- |||||||||| Gammanorm (human immune globulin subcutaneous) / Octapharma
Journal: Subcutaneous immunoglobulin 16.5% for the treatment of pediatric patients with primary antibody immunodeficiency. (Pubmed Central) - Nov 9, 2022 This review provides an overview of PIDD with a focus on SCIG treatment, including the properties and clinical trial results of a new SCIG 16.5 % (Cutaquig, Octapharma) in pediatric patients...The importance of early diagnosis and treatment in the pediatric patient population cannot be overstated. The safety, efficacy, and tolerability of SCIG 16.5% have been demonstrated in pediatric patients with PIDDs providing an additional therapeutic option in this vulnerable population.
- |||||||||| Nuwiq (simoctocog alfa) / Octapharma
Prophylactic Treatment of Severe Haemophilia a Patients with Inhibitors to FVIII with Peglip-FVIII (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_3892; The dosing interval of 5.5days at 35IU/kg represents a significant reduction in FVIII infusion frequency. Acknowledgements: The Authors acknowledge the co-operation of the following clinicians in undertaking the study: Nadezhda Zozulia1, Margarita Timofeeva2, Tatiana Pospelov32, Marina Kosinova4, Igor Kurtov5, Heghine Khachatryan6.
- |||||||||| Wilate (human factor VIII/von Willebrand factor) / Octapharma
Early Experiences in the Von Willebrand Factor in Pregnancy (VIP) Study (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_1978; P=N/A The VIP study aims to address the knowledge gap regarding bleeding during and after childbirth in VWD. The data obtained will provide important information to help guide future steps to study and reduce PPH in VWD and to develop evidence-based management for these patients.
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Journal: Myositis (Pubmed Central) - Oct 15, 2022 Based on the INBUILD study, antifibrotic treatment with nintedanib is available for progressive fibrosing pulmonary involvement. For rheumatologists, the updated guidelines represent a document relevant for daily practice with many recommendations for the treatment of patients with myositis.
- |||||||||| Painful skin lesions after starting subcutaneous immunoglobulin replacement (Exhibit Hall (Upper Concourse); Monitor 03) - Oct 10, 2022 - Abstract #ACAAI2022ACAAI_866;
Case Description Patient is on multiple immunosuppressants including ustekinumab, canakinumab, and leflunomide managed by Rheumatology...Past immune evaluation showed normal IgG and appropriate response to Pneumovax two years ago...Additionally, the patient also had a few ear infections; thus, A/I currently trialing Cuvitru at IgG replacement dosing (∼500 mg/kg)...In contrast, local reactions with swelling, pain, and bruising on SCIg infusion sites have been well reported. To our knowledge, systemic dermatological adverse reactions due to SCIg have not been reported in the past.
- |||||||||| ASP7317 / Octapharma, CHA Bio & Diostech, Astellas
Enrollment open, Trial completion date, Trial primary completion date: A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration (clinicaltrials.gov) - Aug 29, 2022 P1b, N=18, Recruiting, For the treatment of patients with severe Haemophilia-A in Mexico, lonoctocog-alfa was a cost-saving option compared to existing rFVII in Mexico from the public payer perspective. Active, not recruiting --> Recruiting | Trial completion date: Nov 2022 --> Aug 2024 | Trial primary completion date: Nov 2022 --> Aug 2024
- |||||||||| Clinical, Review, Journal: Current and new targets for treating myositis. (Pubmed Central) - Jul 28, 2022
Further studies are needed to assess the role of newer therapies such as abatacept (inhibition of T cell co-stimulation), sifalimumab (anti-IFNα), Janus kinase [JAK] inhibitors, apremilast (phosphodiesterase 4 inhibitor), and KZR-616 (selective inhibitor of the immunoproteasome) given their biological plausibility and encouraging recent small-case series results. The future of IIM therapy will depend on exploring biomarkers implicated in the etiopathogenesis of IIM, improvements in myositis classification based on serological and histopathological features, and well-designed controlled clinical trials using validated consensus outcome measures.
- |||||||||| Savaysa (edoxaban) / Daiichi Sankyo, Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
Using heparin-calibrated assays to estimate anti-factor Xa activity of factor Xa inhibitors (FXaI): correlation analysis of published data (Poster eBoard 5) - Jun 17, 2022 - Abstract #Euroanaesthesia2022Euroanaesthesia_1539; P3 Investigators can use conversion tables when only heparin-calibrated assays are available for enrolling patients in LEX-210.Conclusion(s): Conversion tables based on correlation data enable clinicians to estimate FXaI plasma activity using assays calibrated for heparin, if FXaI-calibrated assays are unavailable, for clinical decision making including use of reversal/hemostatic agents. Until FXaI calibrations become more widespread, this approach may be valuable in managing patients with FXaI-related major bleeding.
- |||||||||| Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
A randomized, double-blind, phase 3 study of 4-factor prothrombin complex concentrate in patients with acute major bleeding on direct oral anticoagulant therapy with factor Xa inhibitors: the LEX-210 study (Poster eBoard 5) - Jun 17, 2022 - Abstract #Euroanaesthesia2022Euroanaesthesia_1538; P3 LEX-210 aims to demonstrate hemostatic efficacy/safety of four-factor PCC (4F-PCC; Octaplex®; Octapharma) in adults with FXaI-related major bleeding.Materials and LEX-210 (NCT04867837) is a Phase 3, multicenter, prospective, randomized, double-blinded, group-sequential, parallel-group, adaptive design study (sponsor: Octapharma)... Results could confirm the hemostatic efficacy/safety of 4F-PCC for managing FXaI-related major bleeding, potentially offering an alternative treatment for these patients.
- |||||||||| Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
LEX-211 (FARES-II): a phase 3, prospective, active-control randomised study of four-factor prothrombin complex concentrate versus frozen plasma in bleeding adult cardiac surgery patients (Virtual Platform - Poster section) - Jun 17, 2022 - Abstract #Euroanaesthesia2022Euroanaesthesia_672; The objective of LEX-211 is to demonstrate that PCC (Octaplex®; Octapharma) is clinically non-inferior to FP in terms of haemostatic effectiveness, as measured by the need for post-therapy haemostatic interventions.Materials and LEX-211 (sponsor: Octapharma) will include patients (≥18 years) undergoing cardiac surgery with cardiopulmonary bypass (CPB) who require coagulation factor replacement due to post-CPB bleeding and known/suspected coagulation factor deficiency...An unblinded interim analysis (100 evaluable patients/group) will test sample size assumptions and re-estimate if necessary. Completion is expected Q1 2024.Conclusion(s): The results of this study will inform clinical practice for bleeding cardiac surgery patients requiring coagulation factor replacement, potentially reducing blood product usage, and improving outcomes.
- |||||||||| Gammanorm (human immune globulin subcutaneous) / Octapharma
Trial completion date, Trial primary completion date: Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency. (clinicaltrials.gov) - Jun 15, 2022 P=N/A, N=30, Not yet recruiting, Weight-adjusted dosing was non-inferior to fixed dosing in hypofibrinogenemic bleeding cardiac surgery patients.QuartileFibrinogen concentrateCryoprecipitateMean (SD) dosing (mg/kg)Relative risk (95% CI); p-valueMean (SD) dosing (IU/10kg)Relative risk (95% CI); p-value140 (5) Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2022 --> Jun 2024
- |||||||||| Hemlibra (emicizumab-kxwh) / Roche, Eloctate (efraloctocog alfa) / Sanofi, SOBI, Nuwiq (simoctocog alfa) / Octapharma
Hemophilia Registry in a province in nothern Spain (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1958; Of the 66 hemophiliac patients, with age ranging from 3 to 86 (median 35), 92.4% are type A and 7% type B. 50% of the cases are mild; 6.1% are moderate and 43.9% are severe. 45.5% of them receive prophylactic treatment while 54.5% receive it on demand.
- |||||||||| Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Dose optimisation in children with severe haemophilia A on long-term octanate® prophylaxis (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1143; The estimated time to 1% FVIII activity for children on a 72-h dosing interval was 78 h in those with no previous BEs (Group 1) and 70 h in those with previous BEs (Group 2). For patients on a 96-h dosing interval, the values were 116 h in children without previous BEs (Group 3) and 111 h in those with previous BEs (Group 4).
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