Real World Lymphopenia Rates

Question 1

What is a fair summary of common and serious infection rates with FGD and DMF before this study was complete ?

Answer 1

FGD -Common infections seemed to correlate strongly with lymphonia rates, showing high frequencies (57%-75%) in moderate to severe lymphopenic patients. - Serious, signals may be appearing. ‘There have been increasing reports of opportunistic fungal (eg., disseminated cryptococcus) and viral infections (Prog MultiF Enceph).’ There were clear links between infection rates and rates of lymphopenia (70% reduction and plateau) and leukopenia with FGD.
DMF, common - not recorded. Serious - PML ‘there have been several reports of PML’ but no other serious opportunistic infections.

Question 2

Noticing increased signals for both common and serious infections (Warnke, 2014), why do the authors want to focus on lymphopenia rates ?

Answer 2

Common infections were at high levels in moderate to severe lymphopenic patients. In combined pivotal trial data for FGD, common infections increased from 57% to 75% between Grade 3 to Grade 4 lymphopenia respectively. For DMF, authors provided no data here.

Question 3

DMF Mod-Sev Lymph results ?

Answer 3

Re-categorised Mod-Sev Lymph for DMF is Grade 2 and Grade 3 in relation to PML. End of Year 2: 17%/11% = 28%…almost a third of DMF patients! Of equal concern is that end of year 3 most did not recover to healthier L levels ! This was intractable lymphopenia.

Question 4

FGD Mod-Sev Lymph results ?

Answer 4

[Grade 3b + Grade 4]
59% plus 17% = 76%
Almost 3 out 4 FGD patients were in cautionary lymph gradings.