- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
The many faces of primary immune deficiency in childhood (Poster Zone) - Apr 21, 2024 - Abstract #EAACI2024EAACI_2542;
Replacement therapy with human immunoglobulin (Octagam 10%) and isoprinosine was started at the age of 5 years and 4 months...The identification of defects in specific molecules or molecular signaling pathways has led to opportunities to apply targeted treatments that have proven particularly effective in controlling disease and improving health. ?ey words: immune deficiency, immune dysregulation, lymphoma, replacement therapy
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Unveiling the Connection Between ?-Gal Allergy and Cardiovascular Disease (Cordoba) - Apr 5, 2024 - Abstract #EAACI2024EAACI_554;
?ey words: immune deficiency, immune dysregulation, lymphoma, replacement therapy Method For this, anti-?-Gal IgG antibodies were purified from a commercial intravenous human IgG concentrate (Octagam
- |||||||||| 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.
- |||||||||| 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.
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Review, Journal: Use of Janus kinase inhibitors in dermatomyositis: a systematic literature review. (Pubmed Central) - Jun 30, 2022
Systemic corticosteroids are a cornerstone of therapy, and more recently intravenous immunoglobulin (IVIG; OCTAGAM®) has been approved by the US Food and Drug Administration for the treatment of adults with DM...Although the conclusions that can be drawn from this analysis are limited because of the differences in assessments used across publications, overall treatment of patients with DM or JDM with a JAK inhibitor was associated with significant improvement of a wide range of DM manifestations, including skin lesions, muscle weakness, and ILD. Our systematic literature review suggests that JAK inhibitors may be a viable treatment option for DM/JDM, and randomised controlled trials are necessary to confirm these findings.
- |||||||||| Neofordex (dexamethasone acetate high-dose) / CTRS Laboratories
Trial completion date, Trial initiation date, Trial primary completion date: IVIORDEX: IgIV Plus Prednisone vs High-dose Dexamethasone for ITP (clinicaltrials.gov) - Nov 23, 2021
P3, N=272, Not yet recruiting,
This first large, double-blind, placebo-controlled phase III trial demonstrated safety and tolerability of IVIG as a treatment for DM patients. Trial completion date: Apr 2025 --> Jul 2026 | Initiation date: Oct 2021 --> Jan 2022 | Trial primary completion date: Oct 2024 --> Jan 2025
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Clinical, Journal: Evaluation of Intravenous Immunoglobulin in Pediatric Acute-Onset Neuropsychiatric Syndrome. (Pubmed Central) - Oct 27, 2021
In PANS, which may be associated with an underlying immune dysregulation, sequential infusions of IVIG [Octagam 5%] successfully ameliorated psychological symptoms and dysfunction, with sustained benefits for at least 8 weeks, and up to 46 weeks in a subset of subjects. In addition, baseline immune and autoimmune profiles demonstrated significant elevations in a majority of subjects, which requires further evaluation, characterization, and study to clarify the potential immune dysfunction by which PANS manifests and progresses.
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Enrollment closed, Trial completion date, Trial primary completion date: Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression (clinicaltrials.gov) - Oct 26, 2021
P3, N=208, Active, not recruiting,
In addition, baseline immune and autoimmune profiles demonstrated significant elevations in a majority of subjects, which requires further evaluation, characterization, and study to clarify the potential immune dysfunction by which PANS manifests and progresses. Completed --> Active, not recruiting | Trial completion date: Jan 2021 --> Jan 2022 | Trial primary completion date: Jan 2021 --> Jan 2022
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma, Kiovig (human normal immunoglobulin 10%) / Takeda
In vitro comparison between different 10% intravenous immunoglobulin preparations () - Oct 7, 2021 - Abstract #DGHO2021DGHO_1143;
Although different IVIg preparations essentially consist of polyclonal IgG, the different purification processes lead to variations in other characteristics. The IqYmune manufacturing process developed with a QbD approach has generated a 10% IVIg having a higher level of quality and enhanced safety profile while maintaining a high level of efficacy.
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Trial completion: Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19 (clinicaltrials.gov) - Jun 25, 2021
P4, N=34, Completed,
Overall 96% and 73% patients completed the first and extension period, with 3 (3%) and 9 (10%) subjects discontinuing due to adverse events (1 of 3 and 6 of 9 due to IVIg related events), respectively. Active, not recruiting --> Completed
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
[VIRTUAL] A CLINICAL CASE OF X-LINKED HYPER-IGM SYNDROME () - Jun 2, 2021 - Abstract #ESPID2021ESPID_1432;
Against the background of the treatment (antibiotic therapy, octagam), a slight improvement in the condition of the boy was noted, however, after a short period of relief, complaints again appeared about fever, diarrhea, aphthous stomatitis, weight loss...The CD40LG gene is associated with X-linked hyper-IgM syndrome (HIGM). Learning Points/ Since primary immunodeficiency states can manifest themselves with malabsorption syndrome, diarrhea, IBD, pediatricians should be more alert and take into account in the differential diagnosis of these conditions and the choice of treatment regimens.
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Retrospective data, Journal: Effects of adjunct treatment with intravenous Octagam on the course of severe COVID-19: results from a retrospective cohort study. (Pubmed Central) - Apr 7, 2021
Conclusion This study will evaluate the efficacy and safety of IVIg 10% as primary prophylaxis of infections inCLL patients with SID in a large clinical setting for the first time. To evaluate the effect of adjunct treatment with Octagam, an intravenous immunoglobulin (IVIG) product, on clinical outcomes and biomarkers in critically ill COVID-19 patients...Clinically relevant benefits through adjunct Octagam treatment in COVID-19 need to be confirmed in a randomized, controlled trial.
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Trial completion: Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression (clinicaltrials.gov) - Mar 10, 2021
P3, N=208, Completed,
This is the first large international phase III randomized, placebo-controlled trial demonstrating the efficacy and safety of IVIg as a treatment for patients with DM. Active, not recruiting --> Completed
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
[VIRTUAL] Intravenous Immunoglobulin for Treatment of Severe Coronavirus Disease 19 (COVID-19) – A Literature Overview () - Feb 3, 2021 - Abstract #AAAAI2021AAAAI_886;
An observational study conducted in 10 COVID-19 patients demonstrated short-term moderate-dose corticosteroid combined with high-dose IVIg reversed severe, deteriorating COVID-19 patients who failed initial low-dose therapy. Three published papers were identified using IVIg in pediatric COVID-19 patients who presented with Kawasaki-like or PMIS (Pediatric COVID-associated Multi-system Inflammatory Syndrome). Conclusions It may be useful to consider high-dose IVIg at the time of initiation of respiratory distress to potentially promote satisfactory clinical recovery and reduce burden of care for COVID-19 patients.
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Clinical, Observational data, Retrospective data, Review, Clinical Trial,Phase III, Journal: Use of Intravenous Immunoglobulin (Prevagen or Octagam) for the Treatment of COVID-19: Retrospective Case Series. (Pubmed Central) - Jan 29, 2021
No thrombotic events occurred and IVIG was well tolerated, despite most cases demonstrating very elevated D-dimer suggestive of active intravascular fibrinolysis. We believe that IVIG warrants immediate clinical trial evaluation in COVID-19 to confirm its role as a mainstay treatment of moderate to severe COVID-19 infection as a means to reduce hospital stay and utilization of ICU resources, including mechanical ventilation, and potentially reduce mortality.
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Enrollment closed: Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression (clinicaltrials.gov) - Jan 13, 2021
P3, N=208, Active, not recruiting,
The study aimed to inform on the use of IVIg in the treatment of DM, and results are expected in Q3 2020. Recruiting --> Active, not recruiting
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Journal: Reduction of Amyloid in the Brain and Retina After Treatment With IVIG for Mild Cognitive Impairment. (Pubmed Central) - Dec 18, 2020
All were administered IVIG (Octagam 10%) at 0.4 g/kg every 14 days for a total of 5 infusions...Three subjects had a reduction in amyloid SUVR and all 5 subjects had a reduction in amyloid retinal deposits in at least 1 eye. A short course of IVIG over 2 months removes a measurable amount of amyloid from the CNS in persons with MCI.
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Enrollment closed: Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19 (clinicaltrials.gov) - Nov 4, 2020
P4, N=34, Active, not recruiting,
A short course of IVIG over 2 months removes a measurable amount of amyloid from the CNS in persons with MCI. Recruiting --> Active, not recruiting
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma, Panzyga (human immune globulin intravenous 10% stabilised with glycine) / Octapharma
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: GAM 10-06: Non-Interventional Study on the Tolerability and Efficacy of IVIG (clinicaltrials.gov) - Sep 23, 2020
P=N/A, N=348, Completed,
This is the first large international phase III randomized, placebo-controlled trial demonstrating the efficacy and safety of IVIg as a treatment for patients with DM. Recruiting --> Completed | N=500 --> 348 | Trial completion date: Dec 2019 --> Jun 2020 | Trial primary completion date: Dec 2019 --> Jun 2020
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: CAST: Cardiac Safe Transplants for Systemic Sclerosis (clinicaltrials.gov) - Aug 12, 2020
P2/3, N=9, Terminated,
Recruiting --> Completed | N=500 --> 348 | Trial completion date: Dec 2019 --> Jun 2020 | Trial primary completion date: Dec 2019 --> Jun 2020 N=50 --> 9 | Trial completion date: Jan 2026 --> Oct 2019 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2025 --> Oct 2019; PI Sabbatical
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date: Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression (clinicaltrials.gov) - Jun 29, 2020
P3, N=208, Recruiting,
N=50 --> 9 | Trial completion date: Jan 2026 --> Oct 2019 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2025 --> Oct 2019; PI Sabbatical Not yet recruiting --> Recruiting | N=54 --> 208 | Trial completion date: Sep 2020 --> Dec 2020 | Trial primary completion date: Sep 2020 --> Dec 2020
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