The effects of plasma exchange in patients with ANCA-associated vasculitis: an updated systematic review and meta-analysis

Walsh, Michael; Collister, David; Zeng, Linan; Merkel, Peter A.; Pusey, Charles D.; Guyatt, Gordon; Peh, Chen Au; Szpirt, Wladimir; Ito-Hara, T.; Jayne, David

doi:10.1136/bmj-2021-064604

Cited by 61 publications

(66 citation statements)

References 29 publications

(55 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…We used the control group event rates in the systematic review to estimate the baseline risks for outcomes of mortality, serious infections, and relapse of AAV, and used the data from seven multinational RCTs conducted by the European Vasculitis Study Group with 798 patients to estimate the baseline risk for the outcome of ESKD 23242526272829. The systematic review found no credible evidence that the relative effect of plasma exchange would vary on the basis of kidney function or pulmonary haemorrhage 12. We therefore used the baseline risks, along with the pooled relative risk for overall patients at the timeline of one year and long term follow-up (median 3 years) from the systematic review, to calculate the absolute effect estimates presented in our evidence summaries.…”

Section: The Evidencementioning

confidence: 99%

“…Because of availability of baseline risk strata, the linked systematic review provided the absolute effects of plasma exchange in ESKD and serious infections in a time frame of 1 year rather than a longer time frame 12. Plasma exchange probably reduces the 1 year risk of ESKD (the absolute risk reduction approximately 0.1% in low risk group, 2.1% reduction in low-moderate risk group, 4.6% reduction in moderate-high risk group, and 16.0% in high risk group or patients requiring dialysis) but increases the risk of serious infections (the absolute risk increase approximately 2.7% in low risk group, 4.9% in low-moderate risk group, 8.5% increase in moderate-high risk group, and 13.5% in high risk group or patients requiring dialysis) at 1 year (moderate to high certainty).…”

Section: The Evidencementioning

confidence: 99%

“…The recommendation is based on two linked systematic reviews on benefits and harms of plasma exchange and different dose regimens of glucocorticoids in patients with AAV 1213. The main infographic provides an overview of the relative and absolute benefits and harms of plasma exchange and reduced dose regimen of glucocorticoids in standard GRADE format.…”

mentioning

confidence: 99%

See 2 more Smart Citations

Plasma exchange and glucocorticoid dosing for patients with ANCA-associated vasculitis: a clinical practice guideline

Zeng

Walsh

Guyatt

et al. 2022

BMJ

Self Cite

View full text Add to dashboard Cite

Clinical questions What is the role of plasma exchange and what is the optimal dose of glucocorticoids in the first 6 months of therapy of patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV)? This guideline was triggered by the publication of a new randomised controlled trial. Current practice Existing guideline recommendations vary regarding the use of plasma exchange in AAV and lack explicit recommendations regarding the tapering regimen of glucocorticoids during induction therapy. Recommendations The guideline panel makes a weak recommendation against plasma exchange in patients with low or low-moderate risk of developing end stage kidney disease (ESKD), and a weak recommendation in favour of plasma exchange in patients with moderate-high or high risk of developing ESKD. For patients with pulmonary haemorrhage without renal involvement, the panel suggests not using plasma exchange (weak recommendation). The panel made a strong recommendation in favour of a reduced dose rather than standard dose regimen of glucocorticoids, which involves a more rapid taper rate and lower cumulative dose during the first six months of therapy. How this guideline was created A guideline panel including patients, a care giver, clinicians, content experts, and methodologists produced these recommendations using GRADE and in adherence with standards for trustworthy guidelines. The recommendations are based on two linked systematic reviews. The panel took an individual patient perspective in the development of recommendations. The evidence The systematic review of plasma exchange identified nine randomised controlled trials (RCTs) that enrolled 1060 patients with AAV. Plasma exchange probably has little or no effect on mortality or disease relapse (moderate and low certainty). Plasma exchange probably reduces the one year risk of ESKD (approximately 0.1% reduction in those with low risk, 2.1% reduction in those with low-moderate risk, 4.6% reduction in those with moderate-high risk, and 16.0% reduction in those with high risk or requiring dialysis) but increases the risk of serious infections (approximately 2.7% increase in those with low risk, 4.9% increase in those with low-moderate risk, 8.5% increase in those with moderate-high risk, to 13.5% in high risk group) at 1 year (moderate to high certainty). The guideline panel agreed that most patients with low or low-moderate risk of developing ESKD would consider the harms to outweigh the benefits, while most of those with moderate-high or high risk would consider the benefits to outweigh the harms. For patients with pulmonary haemorrhage without kidney involvement, based on indirect evidence, plasma exchange may have little or no effect on death (very low certainty) but may have an important increase in serious infections at 1 year (approximately 6.8% increase, low certainty). The systematic review of different dose regimens of glucocorticoids identified two RCTs at low risk of bias with 704 and 140 patients respectively. A reduced dose regimen of glucocorticoid probably reduces the risk of serious infections by approximately 5.9% to 12.8% and probably does not increase the risk of ESKD at the follow-up of 6 months to longer than 1 year (moderate certainty for both outcomes). Understanding the recommendation The recommendations were made with the understanding that patients would place a high value on reduction in ESKD and less value on avoiding serious infections. The panel concluded that most (50-90%) of fully informed patients with AAV and with low or low-moderate risk of developing ESKD with or without pulmonary haemorrhage would decline plasma exchange, whereas most patients with moderate-high or high risk or requiring dialysis with or without pulmonary haemorrhage would choose to receive plasma exchange. The panel also inferred that the majority of fully informed patients with pulmonary haemorrhage without kidney involvement would decline plasma exchange and that all or almost all (≥90%) fully informed patients with AAV would choose a reduced dose regimen of glucocorticoids during the first 6 months of therapy.

show abstract

Section: The Evidencementioning

confidence: 99%

Section: The Evidencementioning

confidence: 99%

See 1 more Smart Citation

Plasma exchange and glucocorticoid dosing for patients with ANCA-associated vasculitis: a clinical practice guideline

Zeng

Walsh

Guyatt

et al. 2022

BMJ

Self Cite

View full text Add to dashboard Cite

show abstract

“…Related systematic reviews [ 15 , 16 ] have been published in 2016, which have conducted comprehensive literature search and identified eligible ME studies published before 2015. By adopting the common practice of previous updated systematic reviews [ 25 , 26 ], we referred to the search strategies of previous systematic review [ 15 ] and searched PubMed, Embase, and Web of science with "meta-epidemiology", "treatment effect" and related keywords from January 2015 to August 2020. Reference lists of previously published systematic reviews [ 15 , 16 ] as well as the identified ME studies were screened for additional studies.…”

Section: Methodsmentioning

confidence: 99%

Trial-level characteristics associate with treatment effect estimates: a systematic review of meta-epidemiological studies

Wang¹,

Song²,

Lin³

et al. 2022

BMC Med Res Methodol

View full text Add to dashboard Cite

Background To summarize the up-to-date empirical evidence on trial-level characteristics of randomized controlled trials associated with treatment effect estimates. Methods A systematic review searched three databases up to August 2020. Meta-epidemiological (ME) studies of randomized controlled trials on intervention effect were eligible. We assessed the methodological quality of ME studies using a self-developed criterion. Associations between treatment effect estimates and trial-level characteristics were presented using forest plots. Results Eighty ME studies were included, with 25/80 (31%) being published after 2015. Less than one-third ME studies critically appraised the included studies (26/80, 33%), published a protocol (23/80, 29%), and provided a list of excluded studies with justifications (12/80, 15%). Trials with high or unclear (versus low) risk of bias on sequence generation (3/14 for binary outcome and 1/6 for continuous outcome), allocation concealment (11/18 and 1/6), double blinding (5/15 and 2/4) and smaller sample size (4/5 and 2/2) significantly associated with larger treatment effect estimates. Associations between high or unclear risk of bias on allocation concealment (5/6 for binary outcome and 1/3 for continuous outcome), double blinding (4/5 and 1/3) and larger treatment effect estimates were more frequently observed for subjective outcomes. The associations between treatment effect estimates and non-blinding of outcome assessors were removed in trials using multiple observers to reach consensus for both binary and continuous outcomes. Some trial characteristics in the Cochrane risk-of-bias (RoB2) tool have not been covered by the included ME studies, including using validated method for outcome measures and selection of the reported results from multiple outcome measures or multiple analysis based on results (e.g., significance of the results). Conclusions Consistently significant associations between larger treatment effect estimates and high or unclear risk of bias on sequence generation, allocation concealment, double blinding and smaller sample size were found. The impact of allocation concealment and double blinding were more consistent for subjective outcomes. The methodological and reporting quality of included ME studies were dissatisfactory. Future ME studies should follow the corresponding reporting guideline. Specific guidelines for conducting and critically appraising ME studies are needed.

show abstract

“…Jedoch konnte gezeigt werden, dass unter niedriger dosierten Glukokortikoiden bei gleichen Remissionsraten Infektionen reduziert werden können. Daher werden in neueren Therapiestrategien Steroide schneller reduziert 43 .…”

Section: Therapieunclassified

Granulomatose mit Polyangiitis – Manifestationen im Kopf-Hals-Bereich

Steinke

Welkoborsky

2021

Laryngorhinootologie

View full text Add to dashboard Cite

ZusammenfassungDie Granulomatose mit Polyangiitis ist eine seltene chronische rheumatologische Systemerkrankung, die mit einer Vaskulitis der kleinen und mittleren Gefäße einhergeht. Am häufigsten betrifft sie die oberen Atemwege, die Lunge und die Nieren. Die Beschwerden sind unspezifisch, häufig beklagen die Patienten anfangs eine Nasenatmungsbehinderung, Borkenbildung in der Nase, Ulzera der Mundschleimhäute oder Epistaxis. Nicht selten wird deshalb der Hals-Nasen-Ohren-Arzt zu Beginn der Krankheit hinzugezogen. Langfristig können schwerwiegende kardiale, renale oder pulmonale Komplikationen auftreten. Die Ätiologie ist bis heute nicht komplett geklärt. Als Therapie wird eine Immunsuppression eingeleitet. Klinische und laborchemische Kontrollen sind lebenslang obligat.

show abstract

The effects of plasma exchange in patients with ANCA-associated vasculitis: an updated systematic review and meta-analysis

Cited by 61 publications

References 29 publications

Plasma exchange and glucocorticoid dosing for patients with ANCA-associated vasculitis: a clinical practice guideline

Plasma exchange and glucocorticoid dosing for patients with ANCA-associated vasculitis: a clinical practice guideline

Trial-level characteristics associate with treatment effect estimates: a systematic review of meta-epidemiological studies

Granulomatose mit Polyangiitis – Manifestationen im Kopf-Hals-Bereich

Contact Info

Product

Resources

About