Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 Aug:73:152748.
doi: 10.1016/j.semarthrit.2025.152748. Epub 2025 May 3.

A comparison of short-term efficacy and toxicity of 2 glucocorticoid bridging strategies in 2 clinical trials in early rheumatoid and undifferentiated arthritis

J A van der Pol  1 , E G Brilman  2 , P H P de Jong  3 , A E A M Weel  4 , L R Lard  5 , E T Molenaar  6 , T W J Huizinga  2 , S A Bergstra  2 , C F Allaart  2
Affiliations
Randomized Controlled Trial

A comparison of short-term efficacy and toxicity of 2 glucocorticoid bridging strategies in 2 clinical trials in early rheumatoid and undifferentiated arthritis

J A van der Pol et al. Semin Arthritis Rheum. 2025 Aug.

Abstract

Objectives: To compare short-term outcomes of initial methotrexate therapy with higher or lower-dose glucocorticoid (GC) bridging in patients with early rheumatoid or undifferentiated arthritis.

Methods: We compared two trials: a 'higher-dose GC'-study starting with methotrexate and 60 mg/day prednisone, tapered in 7 weeks to 7.5 mg/day (IMPROVED trial) and a 'lower-dose GC'-study, starting with methotrexate and prednisone 15 mg/day tapered in 10 weeks to nil (arm C of the tREACH trial). After multiple imputation, we compared the DAS and HAQ, rates of DAS-remission (DAS<1.6) and low disease activity (DAS≤2.4) at the first follow-up visit after 3 to 4 months with linear and logistic regression models, adjusted for baseline DAS/HAQ, age, gender, symptom duration, ACPA positivity, BMI and damage.

Results: Baseline symptom duration, DAS and HAQ were comparable, but more patients in the lower-dose GC-study arm C fulfilled the 2010 criteria for RA. After correction for confounders, patients in the lower-dose GC-study arm C had a significantly higher DAS (0.62 higher (95 % CI 0.43; 0.80) and HAQ (0.28 higher (95 % CI 0.17; 0.39) at the first follow-up visit compared to patients in the higher-dose GC-study, and less often DAS-remission (63.4 % versus 28.9 %) and low disease activity (80.6 % versus 55.7 %). Fewer adverse events were reported in the higher-dose GC-study.

Conclusion: In patients with early RA or UA, a study with higher dosed glucocorticoids as part of initial treatment was associated with significantly better early clinical outcomes compared to a study with lower dosed glucocorticoids, and fewer early side effects. These results should be interpreted with caution due to risk of bias when comparing two distinct clinical trials instead of performing one trial.

Keywords: Combination therapy; DMARD; Monotherapy; Prednisone dose; Rheumatoid arthritis.

PubMed Disclaimer

Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Publication types

MeSH terms

LinkOut - more resources