The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study

Summary

Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis: The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study (GLORIA)

Timeline

Start

2016-06-30

Primary completion

2020-12-31

Completion

2020-12-31

Outcome

Mixed primary results

paper Disease activity was 0.37 points lower on prednisolone (95% CL 0.23, p<0.0001) PMID 35641125 ↗

paper 60% versus 49% of patients experienced the harm outcome, adjusted relative risk 1.24 (95% CL 1.04, p=0.02) PMID 35641125 ↗

Publications

• Background Palmowski Y, Buttgereit T, Dejaco C, Bijlsma JW, Matteson EL, Voshaar M, Boers M, Buttgereit F. "Official View" on Glucocorticoids in Rheumatoid Arthritis: A Systematic Review of International Guidelines and Consensus Statements. Arthritis Care Res (Hoboken). 2017 Aug;69(8):1134-1141. doi: 10.1002/acr.23185. Epub 2017 Jul 10.
• Background Palmowski Y, Buttgereit F, Boers M. Reply. Arthritis Care Res (Hoboken). 2019 Apr;71(4):577-578. doi: 10.1002/acr.23452. No abstract available.
• Background Hartman L, Rasch LA, Klausch T, Bijlsma HWJ, Christensen R, Smulders YM, Ralston SH, Buttgereit F, Cutolo M, Da Silva JAP, Opris D, Rovensky J, Szamosi S, Middelink LM, Lems WF, Boers M. Harm, benefit and costs associated with low-dose glucocorticoids added to the treatment strategies for rheumatoid arthritis in elderly patients (GLORIA trial): study protocol for a randomised controlled trial. Trials. 2018 Jan 25;19(1):67. doi: 10.1186/s13063-017-2396-3.
• Background Hartman L, Lems WF, Boers M. Outcome measures for adherence data from a medication event monitoring system: A literature review. J Clin Pharm Ther. 2019 Feb;44(1):1-5. doi: 10.1111/jcpt.12757. Epub 2018 Sep 1.
• Background Hartman L, Cutolo M, Bos R, Opris-Belinski D, Kok MR, Griep-Wentink HJRM, Klaasen R, Allaart CF, Bruyn GAW, Raterman HG, Voshaar MJH, Gomes N, Pinto RMA, Klausch LT, Lems WF, Boers M. Medication adherence in older people with rheumatoid arthritis is lower according to electronic monitoring than according to pill count. Rheumatology (Oxford). 2021 Nov 3;60(11):5239-5246. doi: 10.1093/rheumatology/keab207.
• Background Palmowski A, Nielsen SM, Buttgereit T, Palmowski Y, Boers M, Christensen R, Buttgereit F. Association Between Participant Retention and the Proportion of Included Elderly People in Rheumatology Trials: Results From a Series of Exploratory Meta-Regression Analyses. Arthritis Care Res (Hoboken). 2020 Oct;72(10):1490-1496. doi: 10.1002/acr.24051.
• Background Palmowski A, Buttgereit T, Palmowski Y, Nielsen SM, Boers M, Christensen R, Buttgereit F. 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 Rheum. 2019 Jun;48(6):983-989. doi: 10.1016/j.semarthrit.2018.10.017. Epub 2018 Nov 2.
• Background Palmowski A, Nielsen SM, Buttgereit T, Palmowski Y, Boers M, Christensen R, Buttgereit F. Glucocorticoid-trials in rheumatoid arthritis mostly study representative real-world patients: A systematic review and meta-analysis. Semin Arthritis Rheum. 2020 Dec;50(6):1400-1405. doi: 10.1016/j.semarthrit.2020.02.016. Epub 2020 Mar 2.
• Background Forsat ND, Palmowski A, Palmowski Y, Boers M, Buttgereit F. Recruitment and Retention of Older People in Clinical Research: A Systematic Literature Review. J Am Geriatr Soc. 2020 Dec;68(12):2955-2963. doi: 10.1111/jgs.16875. Epub 2020 Oct 19.
• Background Buttgereit T, Palmowski A, Forsat N, Boers M, Witham MD, Rodondi N, Moutzouri E, Navidad AJQ, Van't Hof AWJ, van der Worp B, Coll-Planas L, Voshaar M, de Wit M, da Silva J, Stegemann S, Bijlsma JW, Koeller M, Mooijaart S, Kearney PM, Buttgereit F. Barriers and potential solutions in the recruitment and retention of older patients in clinical trials-lessons learned from six large multicentre randomized controlled trials. Age Ageing. 2021 Nov 10;50(6):1988-1996. doi: 10.1093/ageing/afab147.
• Background Santiago T, Voshaar M, de Wit M, Carvalho PD, Buttgereit F, Cutolo M, Paolino S, Castelar Pinheiro GR, Boers M, Da Silva JAP. Patients' and rheumatologists' perspectives on the efficacy and safety of low-dose glucocorticoids in rheumatoid arthritis-an international survey within the GLORIA study. Rheumatology (Oxford). 2021 Jul 1;60(7):3334-3342. doi: 10.1093/rheumatology/keaa785.
• Background van der Heijde DM, van Leeuwen MA, van Riel PL, van de Putte LB. Radiographic progression on radiographs of hands and feet during the first 3 years of rheumatoid arthritis measured according to Sharp's method (van der Heijde modification). J Rheumatol. 1995 Sep;22(9):1792-6.
• Results Hartman L, Bos R, Buttgereit F, Guler-Yuksel M, Ionescu R, Kok MR, Lems WF, Micaelo M, Opris-Belinski D, Pusztai A, Santos E, Da Silva J, Szekanecz Z, Zeiner K, Zhang D, Boers M. Remarkable international variability in reasons for ineligibility and non-participation in the GLORIA trial. Scand J Rheumatol. 2019 Jul;48(4):340-341. doi: 10.1080/03009742.2018.1559880. Epub 2019 May 27. No abstract available.
• Results Boers M, Hartman L, Opris-Belinski D, Bos R, Kok MR, Da Silva JA, Griep EN, Klaasen R, Allaart CF, Baudoin P, Raterman HG, Szekanecz Z, Buttgereit F, Masaryk P, Klausch LT, Paolino S, Schilder AM, Lems WF, Cutolo M; GLORIA Trial consortium. Low dose, add-on prednisolone in patients with rheumatoid arthritis aged 65+: the pragmatic randomised, double-blind placebo-controlled GLORIA trial. Ann Rheum Dis. 2022 Jul;81(7):925-936. doi: 10.1136/annrheumdis-2021-221957. Epub 2022 May 31.
• Results Hartman L, da Silva JAP, Buttgereit F, Cutolo M, Opris-Belinski D, Szekanecz Z, Masaryk P, Voshaar MJH, Heymans MW, Lems WF, van der Heijde DMFM, Boers M. Development of prediction models to select older RA patients with comorbidities for treatment with chronic low-dose glucocorticoids. Rheumatology (Oxford). 2023 May 2;62(5):1824-1833. doi: 10.1093/rheumatology/keac547.
• Results Hartman L, El Alili M, Cutolo M, Opris D, Da Silva J, Szekanecz Z, Buttgereit F, Masaryk P, Bos R, Kok MR, Paolino S, Coupe V, Lems WF, Boers M; GLORIA consortium. Cost-effectiveness and cost-utility of add-on, low-dose prednisolone in patients with rheumatoid arthritis aged 65+: The pragmatic, multicenter, placebo-controlled GLORIA trial. Semin Arthritis Rheum. 2022 Dec;57:152109. doi: 10.1016/j.semarthrit.2022.152109. Epub 2022 Oct 21.
• Palmowski A, Nielsen SM, Boyadzhieva Z, Schneider A, Pankow A, Hartman L, Da Silva JAP, Kirwan J, Wassenberg S, Dejaco C, Christensen R, Boers M, Buttgereit F. Safety and efficacy associated with long-term low-dose glucocorticoids in rheumatoid arthritis: a systematic review and meta-analysis. Rheumatology (Oxford). 2023 Aug 1;62(8):2652-2660. doi: 10.1093/rheumatology/kead088.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prednisolone	Other / unclassified	5 mg	Oral

Indications