@article{e5b98786570344eb8aebd9ae514ee339,
title = "Infections in baricitinib clinical trials for patients with active rheumatoid arthritis",
abstract = "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. ",
keywords = "DMARDs (synthetic), infections, rheumatoid arthritis",
author = "Winthrop, {Kevin L.} and Masayoshi Harigai and Genovese, {Mark C.} and Stephen Lindsey and Tsutomu Takeuchi and Roy Fleischmann and Bradley, {John D.} and Byers, {Nicole L.} and Hyslop, {David L.} and Maher Issa and Atsushi Nishikawa and Rooney, {Terence P.} and Sarah Witt and Dickson, {Christina L.} and Smolen, {Josef S.} and Maxime Dougados",
note = "Funding Information: This work was funded by eli lilly and Company, under licence from incyte. Funding Information: Competing interests KlW has received grants from BMs and Pfizer and consultancies from abbVie, amgen, BMs, eli lilly and Company, Galapagos, Gilead, Pfizer, and UCB. MH has received grants from BMs KK, eisai, Ono, and Takeda and consultancies from eli lilly and Company. MCG has received grants and consultancies from abbVie, eli lilly and Company, Galapagos, and Pfizer. sl has received speaking fees and/or honoraria from eli lilly and Company, novartis, and Pfizer. TT has received consultancies and speaking fees and/or honoraria from abbVie GK, asahi Kasei KK, astellas, astra-Zeneca KK, BMs KK, Chugai, Daiichi sankyo, eisai, eli lilly and Company, Janssen KK, Mitsubishi Tanabe, nipponkayaku, novartis, Pfizer Japan, Takeda, Taiho, Taisho Toyama, GsK, and UCB Japan. RF has received grants from abbVie, amgen, astra-Zeneca, BMs, Celgene, Centrexion, eli lilly and Company, Genetech, GsK, Janssen, Merck, and Pfizer and consultancies from abbVie, amgen, BMs, Celgene, Celltrion, eli lilly and Company, GsK, Janssen, novartis, Pfizer, samsung, sanofi-aventis, and Taiho. JDB, nlB, DlH, Mi, an, TPR, sW and CD are employees and may be shareholders of eli lilly and Company. Jss has received grants from abbVie, eli lilly and Company, novartis, Pfizer, and Roche and consultancies from abbVie, amgen, astra-Zeneca, astro, BMs, Celgene, Celltrion, Chugai, eli lilly and Company, Gilead, ilTOO, Janssen, Medimmune, MsD, novartis-sandoz, Pfizer, Roche, samsung, sanofi-aventis, and UCB. MD has received grants and consultancies from abbVie, BMs, eli lilly and Company, Merck, novartis, Pfizer, Roche and UCB.",
year = "2020",
month = oct,
day = "1",
doi = "10.1136/annrheumdis-2019-216852",
language = "English (US)",
volume = "79",
pages = "1290--1297",
journal = "Annals of the Rheumatic Diseases",
issn = "0003-4967",
publisher = "BMJ Publishing Group",
number = "10",
}