Structural damage progression in patients with early rheumatoid arthritis treated with methotrexate, baricitinib, or baricitinib plus methotrexate based on clinical response in the phase 3 RA-BEGIN study

Van Der Heijde D, Durez P, Schett G, Naredo E, Ostergaard M, Meszaros G, De Leonardis F, De La Torre I, Lopez-Romero P, Schlichting D, Nantz E, Fleischmann R (2018)

Publication Type: Journal article

Publication year: 2018

Journal

Clinical Rheumatology Springer Verlag (Germany)

Book Volume: 37

Pages Range: 2381-2390

Journal Issue: 9

DOI: 10.1007/s10067-018-4221-0

Abstract

The objective of this study was to evaluate structural damage progression based on clinical response in rheumatoid arthritis patients with no or limited prior disease-modifying anti-rheumatic drug treatment receiving the Janus kinase (JAK)1/JAK2 inhibitor baricitinib 4 mg, methotrexate (MTX), or the combination. Data from the phase 3 RA-BEGIN study were analysed post hoc. Proportions of patients with structural damage progression (change from baseline greater than the smallest detectable change in modified total Sharp score) at week 52 were evaluated based on sustained Disease Activity Score for 28-joint count with serum high-sensitivity C-reactive protein (DAS28-hsCRP) ≤ 3.2 or Simplified Disease Activity Index (SDAI) score ≤ 11; no formal statistical comparisons between treatments were performed to test these proportions. Baseline factors associated with risk of structural damage progression, including Clinical Disease Activity Index (CDAI) score, were identified using multivariate analysis. Patients achieving versus not achieving sustained DAS28-hsCRP ≤ 3.2 or SDAI score ≤ 11 were less likely to experience structural damage progression at week 52. In patients achieving these responses, structural damage progression was less likely with baricitinib monotherapy or plus MTX than with MTX monotherapy. In patients not achieving these sustained clinical thresholds, structural damage progression was less likely with baricitinib plus MTX than with either monotherapy. Independent of treatment, baseline factors significantly associated with increased risk of structural damage progression included higher hsCRP and CDAI score, smoking, female sex, and lower body mass index. In conclusion, patients achieving versus not achieving sustained DAS28-hsCRP ≤ 3.2 or SDAI score ≤ 11 were less likely to show structural damage progression, irrespective of treatment.

Authors with CRIS profile

Georg Schett Lehrstuhl für Innere Medizin III

Involved external institutions

Eli Lilly and Company US United States (USA) (US) University of Texas Southwestern Medical Center (UT Southwestern) US United States (USA) (US) Leiden University NL Netherlands (NL) Fundación Jiménez Díaz ES Spain (ES) Université Catholique de Louvain (UCL) BE Belgium (BE) Rigshospitalet DK Denmark (DK)

How to cite

APA:

Van Der Heijde, D., Durez, P., Schett, G., Naredo, E., Ostergaard, M., Meszaros, G.,... Fleischmann, R. (2018). Structural damage progression in patients with early rheumatoid arthritis treated with methotrexate, baricitinib, or baricitinib plus methotrexate based on clinical response in the phase 3 RA-BEGIN study. Clinical Rheumatology, 37(9), 2381-2390. https://dx.doi.org/10.1007/s10067-018-4221-0

MLA:

Van Der Heijde, Desiree, et al. "Structural damage progression in patients with early rheumatoid arthritis treated with methotrexate, baricitinib, or baricitinib plus methotrexate based on clinical response in the phase 3 RA-BEGIN study." Clinical Rheumatology 37.9 (2018): 2381-2390.

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