Real-world Patient Profile and Treatment Persistence of Ocrelizumab in Multiple Sclerosis: A Retrospective Analysis in Latin America

Multiple sclerosis is a chronic inflammatory disease of the CNS that leads to focal plaques of primary demyelination and diffuse neurodegeneration in the grey and white matter of the brain and spinal cord 1. In most patients, the disease starts with a relapsing-remitting course (RRMS), which is followed several years by a secondary progressive phase (SPMS). Patients with primary progressive disease (PPMS) miss the relapsing and remitting stage and start with uninterrupted progression from disease onset 1-3.

It has been almost 25 years since the publication of the pivotal trial results for the first disease-modifying therapy (DMT) for RRMS 4. Currently disease modifying therapies (DMTs) for MS approved by the European Medicine Agency (EMA) and Food and Drug Administration (FDA) include interferon beta (IFNβ) 1-a and 1-b, glatiramer acetate (GA), mitoxantrone, natalizumab, fingolimod, teriflunomide, dimethyl fumarate, alemtuzumab, daclizumab and ocrelizumab 5-7.

Ocrelizumab was approved in March 2017 for the treatment of relapsing or primary progressive MS 8. A phase II trial established 600 mg intravenously every 6 months as the preferred dosing schedule. Two phase III trials evaluated the efficacy of ocrelizumab in patients with relapsing remitting MS, and individual and pooled analysis demonstrated a significant reduction in annualized relapse rate (P < 0.001 pooled), disability progression at 12 weeks ( P < 0.001 pooled), and gadolinium-enhancing lesions on magnetic resonance imaging (MRI; P < 0.001) 8. Patients with PPMS were evaluated in a third phase III trial, which showed a significant decrease in disease progression at 12 weeks ( P = 0.03) and volume of T2-weighted lesions on MRI ( P < 0.001) 8. As with other monoclonal antibodies, adverse effects seen with ocrelizumab were primarily infusion-related reactions and infection8. Despite much information exists about efficacy and safety of ocrelizumab in phase III clinical trials, scarce evidence exists regarding real world patients profile and safety.

The aim of this study is therefore to evaluate patient profiles and persistence to treatment during follow up in a retrospective study of patients who had been prescribed ocrelizumab for the treatment of MS in Latin America (LATAM)

Methods