Efficacy and safety of upadacitinib therapy in patients with rheumatoid arthritis in real-world clinical practice: 12-month follow-up results

Background/Purpose . Upadacitinib (UPA) is an oral Janus kinase inhibitor, which has selectivity of JAK1 over JAK2, JAK3, and tyrosine kinase 2. UPA demonstrated efficacy for the treatment of RA, with acceptable safety profiles. We analyzed efficacy and tolerability of UPA in small Russian cohort of patients with rheumatoid arthritis. Materials and methods . Patients (n=24) with high RA activity (DAS 28 5.1±1.1, SDAI 27,5±11,2, CDAI 24,5±9,7) and an inadequate response of synthetic DMARDs (mainly methotrexate, 71 %) and biologics (mainly TNF-α blockers, 24 %) were included in the study. The majority of patients were middle-aged (46,8±15,4), RF (88 %) and ACPA (84 %) positive, with moderate functional impairment – 1.6 (1.25–2). UPA were administered per os, 15 mg daily. The evaluation of the effectiveness of the therapy was carried out according to the EULAR/ACR 2011 criteria and using SDAI, CDAI. Results . UPA led to a significant (p<0.05) decrease activity of RA. Initially, more than half of the patients have high activity of the RA by SDAI (52 %; n=12), and moderate disease activity by CDAI (52 %; n=12), DAS 28 (58 %; n=14). After 6 months of therapy, the percentage of patients achieving low disease activity by CDAI was 42,9 % (n=6), after 12 months was 75 % (n=6), respectively. After 12 month of therapy DAS 28 was 2,2 (1,2–3,3), SDAI was 7,6 (3–10,9), CDAI was 7,5 (3–10,5). Clinical improvement according to EULAR criteria after 3 months of treatment was registered in 86,7 %, after 6 months was 76,9 %, after 9 months 92,3 % and after 12 months was 87,5 %. More than half of patients (53,3 %) achieved a good response after 3 months of therapy, 70 % – after 6 months and 87,5 % – after 12 months. Adverse events (AE) were registered in 14 % patients, the most frequent AE were upper respiratory tract infections. One case of Herpes Zoster infection was registered. Conclusion . UPA has shown significant improvement clinical status in patients who had an inadequate response to previous therapy. UPA was well tolerated. AE were registered in a small number of patients.