Gammanorm (human immune globulin subcutaneous) / Octapharma - LARVOL DELTA

MG_SCIG: Subcutaneous Immunoglobulin for Myasthenia Gravis (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: University Health Network, Toronto | Recruiting ➔ Completed

Trial completion • CNS Disorders • Myasthenia Gravis

Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency. (clinicaltrials.gov) - P=N/A | N=36 | Active, not recruiting | Sponsor: University of Alberta | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Dec 2024 ➔ Sep 2025

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Primary Immunodeficiency

Customizing subcutaneous immunoglobulin administration in primary antibody deficiency: patient-centric care perspectives. (PubMed, Immunotherapy) - "Patient-centric strategies that promote shared decision-making and awareness of patient status not only promote medical efficacy but also enhance the overall patient experience. The authors of this report call attention for a need to shift toward more adaptable and individualized SCIG treatment plans for PAD patients whose needs may change over the long-term course of treatment."

Journal • Review • Primary Immunodeficiency

Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency. (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: University of Alberta | Trial completion date: Jun 2024 ➔ Dec 2024 | Trial primary completion date: Jun 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Immunology • Primary Immunodeficiency

Evaluation of Subcutaneous Immunoglobulin Product Cutaquig in Terms of Safety and Efficacy in the Treatment of Patients With Primary Immunodeficiencies (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

New trial • Immunology • Primary Immunodeficiency

Subcutaneous Immunoglobulin 16.5% (Cutaquig) in Primary Immunodeficiency Disease: Safety, Efficacy, and Patient Satisfaction with Modified Dosing Regimens (CIS 2023) - "Table 1 . Summary of Patient Questionnaire Rating New Infusion Regimens Compared to Previous Regimens Empty Cell Cohort 1 (n = 15) Cohort 2 (n = 15) Cohort 3 (n = 34) Better 6 6 15 Somewhat Better 6 3 6 Neutral 2 5 8 Somewhat Worse 0 0 2 Worse 1 1 2"

Clinical • Dermatology • Immunology • Infectious Disease • Otorhinolaryngology • Pain • Primary Immunodeficiency • Pruritus • Respiratory Diseases • Sinusitis

Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency. (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: University of Alberta | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Primary Immunodeficiency

Subcutaneous Immunoglobulin 16.5% (Cutaquig®) in Primary Immunodeficiency Disease: Safety, Tolerability, Efficacy, and Patient Experience with Enhanced Infusion Regimens. (PubMed, J Clin Immunol) - "SCIG 16.5% (Cutaquig®), infusions are efficacious, safe, and well tolerated with reduced infusion time, fewer infusion sites, and reduced frequency. Further, the majority of patients found the new infusion regimens to be better or somewhat better than their previous regimens."

Journal • Immunology • Infectious Disease • Primary Immunodeficiency

Long-term Efficacy, Safety, and Tolerability of a Subcutaneous Immunoglobulin 16.5% (cutaquig®) in the Treatment of Adult and Pediatric Patients with Primary Immunodeficiencies (AAP-NCE 2022) - P3 | "In conclusion, this unique prospective, up to 4-year long-term use of cutaquig® showed effective protection from SBIs, and low rates of local and systemic adverse reactions, supporting the favorable safety profile of cutaquig®."

Clinical • Asthma • Cough • Immunology • Infectious Disease • Pain • Pediatrics • Primary Immunodeficiency • Pulmonary Disease • Respiratory Diseases

Subcutaneous Immunoglobulin 16.5% (Cutaquig) is Safe and Efficacious at Modified Dosing Regimens in Patients With Primary Immunodeficiency Disease (AAAAI 2023) - "SCIG 16.5% (Cutaquig) infusions are safe and well tolerated at higher infusion parameters. Dosing every other week demonstrated equivalency to trough levels with weekly dosing, which may result in fewer infusions allowing for greater dosing flexibility, compliance, and patient satisfaction."

Clinical • Late-breaking abstract • Dermatology • Immunology • Infectious Disease • Otorhinolaryngology • Pain • Primary Immunodeficiency • Pruritus • Respiratory Diseases • Sinusitis

Real-World Outcomes After Switching to Immune Globulin Subcutaneous 16.5% In Patients with Primary Humoral Immunodeficiency: A 3-Year Study (AAAAI 2023) - "A retrospective, observational analysis was conducted over a 3-year period in IGSC-experienced patients with PI who switched from another IGSC therapy to IGSC 16.5% (Cutaquig®)...IGSC 16.5% demonstrated efficacy and tolerability when switched from another IGSC therapy."

Clinical • Real-world • Real-world evidence • Fatigue • Immunology • Infectious Disease • Pain • Pediatrics • Primary Immunodeficiency • Pruritus • Respiratory Diseases

MG_SCIG: Subcutaneous Immunoglobulin for Myasthenia Gravis (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: University Health Network, Toronto | Trial completion date: Jun 2022 ➔ Dec 2023 | Trial primary completion date: Jan 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • CNS Disorders • Myasthenia Gravis

Cutaquig Is Well Tolerated in Immunodeficient Patients Who Did Not Tolerate Other Subcutaneous Immunoglobulin Products. (PubMed, Hematol Rep) - "Cutaquig may be used as an alternative treatment option for patients who did not tolerate 20% SCIG products."

Journal • Infectious Disease • Nephrology

Painful skin lesions after starting subcutaneous immunoglobulin replacement (ACAAI 2022) - "Introduction 17-year-old female with history of Behcet's, Sweet's syndrome, Chilblain lupus, inflammatory arthritis and ileitis complains of painful skin lesions of the extremities after initiation of subcutaneous immunoglobulin (SCIg) replacement (Cutaquig). 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."

Allergy • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Otorhinolaryngology • Pain • Rheumatology

Subcutaneous immunoglobulin 16.5% for the treatment of pediatric patients with primary antibody immunodeficiency. (PubMed, Expert Rev Clin Immunol) - "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."

Journal • Immunology • Infectious Disease • Pediatrics • Primary Immunodeficiency

Long-term Efficacy, Safety, and Tolerability of a Subcutaneous Immunoglobulin 16.5% (cutaquig®) in the Treatment of Patients with Primary Immunodeficiencies. (PubMed, Clin Exp Immunol) - "The incidence of related systemic adverse events was 14.7% in the main study and 7.4% in the extension. In conclusion, this prospective, long-term study with cutaquig ® showed maintained efficacy and low rates of local and systemic adverse reactions in PID patients over up to 238 weeks of follow-up."

Journal • Immunology • Infectious Disease • Primary Immunodeficiency

Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency. (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: University of Alberta | Trial completion date: Jun 2023 ➔ Jun 2024 | Trial primary completion date: Jun 2022 ➔ Jun 2024

Trial completion date • Trial primary completion date • Immunology • Primary Immunodeficiency

The Effect of Subcutaneous Immunoglobulin Gammanorm on the Distribution of IgG Subclasses and on Immunity of Patients With Secondary Immunodeficiency (clinicaltrials.gov) - P=N/A | N=102 | Completed | Sponsor: Octapharma | N=200 ➔ 102

Enrollment change • Immunology • Multiple Myeloma • CD14 • CD19 • CD27 • CD4 • CD8 • NCAM1

The Effect of Subcutaneous Immunoglobulin Gammanorm on the Distribution of IgG Subclasses and on Immunity of Patients With Secondary Immunodeficiency (clinicaltrials.gov) - P=N/A | N=200 | Completed | Sponsor: Octapharma | Recruiting ➔ Completed

Trial completion • Immunology • Multiple Myeloma • CD14 • CD19 • CD27 • CD4 • CD8 • NCAM1

Subcutaneous Gammanorm® by pump or rapid push infusion: Impact of the device on quality of life in adult patients with primary immunodeficiencies. (PubMed, Clin Immunol) - "Rapid push was preferred by 34.5% of patients. It proved to be an efficacious and cost-effective alternative to pumps adding to patient choice and increasing flexibility during long-term IgRT."

HEOR • Journal • Immunology • Infectious Disease • Primary Immunodeficiency

Transition to Subcutaneous Immune Globulin 16.5% Improves Patient-Reported Quality of Life (AAAAI 2022) - "We report QoL survey results for patients transitioned to IGSC 16.5% (Cutaquig®) from IVIG or alternative IGSC in a real-world setting...Excellent QoL was achieved in IG-experienced patients receiving IGSC 16.5%."

Clinical • HEOR • Immunology • Primary Immunodeficiency

Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases (clinicaltrials.gov) - P3; N=64; Completed; Sponsor: Octapharma; Active, not recruiting ➔ Completed

Clinical • Trial completion • Immunology • Primary Immunodeficiency

Overview of subcutaneous immunoglobulin 16.5% in primary and secondary immunodeficiency diseases. (PubMed, Immunotherapy) - "In determining an appropriate IG regimen, one must consider specific patient needs, characteristics and preferences. There are advantages to SCIG, such as stable serum immunoglobulin G levels, high tolerability and the flexibility of self-administered home treatment."

Journal • Immunology • Primary Immunodeficiency

Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases (clinicaltrials.gov) - P3; N=64; Active, not recruiting; Sponsor: Octapharma; Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Primary Immunodeficiency

Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases (clinicaltrials.gov) - P3; N=65; Recruiting; Sponsor: Octapharma; Trial completion date: Mar 2021 ➔ Jul 2021; Trial primary completion date: Mar 2021 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date • Immunology • Primary Immunodeficiency