Terzi Murat, Boz Cavit, Demir Caner Feyzi, Cilingir Vedat, Helvaci Elif Merve
Objective: To evaluate the efficacy and safety of OCR in a real-world setting.
Methods: Clinical data for patients aged ≥ 18 years with relapsing forms of MS or Primary Progressive MS (PPMS) were retrospectively collected from medical records. The main efficacy outcomes were several relapses and a proportion of patients free from relapses, disability progression, and brain MRI activity (gadolinium [gd+] enhanced and new t2 lesions).
Results: A total of 460 patients were included: 246 with relapsing-remitting MS (RRMS), 196 Progressive Relapsing MS (PRMS), and 18 PPMS. The patients were 58.6% females with a mean age of 46.8 years. Fingolimod was the most commonly used disease-modifying therapy (DMT; 35.2%), followed by interferon β 1a+1b+glatiramer acetate (23.9%), and teriflunomide (10.4%) before OCR. The mean Expanded Disability Status Scale (EDSS) was 4.91 in PPMS, 4.90 in PRMS, and 4.45 in RRMS and almost remained unchanged during treatment. The number of relapses was 2.04 and 1.01 at 12 months before OCR in PRMS and RRMS, respectively, and decreased to 0.30 at 6 months and 0.21 at 12 months in PRMS (p=0.000) and 0.13 at 6 months and 0.09 at 12-month in RRMS (p=0.000) after OCR initiation. The reduction in new T2 lesions was statistically significant. Infusion-related reactions (IRRs) occurred in 8.91% of the patients. OCR discontinuation rate due to IRRs was 2.83%.
Conclusions: This study showed that OCR was associated with a statistically significant reduction in the number of relapses and T2 lesions. However, the number of patients was low which led to a severely limited quantity of data collected and thus resulting in a limited informative value of the analysis results.