Effectiveness of immunoglobulin prophylaxis in reducing clinical complications of hematopoietic stem cell transplantation: a systematic review and meta‐analysis

Ahn, Hilalion; Tay, Jason; Shea, Beverley; Hutton, Brian; Shorr, Risa; Knoll, Greg; Cameron, Donald W.; Cowan, Juthaporn

doi:10.1111/trf.14656

Cited by 21 publications

(23 citation statements)

References 56 publications

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“…Intravenous immunoglobulins (IV-Ig) have been proposed as potentially useful either in prophylaxis or in the pre-emptive setting against CMV. Even though some recently data in the pediatric population showed that IV-Ig significantly reduced the incidence of CMV infections,16 and a recently published meta-analysis showed that the prophylactic use of IV-Ig reduced CMV disease,17 the results of historical meta-analysis did not lead to similar conclusions,18 and currently the routinely use of IV-Ig for CMV prophylaxis is not recommended 19–22. Anti-CMV Ig (Megalotect) is a specific Ig, which inhibits the entrance of CMV in the host cells.…”

Section: Introductionmentioning

confidence: 99%

CMV Management With Specific Immunoglobulins: A Multicentric Retrospective Analysis on 92 Allotransplanted Patients.

Malagola

Greco

Santarone³

et al. 2019

Mediterr J Hematol Infect Dis

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CMV represents one of the most serious life-threatening complications of allogeneic stem cell transplantaion (allo-SCT). Pre-emptive treatment is highly effective, but toxicity and repetitive reactivation of CMV represent a major challenge in the clinical practice. The use of anti-CMV specific immunoglobulins (Megalotect) is controversial. We retrospectively collected data on 92 patients submitted to allo-SCT for hematological malignancies, in whom Megalotect was used either for prophylaxis (n=14) or with pre-emptive therapy (n=78). All the patients were considered at high-risk of developing CMV reactivation and CMV disease. The treatment was well tolerated, with no reported infusion reactions, nor other adverse events. None of the 14 cases treated with Megalotect as prophylaxis developed CMV reactivation. 51/78 (65%) patients who received Megalotect during pre-emptive treatment achieved complete clearance of CMV viremia, and 14/51 patients (29%) developed a breakthroug CMV infection. 7/78 patients (9%) developed CMV disease. The projected 1-year OS, 1-year TRM and 1-year RR is 74%, 15% and 19%, respectively. No differences were observed in terms of OS, TRM and RR by comparing patients who achieved a complete response after treatment versus those who did not.. These retrospective data suggest that Megalotect is safe and well tolerated. When used as prophylaxis, no CMV reactivation was recorded. We have no conclusive data regarding its efficacy in reducing the cumulative dose of anti-CMV specific drugs in the pre-emptive setting. Further prospective trials are warrented to identify the best setting of patients who can benefit from Megalotect alone or in addition to anti-CMV specific drugs.

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Section: Introductionmentioning

confidence: 99%

CMV Management With Specific Immunoglobulins: A Multicentric Retrospective Analysis on 92 Allotransplanted Patients.

Malagola

Greco

Santarone³

et al. 2019

Mediterr J Hematol Infect Dis

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“…Amongs the two remaining studies, Steinmuller et al 1989 reported mean rejections per patient of 0.5 and 0.8 at 6 months in the intervention group and the control group, respectively; the corresponding standard deviations were not provided . Vu et al 2015 reported 10% acute rejection in 20 allografts at 4.2 ± 3.5 months after IVIG treatment for BK nephropathy …”

Section: Resultsmentioning

confidence: 99%

“…Note that all the included studies for this review used polyvalent IG, not CMVIG that contains higher concentration of CMV specific IgG antibody. CMVIG had been studied in hematopoietic stem cell transplant recipients with mixed results . Therefore, it is not used in current clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Clinical outcomes of polyvalent immunoglobulin use in solid organ transplant recipients: A systematic review and meta‐analysis

Bourassa‐Blanchette

Knoll

Hutton

et al. 2019

Clinical Transplantation

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Polyvalent immunoglobulin is commonly used for desensitization and treatment of antibody‐mediated rejection in kidney transplantation but its impact on other outcomes is not known. This systematic review investigated the impact of immunoglobulin prophylaxis on infection, rejection, graft loss, and death following kidney transplantation. A comprehensive literature search located 18 studies (n = 8 randomized controlled trials). None examined the effect of immunoglobulin prophylaxis in transplant recipients with hypogammaglobulinemia. Quality of included studies was variable with high to very high risk of bias. In the randomized trials, immunoglobulin use did not reduce cytomegalovirus infection (OR 0.68 [0.39, 1.21]; 6 studies, n = 295), rejection (OR 0.96 [0.50, 1.82]; 4 studies, n = 187), or graft loss (OR 1.03 [0.46, 2.30]; 6 studies, n = 265). In non‐randomized studies, immunoglobulin did not reduce cytomegalovirus infection (OR 0.63 [0.20, 1.94]; 6 studies, n = 361) or death (OR 1.32 [0.05, 38.79]; 3 studies, n = 222) but reduce rejection (OR 0.47 [0.24, 0.94]; 4 studies, n = 268) and graft loss (OR 0.15 [0.05, 0.43]; 2 studies, n = 118). Data were scarce and sample size of current evidence was small. Adequately powered randomized trials are needed to determine if immunoglobulin is an effective intervention to reduce infection, rejection, graft loss, or death following kidney transplantation with and without hypogammaglobulinemia.

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“…ВВИГ при ТГСК выступает как профилактическое и средство лечения инфекционных осложнений, а также как иммуномодулирующее средство лечения острой реакции трансплантат против хозяина (РТПХ). Именно снижение риска РТПХ и цитомегаловирусной инфекции, особенно при гипогаммаглобулинэмии (IgG < 4,0 г/л) является основным благоприятным терапевтическим эффектом применения ВВИГ в дозе от 0,6 до 5 г/кг веса и более при ТГСК [14]. В 2000-х годах ВВИГ оправдывал возлагаемые надежды (степень доказательности Ib) и был рекомендован к широкому применению при аллогенной ТГСК.…”

Section: другие хорошо известные синдромы с иммунодефицитомunclassified

“…Побочные реакции замедленного типа -это тромбозы, неврологические расстройства, почечная недостаточность, гематологические расстройства (гемолитические реакции, нейтропению), нарушение электролитного баланса, инфекции [2,14,38]. Они встречаются менее чем у 1% пациентов, получавших ВВИГ.…”

Section: частотаunclassified

Human normal immunoglobulin for intravenous administration: indications, effectiveness and safety of clinical application.

Потапнев¹,

Карпенко²

2018

Immunopathol Allergol Infectol

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В обзоре литературы рассмотрены вопросы клинического применения ВВИГ, в том числе как с заместительной целью, так и связанные с иммуномодулирующим действием препарата. Основным показанием для применения ВВИГ является первичные иммунодефицитные состояния гуморального иммунитета, связанные прежде всего с дефицитом содержания IgG и риском инфекций. Более 50% показаний к применению ВВИГ в настоящее время связаны с оказанием иммуномодулирующего действия. Это септические состояния, трансплантация органов и тканей, онкологические, неврологические, ревматические, аллергические заболевания, системные васкулиты, коагулопатии, невынашивание беременности и другие заболевания человека. В обзоре описаны результаты клинической эффективности ВВИГ при основных заболеваниях человека. Важный раздел-профилактика побочных реакций и осложнений, возникающих у 5-15% пациентов после введения препарата. Перечислены основные меры профилактики, включающие прогнозирование возможных осложнений на основе оценки анамнеза и объективного состояния пациента, индивидуализацию дозы, применение подкожного введения, премедикацию, мониторинг пациента после введения препарата. Сделан вывод о соблюдении баланса между клинической эффективностью и риском возникновения побочных реакций и осложнений при все расширяющихся показаниях к применению ВВИГ. Ключевые слова Иммуноглобулин человека нормальный для внутри венного введения, заместительная терапия, иммуномодулирующая терапия, побочные реакции, осложнения, профилактика

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Effectiveness of immunoglobulin prophylaxis in reducing clinical complications of hematopoietic stem cell transplantation: a systematic review and meta‐analysis

Cited by 21 publications

References 56 publications

CMV Management With Specific Immunoglobulins: A Multicentric Retrospective Analysis on 92 Allotransplanted Patients.

CMV Management With Specific Immunoglobulins: A Multicentric Retrospective Analysis on 92 Allotransplanted Patients.

Clinical outcomes of polyvalent immunoglobulin use in solid organ transplant recipients: A systematic review and meta‐analysis

Human normal immunoglobulin for intravenous administration: indications, effectiveness and safety of clinical application.

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