Safety Summary Results of Baricitinib Focusing on Serious Infections Events and Preselected Comorbidities


Bernard Combe1, Alejandro Balsa2, Kevin Winthrop3, Hans-Peter Tony4, Mark C Genovese5, Masayoshi Harigai6, Josef S. Smolen7, Paul Emery8, Jean Dudler9, Stephen Hall10, Cristiano A. Zerbini11, Filip Van Den Bosch12, Frederick Durand13, Subhashini Arthanari14, Veronica Rogai15, Jinglin Zhong16, Gabriella Meszaros17, Maxime Dougados18, Erica Tierney (Presenter only)19


1CHRU Montpellier, Montpellier, France; 2Hospital Universitario la Paz, Madrid, Spain; 3Oregon Health and Science University, Portland, OR, USA; 4Rheumatology and Clinical Immunology, Dept. of Medicine 2, University of Wuerzburg, Wuerzburg, Germany; 5Stanford University Medical Center, Palo Alto, CA, USA; 6Tokyo Women's Medical University, Tokyo, Japan; 7Medical University of Vienna, Vienna, Austria; 8Leeds MSK Biomed/Chapel Allerton Hosp, Leeds, United Kingdom; 9Hôpital Cantonal, Fribourg, Switzerland; 10Cabrini Medical Centre, Malvern, Victoria, Australia; 11CEPIC-Centro Paulista de Investigacao Clinica, Sao Paulo, Brazil; 12UZ Gent, Reumatologie, Gent, Belgium; 13Lilly France, Neuilly-sur-Seine, France; 14ELilly UK, Eli Lilly and Company Ltd, Basingstoke, United Kingdom; 15Eli Lilly Italia S.p.A., Sesto Fiorentino (FI), Italia; 16IQVIA, Morrisville, NC, USA; 17Eli Lilly Ges.m.b.H., Vienna, Austria; 18Department of Rheumatology, Cochin Hospital, Paris, France; 19Presenting on behalf of the authors


Baricitinib (BARI) is an oral selective JAK1/JAK2 inhibitor for the treatment of patients with Rheumatoid Arthritis (RA) with an acceptable safety profile.


Objective is to evaluate the incidence rate (IR) of serious infection events (SIE) and selected comorbidities.


Exposure adjusted IR of SIE were summarized in 6-study- and 4-study- PBO-controlled sets, 0-24 weeks (wks), plus in ALL-BARI-RA set (any BARI dose for ≤5years (Ph 1-3/LTE studies)). Potential risk factors for SIE were investigated in ALL-BARI-RA set using Cox models. Sensitivity analysis for comorbidities included patients (N=1683) from 5 studies (BARI 4mg/PBO) up to 16wks.


The most frequent SIE observed in the ALL-BARI-RA-set (N=3492; 5133 patient-years (PY) of exposure [PYE]) were pneumonia, herpes zoster, urinary tract infection, and cellulitis (all <1%), 150 patients reported SIE (IR=2.9/100PY), and 2 patients with SIE died (IR=0.04/100PY). During wks0-24, similar SIE rates were observed in BARI 4mg (N=997;417PYE) and PBO (N=1070;403PYE) groups in the 6-study-set, and between BARI 2/4 mg (N=479;192PYE/N=479;194PYE) dose groups in the 4-study-set. Prior biologic use, advancing age, region of Asia (excluding Japan), abnormal body mass index (BMI), and corticosteroid use were identified as independent factors for SIE in the ALL-BARI-RA-set, and none differed significantly between BARI 4mg and PBO in the 6-study-set (data not shown).
The presence of selected comorbidities did not affect the incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAE), discontinuations, or deaths caused by SAEs for BARI 4mg vs PBO. The most common TEAEs were nasopharyngitis and upper respiratory tract infection.


SIE incidence was similar between BARI- and PBO-and BARI 2mg/4mg treated RA patients up to wk24. No trends were noted for patients in each preselected comorbidity subgroup for increased risk of events after treatment with BARI 4mg compared with PBO up to wk16.