Clinical trial population: Change in serum IgG levels
*In patients treated with IFN, an increase in serum IgG levels was observed over a 2-year period. This is consistent with previous findings from other groups.2
Data on proportion of patients with immunoglobulin levels <LLN shown only until Week 312, as data at Week 336 are not mature. The proportion of patients randomised to OCR in the OPERA population with IgG levels <LLN was 1.5% at Week 96, and 7.7% at Week 312 (OCR/OCR data). Similarly, the proportion of patients randomised to OCR in the ORATORIO population with IgG levels <LLN was 1.1% at Week 120, and 5.1% at Week 312 (OCR/OCR data).
BL, baseline; CTP, controlled treatment period; IFN, interferon; Ig, immunoglobulin; LLN, lower limit of normal; OCR, ocrelizumab; OLE, open-label extension; PBO, placebo; PPMS, primary progressive MS; PY, patient-years; RMS, relapsing MS; SI, serious infection.
M-XX-00007060 (Date of preparation: October 2021)