Serum Ig levels

Overview1

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

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: Change in serum IgG levels

change in serum IgG levels in patients with RMS
change in serum IgG levels in patients with PPMS

Clinical trial population: Relationship between rates of SIs and Ig values

rates of serious infections associated with IG levels above or below the LLN
Indications vary in different countries. The local prescribing information from your country is the primary source of information on the known and potential risks associated with ocrelizumab.

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

  1. Hauser SL, et al. Neurology 2021;doi:10.1212/WNL.0000000000012700;
  2. Mehling M, et al. PLoS ONE 2013;8:e78532.

M-XX-00007060 (Date of preparation: October 2021)