follow-up (mean 4.1 years) showed stable EDSS in 70% of patients receiving ITMTX.

Conclusions:

  • ITMTX appears to be a safe and well-tolerated treatment for PMS.
  • The therapy demonstrated potential for stabilizing disability in a majority of long-term treated patients.
  • ITMTX may be a viable option for PMS patients unresponsive or intolerant to other therapies.