Safety and efficacy associated with long-term low-dose glucocorticoids in rheumatoid arthritis: a systematic review and meta-analysis
Abstract Objectives The aim of this study was to assess the safety and efficacy of long-term low-dose glucocorticoids (GCs) in RA. Methods A protocolised systematic review and meta-analysis (PROSPERO No. CRD42021252528) of double-blind, placebo-controlled randomised trials (RCTs) comparing a low dos...
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Published in | Rheumatology (Oxford, England) Vol. 62; no. 8; pp. 2652 - 2660 |
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Main Authors | , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
England
Oxford University Press
01.08.2023
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Abstract | Abstract
Objectives
The aim of this study was to assess the safety and efficacy of long-term low-dose glucocorticoids (GCs) in RA.
Methods
A protocolised systematic review and meta-analysis (PROSPERO No. CRD42021252528) of double-blind, placebo-controlled randomised trials (RCTs) comparing a low dose of GCs (≤ 7.5mg/day prednisone) to placebo over at least 2 years was performed. The primary outcome investigated was adverse events (AEs). We performed random-effects meta-analyses and used the Cochrane RoB tool and GRADE to assess risk of bias and quality of evidence (QoE).
Results
Six trials with 1078 participants were included. There was no evidence of an increased risk of AEs (incidence rate ratio 1.08; 95% CI 0.86, 1.34; P = 0.52); however, the QoE was low. The risks of death, serious AEs, withdrawals due to AEs, and AEs of special interest did not differ from placebo (very low to moderate QoE). Infections occurred more frequently with GCs (risk ratio 1.4; 1.19–1.65; moderate QoE). Concerning benefit, we found moderate to high quality evidence of improvement in disease activity (DAS28: −0.23; −0.43 to −0.03), function (HAQ −0.09; −0.18 to 0.00), and Larsen scores (–4.61; −7.52 to −1.69). In other efficacy outcomes, including Sharp van der Heijde scores, there was no evidence of benefits with GCs.
Conclusion
There is very low to moderate QoE for no harm with long-term low dose GCs in RA, except for an increased risk of infections in GC users. The benefit-risk ratio might be reasonable forusing low-dose long-term GCs considering the moderate to high quality evidence for disease-modifying properties. |
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AbstractList | Abstract
Objectives
The aim of this study was to assess the safety and efficacy of long-term low-dose glucocorticoids (GCs) in RA.
Methods
A protocolised systematic review and meta-analysis (PROSPERO No. CRD42021252528) of double-blind, placebo-controlled randomised trials (RCTs) comparing a low dose of GCs (≤ 7.5mg/day prednisone) to placebo over at least 2 years was performed. The primary outcome investigated was adverse events (AEs). We performed random-effects meta-analyses and used the Cochrane RoB tool and GRADE to assess risk of bias and quality of evidence (QoE).
Results
Six trials with 1078 participants were included. There was no evidence of an increased risk of AEs (incidence rate ratio 1.08; 95% CI 0.86, 1.34; P = 0.52); however, the QoE was low. The risks of death, serious AEs, withdrawals due to AEs, and AEs of special interest did not differ from placebo (very low to moderate QoE). Infections occurred more frequently with GCs (risk ratio 1.4; 1.19–1.65; moderate QoE). Concerning benefit, we found moderate to high quality evidence of improvement in disease activity (DAS28: −0.23; −0.43 to −0.03), function (HAQ −0.09; −0.18 to 0.00), and Larsen scores (–4.61; −7.52 to −1.69). In other efficacy outcomes, including Sharp van der Heijde scores, there was no evidence of benefits with GCs.
Conclusion
There is very low to moderate QoE for no harm with long-term low dose GCs in RA, except for an increased risk of infections in GC users. The benefit-risk ratio might be reasonable forusing low-dose long-term GCs considering the moderate to high quality evidence for disease-modifying properties. OBJECTIVESThe aim of this study was to assess the safety and efficacy of long-term low-dose glucocorticoids (GCs) in RA. METHODSA protocolised systematic review and meta-analysis (PROSPERO No. CRD42021252528) of double-blind, placebo-controlled randomised trials (RCTs) comparing a low dose of GCs (≤ 7.5mg/day prednisone) to placebo over at least 2 years was performed. The primary outcome investigated was adverse events (AEs). We performed random-effects meta-analyses and used the Cochrane RoB tool and GRADE to assess risk of bias and quality of evidence (QoE). RESULTSSix trials with 1078 participants were included. There was no evidence of an increased risk of AEs (incidence rate ratio 1.08; 95% CI 0.86, 1.34; P = 0.52); however, the QoE was low. The risks of death, serious AEs, withdrawals due to AEs, and AEs of special interest did not differ from placebo (very low to moderate QoE). Infections occurred more frequently with GCs (risk ratio 1.4; 1.19-1.65; moderate QoE). Concerning benefit, we found moderate to high quality evidence of improvement in disease activity (DAS28: -0.23; -0.43 to -0.03), function (HAQ -0.09; -0.18 to 0.00), and Larsen scores (-4.61; -7.52 to -1.69). In other efficacy outcomes, including Sharp van der Heijde scores, there was no evidence of benefits with GCs. CONCLUSIONThere is very low to moderate QoE for no harm with long-term low dose GCs in RA, except for an increased risk of infections in GC users. The benefit-risk ratio might be reasonable forusing low-dose long-term GCs considering the moderate to high quality evidence for disease-modifying properties. The aim of this study was to assess the safety and efficacy of long-term low-dose glucocorticoids (GCs) in RA. A protocolised systematic review and meta-analysis (PROSPERO No. CRD42021252528) of double-blind, placebo-controlled randomised trials (RCTs) comparing a low dose of GCs (≤ 7.5mg/day prednisone) to placebo over at least 2 years was performed. The primary outcome investigated was adverse events (AEs). We performed random-effects meta-analyses and used the Cochrane RoB tool and GRADE to assess risk of bias and quality of evidence (QoE). Six trials with 1078 participants were included. There was no evidence of an increased risk of AEs (incidence rate ratio 1.08; 95% CI 0.86, 1.34; P = 0.52); however, the QoE was low. The risks of death, serious AEs, withdrawals due to AEs, and AEs of special interest did not differ from placebo (very low to moderate QoE). Infections occurred more frequently with GCs (risk ratio 1.4; 1.19-1.65; moderate QoE). Concerning benefit, we found moderate to high quality evidence of improvement in disease activity (DAS28: -0.23; -0.43 to -0.03), function (HAQ -0.09; -0.18 to 0.00), and Larsen scores (-4.61; -7.52 to -1.69). In other efficacy outcomes, including Sharp van der Heijde scores, there was no evidence of benefits with GCs. There is very low to moderate QoE for no harm with long-term low dose GCs in RA, except for an increased risk of infections in GC users. The benefit-risk ratio might be reasonable forusing low-dose long-term GCs considering the moderate to high quality evidence for disease-modifying properties. |
Author | Da Silva, José A P Christensen, Robin Palmowski, Andriko Boers, Maarten Wassenberg, Siegfried Boyadzhieva, Zhivana Nielsen, Sabrina M Kirwan, John Buttgereit, Frank Schneider, Abelina Pankow, Anne Dejaco, Christian Hartman, Linda |
Author_xml | – sequence: 1 givenname: Andriko orcidid: 0000-0002-3456-0597 surname: Palmowski fullname: Palmowski, Andriko email: andriko.palmowski@charite.de – sequence: 2 givenname: Sabrina M surname: Nielsen fullname: Nielsen, Sabrina M – sequence: 3 givenname: Zhivana surname: Boyadzhieva fullname: Boyadzhieva, Zhivana – sequence: 4 givenname: Abelina surname: Schneider fullname: Schneider, Abelina – sequence: 5 givenname: Anne surname: Pankow fullname: Pankow, Anne – sequence: 6 givenname: Linda surname: Hartman fullname: Hartman, Linda – sequence: 7 givenname: José A P orcidid: 0000-0002-2782-6780 surname: Da Silva fullname: Da Silva, José A P – sequence: 8 givenname: John surname: Kirwan fullname: Kirwan, John – sequence: 9 givenname: Siegfried surname: Wassenberg fullname: Wassenberg, Siegfried – sequence: 10 givenname: Christian orcidid: 0000-0002-0173-0668 surname: Dejaco fullname: Dejaco, Christian – sequence: 11 givenname: Robin surname: Christensen fullname: Christensen, Robin – sequence: 12 givenname: Maarten surname: Boers fullname: Boers, Maarten – sequence: 13 givenname: Frank orcidid: 0000-0003-2534-550X surname: Buttgereit fullname: Buttgereit, Frank |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/36810945$$D View this record in MEDLINE/PubMed |
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CitedBy_id | crossref_primary_10_1038_s41584_024_01120_w crossref_primary_10_7326_M23_0192 crossref_primary_10_1055_a_2189_0667 crossref_primary_10_1093_rheumatology_kead309 crossref_primary_10_1001_jamanetworkopen_2024_14316 crossref_primary_10_1016_j_semarthrit_2023_152349 crossref_primary_10_1016_S2665_9913_23_00159_5 crossref_primary_10_1080_25785826_2023_2265148 crossref_primary_10_1093_rheumatology_keae077 crossref_primary_10_1093_rap_rkad102 crossref_primary_10_1093_rheumatology_kead167 crossref_primary_10_1016_j_addr_2024_115194 |
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Objectives
The aim of this study was to assess the safety and efficacy of long-term low-dose glucocorticoids (GCs) in RA.
Methods
A protocolised... The aim of this study was to assess the safety and efficacy of long-term low-dose glucocorticoids (GCs) in RA. A protocolised systematic review and... OBJECTIVESThe aim of this study was to assess the safety and efficacy of long-term low-dose glucocorticoids (GCs) in RA. METHODSA protocolised systematic... |
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Title | Safety and efficacy associated with long-term low-dose glucocorticoids in rheumatoid arthritis: a systematic review and meta-analysis |
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