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Glucocorticoid-trials in rheumatoid arthritis mostly study representative real-world patients: A systematic review and meta-analysis

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Palmowski, Andriko ; Nielsen, Sabrina M ; Buttgereit, Thomas ; Palmowski, Yannick ; Boers, Maarten ; Christensen, Robin ; Buttgereit, Frank. / Glucocorticoid-trials in rheumatoid arthritis mostly study representative real-world patients : A systematic review and meta-analysis. I: Seminars in Arthritis and Rheumatism. 2020 ; Bind 50, Nr. 6. s. 1400-1405.

Bibtex

@article{38edde5b7c6b4282a7a1a82b25a77593,
title = "Glucocorticoid-trials in rheumatoid arthritis mostly study representative real-world patients: A systematic review and meta-analysis",
abstract = "OBJECTIVE: Randomized controlled trials (RCTs) are considered the gold standard in clinical research due to credible causality. Their results, however, may not be generalizable to real-world populations. While glucocorticoids (GCs) remain a mainstay of rheumatoid arthritis (RA) treatment, it is unclear whether the results of GC-RCTs are generalizable to current real-world RA patients.METHODS: MEDLINE was searched for RCTs and, as comparators, cohort studies (CSs) in RA evaluating systemic GCs. Random-effects meta-analyses were performed for descriptive baseline characteristics (including general demographics, comorbidities, and disease activity) that have been shown to be able to modify the benefit-risk-ratio of various RA therapeutics. These meta-analyses were stratified by study type (RCT and CS). Stratified estimates were subsequently compared. Further sensitivity analyses were performed stratifying by disease duration.RESULTS: 56 RCTs (7053 participants) and 10 CSs (14,688 participants) were included. 12 characteristics were reported frequently enough to allow for comparative analysis. In 10/12 characteristics (83%), RCT estimates did not appear to differ from CS estimates. However, RCT participants were younger (-4.7 years [95% CI -7.2 to -2.1]; p < 0.001) and had higher erythrocyte sedimentation rates (11.8 mm/h [5.7 to 17.8]; p < 0.001) than CS participants. Comorbidities could not be assessed due to insufficient reporting.CONCLUSION: Our findings suggest that evidence from GC trials in RA is of acceptable generalizability to current real-world patients - especially compared to findings from biologic agents in RA. However, RCT participants were younger than real-world patients, potentially limiting the generalizability of trial results to elderly patients.SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD42019134675).",
author = "Andriko Palmowski and Nielsen, {Sabrina M} and Thomas Buttgereit and Yannick Palmowski and Maarten Boers and Robin Christensen and Frank Buttgereit",
note = "Copyright {\textcopyright} 2020 Elsevier Inc. All rights reserved.",
year = "2020",
month = dec,
doi = "10.1016/j.semarthrit.2020.02.016",
language = "English",
volume = "50",
pages = "1400--1405",
journal = "Seminars in Arthritis and Rheumatism",
issn = "0049-0172",
publisher = "W.B./Saunders Co",
number = "6",

}

RIS

TY - JOUR

T1 - Glucocorticoid-trials in rheumatoid arthritis mostly study representative real-world patients

T2 - A systematic review and meta-analysis

AU - Palmowski, Andriko

AU - Nielsen, Sabrina M

AU - Buttgereit, Thomas

AU - Palmowski, Yannick

AU - Boers, Maarten

AU - Christensen, Robin

AU - Buttgereit, Frank

N1 - Copyright © 2020 Elsevier Inc. All rights reserved.

PY - 2020/12

Y1 - 2020/12

N2 - OBJECTIVE: Randomized controlled trials (RCTs) are considered the gold standard in clinical research due to credible causality. Their results, however, may not be generalizable to real-world populations. While glucocorticoids (GCs) remain a mainstay of rheumatoid arthritis (RA) treatment, it is unclear whether the results of GC-RCTs are generalizable to current real-world RA patients.METHODS: MEDLINE was searched for RCTs and, as comparators, cohort studies (CSs) in RA evaluating systemic GCs. Random-effects meta-analyses were performed for descriptive baseline characteristics (including general demographics, comorbidities, and disease activity) that have been shown to be able to modify the benefit-risk-ratio of various RA therapeutics. These meta-analyses were stratified by study type (RCT and CS). Stratified estimates were subsequently compared. Further sensitivity analyses were performed stratifying by disease duration.RESULTS: 56 RCTs (7053 participants) and 10 CSs (14,688 participants) were included. 12 characteristics were reported frequently enough to allow for comparative analysis. In 10/12 characteristics (83%), RCT estimates did not appear to differ from CS estimates. However, RCT participants were younger (-4.7 years [95% CI -7.2 to -2.1]; p < 0.001) and had higher erythrocyte sedimentation rates (11.8 mm/h [5.7 to 17.8]; p < 0.001) than CS participants. Comorbidities could not be assessed due to insufficient reporting.CONCLUSION: Our findings suggest that evidence from GC trials in RA is of acceptable generalizability to current real-world patients - especially compared to findings from biologic agents in RA. However, RCT participants were younger than real-world patients, potentially limiting the generalizability of trial results to elderly patients.SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD42019134675).

AB - OBJECTIVE: Randomized controlled trials (RCTs) are considered the gold standard in clinical research due to credible causality. Their results, however, may not be generalizable to real-world populations. While glucocorticoids (GCs) remain a mainstay of rheumatoid arthritis (RA) treatment, it is unclear whether the results of GC-RCTs are generalizable to current real-world RA patients.METHODS: MEDLINE was searched for RCTs and, as comparators, cohort studies (CSs) in RA evaluating systemic GCs. Random-effects meta-analyses were performed for descriptive baseline characteristics (including general demographics, comorbidities, and disease activity) that have been shown to be able to modify the benefit-risk-ratio of various RA therapeutics. These meta-analyses were stratified by study type (RCT and CS). Stratified estimates were subsequently compared. Further sensitivity analyses were performed stratifying by disease duration.RESULTS: 56 RCTs (7053 participants) and 10 CSs (14,688 participants) were included. 12 characteristics were reported frequently enough to allow for comparative analysis. In 10/12 characteristics (83%), RCT estimates did not appear to differ from CS estimates. However, RCT participants were younger (-4.7 years [95% CI -7.2 to -2.1]; p < 0.001) and had higher erythrocyte sedimentation rates (11.8 mm/h [5.7 to 17.8]; p < 0.001) than CS participants. Comorbidities could not be assessed due to insufficient reporting.CONCLUSION: Our findings suggest that evidence from GC trials in RA is of acceptable generalizability to current real-world patients - especially compared to findings from biologic agents in RA. However, RCT participants were younger than real-world patients, potentially limiting the generalizability of trial results to elderly patients.SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD42019134675).

U2 - 10.1016/j.semarthrit.2020.02.016

DO - 10.1016/j.semarthrit.2020.02.016

M3 - Journal article

C2 - 32222381

VL - 50

SP - 1400

EP - 1405

JO - Seminars in Arthritis and Rheumatism

JF - Seminars in Arthritis and Rheumatism

SN - 0049-0172

IS - 6

ER -

ID: 62313617