Changes in Intravenous Immunoglobulin Usage for Hypogammaglobulinemia After Implementation of a Stewardship Program

Derman, Benjamin A.; Schlei, Zachary; Parsad, Sandeep; Mullane, Kathleen M.; Knoebel, Randall W

doi:10.1200/op.20.00312

Cited by 15 publications

(25 citation statements)

References 27 publications

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“…One clinician particularly tied evidence, economic and legal aspects together by advocating for a strict evidence‐based approach to prescribing Ig, which would dampen demand: ‘ I think we should strive for more evidence‐baseness of using the IVIG, I think the present situation is still a little bit wild and uncontrolled…there will be a stop on that, it will be more strictly regulated…If IVIG would not be reimbursed for specific indications because the evidence is meagre or shallow, then of course, that will influence prescription’. (Expert 10) Literature provides examples of how some hospitals have initiated various stewardship programs to monitor and curb demand 59,71,72 …”

Section: Resultsmentioning

confidence: 99%

“…This includes better understanding of psychological factors, group dynamics, and even logistical reasons for why various initiatives in hospitals to control demand are not successful for the long‐term 54 . Additionally, lessons can be learned and replicated from the hospital stewardship programs/organisational interventions that have sprung up, which exhibits varying levels of (dramatic) success in curbing Ig usage 59,71,72 …”

Section: Discussionmentioning

confidence: 99%

“…54 Additionally, lessons can be learned and replicated from the hospital stewardship programs/organisational interventions that have sprung up, which exhibits varying levels of (dramatic) success in curbing Ig usage. 59,71,72 Strengths of this study include using the combination of a scoping review and interview study that allowed for identifying the contextual factors related to Ig demand. This methodology is customizable for any country, in that it highlights country-specific issues regarding the future demand of Ig and the implications thereof.…”

Section: Discussionmentioning

confidence: 99%

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Using a scenario approach to assess for the current and future demand of immunoglobulins: An interview and literature study from The Netherlands

Sasongko

Kraaij²,

So‐Osman

2022

Transfusion Medicine

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Objectives: To explore the current and future demand of immunoglobulins globally and specifically for the Netherlands by assessing: (I) which specialties contribute to current demand, (II) new areas of medical need, (III) which transformational factors may impact demand and to what effect, by using a scenario approach.Background: As immunoglobulin demand continues to increase globally, there is concern of increasing shortages and questions of whether and how future demand will continue based on medical need. Methods/Materials: In line with scenario principles, a scoping review of Pubmed, Web of Science, Embase and Cochrane and grey literature was conducted. Semistructured interviews with subject matter experts were held. The results of the review and interviews were analysed for major themes. Results: The scoping review resulted in 97 articles, 74 regarding clinical uses, and 23 regarding organisational and other themes. Fifteen clinical and non-clinical experts were interviewed. I) Neurology, immunology, and haematology were specialties that contribute most to current demand. II) Regarding potential new areas of medical need, the literature review resulted in more indications than the interviews, for example, post-renal transplants. III) Four groups of key transformational factors were found: factors that could increase immunoglobulin demand (e.g., EMA revisions), decrease demand (e.g., replacement products, Dutch Transfer Act 2021), factors that remain to be seen how it impacts demand (e.g., further evidence), and miscellaneous factors (e.g., supply-related). Conclusion: Having identified the specialties and relevant transformational factors that affect immunoglobulin demand, more research is needed on what clinical or organisational strategies would be effective in controlling demand in general for the

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Using a scenario approach to assess for the current and future demand of immunoglobulins: An interview and literature study from The Netherlands

Sasongko

Kraaij²,

So‐Osman

2022

Transfusion Medicine

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“…Thirdly, most of the clinical data is derived from patients who underwent matched related HSCT, and clinical efficacy of IgRT for patients with HLA-haploidentical transplantation or CBT has not been fully examined. Finally, to develop an effective use of limited medical resources, a cost-effective approach such as IVIG stewardship program is desired [ 45 ].…”

Section: Discussionmentioning

confidence: 99%

“…They suggested that IVIG application according to the individual IgG level was a cost-effective approach. Aiming at reducing unnecessary IVIG usage, a stewardship IVIG program was carried out in the US [ 45 ]. In this program, the clinical application of IVIG was limited to designated two situations: (1) IgG < 400 mg/dL following autologous HSCT and CAR T-cell therapy; (2) IgG < 400 mg/dL with a history of a bacterial infection within the last 3 months.…”

Section: Current Status Of Igrt In Hsct Recipientsmentioning

confidence: 99%

Controversies about immunoglobulin replacement therapy in HSCT recipients with hypogammaglobulinemia

Ohmoto

Fuji

Shultes

et al. 2022

Bone Marrow Transplant

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The efficacy of immunoglobulin replacement therapy (IgRT) has been demonstrated for primary immune deficiency diseases and hematological malignancies such as chronic lymphocytic leukemia (CLL) or multiple myeloma with hypogammaglobulinemia. Clinical development of anti-B cell therapies including a monoclonal antibody, bispecific antibody, or chimeric antigen receptor T-cell therapy which could result in severe hypogammaglobulinemia accelerates the argument of prophylactic use of IgRT. Clinical guidelines for CLL describe immunoglobulin administration in patients with a low IgG who have experienced a severe/repeated bacterial infection. The utility in hematopoietic stem-cell transplantation (HSCT) remains unknown. Although an early randomized trial demonstrated that IgRT decreased infection risk and transplant-related mortality after HSCT, subsequent clinical trials could not validate the benefit. Consequently, a meta-analysis did not show the benefit of IgRT in HSCT. Most of the available data derives from matched-related HSCT using myeloablative regimen, and the impact in haploidentical and cord blood transplantation, or reduced-intensity HSCT remains unknown. One crucial issue is that no studies exist for patients with only hypogammaglobulinemia after HSCT. Other challenges are heterogeneous patient characteristics, or immunoglobulin formulation, dosage, schedule, route and duration of IgRT. Without evidence in HSCT, it would be reasonable to follow the guidelines for other diseases with hypogammaglobulinemia.

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Incidence, timing, and management of infections in patients receiving teclistamab for the treatment of relapsed/refractory multiple myeloma in the MajesTEC‐1 study

Nooka,

Rodriguez,

Mateos

et al. 2023

Cancer

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BackgroundPatients with relapsed/refractory multiple myeloma are at increased risk of infection. Infections during treatment with teclistamab, the first B‐cell maturation antigen‐directed bispecific antibody approved for triple‐class–exposed relapsed/refractory multiple myeloma, was examined in the phase 1/2 MajesTEC‐1 study.MethodsPatients (N = 165) received subcutaneous teclistamab 1.5 mg/kg weekly after a step‐up dosing schedule (0.06 mg/kg and 0.3 mg/kg, each separated by 2–4 days). Patients were monitored frequently for infections; prophylaxis and management were per institutional guidelines.ResultsAt a median follow‐up of 22.8 months (range, 0.3–33.6), infections were reported in 132 patients (80.0%). Grade 3/4 infections occurred in 91 patients (55.2%), including COVID‐19 (21.2%), respiratory infections (19.4%), Pneumocystis jirovecii pneumonia (4.2%), viral infections (4.2%), and gastrointestinal infections (1.2%). Twenty‐one patients died from infections (18 from COVID‐19). Median time to first onset of any‐grade and grade 3 to 5 infections was 1.7 and 4.2 months, respectively. Overall, 70.9% of patients had ≥1 postbaseline immunoglobulin G (IgG) level <400 mg/dL; median time to IgG <400 mg/dL was 1.2 months (range, 0.2–19.8) and 46.1% received ≥1 dose of IgG replacement. Grade 3/4 neutropenia occurred in 65.5% of patients (median time to grade ≥3 neutropenia/febrile neutropenia was 2.3 months [range, 0–18.1]).ConclusionBased on the infection profile of B‐cell maturation antigen–targeted bispecific antibodies such as teclistamab, it is recommended that clinicians and patients remain vigilant for a range of infection types throughout treatment to facilitate prompt intervention. Appropriate screening, prophylaxis, and management of infections, hypogammaglobulinemia, and neutropenia are important.Clinical trial registrationNCT03145181/NCT04557098 (ClinicalTrials.gov)Plain Language Summary Before starting teclistamab, patients should be up to date with vaccinations (including COVID‐19) and screened for hepatitis B and C and HIV. Teclistamab should not be given to patients with any active infections. Prophylactic antimicrobials should be administered per institutional guidelines. Prophylaxis for Pneumocystis jirovecii pneumonia and herpes simplex/varicella zoster virus is recommended during teclistamab treatment. Close monitoring of infections and immunoglobulin G (IgG) levels should continue throughout teclistamab treatment. IgG replacement (administered every 3–6 weeks) should be used to maintain IgG ≥400 mg/dL. Growth factors should be considered for grade ≥3 neutropenia with infection/fever and grade 4 neutropenia.

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Changes in Intravenous Immunoglobulin Usage for Hypogammaglobulinemia After Implementation of a Stewardship Program

Cited by 15 publications

References 27 publications

Using a scenario approach to assess for the current and future demand of immunoglobulins: An interview and literature study from The Netherlands

Using a scenario approach to assess for the current and future demand of immunoglobulins: An interview and literature study from The Netherlands

Controversies about immunoglobulin replacement therapy in HSCT recipients with hypogammaglobulinemia

Incidence, timing, and management of infections in patients receiving teclistamab for the treatment of relapsed/refractory multiple myeloma in the MajesTEC‐1 study

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