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In this issue of the journal, Takeuchi et al presented results of a baricitinib long-term extension study of patients who received baricitinib 4 mg for ≥15 months and maintained a clinical disease activity index (CDAI) low disease activity (LDA; CDAI <10) or remission (CDAI ≤2.8) for ≥3 months.1 Patients with rheumatoid arthritis (RA) were randomised to baricitinib tapering to 2 mg daily dose versus continuing the baricitinib 4 mg daily.
Patients in this study had a mean (SD) age of 54 (12) years, 75% were female, 75% were anticyclic citrullinated protein antibody (ACPA) positive, 75% were rheumatoid factor positive, 46% on concomitant glucocorticoids, 82% were on concomitant methotrexate, one-third each had previously failed one or two traditional disease-modifying antirheumatic drugs (DMARDs), but only 13% previously failed a biologic. Patients had one swollen and one tender joint count, and the CDAI score was 3.6 (SD, 2.8), just before tapering.
The rates of LDA (67% vs 80%) and remission (33% vs 40%) at 48 weeks and non-serious infection rates (24.9 vs 30.6) were lower and relapse (CDAI score >10; 37% vs 23%) and rescue rates (18% vs 10%) higher in baricitinib 2 mg (tapering) vs 4 mg (continuing) daily dose groups. Among the rescued patients, most people who lost response (up to two-thirds) could regain the LDA or remission within 24 weeks after rescue to baricitinib 4 mg daily, 67% for the 2 mg group vs 54% for the 4 mg group. Compared with 4 mg daily dosing, baricitinib dose reductions to 2 mg daily were associated with statistically significant increase in CDAI, simplified disease activity, disease activity score (DAS) and earlier relapse. Among DMARD-incomplete responder (IR) patients who had achieved remission at step-down baseline, the majority maintained remission in both dose groups, 56% vs 68% …
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