A. Palmowski, S. M. Nielsen, T. Buttgereit, Y. Palmowski, M. Boers, R. Christensen, F. Buttgereit
2020 Annals of the Rheumatic Diseases  
Background:Randomised controlled trials (RCTs) are considered the gold standard in clinical research. Their results, however, may not be generalizable to patients in routine care.1Together with methotrexate, glucocorticoids (GCs) constitute the mainstay of therapy for many patients with rheumatoid arthritis (RA), but it is unclear whether trial evidence is actually generalizable to real-world patients.Objectives:This review assesses to what extent RA patients participating in GC-RCTs differ
more » ... GC-RCTs differ from RA patients taking GCs in routine care.Methods:This study was registered with PROSPERO (CRD42019134675). MEDLINE was searched for RCTs and, as comparators, cohort studies in RA evaluating systemic GC therapy. Cohorts were not allowed to exhibit apparent selection mechanisms concerning gender or age. Random-effects meta-analyses combined descriptive baseline characteristics that may modify the benefit-risk-ratio of various RA therapeutics. Meta-analyses were stratified by study type (RCT and CS). Stratified estimates were subsequently compared.Results:55 RCTs and ten cohort studies (21,657 participants overall) were included. Twelve characteristics (related to general demographics and disease activity) were reported frequently enough to allow for comparative analysis. Compared to cohorts, RCT participants were younger (-4.7 [-7.2 to -2.1] years) and had somewhat higher erythrocyte sedimentation rates (12 [6 to 18] mm/h) (Table 1). In the other ten characteristics, estimates did not differ significantly. Numerically, cohort patients had more longstanding disease and slightly more favourable disease levels in core set variables. Comorbidities could not be assessed.Table 1.Pooled estimatesOutcomeRCTkCohortkContrast(95% CI)pGeneral demographics Age (years)54.25058.910–4.7(–7.2 to –2.1)<0.001 Female (proportion)0.70520.73100.89(0.68 to 1.16)0.38 Current or previous smokers (proportion)0.5930.5121.38(0.61 to 3.14)0.44 BMI (kg/m2)25.9525.930.0(–1.9 to 1.9)0.98 Disease duration (months)56.54385.17–28.6(–85.6 to 28.4)0.33Disease activity ESR (mm/h)40.13128.2311.8(5.7 to 18.0)<0.001 DAS5.3244.950.4(–0.1 to 0.9)0.12 RF+, (proportion)0.67320.6361.19(0.80 to 1.78)0.39 ACPA+, (proportion)0.6470.5631.38(0.64 to 3.00)0.41 HAQ1.3311.140.2(–0.1 to 0.5)0.15 Pain (0-10)5.2264.820.4(–0.8 to 1.6)0.52 Patient global assessment (0-10)5.2174.930.3(–0.9 to 1.5)0.58Conclusion:The results of our study suggest that evidence from RA GC-RCTs can be generalized to most patients in routine practice. We note that comorbidities – a frequent exclusion criterion for trial participation – could not be evaluated due to insufficient reporting. Our findings contrast with a similar study on RCTs investigating biologics in RA: There, trial participants were found to differ significantly in 4 out of 8 investigated baseline characteristics.2References:1]Palmowski A et al. Applicability of trials in rheumatoid arthritis and osteoarthritis: A systematic review and meta-analysis of trial populations showing adequate proportion of women, but underrepresentation of elderly people.Semin Arthritis Rheum2018 doi: 10.1016/j.semarthrit.2018.10.017 and[2]Kilcher G et al. Rheumatoid arthritis patients treated in trial and real world settings: comparison of randomized trials with registries.Rheumatology (Oxford) 2017 doi: 10.1093/rheumatology/kex394Acknowledgments:Part of the GLORIA project and trial, funded by the EU (Horizon 2020, Grant No 634886)Disclosure of Interests:Andriko Palmowski: None declared, Sabrina Mai Nielsen: None declared, Thomas Buttgereit: None declared, Yannick Palmowski: None declared, Maarten Boers: None declared, Robin Christensen: None declared, Frank Buttgereit Grant/research support from: Amgen, BMS, Celgene, Generic Assays, GSK, Hexal, Horizon, Lilly, medac, Mundipharma, Novartis, Pfizer, Roche, and Sanofi.
doi:10.1136/annrheumdis-2020-eular.732 fatcat:saiudw3avfen3b3zaguvgaslce