Safety profile of baricitinib in patients with active rheumatoid arthritis with over 2 years median time in treatment

Josef S. Smolen, Mark C. Genovese, Tsutomu Takeuchi, David L. Hyslop, William L. Macias, Terence Rooney, Lei Chen, Christina L. Dickson, Jennifer Riddle Camp, Tracy E. Cardillo, Taeko Ishii, Kevin L. Winthrop

研究成果: Article査読

130 被引用数 (Scopus)

抄録

Objective. Baricitinib is an oral, once-daily selective Janus kinase (JAK1/JAK2) inhibitor for adults with moderately to severely active rheumatoid arthritis (RA). We evaluated baricitinib's safety profile through 288 weeks (up to September 1, 2016) with an integrated database [8 phase III/II/Ib trials, 1 longterm extension (LTE)]. Methods. The “all-bari-RA” group included patients who received any baricitinib dose. Placebo comparison was based on the 6 studies with 4 mg and placebo up to Week 24 (“placebo-4 mg” dataset). Dose response assessment was based on 4 studies with 2 mg and 4 mg including LTE data (“2 mg-4 mg-extended”). The uncommon events description used the non-controlled all-bari-RA. Results. There were 3492 patients who received baricitinib for 6637 total patient-years (PY) of exposure (median 2.1 yrs, maximum 5.5 yrs). No differences in rates of death, adverse events leading to drug discontinuation, malignancies, major adverse cardiovascular event (MACE), or serious infections were seen for 4 mg versus placebo or for 4 mg versus 2 mg. Infections including herpes zoster were significantly more frequent for 4 mg versus placebo. Deep vein thrombosis/pulmonary embolism were reported with 4 mg but not placebo [all-bari-RA incidence rate (IR) 0.5/100 PY]; the IR did not differ between doses (0.5 vs 0.6/100 PY, 2 mg vs 4 mg, respectively) or compared to published RA rates. All-bari-RA had 6 cases of lymphoma (IR 0.09/100 PY), 3 gastrointestinal perforations (0.05/100 PY), 10 cases of tuberculosis (all in endemic areas; 0.15/100 PY), and 22 all-cause deaths (0.33/100 PY). IR for malignancies (0.8/100 PY) and MACE (0.5/100 PY) were low and did not increase with prolonged exposure. Conclusion. In this integrated analysis of patients with moderate to severe active RA with exposure up to 5.5 years, baricitinib has an acceptable safety profile in the context of demonstrated efficacy.

本文言語English
ページ(範囲)7-18
ページ数12
ジャーナルJournal of Rheumatology
46
1
DOI
出版ステータスPublished - 2019 1 1

ASJC Scopus subject areas

  • 免疫アレルギー学
  • リウマチ学
  • 免疫学

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