Ocrelizumab is an anti-CD20 humanized monoclonal antibody approved for the treatment of relapsing-remitting multiple sclerosis
To describe baseline characteristics of patients with RRMS treated with OCR. Analyze previous disease modifying treatments(DMT), reasons to change, safety and laboratory parameters
Retrospective observational study in patients with RRMS treated with OCR from November 2016 to May 2020 at Virgen Macarena Hospital, Seville, Spain.
Demographic/disease characteristics, ARR, previous DMTs, reasons to change DMT, adverse events changes in disability, and cerebral MRI findings were collected at enrolment.
38 RRMS patients were treated with OCR (65,8%females) Mean follow-up after OCR initiation:11,4 months (1-40) 47,4% have received two or more cycles of treatment.
Average age was 39.8 years (21-58) Mean time since RRMS diagnosis was 9,9 years (0,3-26,2) The patients had been treated with a mean of 1,5DMT prior to OCR. 3 of them were treatment naïve. DMT previous OCR was IFN-b 2pax, glatiramer acetate 2pax, teriflunomide 4pax, dimethyl fumarate 3pax, rituximab 1pax, fingolimod 16pax, natalizumab 3pax, alemtuzumab 3pax. The reason to DMT change were: lack of efficacy:32 pax; security:6 pax (vJC seroconversion or alemtuzumab contraindications)
After 11,4 months of OCR initiation, annualized relapse rate (ARR) decreased from 1,2 to 0, and the EDSS score remained unchanged: mean 3,8 (1,5-6,5). None of the patients had relapses after OCR initiation.
Regarding cerebral MRI parameters, Gd+ lesions diminished from 1,3 previous to 0 after OCR. T2 lesion burden showed no changes on cerebral MRI.
The more frequent adverse events were infusion reactions (26,32% of patients: 4 fatigue; 3 headache; 3 redness skin; 2 allergic reaction) All of them were mild but in two patients lead to treatment discontinuation (allergic reaction). Infections occurred in 3 patients (2 urinary tract infection, 1 zoster reactivation)
Five patients (13,2%) showed decrease in total lymphocyte count (3 grade 1; 2 grade 2) 18,9% patients 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 14%(previous) to 1%(after OCR) No clear associations between lymphopenia/immunoglobulines and infections was detected.
This data shows that RRMS patients treated with OCR in a real world clinical setting show significant decreases in ARR and the majority maintain EDSS score unchanged. The most common adverse event were mild infusion reactions and mild infectious diseases. Some patients showed lymphopenia and IgM below lower limit of normal. No clear associations between lymphopenia/immunoglobulines and infections was detected.