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Background In an effort to reset the immune system, individuals with multiple sclerosis (MS) have undergone autologous hematopoietic stem cell transplant; this approach has produced promising results in terms of feasibility, efficacy and safety, however, the role of post-transplant adjuvant therapeutic agents needs to be further clarified. Methods Consecutive patients autografted using the "Mexican method" (ClinicalTrials.gov NCT02674217) to graft persons with MS were prospectively accrued in the study. All autografts were carried out on an outpatient basis, using cyclophosphamide (Cy) and filgrastim as mobilization regimen, the cumulative dose of Cy being 200 mg/kg, delivered on two separate blocks, nine days apart. After granulocyte recovery, all individuals received a rituximab infusion (375 mg/m2) and at discharge, patients were recommended to continue a follow-up period with additional rituximab infusions (100 mg) every two months for 1 year. Results Eighty two subjects were prospectively enrolled between June 2015 and November 2016. Twenty nine were male (35%). Median age was 45 y (range, 28-66 y). Nineteensubjects (23%) had primary progressive MS, 37 (45%) relapsing remitting MS and 26 (32%) secondary progressive MS. Median EDSS score was 5.5 (range, 0 - 7). After recovering hematopoiesis and receiving the initial dose of rituximab, 41 patients were administered rituximab in their residence countries every two months during one year, whilst 41 did not. There were not significant differences in clinical and demographic data among both groups. In order to analyze data comparatively, the EDSS values prior to and 12 mo. after the HSCT were compared in the groupswith and without additional rituximab; the median change in the EDSS score in the rituximab group was 0 (CI -3.5 to 4), and in the no rituximab group was also 0 (CI -1.5 to 3); accordingly, the change in the EDSS score between patients receiving or not rituximab was not statistically significant (P = 0.93, 95% CI -0.5 to 0.5). We found no short-term difference in MS-relapse free survival (RFS). Conclusion The 12-month period therapy with rituximab in patients with MS who underwent autologous transplant was not effective to prevent relapses nor to cause reduction in the EDSS score. |
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