SAT0349 Patient-Reported Outcomes from a Phase 3 Study of Baricitinib in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to Tumor Necrosis Factor Inhibitors

• Published in: Annals of the rheumatic diseases Vol. 74; no. Suppl 2; pp. 785 - 786
• Main Authors: Smolen, J.S., Kremer, J., Gaich, C., DeLozier, A.M., Schlichting, D., Xie, L., Genovese, M.C.
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Limited 01.06.2015
• ISSN: 0003-4967; 1468-2060
• DOI: 10.1136/annrheumdis-2015-eular.1435

BackgroundIn ph 2 studies, baricitinib (bari) improved disease activity with an acceptable safety profile in pts with active RA naïve to biologic DMARDs (bDMARDs).1,2ObjectivesTo report patient-reported outcomes (PRO) from a ph 3 study of bari in pts with active RA on 1 or 2 conventional DMARDs (cDMARDs) and an inadequate response or intolerance to ≥1 TNF inhibitors.MethodsPts were randomized 1:1:1 to placebo (PBO) or bari (2 or 4 mg) QD for 24 wks. PROs are listed in the table. Analyses included ANCOVA, logistic regression, and nonparametric methods and compared bari 2 or 4 mg vs. PBO.Results527 pts were randomized. Assessment of PROs at baseline revealed severe impairment of physical function (HAQ-DI: 1.7-1.8) and QoL. Bari 2 and 4 mg resulted in statistically significant improvements from baseline vs. PBO in most PROs at 24 wks (Table).Table 1PRO, LSM change from baseline (unless noted)Wk 24PBO (N=176)2 mg QD (N=174)4 mg QD (N=177)Physical function (HAQ-DI) (% Achieving MCID [≥0.22]/% Achieving MCID [≥0.3])−0.15 [30/24]−0.37***[50***/41***]−0.42*** [53***/44***]Patient global assessment of disease activity−8.8−20.3***−24.8***Patient Assessment of Pain−8.8−18.8***−24.0***QoL: SF-36 PCS (% Achieving MCID [≥5])/MCS (% Achieving MCID [≥5])1.9 [21]/1.9 [22]6.2*** [39***]/2.8 [26]7.1*** [45***]/2.7 [29]EQ-5D Health State Index Score US algorithm/UK algorithm/VAS0.025/0.038/1.90.074**/0.111**/7.9*0.107***/0.159***/11.3***Fatigue (FACIT-F) (% Achieving MCID [≥3.56])5.7 [38]8.1*[50*]9.2** [53**]Median duration of morning joint stiffness (minutes), change from baseline−8.0−25.5**−27**WPAI-RA: Employment both at baseline & at 24 weeks, N (%)22 (82)38 (86)42 (89)Absenteeism (% of work-time missed)8.05.76.0Presenteeism (% of work-time impaired)−3.2−7.6−11.7Work productivity loss (% of overall work impairment)−0.6−6.3−8.4Activity impairment (% regular activity impairment)−15.2−22.2*−26.3***LSM, least squares mean; MCID, minimum clinically important difference; MCS, mental component score; PCS, physical component score; QoL, quality of life.*p≤0.05,**p≤0.01,***p≤0.001 vs. PBO; p-values not adjusted for multiple comparisons.ConclusionsIn this ph 3 study of pts with active RA on cDMARDs and an inadequate response to bDMARDs, bari was associated with significant improvement in most PROs through 24 wks compared to PBO.ReferencesKeystone et al. Ann Rheum Dis 2015;74:333-340.Tanaka et al. Arthritis Rheum 2013;65(S10):S765.Disclosure of InterestJ. Smolen Grant/research support from: Abbvie, Janssen, MSD, Pfizer, Roche, UCB, Consultant for: Abbvie, Amgen, Astra-Zeneca, Astro, Celgene, Glaxo, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, J. Kremer Grant/research support from: Abbvie, Amgen, BMS, Genentech, Lilly, Pfizer and UCB, Employee of: Part time employment with Corrona, C. Gaich Employee of: Eli Lilly and Company, A. DeLozier Employee of: Eli Lilly and Company, D. Schlichting Employee of: Eli Lilly and Company, L. Xie Employee of: Eli Lilly and Company, M. Genovese Grant/research support from: Abbvie, Astellas, Eli Lilly and Company, Galapagos, Pfizer, and Vertex