Cuvitru (human immune globulin subcutaneous 20%) / Takeda - LARVOL DELTA

A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants with Primary Immunodeficiency (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Primary Immunodeficiency

A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: Takeda

New trial • Immunology • Primary Immunodeficiency

An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease (clinicaltrials.gov) - P3 | N=12 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed

Trial completion • Immunology • Primary Immunodeficiency

Pharmacokinetics, safety, and efficacy of 20% subcutaneous immunoglobulin (Ig20Gly) administered weekly or every 2 weeks in Japanese patients with primary immunodeficiency diseases: a phase 3, open-label study. (PubMed, Immunother Adv) - P3 | "Related treatment-emergent adverse events were all mild in severity; the most common treatment-emergent adverse events (excluding infections) in Epochs 2 and 3 were injection site swelling (24%) and injection site erythema (18%). This is the first trial to demonstrate the efficacy and favourable safety profile of 20% subcutaneous immunoglobulin administered every 2 weeks in adult and paediatric Japanese patients with PIDs."

Journal • P3 data • PK/PD data • Dermatology • Immunology • Infectious Disease • Pediatrics • Primary Immunodeficiency

Takeda Announces Approval of CUVITRU Subcutaneous Immunoglobulin in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia (Businesswire) - "Takeda...announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of CUVITRU™ [Immune Globulin Subcutaneous (Human), 20% Solution] in patients aged 2 years and older with agammaglobulinemia or hypogammaglobulinemia, disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency (PID) or secondary immunodeficiency (SID). The approval marks Takeda’s first subcutaneous immunoglobulin (SCIG) therapy for patients in Japan. The approval is based on results from a Phase 3 clinical trial..."

Japanese regulatory • Immunology • Primary Immunodeficiency

Real-World Use, Safety, and Patient Experience of 20% Subcutaneous Immunoglobulin for Primary Immunodeficiency Diseases. (PubMed, Adv Ther) - "The CORE study provides real-world evidence of the flexibility, feasibility, safety, and tolerability of Ig20Gly infusions, at mostly weekly intervals, over 1 year in patients with PIDs."

Journal • Real-world • Real-world evidence • Immunology • Primary Immunodeficiency

Subcutaneous immunoglobulin 20% (Ig20Gly) treatment regimens in pediatric patients with primary immunodeficiencies - real-world data from the IG TATRY study. (PubMed, Expert Rev Clin Immunol) - P=N/A | "We retrospectively analyzed the medical documentation of 75 pediatric patients aged 0-17 years (mean 9.9) who received Ig20Gly (Cuvitru®; Baxalta US, Inc.; part of Takeda, MA, U.S.A.)...The results of this study support the feasibility and tolerability of Ig20Gly usage in PIDD patients across the pediatric age spectrum. The trial is registered at ClinicalTrials.gov (NCT04636502)."

Journal • Real-world • Real-world evidence • Immunology • Infectious Disease • Pediatrics • Primary Immunodeficiency

Passive transfer of hepatitis B core antibody after intravenous immunoglobulin administration in adult patients: a retrospective review (EASL-ILC 2023) - "Because of uncertainly and poor knowledge around baseline testing, all received antiviral treatment consisting of either tenofovir (10%), entecavir (13%) or lamivudine (77%), prior to being initiated on immunosuppressive therapy...The most common HNIg used was Privigen/Hizentra with 30 patients (38%) for both seronegative and seropositive patients. Many patients changed to subcutaneous immunoglobulin (SCIg) administration of HNIg during the Covid-19 pandemic, which included Hizentra and Cuvitru... Passive transfer of hepatitis B core antibody is common after HNIg infusions. Hepatitis B core antibody screening should be considered standard practice for each human normal immunoglobulin administration, effectively improving therapeutic decisions by preventing wrong diagnosis of hepatitis B exposure and therefore preventing unnecessary anti-viral use."

Retrospective data • Review • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Novel Coronavirus Disease

Prevalence of Humoral Dysfunction in Pts With Frequent Exacerbations of COPD, and the Effect of SCIgR for Prevention (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Rochester General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

In-line warming reduces in-line pressure of subcutaneous infusion of concentrated immunoglobulins. (PubMed, Drug Deliv Transl Res) - "Subcutaneous infusion studies in pigs confirmed the feasibility of infusion rates of up to 7.5 mL/min with in-line warmed TAK-881, an immunoglobulin 20% facilitated with recombinant human hyaluronidase...In summary, an in in-line warming device can circumvent the limitation of high viscosity, while product quality and local tolerance are maintained. The results of the presented studies warrant further testing in a phase 1 clinical study."

Journal • Immunology

Prevalence of Humoral Dysfunction in Pts With Frequent Exacerbations of COPD, and the Effect of SCIgR for Prevention (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Rochester General Hospital

New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease (clinicaltrialsregister.eu) - P3 | N=10 | Sponsor: Takeda

New P3 trial • Immunology • Primary Immunodeficiency

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

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

Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study. (PubMed, Allergy Asthma Clin Immunol) - P=N/A | "This study provides a detailed description of Ig20Gly infusion parameters, tolerability, and quality of life in clinical practice among patients with PID or SID switching to Ig20Gly from another SCIG and confirms the feasibility of infusing Ig20Gly via pump or manual administration. Trial registration NCT03716700, Registered 31 August 2018, https://clinicaltrials.gov/ct2/show/NCT03716700."

Journal • Real-world evidence • Immunology • Pain • Primary Immunodeficiency

A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID) (clinicaltrialsregister.eu) - P3 | N=17 | Sponsor: Baxalta US Inc.`Baxalta Innovations GmbH`Takeda Pharmaceutical Company Limited

New P3 trial • Immunology • Primary Immunodeficiency

A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID) (clinicaltrials.gov) - P3 | N=17 | Completed | Sponsor: Baxalta now part of Shire | Active, not recruiting ➔ Completed

Trial completion • Immunology • Primary Immunodeficiency

An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease (clinicaltrials.gov) - P3; N=12; Active, not recruiting; Sponsor: Takeda; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Immunology • Primary Immunodeficiency

A Study of TAK-881 in Healthy Adults (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Takeda; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

IG-TATRY: Retrospective, Observational Chart Review Study Conducted in Poland to Document the Management and Clinical Outcome of CUVITRU and HYQVIA in Pediatric Participants (< 18 Years) With Primary Immunodeficiency (PID) (clinicaltrials.gov) - P=N/A; N=96; Completed; Sponsor: Shire; Recruiting ➔ Completed; N=150 ➔ 96

Clinical data • Enrollment change • Review • Trial completion • Immunology • Pediatrics • Primary Immunodeficiency

Population pharmacokinetic simulation of varied Immune Globulin Subcutaneous (Human), 20% solution (Ig20Gly) loading and maintenance dosing regimens in immunoglobulin-naïve patients with primary immunodeficiency diseases. (PubMed, Int Immunopharmacol) - P2/3 | "Simulations indicated IG-naïve patients with PID can achieve protective serum IgG levels within 1-3 weeks using appropriate Ig20Gly loading regimens. Patients with low endogenous IgG may benefit most from an 800-mg/kg/month loading dose. 400- or 800-mg/kg/month Ig20Gly maintenance regimens appeared adequate to maintain stable IgG levels. Serum IgG monitoring and clinical status can guide dosing parameters."

Clinical • Journal • PK/PD data • Immunology • Primary Immunodeficiency

Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients With Bronchiectasis (clinicaltrials.gov) - P4; N=0; Withdrawn; Sponsor: University of Edinburgh; N=20 ➔ 0; Suspended ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • ELANE • ICAM1 • MPO

IG-TATRY: Retrospective, Observational Chart Review Study Conducted in Poland to Document the Management and Clinical Outcome of CUVITRU and HYQVIA in Pediatric Participants (< 18 Years) With Primary Immunodeficiency (PID) (clinicaltrials.gov) - P=N/A; N=150; Recruiting; Sponsor: Shire; Trial completion date: Jul 2021 ➔ Sep 2021; Trial primary completion date: Jul 2021 ➔ Sep 2021

Clinical data • Review • Trial completion date • Trial primary completion date • Immunology • Pediatrics • Primary Immunodeficiency

An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease (clinicaltrials.gov) - P3; N=10; Recruiting; Sponsor: Takeda; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Immunology • Primary Immunodeficiency

Steady-State Serum IgG Trough Levels Are Adequate for Pharmacokinetic Assessment in Patients with Immunodeficiencies Receiving Subcutaneous Immune Globulin. (PubMed, J Clin Immunol) - P2/3 | "Based on individual patient serum IgG trough levels from two pivotal trials (phase 2/3 European [NCT01412385] and North American [NCT01218438]) of weekly 20% subcutaneous IG (SCIG; Cuvitru, Ig20Gly), trough level-predicted IgG AUC (AUC) were calculated and compared with the reported AUC calculated from serum IgG concentration-time profiles (AUC)...Mean AUC values calculated for 4 other SCIG products (based on mean IgG trough levels reported in the literature/labels) were also essentially equivalent to the reported AUC (differences 20%. In conclusion, steady-state serum IgG levels following weekly SCIG remain stable, allowing for reliable prediction of AUC over the dosing interval using trough IgG levels. These findings indicate that measuring steady-state serum IgG trough levels alone may be adequate for PK assessment of weekly SCIG."

Clinical • Journal • PK/PD data • Immunology • Primary Immunodeficiency