Safety of intravenous immune globulin in an outpatient setting for patients with neuromuscular disease

Waheed, Waqar; Ayer, Gretchen; Jadoo, Cindy; Badger, Gary J.; Aboukhatwa, Marwa; Brannagan, Thomas H.; Tandan, Rup

doi:10.1002/mus.26678

Cited by 9 publications

(15 citation statements)

References 51 publications

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“…In particular, the likelihood of ARs to IVIG correlated with having neuromuscular diseases (odds: 6.914) among patients with any autoimmune disease. In fact, in that subgroup, the incidence of ARs for neuromuscular diseases was 28.4% (data not shown), consistent with other studies (12,14,21) that have reported ARs in more than 20% of patients with neuromuscular diseases. Wietek et al (22) analyzed data from 112 patients with ITP receiving IVIG, in which there were five cases with at least one AR.…”

Section: Discussionsupporting

confidence: 91%

“…In contrast, on a per-infusion basis, multivariate logistic regression of risk factors for ARs to IVIG identified adolescents to middle age (age < 60 years) (p < 0.001) as significant risk factors. Waheed et al ( 12 ) reported that multivariate analyses identified the following risk factors for ARs on a per-infusion: younger age. Thus, the age as risk factors for ARs was reflected on a per-infusion basis rather than on a per-patient basis.…”

Section: Discussionmentioning

confidence: 99%

“…Although a large number of clinical trials have demonstrated that IVIG is generally safe and well tolerated, various ARs do occur. The reported incidence of ARs varies widely, from 1% to more than 50% of patients, depending on the study (10)(11)(12)(13)(14). ARs are rare among immunodeficient patients when receiving the same dose as previously well tolerated at regular intervals.…”

Section: Discussionmentioning

confidence: 99%

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A Retrospective Observational Study of Adverse Reactions Associated With Intravenous Immunoglobulin Infusion

et al. 2021

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BackgroundAlthough intravenous immunoglobulin (IVIG) therapy is generally safe and well tolerated, adverse reactions (ARs) do occur. The majority of these ARs are mild and transient. Risk factors for ARs associate with IVIG infusions are not well established. This study investigated possible risk factors influencing the occurrence of IVIG-associated ARs.Study Design and MethodsThis was a retrospective observational analysis of data accumulated over 5 years, including patient demographics, clinical condition, IVIG dosing regimens, number of IVIG infusions, and any ARs.ResultsARs were associated with IVIG in 4.9% of patients and 2.5% of infusions. By univariate analyses, ARs correlated with female sex, adult age, high dose IVIG, and autoimmune disease. Multivariate logistic regression identified three statistically significant of risk factors: on a per-patient basis, being female (p=0.0018), having neuromuscular disease (p=0.0002), and receiving higher doses of IVIG per patient body weight (p<0.001), on a per-infusion basis, being female (p < 0.001), being adolescents to middle age (p < 0.001), and having neuromuscular disease (p < 0.001).ConclusionNeuromuscular disease emerged as one of the significant factors for ARs to IVIG.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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A Retrospective Observational Study of Adverse Reactions Associated With Intravenous Immunoglobulin Infusion

et al. 2021

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“…Rates of product-related headache were significantly higher for adults than for pediatric patients at the infusion level but not on a per-patient basis, suggesting that adults were more likely to report multiple headache events than pediatric patients. Consistent with previously published studies, rates of headache were significantly higher for adult females than adult males at the infusion level and on a per-patient basis ( 6 , 14 ). However, in the pediatric subgroup, headache rates were similar for males and females.…”

Section: Discussionsupporting

confidence: 91%

“…With IVIG therapy, first doses have been associated with more reported AEs than subsequent doses ( 2 , 14 , 26 ). In our study, most headaches and migraines occurred within 72 hours of the infusion and most occurred in association with the first few infusions, with rates decreasing over time.…”

Section: Discussionmentioning

confidence: 99%

Low rates of headache and migraine associated with intravenous immunoglobulin infusion using a 15-minute rate escalation protocol in 123 patients with primary immunodeficiency

Geng

Clark

Evangelista³

et al. 2023

Front. Immunol.

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IntroductionHeadache and migraine adverse events are common concerns in the administration of intravenous immune globulins (IVIG). Trials of IVIG for primary immunodeficiency (PI) are typically small and have reported headache and migraine data inconsistently.MethodsWe analyzed headache and migraine in pooled data from three pivotal trials of Gammaplex® 5% and 10% in PI (NCT00278954 from January 18, 2006; NCT01289847 from January 27, 2011; NCT01963143 from September 13, 2013). The trials were pooled in a retrospective analysis that included two 12-month open-label non-comparative trials of the 5% IVIG product and one 6-month open-label crossover bioequivalence trial comparing the 5% IVIG and 10% IVIG products. The population included adult and pediatric patients, who received IVIG infusions of 300-800 mg/kg/infusion every 21 or 28 days using a 15-minute rate escalation protocol.ResultsIn total, 1482 infusions were administered to 123 patients, with 94.6% of infusions achieving the maximum infusion rate. At least one product-related headache was reported in 6.1% (90/1482) of infusions. At least one product-related migraine was reported in 0.5% (7/1482) of infusions. Headache rates were higher for adults vs pediatric patients, females vs males, and 21-day vs 28-day dosing schedules, but were similar for the 5% and 10% IVIG products. Most headaches and migraines occurred during or within 72 hours of the infusion. Rates decreased after the first few infusions.DiscussionPatients receiving this IVIG product on a 15-minute rate escalation protocol had low rates of headache and migraine for both the 5% and 10% formulations.

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Effect of intravenous immunoglobulin on mortality in hospitalized patients with COVID‐19: A systematic review and meta‐analysis of randomized controlled trials

Ramachandram,

Kow,

Hasan

et al. 2024

Health Science Reports

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Background and AimsWe performed a meta‐analysis of randomized controlled trials (RCTs) to summarize the overall effect of intravenous immunoglobulin (IVIG) on mortality outcomes among hospitalized coronavirus disease 2019 (COVID‐19) patients.MethodsWe systematically searched electronic databases up to June 1, 2023. Pooled odds ratio (OR) of mortality with a 95% confidence interval (CI) was generated using a random‐effects model. The risk of bias was appraised using the Cochrane risk‐of‐bias Version 2 tool for randomized trials.ResultsNine RCTs were included: three RCTs had an overall low risk of bias, four RCTs had some concerns in the overall risk of bias, and two RCTs trials had an overall high risk of bias. The use of IVIG indicated a significant reduction in the odds of mortality (pooled OR = 0.69; 95% CI 0.50–0.96) relative to nonuse of IVIG. Subgroup analysis in patients with a severe course of COVID‐19 revealed no significant reduction in the odds of mortality (pooled OR = 0.58; 95% CI 0.29–1.16).ConclusionsWe suggest exercising caution when interpreting effectiveness of IVIG in reducing mortality among hospitalized patients with COVID‐19. Our findings emphasize for larger trials with rigorous study designs to better understand the impact of IVIG, particularly in those with severe COVID‐19.

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Safety of intravenous immune globulin in an outpatient setting for patients with neuromuscular disease

Cited by 9 publications

References 51 publications

A Retrospective Observational Study of Adverse Reactions Associated With Intravenous Immunoglobulin Infusion

A Retrospective Observational Study of Adverse Reactions Associated With Intravenous Immunoglobulin Infusion

Low rates of headache and migraine associated with intravenous immunoglobulin infusion using a 15-minute rate escalation protocol in 123 patients with primary immunodeficiency

Effect of intravenous immunoglobulin on mortality in hospitalized patients with COVID‐19: A systematic review and meta‐analysis of randomized controlled trials

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