Clinical and Molecular Data to Predict Flares in DMARD optimization in Rheumatoid Arthritis: A Randomised, Controlled, Open-label, Non-inferiority Trial Article Swipe
Francisco J. Blanco
,
L.E. Berumen Dominguez
,
B. Acasuso
,
Vanesa Balboa‐Barreiro
,
Juan D. Cañete
,
Benjamín Fernández‐Gutiérrez
,
Isidoro González‐Álvaro
,
José L. Pablos
,
Carmen Bejarano-Herreria
,
Maite Silva-Díaz
,
Ignacio Rego‐Pérez
,
L. Lourido
,
Cristina Ruíz‐Romero
,
Miren Uriarte-Ecenarro
,
Rosario García‐Vicuña
,
Andrea Cuervo
,
Julio Ramírez
,
Raquel Celis
,
Luis Rodríguez‐Rodríguez
,
Lydia Abásolo
,
D. Freites
,
María Martín-López
,
Francisco Javier de Toro Santos
,
N. Oreiro
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1101/2025.09.30.25336957
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1101/2025.09.30.25336957
Objectives Optimization of biological DMARDs (bDMARDs) in patients with rheumatoid arthritis (RA) may be feasible in those who have maintained remission for at least six months. However, this approach carries the risk of disease flare, underscoring the need for reliable predictors to guide clinical decisions. Methods The OPTIBIO trial (EudraCT 2012-004482-40) was a phase IV, randomized, open-label, non-inferiority study conducted in five hospitals in Spain. RA patients in sustained remission on stable bDMARD therapy were randomized 1:1 to standard care or dose reduction. The primary outcome was to compare to proportion of joint flare at 12 months by a non-inferiority analysis analyzed by the intention-to-treat principle and identify predictors for flare and sustained remission. Results 195 patients were randomized: 99 to the control group and 96 to the optimization group. Thirty-nine flares occurred (optimization: 22.7%, control: 17.2%), with a risk difference of -5.5% (95% CI: -16.8% to 5.7%; P = 0.33). Two predictive models were developed: one for flares (AUC: 0.84) including 3v-DAS28-CRP, VAS pain, erosions, systolic blood pressure, and hemoglobin, and another for sustained remission (AUC: 0.77) including 3v-DAS28-CRP, age, and rheumatoid factor. Adding molecular biomarkers improved AUCs to 0.91 and 0.88, respectively. No significant differences in adverse events were observed. Conclusion bDMARD dose optimization was non-inferior to standard therapy on the flare rate but demonstrated similar safety. Predictive models for remission and flares were developed, which may help select patients to ensure safe implementation of this strategy, highlighting the need for personalized treatment. Key messages bDMARD dose optimization was non-inferior to standard therapy on the flare Clinical models classified patients in terms of disease severity Incorporation of molecular markers to clinical models improved their prediction power
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- article
- Language
- en
- Landing Page
- https://doi.org/10.1101/2025.09.30.25336957
- https://www.medrxiv.org/content/medrxiv/early/2025/10/01/2025.09.30.25336957.full.pdf
- OA Status
- green
- References
- 28
- OpenAlex ID
- https://openalex.org/W4414699061
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https://openalex.org/W4414699061Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1101/2025.09.30.25336957Digital Object Identifier
- Title
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Clinical and Molecular Data to Predict Flares in DMARD optimization in Rheumatoid Arthritis: A Randomised, Controlled, Open-label, Non-inferiority TrialWork title
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articleOpenAlex work type
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enPrimary language
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2025Year of publication
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2025-10-01Full publication date if available
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Francisco J. Blanco, L.E. Berumen Dominguez, B. Acasuso, Vanesa Balboa‐Barreiro, Juan D. Cañete, Benjamín Fernández‐Gutiérrez, Isidoro González‐Álvaro, José L. Pablos, Carmen Bejarano-Herreria, Maite Silva-Díaz, Ignacio Rego‐Pérez, L. Lourido, Cristina Ruíz‐Romero, Miren Uriarte-Ecenarro, Rosario García‐Vicuña, Andrea Cuervo, Julio Ramírez, Raquel Celis, Luis Rodríguez‐Rodríguez, Lydia Abásolo, D. Freites, María Martín-López, Francisco Javier de Toro Santos, N. OreiroList of authors in order
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https://doi.org/10.1101/2025.09.30.25336957Publisher landing page
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https://www.medrxiv.org/content/medrxiv/early/2025/10/01/2025.09.30.25336957.full.pdfDirect link to full text PDF
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