Predictors of Ocrelizumab Effectiveness in Patients with Multiple Sclerosis

Maria Cellerino, Giacomo Boffa, Caterina Lapucci, Francesco Tazza, Elvira Sbragia, Elisabetta Mancuso, Nicolò Bruschi, Simona Minguzzi, Federico Ivaldi, Ilaria Poirè, Alice Laroni, Gianluigi Mancardi, Elisabetta Capello, Antonio Uccelli, Giovanni Novi, Matilde Inglese

Research output: Contribution to journalArticlepeer-review

12 Scopus citations


Data regarding effectiveness and safety of ocrelizumab in the post-marking setting are lacking. The aim of our study was to provide effectiveness and safety data of ocrelizumab treatment in patients with relapsing–remitting (RR-) and progressive multiple sclerosis (PMS) and to evaluate clinical and immunological predictors of early treatment response. In this single-center prospective observational study, we investigated effectiveness outcomes (time-to-confirmed disability worsening, time-to-first relapse, time-to-first evidence of MRI activity and time-to-first evidence of disease activity), clinical and immunological predictors of early treatment response, and incidence of adverse events (AEs). One hundred and fifty-three subjects were included (93 RRMS; 84 females). Median follow-up was 1.9 (1.3–2.7). At 2-year follow-up (FU), disability worsening-free survival were 90.5%, 64.7%, and 68.8% for RRMS, primary-progressive MS (PPMS), and secondary-progressive MS (SPMS) patients, respectively. At 2-year FU, 67.1%, 72.7%, and 81.3% of patients with RRMS, PPMS, and SPMS were free of MRI activity, with NEDA-3 percentages of 62.1%, 54.6%, and 55.1%, respectively. Lower baseline EDSS was independently associated with a reduced risk of disability worsening (HR(95%CI) = 1.45(1.05–2.00), p = 0.024) and previous treatment exposure was independently associated with increased probability of radiological activity (HR = 2.53(1.05–6.10), p = 0.039). At 6-month FU, CD8 + cell decrease was less pronounced in patients with inflammatory activity (p = 0.022). Six patients (3.9%) discontinued ocrelizumab due to severe AEs. Our findings suggest that ocrelizumab is an effective treatment in real-world patients with RRMS and PMS, with a manageable safety profile. Better outcomes were observed in treatment-naïve patients and in patients with a low baseline disability level. Depletion of CD8 + cells could underlie early therapeutic effects of ocrelizumab.

Original languageEnglish
Pages (from-to)2579-2588
Number of pages10
Issue number4
StatePublished - Oct 2021


  • Advanced multiple sclerosis
  • CD8
  • Highly active multiple sclerosis
  • Multiple sclerosis
  • Ocrelizumab


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