Low-dose prednisolone effective in patients with established rheumatoid arthritis: study

Rheumatoid arthritis or RA is an autoimmune and inflammatory disease; This means that your immune system mistakenly attacks healthy cells in your body, causing inflammation (painful swelling) in the affected areas of the body. RA mainly attacks the joints, often many joints at once.

Low-dose glucocorticoid (GC) therapy is widely used in rheumatoid arthritis (RA), but the balance of benefit and harm is still unclear.

The GLORIA (Glucocorticoid LOW dose in Rheumatoid Arthritis) pragmatic double-blind randomized study compared 2 years of prednisolone, 5 mg/day to placebo in patients over 65 years of age with active RA. We allowed all co-treatments except long-term open-label GC and elderly-specific minimized exclusion criteria. Benefit outcomes included disease activity (disease activity score; DAS28, secondary) and joint damage (Sharp/van der Heijde, secondary). The other secondary outcome was harm, expressed as the proportion of patients with ≥1 adverse event (AE) of special interest. Such events include serious events, GC-specific events, and interruption events. Longitudinal models analyzed data with one-sided testing and 95% confidence limits (95% CL).

Results:

• The investigators randomized 451 patients with established RA and mean comorbidity of 2.1, 72 years of age, 11 years of disease duration, and DAS28 4.5. 79% were receiving disease-modifying therapy, 14% biologic. 63% of prednisolone and 61% of placebo patients completed the study.

• Interruptions were due to AE (both 14%), active disease (3% vs. 4%), and other (including covid pandemic-related disease) (19% vs. 21%); The average working time was 19 months.

• Disease activity was 0.37 points lower in prednisolone; joint damage progression was 1.7 points lower.

• 60% versus 49% of patients experienced a harm outcome with an adjusted relative risk of 1.24, with the greatest contrast (mostly non-severe) infections.

• Other GC-specific events were rare.

Therefore, additional low-dose prednisolone has long-term beneficial effects in elderly patients with established RA, mostly a tradeoff of 24% in patients with non-severe AE; this indicates a positive balance of benefit and harm.

Reference:

Boers M, Hartman L, Opris-Belinski D For the GLORIA Trial consortium, et alLow dose, add-on prednisolone in patients with rheumatoid arthritis aged 65+: the pragmatic randomised, double-blind placebo-controlled GLORIA trialAnnals of the Rheumatic Diseases 2022;81:925-936.

Keywords:

Low dose, add-on, prednisolone, patients, rheumatoid, arthritis, aged 65, pragmatic, randomised, double-blind, placebo-controlled, GLORIA, trial, Maarten Boers, Linda Hartman, Daniela Opris-Belinski, Reinhard Bos, Marc R Kok, Annals of the Rheumatic Diseases