Safety of different IVIG doses for treatment of CIDP. The ProCID study (P3-1.003)
Notice bibliographique
Résumé
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.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».