Infections in baricitinib clinical trials for patients with active rheumatoid arthritis

Kevin L. Winthrop, Masayoshi Harigai, Mark C. Genovese, Stephen Lindsey, Tsutomu Takeuchi, Roy Fleischmann, John D. Bradley, Nicole L. Byers, David L. Hyslop, Maher Issa, Atsushi Nishikawa, Terence P. Rooney, Sarah Witt, Christina L. Dickson, Josef S. Smolen, Maxime Dougados

研究成果: Article査読

26 被引用数 (Scopus)

抄録

Objectives To evaluate the incidence of infection in patients with active rheumatoid arthritis (RA) treated with baricitinib, an oral selective Janus kinase (JAK)1 and JAK2 inhibitor. Methods Infections are summarised from an integrated database (8 phase 3/2/1b clinical trials and 1 long-term extension (LTE)) with data to 1 April 2017. The € all-bari-RA' analysis set included patients who received any baricitinib dose. Placebo comparison was based on six studies with 4 mg and placebo to week 24, including four trials with 2 mg (placebo-controlled set). Dose-response assessment was based on four studies with 2 mg and 4 mg, including LTE data (2-4 mg extended set). Results There were 3492 patients who received baricitinib for 7860 patient-years (PY) of exposure (median 2.6 years, maximum 6.1 years). Treatment-emergent infections were higher for baricitinib versus placebo (exposure-Adjusted incidence rate (IR)/100 PY: placebo 75.9, 2 mg 84.0 (p not significant), 4 mg 88.4 (p≤0.001)). The IR of serious infection was similar for baricitinib versus placebo and stable over time (all-bari-RA IR 3.0/100 PY). There were 11 cases of tuberculosis (all-bari-RA IR 0.1/100 PY); all occurred with 4 mg in endemic regions. Herpes zoster (HZ) IR/100 PY was higher for baricitinib versus placebo (placebo 1.0, 2 mg 3.1 (p not significant), 4 mg 4.3 (p≤0.01)); rates remained elevated and stable over time (all-bari-RA 3.3). Opportunistic infections, including multidermatomal HZ, were infrequent in the baricitinib programme (all-bari-RA IR 0.5/100 PY). Conclusions Increased rates of treatment-emergent infections including HZ were observed in patients with RA treated with baricitinib, consistent with baricitinib's immunomodulatory mode of action.

本文言語English
ページ(範囲)1290-1297
ページ数8
ジャーナルAnnals of the rheumatic diseases
79
10
DOI
出版ステータスPublished - 2020 10月 1

ASJC Scopus subject areas

  • リウマチ学
  • 免疫アレルギー学
  • 免疫学
  • 生化学、遺伝学、分子生物学(全般)

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