Figure 5.
Effects of tofacitinib in combination with csDMARD on (a) disease activity and (b) patient-reported outcomes at Month 3 in a phase III study of patients with TNFi-IR RA,10,82 and change from baseline in (c) DAS28-4(ESR) and (d) HAQ-DI at Month 3 in phase II/III trials of bDMARD-naïve and bDMARD-IR patients (adapted by permission from BMJ publishing Group Limited [Charles-Schoeman C, et al. Ann Rheum Dis 2016]). 74
bDMARD, biologic disease-modifying antirheumatic drug; BID, twice daily; CDAI, Clinical Disease Activity Index; CI, confidence interval; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAS28-4(ESR), Disease Activity Score in 28 joints, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; IR, inadequate response; LDA, low disease activity; LSM, least squares mean; MCID, minimal clinically important difference; MTX, methotrexate; N, number of patients randomized and treated; RA, rheumatoid arthritis; SDAI, Simplified Disease Activity Index; TNFi, tumor necrosis factor inhibitor.
aDAS28-4(ESR) LDA defined as ⩽3.2.
bDAS28-4(ESR) remission defined as <2.6.
cCDAI remission defined as ⩽2.8.
dSDAI remission defined as ⩽3.3.
e⩾0.22-point decrease from baseline in HAQ-DI.
*p < 0.05 versus MTX plus placebo or placebo, ***p < 0.0001 versus MTX plus placebo or placebo.
