Janssen&Janssen schreef op 19 juli 2022 21:35:
Volgens sommige hier is het profylaxe verhaal voor pharming een NO GO en is het zelfs over en uit op termijn voor de acute behandeling. Omdat er voldoende andere betere medicijnen zijn.
Sommige van deze noemen zich de ….. expert, dan moet je het wel weten want een expert mag je jezelf niet zomaar noemen, dan heb je kennis van zaken…..
Ik vraag me af wie de toekomst van pharming beter kent. pharming zelf of sommige diehards op een forum die menen pharming te kennen. Ik gok voor keuze 1 want anders hebben alle diehards de volgende info bewust verzwegen, omdat anders hun verhaal niet meer geloofwaardig overkomt..
pharming is momenteel nog altijd bezig met een profylaxe toepassing voor HAE, in samenwerking met het UMC Utrecht.
Artikel moet nog gepeer reviewd worden want het is kakelvers geplaatst op 15 juli 2022
Recombinant human C1 esterase inhibitor as prophylactic treatment in idiopathic non-histaminergic angioedema
onlinelibrary.wiley.com/doi/10.1111/a...onlinelibrary.wiley.com/action/downlo...Patients aged 18 years and older suffering from AE attacks with at least two attacks per month during the last six months despite prophylactic treatment with four times the standard daily dose of antihistamines, and no known cause for AE were eligible for inclusion. Additionally, C4 levels and C1-esterase inhibitor (C1-INH) function of functional levels were required (C4>0.1 g/L and C1-INH function > 0.63 U/ml). Patients were excluded in cases of accompanying wheals; pregnancy or breastfeeding; a history of rabbit allergy; ACE-inhibitor use in the past six months; recent or current use of methotrexate, azathioprine, mycophenolic acid, omalizumab or cyclosporine. Patients with clinically relevant conditions that had the potential to compromise the safety of the patient such as renal or hepatic insufficiency or malignancies or when another diagnosis was deemed more likely (e.g. allergic AE, drug-hypersensitivity, mastocytosis or HAE) were also excluded. All patients continued to use 4dd antihistamines in order to reduce the risk of bias due to alterations in treatment other than the initiation of rhC1-INH. Patients were allowed to use rescue medication during acute AE attacks including antihistamines, oral steroids and intramuscular adrenaline.
All patients provided written informed consent, and the study was approved by the local ethics committee (protocol number 17-139).
All enrolled patients completed a four-week observation period, followed by an eight-week treatment period with rhC1-INH (Recombinant human C1 esterase inhibitor (rhC1-INH), Conestat alfa/Ruconest®; Pharming Technologies; Leiden , The Netherlands), followed by another four-week observation period (Supplemental figure 1). Throughout the entire trial, patients continued using 4 doses daily antihistamines. The total dose of rhC1-INH was calculated based on body weight (50 IU/kg; max 4200 IU) and was twice-weekly administered intravenously over a time course of five minutes.
A detailed medical history and physical examination were recorded at first visit and adverse events and concomitant drug use were registered at each following visit.