My CIDP self-injected subcutaneous Immunoglobulin Sub-Q Immune Globulin or SCIG worldwide CIDP IgPro20 Hizentra Clinical Trial

This July 2015 I have begun participating in the CSL Behring Privigen IgPro10 versus Hizentra Sub-Q IgPro20 immunoglobulin clinical drug trial on CIDP that has the objective of determining the effectiveness self-injected subcutaneous IG or SCIG for CIDP Chronic Inflammatory Demyelinating Polyneuropathy. IgPro20 Hizentra® is a 20% subcutaneous IgG solution and is compared with the intravenous IVIG 10% IgG solution (IgPro10; Privigen®). Hizentra is not yet approved for CIDP but is used in much smaller doses for other autoimmune conditions. The IgPro20 version of IG doses will be varied also to test for the most effective dose to be administered for CIDP. In my latest campaign I have been receiving (Gamunex and Privigen) IVIG infusions monthly since March 2015 and this ended June 24, 2015 - see log of results at link ivig-cidp-effect-2015. On assessment of my CIDP situation it was found that I am "dependent" on immunoglobulin IG. Therefore my first two loading doses of IG under the trial will be be infused 140 g IG intravenously July 29&30, 2015 and will receive a further four Privigen IVIG infusions of 70 g IG every three weeks. This is the "stabilization phase" of the trial and the IgPro20 Hizentra subcutaneously infused version of IG will start thereafter.

 

I will try Hizentra Sub-Q "Off-Label" for my CIDP: On September 30, 2015 it was determined that my CIDP had deteriorated in the stabilization period and therefore I could not continue to participate in the IgPro20 Hizentra Clinical Trial. I received my last Privigen IVIG on that day. However, I will in any event switch to IgPro20 Hizentra at my own request. Starting October 8, 2015 II will administer the subcutaneous Hizentra twice weekly (a dose of 26 g or 130 mL Hizentra weekly - split in two doses over two consecutive days) for as long as I need it. The Hizentra dose is 1.53 times the monthly Privigen IVIG dose of 70 g.

 

With the help of my CIDP specialist doctors I will evaluate IgPro20 Hizentra effectiveness after six months. I am confident subcutaneous will be good for me but planning ahead I am thinking that I should try a longer campaign of Gamunex IVIG if IgPro20 Hizentra is not effective in the six months time period. I found it quite simple to self-administer Hizentra October 10, 2014 although I already made a mistake by infusing myself too fast. I felt the consequences (bulging abdomen for a day). I will continue to report on how my CIDP issues respond to Hizentra on this page commencing October 2015 -

Summary Sub-Q Hizentra IG Results Start October 9, 2015
» It took a month to settle in to the routine of Sub-Q - adjusting for efficacy & convenience
» Mid-November I see some stability in my CIDP and feel somewhat better overall than on IVIG

» November 24, 2015 I found the IVIG loading dose booster required for the trial and then weekly Sub-Q Hizentra (in particular) to be wearing me down this month November 2015
»
On November 24, 2015 nerve conduction studies determine that I have not improved, indeed somewhat deteriorated, since similar tests March 2015
»
Also November 24, 2015, my CIDP specialist stopped Hizentra (and all immunoglobulin) and await a reassessment in two months end January 2016 [This to me was the right decision]
»
The results of the Hizentra Sub-Q have not been encouraging but on the other hand the test period may have been way too short - only seven weeks!
»
I very notably deteriorated in the last month using Hizentra Sub-Q last infusion November 17, 2015 - I deteriorated in almost every respect with my overall index pushing up to 86% of where I was when I started March 2015!

» A notable exception was I measured astounding increases in hand strength while on Hizentra (see graph below) and for this reason I would like a re-trial but with NO loading doses and also a less brutal weekly Sub-Q regime

» Two 72 g Privigen IVIG loading doses July 30 and September 30, 2015 plus a switch from 4 to 3 weeks cycle boosted IG infusion volume about 75% for the Hizentra trial period!

» High dose IVIG or Sub-Q Hizentra (in particular) weekly has been proven to be 'overkill' and counter-productive in my case [Lower dose IVIG monthly may be more effective in my case]

» Year ends December 31, 2015 with quite disappointing results with little improvement in pretty much all my CIDP symptoms compared to March 2015. It is comforting that I have perhaps slowed progression, but pain I believe has intensified and seems impossible to control

» January Into February 2016 there is significant improvement as I recover from what I thought was the too heavy dosing of IVIG and Hizentra between July 2015 and November 2015 (at the point where all IG was suspended through February 2016

» However, bad news February 23, 2016 conductive studies showed I deteriorated further in this period

» February 26, 2016 I will have first infusion of three monthly of low dose IVIG - only 40g versus 70 usual. Let's see if this works to at least maintain me stable, keep cramps at bay and reduce the excruciating pain. I will post results at this link.

 

 

 

 

 

 

CIDP Symptoms Day-Score after Sub-Q December 2015 - No Infusions
                                                                         
  Symptom Complaint  Monthly December 2015  
   Symptom day-score 1-5: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31  
  end of day: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31  
    Sub-Q brand and day >                                                                  
1 Breathing Issue
1.1 gasping events 2 2 2 1 2 1 1 1 3 2 2 4 3 3 3 4 2 2 3 2 3 2 2 2 2 4 2 2 2 2 3
1.2 running 2 0 0 0 0
1.3 punched-in-stomach 3 2 3 2 3 2 2 1 2 2 3 2 2 1 1 2 2 2 4 2 3 3 3 3 3 5 5 4 4 2 4
1.4 left diaphragm pain 1 1 1 1 2 1 1 1 1 1 1 1 1 1 1 1 2 1 3 1 1 1 2 2 3 4 4 2 1 1 2
2 Swallow-throat-voice 3 4 3 3 3 3 1 2 2 2 2 3 2 2 2 3 1 2 2 2 2 1 3 2 3 5 4 4 4 4 3
3 Leg solid-pain-cramp 2 3 2 2 3 2 1 2 2 2 2 3 3 3 3 4 3 3 4 4 2 3 2 2 2 3 5 5 5 3 4
4 Right Foot Pain 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1
5 Left Leg Use Issues 3 2 2 2 2 1 2 1 2 2 1 2 1 1 1 1 1 1 2 2 1 1 1 1 2 2 3 2 3 2 2
6 Upper body weakness
6.1 hand pain & weak 3 2 3 3 2 2 1 1 1 1 1 1 1 3 1 3 3 3 3 2 2 3 4 2 3 3 3 3 4 4 4
0 lower back weak 2 2 2 1 3 2 2 2 3 1 2 1 1 1 1 1 2 2 3 3 3 2 2 2 4 5 4 3 3 3 4
6.2 arms & shoulders 3 1 1 1 1 2 2 2 2 2 2 1 2 2 1 1 2 2 3 3 2 3 2 2 3 3 3 3 4 4 4
7 Eye Wave / Vibration 1 1 1 1 1 1 1 1 1 1 1 1 2 2 1 1 1 1 1 2 1 2 3 2 2 3 2 2 2 2 2
8 Fasciculation's 2 3 3 3 3 2 3 3 3 4 3 3 3 3 3 3 4 3 4 5 3 3 3 3 3 5 4 5 5 4 5
9 Pressure sensitivity 2 2 2 2 2 2 3 2 2 2 2 2 2 2 1 2 2 2 2 3 2 3 3 2 3 3 3 3 3 3 4
10 Balance Average
10.1 motion difficulty 3 2 3 2 3 2 2 2 2 2 2 2 2 3 2 2 3 3 4 3 2 3 2 3 3 4 3 3 3 3 4
10.2 disorientation 2 1 2 1 4 2 2 2 2 2 1 1 1 2 1 2 3 2 3 3 2 3 3 3 3 4 3 3 3 3 4
10.3 near fainting 1 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 4 2 4 1 3 4 2 3 3 3 4
11 Sea-Sick Feeling 2 3 3 1 2 2 2 1 1 1 1 1 1 1 0 0 2 1 4 3 3 3 4 3 5 5 5 5 5 4 4
12 Digestive Discomfort 4 3 3 1 2 2 2 1 2 2 2 2 2 3 2 4 3 3 3 4 2 3 2 3 3 5 5 3 4 3 4
OVERALL LOG  3 3 3 2 3 2 2 2 2 2 2 3 3 3 3 3 3 3 4 4 2 3 4 4 4 4 4 4 4 4 4
 - average log day score 2 2 2 2 2 2 2 1 2 2 2 2 2 2 1 2 2 2 3 2 2 2 3 2 3 4 3 3 3 3 3
No infusions December 2015 - Last Hizentra Sub-Q November 17, 2015  

 

IVIg Effectiveness Day-Score Log Infusion Plus Sub-Q November 2015
                                                                       
  Symptom Complaint  Monthly November 2015  
   Symptom day-score 1-5: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30  
  end of day: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30  
    Sub-Q brand and day >     H H           H H           H H             > Sub-Q end    
1 Breathing Issue
1.1 gasping events 1 2 1 1 2 2 2 2 3 3 1 1 1 2 3 1 1 1 1 2 2 1 2 1 2 2 2 2 2 1
1.2 running 3 3 4 1 2 2 2 1 2 0 0
1.3 punched-in-stomach 2 2 2 2 2 2 2 3 3 3 3 2 3 3 3 2 3 2 3 3 3 2 2 2 2 4 4 3 2 3
1.4 left diaphragm pain 1 1 1 1 2 1 2 1 2 1 1 1 2 3 2 1 1 1 1 1 2 1 1 1 1 2 2 1 1 1
2 Swallow-throat-voice 2 1 1 1 2 2 2 3 3 3 2 1 2 4 4 1 1 1 2 2 3 1 3 3 3 3 3 3 3 3
3 Leg solid-pain-cramp 4 2 3 4 2 3 2 2 4 2 2 2 3 3 3 2 2 2 2 2 3 2 2 1 1 3 2 4 3 2
4 Right Foot Pain 1 0 0 1 1 1 2 1 1 1 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
5 Left Leg Use Issues 3 3 2 4 3 4 4 5 4 3 3 3 3 5 3 3 2 2 2 3 4 1 1 2 2 2 2 2 2 2
6 Upper body weakness
6.1 hand pain & weak 3 3 3 2 2 2 2 1 3 2 2 2 3 2 2 2 2 4 4 4 4 3 1 2 2 2 4 3 3
6.2 arms & shoulders 3 3 3 3 3 2 2 3 4 4 3 2 4 3 2 3 2 3 3 3 3 3 2 2 2 2 1 2 2 3
7 Eye Wave / Vibration 3 2 1 2 3 2 2 3 2 2 2 2 3 3 2 2 1 1 1 1 2 3 2 1 1 1 2 2 1 1
8 Fasciculation's 3 2 2 2 2 2 2 3 2 3 2 2 3 3 2 3 3 2 2 2 2 3 2 2 2 3 3 4 1 2
9 Pressure sensitivity 2 2 2 2 2 2 2 2 2 4 3 3 2 3 2 2 2 3 3 4 3 2 2 2 2 3 3 3 2 2
10 Balance Average
10.1 motion difficulty 4 3 2 3 2 3 3 3 2 2 2 2 3 2 2 3 2 3 2 2 3 2 1 1 1 2 2 3 2 3
10.2 disorientation 3 3 2 3 2 2 3 3 2 2 3 2 4 3 3 2 2 2 2 2 2 2 1 1 1 3 2 3 3 2
10.3 near fainting 2 1 0 1 0 0 1 0 0 0 0 0 1 0 0 0 0 2 0 0 0 0 0 0 0 3 2 1 2 2
11 Sea-Sick Feeling 4 3 1 1 1 1 3 4 1 2 1 1 4 3 3 3 2 3 3 3 3 1 0 0 0 2 2 2 1 2
12 Digestive Discomfort 5 3 1 1 3 2 2 3 1 2 2 1 2 2 2 2 3 3 2 3 2 2 2 2 3 3 3 3 2 2
OVERALL LOG  2 2 2 3 3 3 2 4 3 3 3 2 2 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 3 3
 - average log 3 2 2 2 2 2 2 2 2 2 2 2 3 3 2 2 2 2 2 2 2 2 1 1 1 2 2 2 2 2
70 g Privigen booster infused 150 mL/h max Sep 30, 2015 followed by Sub-Q IgPro20 Oct 8, 2015  
IVIG Side-effects & Unexpected (0 - 5)
Lip blister-scab 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 2 1 0 0 0 0 0 0 0 0 0
Mouth sores 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Feeling Tired 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 4 2 0
Body rash-scabs & pain 1 1 1 1 1 1 1 1 1 1 1 2 1 2 1 1 1 2 2 2 2 2 1 1 1 1 1 1 1 1
Hizentra Red Eyes 0 2 1 0 0 1 2 1 1 1 1 0 0 s x x x x x x
Hizentra Cough or Hoarse 1 0 1 1 1 0 1 1 0 1 0 1 0 1 1 2 2 1 1 2 2 1 1 t x x x x x x
Hizentra Digest-Upset 0 0 0 1 2 3 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 o x x x x x x
Hizentra Belly Discomfort 2 1 1 1 0 0 2 2 1 3 2 1 1 2 1 1 2 1 1 0 0 0 1 p x x x x x x
0 H H 0 0 0 0 0 H H 0 0 0 0 0 H H 0 0 0 0 0 0 > Sub-Q end x x x
Treatment (number taken or applied)
Benadryl regular pills 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Benadryl as mouthwash 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Abreva lip cold sore balm 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Low dose Aspirin 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 2 1 0 0
end of day: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 32

 

IVIg Effectiveness Day-Log Infusion Plus SCIG Sep 30, 2015 - Oct 31, 2015
                                                                           
  Symptom Complaint  Sep October 2015 >Hizentra start  
   Symptom detail on date: 30 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31  
  end of day: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32  
        P               H H       H H       H H H     H H H      
1 Breathing Issue
1.1 gasping events 1 1 1 2 3 3 2 2 2 2 2 2 3 2 2 2 1 1 1 1 1 1 1 1 1 1 1 2 1 1 1 1
1.2 running 1
1.3 punched-in-stomach 1 2 2 3 2 4 4 3 3 3 3 3 3 4 2 2 2 2 2 1 1 1 1 2 2 3 3 3 2 2 2 2
1.4 left diaphragm pain 1 2 2 2 2 2 2 2 2 2 2 2 2 3 2 3 2 2 2 2 1 1 1 1 1 1 1 1 1 1 1 1
2 Swallow-throat-voice 2 2 2 3 3 3 4 4 2 2 2 3 2 3 3 4 2 2 1 1 2 3 3 2 2 3 2 2 3 4 2 2
3 Legs solid or cramp 1 2 1 2 2 3 2 2 3 3 2 2 2 1 1 1 1 2 2 2 2 2 1 1 1 2 1 3 2 5 3 2
4 Right Foot Pain 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
5 Left Leg Use Issues 3 3 2 2 3 3 2 2 2 2 2 3 3 2 2 3 3 3 2 2 3 3 3 3 3 3 3 3 2 3 3 3
6 Upper body weakness
6.1 hand pain & weak 3 3 3 3 3 3 3 1 1 2 2 3 3 3 2 3 2 3 3 3 2 3 1 1 2 1 1 1 1 1 1 1
6.2 arms & shoulders 3 3 3 3 3 3 3 2 2 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2
7 Eye Wave / Vibration 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 2 1 2 1 1 1 2 1 2
8 Fasciculation's 1 2 1 1 2 1 1 1 1 3 2 1 1 1 1 1 1 1 1 2 2 2 1 2 3 2 1 1 2 4 2 2
9 Pressure sensitivity 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 2 2 2
10 Balance Average
10.1 motion difficulty 2 2 2 2 3 3 2 2 2 3 2 2 2 2 2 2 2 2 2 2 2 3 3 3 2 3 2 2 2 3 3 3
10.2 disorientation 2 3 3 2 2 2 2 2 2 3 2 1 1 4 3 2 2 2 2 2 3 3 4 2 1 2 2 2 3 4 3 4
10.3 near fainting 1 2 2 2 2 2 1 0 0 0 0 0 0 5 2 2 1 1 1 1 2 1 1 1 0 0 1 1 2 3 2 3
11 Sea-Sick Feeling 0 0 0 0 0 1 1 0 0 0 1 0 0 4 2 3 3 3 2 2 2 3 3 2 2 3 2 3 2 2 2 3
12 Digestive Discomfort 2 2 2 2 4 4 4 3 3 2 2 2 2 4 3 3 2 3 2 2 1 2 2 2 2 2 2 3 2 2 2 2
OVERALL LOG  3 3 3 3 3 2 2 2 2 2 2 3 3 4 3 2 3 3 3 3 3 3 2 2 3 2 3 3 3 3 2 2
  70 g Privigen booster infused 150 mL/h max Sep 30, 2015 followed by SC IgPro20 Oct 8, 2015  
IVIG Side-effects & Unexpected (0 - 5)
Lip blister-scab 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Mouth sores 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Feeling Tired 0 0 0 0 0 0 0 0 0 0 0 0 3 4 1 2 3 4 5 3 2 1 2 1 0 0 0 0 1 1 2 1
Body rash-scabs 1 1 1 1 1 2 1 1 2 2 2 2 3 2 2 2 3 3 3 3 2 2 2 2 2 2 2 2 2 2 2 1
Hizentra Cough  3 3 4 5 4 5 2 1 1 1 1 0 1 1 1 1 1
Hizentra Belly Discomfort - - - - - - - - 2 4 4 3 3 4 1 2 2 1 1 0 0 1 2 2 1 1 1 3 2 2 2 2
Treatment (number taken or applied)
Benadryl regular pills 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Benadryl as mouthwash 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Abreva lip cold sore balm 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Low dose Asprin 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
end of day: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32

Why I am Participating in the IgPro20 Hizentra Trial for CIDP:

  • Possible better outcome: Subcutaneous IG may result in a better CIDP outcome for me than intravenous IG IVIG
  • Good monitoring: I will be receiving much better close monitoring of my CIDP (especially periodic revealing nerve conductive studies) as I am deeply concerned about my accelerated progression 2015
  • IVIG infusion side-effects: Subcutaneous IG may have less side-effects than IVIG. Dependence on immunoglobulin is depressing and tough on the body. IVIG side-effects for me include a mild flue-like symptoms in the first ten days after each infusion, painful body scabbing rash lasting fifteen days, temporary disfiguring large lip scabs, inflamed red eyes and eye-lids lasting about five-days and sometimes inside mouth sores for five days (the latter at first was severe but no-longer as I seem to have got used to it after four years of IVIG)
  • Sustained campaign of IG: I will have eight months of IVIG and another four months of SCIG*: The lengthy campaign will help me decide IG effectiveness overall and also whether periodic or longer term are best for me. It could also assist my doctors determining the best loading amount of IG I should have
  • Treatment convenience: Freedom to travel - required for my heavy business commitments
  • Contribution to CIDP science: I would like to contribute to CIDP knowledge generally and indeed I am very interested in hearing from scientists and entrepreneurs who have IVIG business ideas (especially on more efficient production that could reduce the costs of immunoglobulin)

* There is a 33% probability (one in three groupings) that I will receive a placebo rather than the IgPro20 as it is a double blind trial. I will have the same likelihood of receiving a low-dose or high-dose IgPro20 as dosage levels are also being investigated in the clinical trial for Chronic Inflammatory Demyelinating Polyneuropathy CIDP.