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Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study.
Ann Rheum Dis. 2017 Jan; 76(1):88-95.AR

Abstract

BACKGROUND

Baricitinib is an oral, reversible, selective Janus kinase 1 and 2 inhibitor.

METHODS

In this phase III, double-blind 24-week study, 684 biologic disease-modifying antirheumatic drug (DMARD)-naïve patients with rheumatoid arthritis and inadequate response or intolerance to ≥1 conventional synthetic DMARDs were randomly assigned 1:1:1 to placebo or baricitinib (2 or 4 mg) once daily, stratified by region and the presence of joint erosions. Endpoint measures included American College of Rheumatology 20% response (ACR20, primary endpoint), Disease Activity Score (DAS28) and Simplified Disease Activity Index (SDAI) score ≤3.3.

RESULTS

More patients achieved ACR20 response at week 12 with baricitinib 4 mg than with placebo (62% vs 39%, p≤0.001). Compared with placebo, statistically significant improvements in DAS28, SDAI remission, Health Assessment Questionnaire-Disability Index, morning joint stiffness, worst joint pain and worst tiredness were observed. In a supportive analysis, radiographic progression of structural joint damage at week 24 was reduced with baricitinib versus placebo. Rates of adverse events during the treatment period and serious adverse events (SAEs), including serious infections, were similar among groups (SAEs: 5% for baricitinib 4 mg and placebo). One patient had an adverse event of tuberculosis (baricitinib 4 mg); one patient had an adverse event of non-melanoma skin cancer (baricitinib 4 mg). Two deaths and three major adverse cardiovascular events occurred (placebo). Baricitinib was associated with a decrease in neutrophils and increases in low-density and high-density lipoprotein.

CONCLUSIONS

In patients with rheumatoid arthritis and an inadequate response or intolerance to conventional synthetic DMARDs, baricitinib was associated with clinical improvement and inhibition of progression of radiographic joint damage.

TRIAL REGISTRATION NUMBER

NCT01721057; Results.

Authors+Show Affiliations

Department of Rheumatology, Paris Descartes University, Hôpital Cochin, Assistance Publique, Hôpitaux de Paris, INSERM (U1151), Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France.Leiden University Medical Center, Leiden, The Netherlands.Division of Rheumatology, Department of Internal Medicine, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan; Chang Gung Memorial Hospital - Kaohsiung Medical Center, Chang Gung University College of Medicine, Taiwan.Desert Medical Advances, Palm Desert, California, USA.Veszprém Csolnoky Ferenc County Hospital, Veszprém, Hungary.Eli Lilly and Company, Indianapolis, Indiana, USA.Eli Lilly and Company, Indianapolis, Indiana, USA.Eli Lilly and Company, Indianapolis, Indiana, USA.Eli Lilly and Company, Indianapolis, Indiana, USA.Eli Lilly and Company, Indianapolis, Indiana, USA.Eli Lilly and Company, Indianapolis, Indiana, USA.Eli Lilly and Company, Indianapolis, Indiana, USA.Eli Lilly and Company, Indianapolis, Indiana, USA.Leeds Institute of Rheumatic and Musculoskeletal Medicine, NIHR Leeds Musculoskeletal Biomedical Research Unit, LTHT, University of Leeds, Leeds, UK.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27689735

Citation

Dougados, Maxime, et al. "Baricitinib in Patients With Inadequate Response or Intolerance to Conventional Synthetic DMARDs: Results From the RA-BUILD Study." Annals of the Rheumatic Diseases, vol. 76, no. 1, 2017, pp. 88-95.
Dougados M, van der Heijde D, Chen YC, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Ann Rheum Dis. 2017;76(1):88-95.
Dougados, M., van der Heijde, D., Chen, Y. C., Greenwald, M., Drescher, E., Liu, J., Beattie, S., Witt, S., de la Torre, I., Gaich, C., Rooney, T., Schlichting, D., de Bono, S., & Emery, P. (2017). Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Annals of the Rheumatic Diseases, 76(1), 88-95. https://doi.org/10.1136/annrheumdis-2016-210094
Dougados M, et al. Baricitinib in Patients With Inadequate Response or Intolerance to Conventional Synthetic DMARDs: Results From the RA-BUILD Study. Ann Rheum Dis. 2017;76(1):88-95. PubMed PMID: 27689735.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. AU - Dougados,Maxime, AU - van der Heijde,Désirée, AU - Chen,Ying-Chou, AU - Greenwald,Maria, AU - Drescher,Edit, AU - Liu,Jiajun, AU - Beattie,Scott, AU - Witt,Sarah, AU - de la Torre,Inmaculada, AU - Gaich,Carol, AU - Rooney,Terence, AU - Schlichting,Douglas, AU - de Bono,Stephanie, AU - Emery,Paul, Y1 - 2016/09/29/ PY - 2016/06/21/received PY - 2016/09/06/revised PY - 2016/09/08/accepted PY - 2016/11/4/pubmed PY - 2017/6/7/medline PY - 2016/10/1/entrez KW - DMARDs (synthetic) KW - Rheumatoid Arthritis KW - Treatment SP - 88 EP - 95 JF - Annals of the rheumatic diseases JO - Ann Rheum Dis VL - 76 IS - 1 N2 - BACKGROUND: Baricitinib is an oral, reversible, selective Janus kinase 1 and 2 inhibitor. METHODS: In this phase III, double-blind 24-week study, 684 biologic disease-modifying antirheumatic drug (DMARD)-naïve patients with rheumatoid arthritis and inadequate response or intolerance to ≥1 conventional synthetic DMARDs were randomly assigned 1:1:1 to placebo or baricitinib (2 or 4 mg) once daily, stratified by region and the presence of joint erosions. Endpoint measures included American College of Rheumatology 20% response (ACR20, primary endpoint), Disease Activity Score (DAS28) and Simplified Disease Activity Index (SDAI) score ≤3.3. RESULTS: More patients achieved ACR20 response at week 12 with baricitinib 4 mg than with placebo (62% vs 39%, p≤0.001). Compared with placebo, statistically significant improvements in DAS28, SDAI remission, Health Assessment Questionnaire-Disability Index, morning joint stiffness, worst joint pain and worst tiredness were observed. In a supportive analysis, radiographic progression of structural joint damage at week 24 was reduced with baricitinib versus placebo. Rates of adverse events during the treatment period and serious adverse events (SAEs), including serious infections, were similar among groups (SAEs: 5% for baricitinib 4 mg and placebo). One patient had an adverse event of tuberculosis (baricitinib 4 mg); one patient had an adverse event of non-melanoma skin cancer (baricitinib 4 mg). Two deaths and three major adverse cardiovascular events occurred (placebo). Baricitinib was associated with a decrease in neutrophils and increases in low-density and high-density lipoprotein. CONCLUSIONS: In patients with rheumatoid arthritis and an inadequate response or intolerance to conventional synthetic DMARDs, baricitinib was associated with clinical improvement and inhibition of progression of radiographic joint damage. TRIAL REGISTRATION NUMBER: NCT01721057; Results. SN - 1468-2060 UR - https://www.unboundmedicine.com/medline/citation/27689735/Baricitinib_in_patients_with_inadequate_response_or_intolerance_to_conventional_synthetic_DMARDs:_results_from_the_RA_BUILD_study_ DB - PRIME DP - Unbound Medicine ER -