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Olumiant® (baricitinib) tablets
1mg, 2mg, 4mgbaricitinib
1mg, 2mg, 4mgOlumiant® (baricitinib) tablets
1mg, 2mg, 4mgbaricitinib
1mg, 2mg, 4mgThis information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the incidence of herpes simplex with OLUMIANT® (baricitinib) treatment in rheumatoid arthritis?
In all baricitinib-treated patients with data up to 9.3 years of treatment and 14,744 patient-years of exposure, a treatment-emergent adverse event of herpes simplex was observed in 167 (4.4%) patients.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- What is the safety profile of baricitinib related to herpes simplex?
- What is the incidence of herpes simplex in the rheumatoid arthritis clinical development program?
- What is the incidence of herpes simplex in the postmarketing studies RA BRIDGE and RA BRANCH?
- References
What is the safety profile of baricitinib related to herpes simplex?
Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients with rheumatoid arthritis receiving baricitinib. Avoid use of baricitinib in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating baricitinib in patients with chronic or recurrent infection.1
If a patient develops a new infection during treatment with baricitinib,
- monitor the patient closely
- interrupt baricitinib if the patient is not responding to therapy, and
- do not resume baricitinib until the infection is controlled.1
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with baricitinib. If a patient develops herpes zoster, interrupt baricitinib treatment until the episode resolves.1
Please see local labeling for your country-specific information on this topic.
What is the incidence of herpes simplex in the rheumatoid arthritis clinical development program?
Herpes simplex includes eczema herpeticum, genital herpes, herpes simplex, ophthalmic herpes simplex, and oral herpes.1
In clinical trials in patients with moderately to severely active rheumatoid arthritis, herpes simplex was reported as an adverse reaction in ≥1% of patients.1
Treatment-Emergent Adverse Events
A treatment-emergent adverse event (TEAE) is an adverse event that either occurred or worsened in severity after the first dose of study treatment and did not necessarily have a causal relationship to study treatment.2
7-Study Placebo-Controlled Dataset
Dataset Description
The 7-study pooled dataset included patients with rheumatoid arthritis (RA) randomized to baricitinib 4 mg (N=1142, patient-years of exposure [PYE]=471.8) or placebo (N=1215, PYE=450.8) from 3 phase 2 studies and 4 phase 3 studies (RA-BEAM, RA-BUILD, RA-BEACON, and RA-BALANCE). Patients could have been taking background methotrexate or other conventional disease-modifying antirheumatic drugs. Evaluation time periods included through
- the 12-week placebo-controlled period in phase 2 studies
- 16 weeks of assigned treatment before any opportunity for rescue therapy in phase 3 studies, and
- 24 weeks of assigned treatment or until rescue in phase 3 studies.3
Data from baricitinib 2 mg (N=479, PYE=185.8) were derived from 4 of these studies in which both baricitinib 2 mg and baricitinib 4 mg were options during randomization (2 phase 2 studies as well as RA-BUILD and RA-BEACON).3
Incidence of Herpes Simplex
In this safety analysis, through 24 weeks of treatment, the TEAE of herpes simplex was reported in
- 24 (2.1%) patients in the baricitinib 4-mg group
- 6 (1.3%) patients in the baricitinib 2-mg group, and
- 10 (0.8%) patients in the placebo group.2
All BARI RA Dataset
Dataset Description
The All BARI RA analysis set included 3770 patients with RA who received baricitinib at a variety of doses from 1 phase 1, 3 phase 2, and 5 phase 3 studies (RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON, and RA-BALANCE). Data include a long-term extension study (RA-BEYOND) with
- 14,744 PYE to baricitinib
- 15,114 patient-years overall observation including time on baricitinib and follow-up
- median exposure of 4.6 years, and
- maximum exposure of 9.3 years.4
Incidence of Herpes Simplex
In the All BARI RA dataset, a TEAE of herpes simplex was observed in 167 (4.4%) patients treated with baricitinib. Of the 167 TEAEs of herpes simplex,
- 2 were reported as serious adverse events
- 32 resulted in temporary interruption of baricitinib, and
- 9 resulted in permanent discontinuation of baricitinib.2
What is the incidence of herpes simplex in the postmarketing studies RA BRIDGE and RA BRANCH?
Dataset Description
Two randomized, active-controlled, open-label, event-driven, parallel-group, phase 3b/4 studies, RA-BRIDGE (NCT03915964) and RA-BRANCH (NCT04086745), evaluated the safety of baricitinib 2 mg and 4 mg compared with adalimumab or etanercept in patients with RA who had an inadequate response or intolerance to at least one disease-modifying antirheumatic drug (DMARD) and were at increased risk of venous thromboembolism (VTE). The primary outcome measure of the study was time from the first dose of study treatment to the first VTE event, which included pulmonary embolism (PE), deep vein thrombosis (DVT), or both. The secondary outcome measures were the time from first dose of study treatment to the first event of
- VTE by each baricitinib dose
- arterial thromboembolic event
- major adverse cerebrocardiovascular event
- malignancy, excluding nonmelanoma skin cancer
- opportunistic infection
- serious infection, and
- all-cause death.2,5,6
A total of 3640 patients were included in the combined RA-BRIDGE and RA-BRANCH population (baricitinib 2 mg, N=1219; baricitinib 4 mg, N=1214; tumor necrosis factor inhibitors [TNFi], N=1207) contributing to a total of 7694.4 PYE for baricitinib and 3830.1 PYE for TNFi. Median on-treatment exposure was approximately 3.7 years in both groups.7
These postmarketing studies were closed prematurely following alignment with FDA due to operational difficulties and high discontinuation rates after the 6-year follow-up period. This decision was not related to safety concerns.
Incidence of Herpes Simplex
Briefly, for RA-BRIDGE, all relevant adverse events (AEs) and serious adverse events (SAEs) were collected and reported; whereas RA-BRANCH collected information on specific protocol-specified AEs of interest rather than all AEs.2
The section below presents results from the RA-BRIDGE study only. Additional information on adverse events from the RA-BRANCH study is available on ct.gov website RA-BRANCH (NCT04086745).2
|
Bari 2 mg (N=879) |
BARI 4 mg (N=881) |
TNFi (N=880) |
All BARI (N=1760) |
||||
|---|---|---|---|---|---|---|---|---|
|
n (%) |
IR |
n (%) |
IR |
n (%) |
IR |
n (%) |
IR |
Herpes Simplex |
20 (2.3) |
0.6 |
18 (2.0) |
0.5 |
13 (1.5) |
0.4 |
38 (2.2) |
0.6 |
Severity |
||||||||
Mild |
14 (1.6) |
NA |
14 (1.6) |
NA |
8 (0.9) |
NA |
28 (1.6) |
NA |
Moderate |
8 (0.9) |
NA |
4 (0.5) |
NA |
5 (0.6) |
NA |
12 (0.7) |
NA |
Severe |
0 |
NA |
0 |
NA |
0 |
NA |
0 |
NA |
Events that led to temporary treatment interruption |
2 (0.2) |
NA |
0 |
NA |
1 (0.1) |
NA |
2 (0.1) |
NA |
Events that led to permanent treatment interruption |
0 |
NA |
0 |
NA |
0 |
NA |
0 |
NA |
Abbreviations: BARI = baricitinib; TNFi = tumor necrosis factor inhibitor; IR = incidence rate; N = number of subjects in the analysis population; n = number of subjects in the specified category; NA = not available; PYE = patient-years of exposure.
Note: IR is 100 times the number of patients experiencing the adverse event divided by the event-specific exposure to treatment (exposure time up to the event for patients with the event and exposure time to the end of the period for patients without the event, in years). Percentages are calculated by (n/N)*100%.
All BARI includes all the patients who received at least one dose (2 mg, or 4 mg) of baricitinib at any time of the treatment period.
Date of Last Review: 03-August-2026
Enclosed Prescribing Information
OLUMIANT® (baricitinib) tablets, for oral use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
- Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis over a median of 3 years of treatment: an updated integrated safety analysis. Lancet Rheumatol. 2020;2(6):E347-E357. https://doi.org/10.1016/S2665-9913(20)30032-1
- Taylor PC, Takeuchi T, Burmester GR, et al. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022;81(3):335-343. https://doi.org/10.1136/annrheumdis-2021-221276
- A study of baricitinib in participants with rheumatoid arthritis (RA-BRANCH). ClinicalTrials.gov identifier: NCT04086745. Updated July 10, 2026. Accessed July 14, 2026. https://clinicaltrials.gov/study/NCT04086745
- A study of baricitinib (LY3009104) in participants with rheumatoid arthritis (RA-BRIDGE). ClinicalTrials.gov identifier: NCT03915964. Updated June 24, 2026. Accessed July 14, 2026. https://clinicaltrials.gov/study/NCT03915964
- Taylor PC, Curtis JR, Giles JT, et al. Long-term safety evaluation of baricitinib vs. TNF inhibitors in rheumatoid arthritis patients selected for venous thrombo-embolism risk. Abstract presented at: European Congress of Rheumatology (EULAR); June 3-6, 2026; London, United Kingdom. Accessed July 21, 2026. https://distribution-congress.eular.org/from.storage?image=15rRXWmdOAJ77zPlkD-rQmJC6nskuTUZ69huzQoNF7ENLBCPhZE2MMOfEEpkzdLh0
Date of Last Review: August 03, 2026