The College of Pharmacy discussed the MSc thesis entitled “Therapeutic Drug Monitoring of Natalizumab to Assess Response in Iraqi patients with Multiple Sclerosis: A cross sectional study” by the student Abbas Ahmed Kadhim and his supervisors Lecturer Dr. Mohammed Yawuz Jamal in the Clinical Pharmacy Department and Dr. Ali Kadhim Karem, a neurologist at Baghdad medical city.
The study aimed to evaluate the clinical utility of natalizumab TDM (therapeutic drug monitoring) in Iraqi patients with relapsing remitting multiple sclerosis (RRMS) in evaluating natalizumab drug trough concentrations, anti-natalizumab antibodies (ANA) status, and their relationship with clinical outcomes.
The study included a cross-sectional analysis was conducted on 80 Iraqi patients with relapsing–remitting multiple sclerosis (RRMS) who had been treated with natalizumab for at least six months in the Multiple Sclerosis Ward at Baghdad Teaching Hospital, Medical City. Clinical disability was assessed using the Expanded Disability Status Scale (EDSS), disease status (active/inactive), and JC virus serostatus. Serum osteopontin concentrations, natalizumab trough levels, and anti-natalizumab antibodies were measured. Anti-natalizumab antibodies were quantified using a standardized quantitative ELISA method.
The results showed that, the trough concentrations of natalizumab did not differ significantly between patients in remission and those with active disease (1.126 vs. 1.128 µg/mL, respectively), nor between antibody-positive and antibody-negative groups (1.130 vs. 1.119 µg/mL, respectively). Most patients exhibited concentrations close to the threshold of 1 µg/mL. No significant correlations were observed between natalizumab trough levels and clinical variables such as EDSS or disease duration. However, smoking was significantly associated with higher trough concentrations (p = 0.037).
The study recommended to use serial annotation of drug levels and anti‑drug antibodies to link with relapse, disability progression, and discontinuation. The development of ANA in nearly one-third of patients highlights the ongoing relevance of immunogenicity and the need for vigilant monitoring. Expanded PK/PD profiling across subgroups (disease duration, body weight, smoking, comorbidities) is needed.
