Ocrelizumab is an anti-CD20 humanized monoclonal antibody. Is the first disease modifying treatment(DMT) approved for the treatment of primary-progressive multiple sclerosis(PPMS). It has shown to reduce Confirmed Disability Progression at 12 and 24 weeks over placebo
To describe the baseline characteristics of patients with PPMS. Analyze effectiveness, safety and laboratory parameters in PPMS patients treated with OCR
Retrospective observational study in patients with PPMS treated with OCR from January 2011 to May 2020 at Virgen Macarena Hospital, Seville, Spain.
Demographic/disease characteristics, ARR, previous DMTs, adverse events, changes in disability, and cerebral MRI findings were collected at enrolment.
18 PPMS patients were treated with OCR(50%females) Mean follow-up since OCR initiation:13,8 months(1-38) 16 patients(88,89%) have received ⥸2 courses.
Average age: 47 years(37-57) Mean time since PPMS diagnosis: 5,38 years(0,5-12,3)
6 patients(33,3%) received a previous DMT(3Laquinimod, 1Rituximab, 1Fingolimod, 1Teriflunomide)
Mean EDSS changed from 5,7 to 5,8 after a mean of 13,8 months receiving OCR(1 patient worsened) None of the patients have had relapses or GD+ lesions prior or after OCR. T2 lesion burden showed no changes on cerebral MRI.
The main adverse events were infusion reactions, that appeared in 38,89% of patients (6fatigue, 1skin redness) None lead to treatment discontinuation. Infections appeared in 22,2% of patients (3urinary tract infection, 1herpes simplex reactivation) All solved with treatment.
None of the patient showed decrease in total lymphocyte count. 2 patients (11,1%) showed IgM index under lower limit of the normal range. All patients showed normal levels IgG index before and after OCR. Percentage of CD19+Cells diminished in all patients: median of 13%(previous) to 1%(after OCR) No clear assotiations between lymphopenia or low serum IgM was detected.
In our sample, 94,4% of PPMS patients treated with OCR show EDSS stabilization after 18 months of treatment. ARR and MRI parameters showed no changes. The main adverse events were mild infusion reactions(38,9%) and mild infections(22,2%)
The principal analytical finding was decrease of CD19+Cells and/or IgM decrease. No clear assotiations between lymphopenia or low serum IgM was detected.