Serum Ig levels
Impact on lgG
- As of January 2020, following regular, 6-monthly dosing of OCR 600 mg, a mean reduction in serum IgG levels of approx. 3% per year was seen
- IgG levels remained above LLN for the majority of patients (>90%), over a period of up to 7 years
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SI types and outcomes
- The type, severity, duration, and outcome of SIs observed during episodes of Ig <LLN were similar to the overall population treated with OCR, and to the general MS population
lgG levels and SI incidence
- While incidence of SIs was low, an apparent association between decreased IgG and SIs was observed (but less apparent for IgM and IgA)
- All patients with a SI associated with low IgG recovered
- Few patients had to discontinue OCR due to a SI associated with Ig <LLN
Clinical trial population: Relationship between rates of SIs and Ig values
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).
Abbreviations
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.
References
- Hauser SL, et al. Neurology 2021;doi:10.1212/WNL.0000000000012700;
- Mehling M, et al. PLoS ONE 2013;8:e78532.
M-XX-00007060 (Date of preparation: October 2021)