Safety of different IVIG doses for treatment of CIDP. The ProCID study (P3-1.003)
Bibliographic record
Abstract
Objective: The Pro CID study evaluated efficacy and safety of different doses of IVIG (including high dose of 2 g/kg) in CIDP patients starting with a loading dose followed by 7 maintenance doses. Background: IVIG is commonly used in CIPD. Design/Methods: Patients were randomized to either low (0.5g/kg), standard (1.0g/kg) or high (2.0g/kg) maintenance dosing every 3 weeks (total duration: 24 weeks). Dosing was done by actual bodyweight with no upper limit per day. Patients had to stop or reduce their previous CIDP treatment (87% received corticosteroids) and needed to show deterioration prior to enrollment. Results: Overall 142 patients were enrolled. The mean IVIg amount/day was 76.5g (range 10.6g to 128g). Starting with the first infusion, the infusion rate could be increased stepwise to a maximum of 12mg/kg/min. Infusions were given over 2 consecutive days (= 1 infusion-cycle; patients receiving low or standard dosing, were infused with saline solution on the second day to keep blinding). In 971/982 infusion cycles (98.8%), the maximum infusion speed was reached at least once. In only 8 of 142 patients the highest possible infusion rate was not reached or infusion had to be interrupted and rate reduced due to adverse reaction (AR) occurring at the maximum infusion rate. 11 patients (7.75%) received premedication. Most common adverse reactions were headache, pyrexia, and dermatitis, with headache being the only AR showing a dose dependent effect with an incidence of 2.9%, 14.5% and 23.7% in the 0.5, 1.0 and 2.0g/kg group, respectively. The most serious adverse reaction related to IVIG was vomiting and headache (1 patient). In one patient, allergic dermatitis (related to study drug) led to study discontinuation. Conclusions: The ProCID study showed that Panyzga® infusions were well tolerated at high doses and high infusion rates and rarely needed premedication, even in IVIg naïve CIDP patients. Disclosure: Dr. Clodi has received personal compensation for serving as an employee of Octapharma Pharmazeutika Produktionsges. M.b.H. Dr. Cornblath has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Octapharma. Dr. Cornblath has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Annexon. Dr. Cornblath has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer. Dr. Cornblath has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Grifols. Dr. Cornblath has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cigna. Dr. Cornblath has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alnylam. Dr. Cornblath has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Anavex. Dr. Cornblath has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hansa. Dr. Cornblath has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MPTP. Dr. Cornblath has received intellectual property interests from a discovery or technology relating to health care. The institution of Dr. Van Doorn has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. The institution of Dr. Van Doorn has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hansa. The institution of Dr. Van Doorn has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunics. The institution of Dr. Van Doorn has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. The institution of Dr. Van Doorn has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Octapharma. The institution of Dr. Van Doorn has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Van Doorn has received publishing royalties from a publication relating to health care. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS Celgene. Dr. Hartung has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Geneuro. Dr. Hartung has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Hartung has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers Neurology. An immediate family member of Dr. Katzberg has received personal compensation for serving as an employee of Sanofi Genzyme. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Argenx. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Katzberg has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Octapharma. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Mrs. Hinterberger has received personal compensation for serving as an employee of Octapharma Pharmazeutika Produktionsges. M.b.H. Dr. Clodi has received personal compensation for serving as an employee of Octapharma Pharmazeutika Produktionsges. M.b.H.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".