Saturday, May 31, 2014

FDA is Reconsidering Lemtrada

From the great resource available at multiple-sclerosis-research.blogspot.com comes this news:

Friday, 30 May 2014


Alemtuzumab: Will the FDA be moved?

"Some news regarding alemtuzumab. The FDA has accepted Genzyme’s resubmission of Alemtuzumab for the treatment of relapsing forms of MS. A 6-month review period has been assigned and Genzyme expects an FDA decision before the end of the year. Please note that the resubmission is based on data from the same clinical studies included in the original submission, but provides supplemental analyses and additional information to specifically address issues previously noted by the FDA in its response to the alemtuzumab submission."

"I am quietly confident that the FDA will now license Alemtuzumab, which will save US MSers from having to travel abroad for treatment."


"The full press release can be read below." - Dr. Ben Turner, London

http://multiple-sclerosis-research.blogspot.com/2014/05/alemtuzumab-will-fda-be-moved.html

The entire press release is available on this link.

I hope Lemtrada is available to all in the US in early 2015- MSers need options. 

Week 8 Labs

Week 8 Labs are below. No problems. Some evidence of immune recovery. If you have any questions about these tests please ask by posting a comment on the blog. I can answer you in a private email or with a blog post.

*Thanks to Cat for asking today about ITP- see below under the CBC header. Her great question prompted me to go out and look for an answer I had not even considered. We are all learning this together and post-market research will continue to bring more answers.

Summary
CMP is completely normal. A few protein tests were slightly off last time, but were not significant. Importance of this panel- no evidence of Kidney or Liver problems.

CBC
Total white blood cells are the same. Absolute Neutrophils (a type of WBC) are increasing. The RDW that is high on both labs is just showing that my % of red cells is greater than normal- this is to be expected, as my total white cells are lower, or course in the whole sample there are more red vs white.

Platelets are important to monitor here as well. There is a side effect of Lemtrada that can cause a low platelet count called ITP. This usually manifests 24 months (2 years) after your first dose. As long as we monitor it any problems will be caught in advance and are easily treated and resolve within a week.

During my first month post Lemtrada I abstained from Motrin (used infrequently for headache, but it lowers platelets so I abstained). Turns out Motrin works best for me for the occasional headache and with one or two doses of Motrin in the past 4 weeks my platelets are back to my 'baseline'. Platelets are truly considered a problem when they are less than 50. I have even seen patient's counts get as low as 30 before treatment. So there is plenty of cushion to catch this potential side effect.

Lymphocyte Subset Panel
At week 4 all my CD3, CD4, CD8 & CD19 cells were 'undetectable' below 20. They are all now improving. This shows the immune reconstitution has begun and is happening across the board. These CD markers are present on the cell surface of WBCs- so reflect types of WBCs. The change across the board in this panel is all good news.

Urine Testing
Urine is tested to detect a rare kidney problem called Goodpastures Syndrome. I test for this twice weekly at home with a testing kit used in doctor's offices. This syndrome is rare and presents itself in 2-3 years after first dose. It needs to be caught within 3 days, hence my choice of testing. This syndrome is serious but so rare that the required testing by the drug protocol is only every 4 weeks. It is my belief if you are going to take this potential complication seriously it is important to test at least twice a week. Additional testing at a lab site is not something I think is needed with my current at home testing.


Baseline
5/2/2014
5/30/2014
Normal Range
CMP

Glucose
70
86
98
65-99
mg/dL
BUN
16
17
13
7-25
mg/dL
Creatinine
0.94
0.96
0.99
.5-1.10
mg/dL
eGFR
76
74
71
> OR = 60
mL/min/1.73m2
B/Creatinine Ratio
n/a
n/a
n/a
6-22
(calc)
Sodium
139
138
140
135-146
mmol/L
Potassium
3.6
4.9
4.5
3.5-5.3
mmol/L
Chloride
106
106
109
98-110
mmol/L
Carbon Dioxide
25
23
22
19-30
mmol/L
Calcium
8.7
9.1
9.3
8.6-10.2
mmol/L
Protein, Total
5.7
6
6.2
6.1-8.1
g/dL
Albumin
3.7
4.2
3.9
3.6-5.1
g/dL
Globlulin
2
1.6
2.3
1.9-3.7
g/dL
Albumin/Globulin Ratio
1.9
2.3
1.7
1.0-2.5
(calc)
Bilirubin total
0.3
0.4
0.3
0.2-1.2
mg/dL
Alkaline Phosphatase
80
76
56
33-115
U/L
AST
15
15
14
10-30
U/L
ALT
13
12
13
6-29
U/L
CBC

White Blood Cell Count
9.3
3.2
3.1
3.8-10.8
Thousnd/uL
Red Blood Cell Count
4.45
4.5
4.54
3.90-5.10
Million/uL
Hemoglobin
13.1
13.4
13.5
11.7-15.5
g/dL
Hematocrit
38.6
39.8
39.9
35-45
%
MCV
86.7
88.5
87.9
80-100
fL
MCH
29.3
29.7
29.7
27-33
pg
MCHC
33.8
33.5
33.8
32-36
g/dL
RDW
14.9
16.9
15.6
11-15
%
Platelet count
183
228
189
140-400
Thousnd/uL
Absolute Neutrophils
4957
2854
2403
1500-7800
cells/uL
Absolute Lymphocytes
3357
112
288
850-3900
cells/uL
Absolute Monocytes
660
205
282
200-3900
cells/uL
Absolute Eosinophil
288
22
112
15-500
cells/uL
Absolute Basophils
37
6
16
0-200
cells/uL
Neutrophils
53.3
89.2
77.5

%
Lymphocytes
36.1
3.5
9.3

%
Monocytes
7.1
6.4
9.1

%
Eosinophils
3.1
0.7
3.6

%
Basophils
0.4
0.2
0.5

%


Thyroid

TSH
1.45
0.95

.40-4.50
mU/L
Reflex to T4
n/a
n/a





T & B Subset
5/8/2014

% CD3 (Mature T Cells)

7
97
57-58
%
Absolute CD3+ cells

<20
316
840-3060
cells/uL
% CD4 (Helper Cells)

3
7
30-61
%
Absolute CD4+ cells

<20
23
490-1740
cells/uL
% CD8 (Suppressor T Cells)

3
85
12-42
%
Absolute CD8+ cells

<20
276
180-1170
cells/uL
Helper/Suppressor Ratio

1.1
0.08
.86-5.00

% CD19 (B Cells)

3
2
6-29
%
Absolute CD19+ cells

<20
<20
110-660
cells/uL
Absolute Lymphocytes

138
325
850-3900
cells/uL






Urinalysis 

Urine Culture

normal



Urinalysis Microscopic

normal