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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.
Can Olumiant® (baricitinib) be used with other immune-related therapies, such as biologics, in patients with severe alopecia areata?
Combination with biologic immunomodulators, other JAK inhibitors, cyclosporine or other potent immunosuppressants has not been studied in patients with AA and is not recommended.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- What were the phase 3 placebo-controlled trials of baricitinib in alopecia areata?
- What were the concomitant medication criteria in the phase 3 BRAVE-AA trials?
- What are the efficacy and safety data for baricitinib in patients receiving concomitant immune-related treatments?
- What drug-drug interaction data are available for baricitinib?
- Can baricitinib be used with concomitant immune-related treatments?
- References
What were the phase 3 placebo-controlled trials of baricitinib in alopecia areata?
The efficacy and safety of baricitinib have been evaluated in the following pivotal, phase 3, placebo-controlled trials in adult patients with severe alopecia areata (AA)
- BRAVE-AA1 (N=654) compared baricitinib 2 mg or 4 mg to placebo in adult patients with ≥50% scalp hair loss, and
- BRAVE-AA2 (N=546) compared baricitinib 2 mg or 4 mg to placebo in adult patients with ≥50% scalp hair loss.1
What were the concomitant medication criteria in the phase 3 BRAVE-AA trials?
Prohibited Immune-Related Medications for Alopecia Areata Clinical Trials
Any investigational or commercial topical, intralesional, or systemic therapies to treat AA were not allowed during BRAVE-AA1 and BRAVE-AA2 trials.1,2
Any systemic treatment with an immunosuppressive/immunomodulating substance was prohibited during the AA studies, including, but not limited to
- biologics (eg, monoclonal antibodies)
- cyclosporine
- mycophenolate mofetil
- interferon γ (IFNγ)
- azathioprine
- methotrexate (MTX)
- hydroxychloroquine, or
- dimethyl fumarate derivatives.1,2
The use of topical Janus kinase (JAK) inhibitors applied to the scalp, eyebrows, and eyelids and other oral JAK inhibitors (eg, tofacitinib and ruxolitinib) were prohibited during the AA clinical trials.1,2
Topical calcineurin inhibitors were permitted during the BRAVE-AA studies except on the scalp, eyebrows, and eyelids.1,2
Relevant Exclusion Criteria for Immune-Related Therapies in Alopecia Areata Clinical Trials
Patients were excluded from study enrollment in the BRAVE-AA trials if, in the opinion of the investigator, they were experiencing or had a history of unstable concomitant disease that required frequent hospitalizations and/or frequent use of systemic immunosuppressants that may have interfered with participation in the study.1,2
Timing of Use Prior to Enrollment
Patients were also excluded from enrollment in the BRAVE-AA trials if they had been treated with
- monoclonal antibody less than 5 half-lives prior to randomization
- eg, ustekinumab, secukinumab, adalimumab, dupilumab
- immunosuppressants within 8 weeks of randomization
- eg, methotrexate, cyclosporine, dimethyl fumarate derivatives, mycophenolate mofetil, IFNγ, azathioprine
- other topical therapies for the treatment of AA within 4 weeks prior to randomization
- eg, anthralin, diphenylcyclopropenone, or other topical immunotherapies
- topical JAK inhibitors applied to the scalp within 4 weeks prior to randomization, or
- oral JAK inhibitors within 8 weeks prior to randomization, or had an inadequate response (eg, absence of significant terminal hair growth after at least 12 weeks of treatment).1,2
What are the efficacy and safety data for baricitinib in patients receiving concomitant immune-related treatments?
Subgroup analyses of efficacy and safety have not been conducted in patients with AA who had concomitant use of immune-related treatments.
Table 1 and Table 2 present the percentages of patients with concomitant use of immune-related treatments for AA and non-AA–related conditions in the BRAVE-AA placebo-controlled clinical trials.
Table 1. Summary of Concomitant Immune-Related Medications Used for Alopecia Areata in the Combined Analysis of the Pivotal Phase 3 BRAVE-AA1 and BRAVE-AA2 Trials (Integrated Analysis Set Populationa)2
Categorized by ATC Level 2 Classification, n (%) |
Placebo (n=345) |
BARI 2 mg (n=340) |
BARI 4 mg (n=515) |
|---|---|---|---|
Other dermatological preparations |
|||
Tacrolimus |
0 (0.0) |
0 (0.0) |
1 (0.2) |
Pimecrolimus |
1 (0.3) |
0 (0.0) |
0 (0.0) |
Abbreviations: ATC = Anatomical Therapeutic Chemical; BARI = baricitinib.
a Based on the pooled week 36 efficacy population.
Table 2. Summary of Concomitant Immune-Related Medications Used for Non–Alopecia Areata–Related Conditions in the Combined Analysis of the Pivotal Phase 3 BRAVE-AA1 and BRAVE-AA2 Trials (Integrated Analysis Set Populationa)2
Categorized by ATC Level 2 Classification, n (%) |
Placebo (n=345) |
BARI 2 mg (n=340) |
BARI 4 mg (n=515) |
|---|---|---|---|
Immunosuppressants |
|||
Hydroxychloroquine |
1 (0.3) |
1 (0.3) |
0 (0.0) |
Immunotherapy |
0 (0.0) |
1 (0.3) |
0 (0.0) |
Immune sera and immunoglobulins |
|||
Immunoglobulins NOS |
1 (0.3) |
0 (0.0) |
0 (0.0) |
Other dermatological preparations |
|||
Tacrolimus |
6 (1.7) |
1 (0.3) |
4 (0.8) |
Pimecrolimus |
1 (0.3) |
1 (0.3) |
4 (0.8) |
Abbreviations: ATC = Anatomical Therapeutic Chemical; BARI = baricitinib; NOS = not otherwise specified.
a Based on the pooled week 36 efficacy population.
What drug-drug interaction data are available for baricitinib?
Potential for Drug-Drug Interactions With Baricitinib Based on Pharmacokinetic Studies
Pharmacokinetic Substrate Studies
There were no clinically meaningful changes in the pharmacokinetics (PK) of baricitinib when baricitinib was coadministered with
- a CYP3A inhibitor (ketoconazole)
- a CYP3A/CYP2C19/CYP2C9 inhibitor (fluconazole)
- a CYP3A inducer (rifampicin)
- a P-glycoprotein (Pgp) and breast cancer resistance protein (BCRP) inhibitor (cyclosporine), or
- MTX.3,4
Coadministration with baricitinib had no clinically meaningful effects on the PK of
- a CYP3A substrate (simvastatin, ethinyl estradiol, or levonorgestrel)
- an OATP1B1 substrate (simvastatin acid)
- a Pgp substrate (digoxin), or
- an OAT1, OAT3, and BCRP substrate (MTX).2,3,4
Metabolism and Elimination
Approximately 6% of the orally administered baricitinib dose is identified as metabolites (three from urine and one from feces), with CYP3A4 identified as the main metabolizing enzyme. No metabolites of baricitinib were quantifiable in plasma.4
Baricitinib was excreted predominately as unchanged drug in urine (69%) and feces (15%).4
Renal elimination is the principal clearance mechanism for baricitinib through filtration and active secretion as baricitinib is identified as a substrate of OAT3, Pgp, BCRP, and multidrug and toxic extrusion protein 2-K (MATE2-K) from in vitro studies.4
In a clinical pharmacology study, approximately 75% of the administered dose was eliminated in the urine, while about 20% of the dose was eliminated in the feces.4
Can baricitinib be used with concomitant immune-related treatments?
Baricitinib has not been studied in combination with other JAK inhibitors or with biologic disease-modifying antirheumatic drugs (DMARDs). Baricitinib is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.4 Please refer to the prescribing information for additional guidance on the use of baricitinib together with other immunomodulatory therapies.
The treating physician may use the information provided, the patient’s prior medical history and other concomitant medications, and other individual factors, in formulating an assessment and approach. Decisions about treatment options and monitoring rest with the treating physician, in line with clinical practice and the prescribing information.
Enclosed Prescribing Information
OLUMIANT® (baricitinib) tablets, for oral use, Lilly
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
- King B, Ohyama M, Kwon O, et al; BRAVE-AA Investigators. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022;386(18):1687-1699. https://doi.org/10.1056/NEJMoa2110343
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
- Payne C, Zhang X, Shahri N, et al. Evaluation of potential drug-drug interactions with baricitinib. Ann Rheum Dis. 2015;74(suppl 2):1063. European League Against Rheumatism abstract AB0492. https://doi.org/10.1136/annrheumdis-2015-eular.1627
- Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
Date of Last Review: September 10, 2026