OBJECTIVES
To study the safety and efficacy of long-term low dose glucocorticoids (GCs) in rheumatoid arthritis (RA).


METHODS
A protocolised (PROSPERO [CRD42021252528]) systematic review and meta-analysis of double-blind, placebo-controlled randomised trials (RCTs) comparing a low dose of GCs (≤ 7.5mg/day prednisone) to placebo over at least two years was performed. The primary outcome 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 1,078 participants were included. There was no evidence of an increased risk of AEs (incidence rate ratio 1.08; 95%CI 0.86 to 1.34; p = 0.52), however, QoE was low. The risks of death, serious AEs, withdrawals due to AEs, and AEs of special interest were not different from placebo (very low to moderate QoE). Infections occurred more frequently with GCs (risk ratio 1.4; 1.19 to 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 for using low-dose long-term GCs considering the moderate to high quality evidence for disease-modifying properties.

Safety and efficacy associated with long-term low dose glucocorticoids in rheumatoid arthritis: a systematic review and meta-analysis.

Modern rheumatology enables better and earlier diagnosis and therapy of inflammatory rheumatic system diseases. At the same time, the requirements for the care of rheumatologic patients have risen considerably for non-medical assistant professions and specialists for nursing professions. Since 2006 there has been established an education curriculum "Rheumatological Specialist Assistant DGRh-BDRh" (RFA) with the training to become a "Rheumatological Specialist Assistant (DGRh-BDRh)". In Europe and in parallel in Germany, assistant professions are increasingly involved in the early detection and care of patients with rheumatic diseases and entrusted with tasks.In this work, the overarching principles for delegation of medical tasks to RFA and recommendations for the delegation are published by the Commission for Delegation of the German Society for Rheumatology (DGRh). These recommendations are based on the requirements of the German Medical Association and have been legally evaluated. With the extension of the training of the RFA board certification is aimed for "MFA for Rheumatology". These recommendations enable more transparency and security for delegating doctors and the delegated RFA's.

Delegation of medical tasks in rheumatology

How to taper glucocorticoids in inflammatory rheumatic diseases? A narrative review of novel evidence in rheumatoid arthritis, systemic lupus erythematosus, and giant cell arteritis

Systemische Glukokortikoide (GC) sind ein haufiger Bestandteil der Therapie der rheumatoiden Arthritis (RA). Das Ziel der Arbeit ist es darzulegen, welche Evidenz fur GC-arme oder GC-freie Therapieregimes der RA existiert. Auserdem werden Konzepte fur eine Deeskalation der GC-Therapie der RA vorgestellt. In der initialen Phase gibt es ausreichend Evidenz dafur, dass eine begleitende Therapie von GC zusatzlich zu Methotrexat (MTX) das Ansprechen der Krankheitsaktivitat wie auch die subjektiv empfundene Beeintrachtigung der Patienten bessert. Die Dosis des GC muss aber kritisch abgewogen werden, und das leitliniengemase schrittweise Reduzieren und Absetzen mussen konsequent erfolgen. In den spateren Phasen des Therapiealgorithmus uberwiegen die Risiken der GC-Gaben, und eine Langzeittherapie mit GC sollte nur noch in Ausnahmefallen erfolgen. Stets muss die niedrigstmogliche Dosis individuell bestimmt werden. Dafur bietet sich ein in einer klinischen Studie bewahrtes Schema einer 4‑wochentlichen Reduktion von Prednisolon in 1‑mg-Schritten an. Dieses sollte bei Patienten in niedriger Krankheitsaktivitat oder Remission durch eine DMARD(„disease-modifying antirheumatic drug“)-Therapie angewendet werden, wenn diese 5 mg Prednisolon als Dauertherapie erhalten. Insgesamt muss die gute subjektive Wirkung einer GC-Therapie bei RA-Patienten immer mit den Risiken einer solchen Therapie abgewogen werden. In einem immer wieder zu uberprufenden Prozess der Therapieanpassung nach den Regeln der „shared decision“ sollte sowohl die Dosis der GC angepasst wie auch die weiterbestehende Indikation uberpruft werden. Wenn auch keine GC-freie, so ist doch eine GC-arme Therapie der RA realistisch und sollte zur Reduktion der Risiken dieser Therapie angestrebt werden.

[Glucocorticoid-free and low-dose glucocorticoid treatment of rheumatoid arthritis].

The ideal state for a patient with rheumatoid arthritis (RA) is sustained remission. Contemporary treatment strategies such as early initiation of DMARD(s), optimal methotrexate dosing and treating to a target with validated outcomes have improved the likelihood of remission in RA. Remission, however defined, is not always achieved and even less often will patients with RA maintain sustained remission over time.

Current treatment strategies in rheumatoid arthritis after methotrexate are not enough to maintain sustained remission: There is no holy grail!

Background: The optimal first-line treatment of patients (pts) with early rheumatoid arthritis (RA) is yet to be established. Objectives: The primary aim was to assess and compare the proportion of pts who achieved remission with active conventional therapy (ACT) and with three different biologic therapies after 24 wks. Secondary aims were to assess and compare other efficacy measures. Methods: The investigator-initiated NORD-STAR trial (NCT01491815) was conducted in the Nordic countries and Netherlands. In this multicenter, randomized, open-label, blinded-assessor study pts with treatment-naive, early RA with DAS28>3.2, and positive RF or ACPA, or CRP >10mg/L were randomized 1:1:1:1. Methotrexate (25 mg/week after one month) was combined with: 1) (ACT): oral prednisolone (tapered quickly); or: sulphasalazine, hydroxychloroquine and mandatory intra-articular (IA) glucocorticoid (GC) injections in swollen joints Results: 812 pts were randomized. Age was 54.3±14.7 yrs (mean±SD), 31.2% were male, DAS28 5.0±1.1, 74.9% were RF and 81.9% ACPA positive. Fig 1 shows the adjusted CDAI remission rates over time with 95% CI. Table shows crude remission and response rates and absolute differences in adjusted remission and response rates (superiority analysis). Differences in remission and response rates with CZP and TCZ, but not with ABA, remained within the pre-defined non-inferiority margin versus ACT, Fig 2. Conclusion: High remission rates were found across all four treatment arms at 24 wks. Higher CDAI remission rate was observed for ABA versus ACT (+9%) and for CZP (+4%), but not for TCZ (-1%). With the predefined 15% margin, ACT was non-inferior to CZP and TCZ, but not to ABA. This underscores the efficacy of active conventional therapy based on MTX combined with glucocorticoids and may guide future treatment strategies for early RA. Acknowledgments: Manufacturers provided CZP and ABA. Disclosure of Interests: Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen and Pfizer, Consultant of: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck and Samsung Bioepis, Espen A Haavardsholm Grant/research support from: AbbVie, UCB Pharma, Pfizer Inc, MSD Norway, Roche Norway, Consultant of: Pfizer, AbbVie, Janssen-Cilag, Gilead, UCB Pharma, Celgene, Lilly, Paid instructor for: UCB Pharma, Speakers bureau: Pfizer, AbbVie, UCB Pharma, Celgene, Lilly, Roche, MSD, Anna Rudin Consultant of: Astra/Zeneca, Dan Nordstrom Consultant of: Abbvie, Celgene, Lilly, Novartis, Pfizer, Roche and UCB., Speakers bureau: Abbvie, Celgene, Lilly, Novartis, Pfizer, Roche and UCB., Michael Nurmohamed Grant/research support from: Not related to this research, Consultant of: Not related to this research, Speakers bureau: Not related to this research, Bjorn Gudbjornsson Speakers bureau: Novartis and Amgen, Jon Lampa Speakers bureau: Pfizer, Janssen, Novartis, Kim Horslev-Petersen: None declared, Till Uhlig Consultant of: Lilly, Pfizer, Speakers bureau: Grunenthal, Novartis, Gerdur Grondal: None declared, Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Marte Heiberg: None declared, Jos Twisk: None declared, Simon Krabbe: None declared, Kristina Lend: None declared, Inge Olsen: None declared, Joakim Lindqvist: None declared, Anna-Karin H Ekwall Consultant of: AbbVie, Pfizer, Kathrine L. Gron Grant/research support from: BMS, Meliha C Kapetanovic: None declared, Francesca Faustini: None declared, Riitta Tuompo: None declared, Tove Lorenzen: None declared, Giovanni Cagnotto: None declared, Eva Baecklund: None declared, Oliver Hendricks Grant/research support from: Pfizer, MSD, Daisy Vedder: None declared, Tuulikki Sokka-Isler: None declared, Tomas Husmark: None declared, Maud-Kristine A Ljosa: None declared, Eli Brodin: None declared, Torkell Ellingsen: None declared, Annika Soderbergh: None declared, Milad Rizk Speakers bureau: AbbVie, Asa Reckner: None declared, Per Larsson: None declared, Line Uhrenholt Speakers bureau: Abbvie, Eli Lilly and Novartis (not related to the submitted work), Soren Andreas Just: None declared, David Stevens: None declared, Trine Bay Laurberg Consultant of: UCB Pharma (Advisory Board), Gunnstein Bakland Consultant of: Novartis, UCB, Ronald van Vollenhoven Grant/research support from: BMS, GSK, Lilly, UCB, Pfizer, Roche, Consultant of: AbbVie, AstraZeneca, Biogen, Biotest, Celgene, Gilead, Janssen, Pfizer, Servier, UCB, Speakers bureau: AbbVie, Pfizer, UCB

https://ard.bmj.com/content/annrheumdis/79/Suppl_1/13.full.pdf

A multicenter randomized study in early rheumatoid arthritis to compare active conventional therapy versus three biological treatments: 24 week efficacy results of the nord-star trial

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A multicenter randomized study in early rheumatoid arthritis to compare active conventional therapy versus three biological treatments: 24 week efficacy results of the nord-star trial