Trial Outcomes & Findings for Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis (NCT NCT03046251)

Post-delivery patients enrolled and followed for 52 weeks. Study had difficulty in enrollment locally (Buffalo).

Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis

The primary endpoint are the relapses during 1 year post-delivery in patients treated with natalizumab. This will be compared to the relapse frequency in the parallel control group.

EDSS scores were determined at multiple timepoints, with scores nearest to week 52 selected for analysis. The difference between EDSS scores at baseline and week 52 were calculated, categorizing patients into two groups: stable or worsened. EDSS worsening was defined as a 1.0 increase for baseline scores below 6.0, or a 0.5-point increase for baseline scores of 6.0 or higher.

The Expanded Disability Status Scale (EDSS) is a standardized measure of disability progression in multiple sclerosis (MS), ranging from 0 to 10 in 0.5-unit increments, with higher scores indicating greater disability. EDSS scores were determined at multiple timepoints, with scores nearest to week 52 selected for analysis.

The patients with MS (pwMS) underwent at least two MRI examinations: the first occurring 1-3 months postpartum (before the first post-partum dose of natalizumab) and a follow-up MRI closest to the week 52 visit. For this study, T2-FLAIR and T1-weighted sequences were acquired before and after gadolinium contrast administration. A licensed and experienced neuroradiologist analyzed the MRI scans, determining the number of new or newly enlarging T2 lesions and new T1 contrast-enhancing (GdE) lesions. The identification of new lesions was based on comparisons with pre-pregnancy scans.

Percent of relapse free patients between the groups

The study participants completed multiple patient-reported outcome (PRO) questionnaires: the Multiple Sclerosis Impact Scale-29 (MSIS-29) and the Fatigue Scale for Motor and Cognitive Function (FSMC). The MSIS-29 is a psychometrically validated 29-item measure widely used in MS treatment trials, consisting of two domains: a 20-item physical impact subscale and a 9-item psychological impact subscale. The FSMC is a 20-item scale designed to assess fatigue in MS patients, with 10 items each for cognitive and motor fatigue. Both scales have proven to be valuable tools in assessing the impact of MS on patients' daily lives and are frequently used in clinical trials and research settings.

To evaluate the impact of postpartum DMT use on disability progression, we compared the proportion of patients experiencing confirmed EDSS worsening at 52 weeks between those who restarted DMT after delivery and those who did not. Confirmed EDSS worsening was defined as an increase of ≥1.0 point from baseline for patients with baseline EDSS \<6.0, or ≥0.5 points for patients with baseline EDSS ≥6.0, sustained for at least 12 weeks.

To evaluate the impact of postpartum DMT use on disability progression, we compared the mean EDSS scores (a standardized measure of MS disability ranging from 0-10) at 52 weeks between patients who restarted DMT after delivery and those who did not.