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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 efficacy and safety of Olumiant® (baricitinib) in elderly patients for the treatment of rheumatoid arthritis?
In a post hoc analysis of 2 pooled phase 3 rheumatoid arthritis clinical trials, age did not affect the efficacy of baricitinib; however, more adverse events were reported in the elderly.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- Dosing Recommendations in Elderly Patients
- Safety Warnings and Precautions Related to Elderly Patients
Integrated Safety Dataset Analysis Based on Age
- All BARI RA Dataset Description
- Incidence Rate of MACE by Age Category and Risk Factors
- Incidence Rate of VTE by Age Categroy
- Incidence Rate of Malignancy by Age Category
- Serious Infection Results Based on Age
- Incidence Rate of Safety Topics of Interest by Dose in 65 Years and Older
Post Hoc Subgroup Analysis of Pooled RA-BEAM and RA-BUILD: Effect of Age on Efficacy and Safety
Pooled Analysis of Phase 2 and Phase 3 Studies: Effect of Baseline Demographics on Efficacy
Post Hoc Subgroup Analysis of RA-BEACON: Effect of Age on Efficacy
Dosing Recommendations in Elderly Patients
Of the 3100 patients treated in the rheumatoid arthritis clinical trials, a total of 537 patients with rheumatoid arthritis (RA) were ≥65 years of age, including 71 patients ≥75 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.1
Baricitinib is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function,
- care should be taken in dose selection, and
- monitoring renal function may be useful.1
Safety Warnings and Precautions Related to Elderly Patients
Serious Infections
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.1
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
- who have been exposed to tuberculosis
- with a history of a serious or an opportunistic infection
- who have resided or traveled in areas of endemic tuberculosis or endemic mycoses or
- with underlying conditions that may predispose them to infection.1
Interrupt baricitinib in patients with rheumatoid arthritis or alopecia areata, if the patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with baricitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should be closely monitored, and baricitinib should be interrupted if the patient is not responding to therapy. Do not resume baricitinib until the infection is controlled.1
Mortality
In a large, randomized, postmarketing safety study of another Janus kinase (JAK) inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in patients treated with the JAK inhibitor compared with tumor necrosis factor (TNF) blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with baricitinib.1,2
Major Adverse Cardiovascular Events
In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular (CV) risk factor, a higher rate of major adverse cardiovascular events (MACE) defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke was observed with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk.1,2
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with baricitinib, particularly in patients who are current or past smokers and patients with other CV risk factors. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. Discontinue baricitinib in patients that have experienced a MI or stroke.1
Thrombosis
Thrombosis, including deep vein thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with baricitinib compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with baricitinib. Many of these adverse events (AEs) were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one CV risk factor, higher rates of overall thrombosis, DVT, and PE were observed compared to those treated with TNF blockers.1,2
If clinical features of DVT/PE or arterial thrombosis occur, patients should discontinue baricitinib and be evaluated promptly and treated appropriately. Avoid baricitinib in patients that may be at increased risk of thrombosis.1
Malignancy and Lymphoproliferative Disorders
Malignancies were observed in clinical studies of baricitinib.1
In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. In this study, current or past smokers had an additional increased risk of overall malignancies.1,2
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with baricitinib, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.1
Non-melanoma Skin Cancers
Non-melanoma skin cancers have been reported in patients treated with baricitinib. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.1
Hypoglycemia in Patients with Diabetes
Hypoglycemia, including severe hypoglycemia, has been reported following initiation of baricitinib and other JAK inhibitors in patients with diabetes. During treatment with baricitinib, consider increased monitoring of blood glucose as clinically indicated in patients with diabetes. Advise patients with diabetes to notify their healthcare provider if they develop signs or symptoms of hypoglycemia.1
Integrated Safety Dataset Analysis Based on Age
All BARI RA 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 includes a long-term extension study (RA-BEYOND) with
- 14,744 patient-years of exposure to baricitinib
- 15,114 patient-years (PY) overall observation including time on baricitinib and follow-up
- median exposure of 4.6 years, and
- maximum exposure of 9.3 years.3
Incidence Rate of MACE by Age Category and Risk Factors
In the All BARI RA dataset, the incidence rate (IR) of MACE was
- 1.13 per 100 PY in all patients ≥65 years
- 0.35 per 100 PY in patients >50 to <65 years with no CV risk factors, and
- 0.65 per 100 PY in patients >50 to <65 years with 1 CV risk factor (see Incidence of MACE by Age and Cardiovascular Risk with Baricitinib in the RA Clinical Trials).4
Cardiovascular risk factors included current smoker, hypertension, HDL cholesterol <40 mg/dL, diabetes mellitus, and history of arteriosclerotic cardiovascular disease.4
Figure 1 description: In the All BARI RA dataset, the IR of MACE in patients without CV risk factors was 1.13 per 100 PY in patients ≥65 years, and
0.35 per 100 PY in patients >50 to <65 years. In patients aged >50 to <65 years with 1 CV risk factor the IR increased to 0.65 per 100 PY.
Abbreviations: CV = cardiovascular; MACE = major adverse cardiovascular event.
Note: Cardiovascular risk factors included current smoker, hypertension, HDL cholesterol <40 mg/dL, diabetes mellitus, and history of arteriosclerotic cardiovascular disease.
Incidence Rate of VTE by Age Categroy
In the All BARI RA dataset, the IR of VTE was
- 1.0 per 100 PY in patients ≥65 years, and
- 0.58 per 100 PY in patients >50 to <65 years.4
In patients aged >50 to <65 years, higher IRs were observed in patients with a body mass index (BMI) >30 (1.41 per 100 PY) or severe mobility impairment (1.19 per 100 PY) (see Incidence of VTE by Age and Risk Factors with Baricitinib in the RA Clinical Trials).4
Figure 2 description: In the All BARI RA dataset, the IR of VTE was 1.0 per 100 PY in patients ≥65 years, and 0.58 per 100 PY in patients >50 to <65 years. In patients aged >50 to <65 years, higher IRs were observed in patients with a BMI >30 (1.41 per 100 PY) or severe mobility impairment (1.19 per 100 PY).
Abbreviations: BMI = body mass index; RA = rheumatoid arthritis; VTE = venous thromboembolism.
Incidence Rate of Malignancy by Age Category
In the All BARI RA dataset, the IR of malignancy was
- 1.8 per 100 PY in patients ≥65 years, and
- 1.09 per 100 PY in patients >50 to <65 years.4
In patients aged >50 to <65 years who were current smokers, the IR increased to 2.18 per 100 PY (see Incidence of Malignancy by Age and Risk Factors with Baricitinib in the RA Clinical Trials).4
Figure 3 description: In the All BARI RA dataset, the IR of malignancy was 1.8 per 100 PY in patients ≥65 years, and 1.09 per 100 PY in patients >50 to <65 years. In patients aged >50 to <65 years who were current smokers, the IR increased to 2.18 per 100 PY.
Abbreviations: CV = cardiovascular; RA = rheumatoid arthritis.
Serious Infection Results Based on Age
Incidence Rate of Safety Topics of Interest by Dose in 65 Years and Older
Data analyses were conducted for safety topics of special interest by baricitinib dose (2 mg and 4 mg) in patients 65 years and older from the RA clinical trials. Incidence rates were calculated for the "randomised" group and "as-treated" group since dose could have been up-titrated or down-titrated in the clinical trials based on response or rescue (see Incidence of Adverse Events of Special Interest by Baricitinib Dose in Patients ≥65 Years Old notes for numbers of patient included).4
In the randomized RA group, the number of MACE and VTE were low with both doses in patients ≥65 years old. The IR of serious infections in the group aged 65 years and older was
- 6.0 in patients randomized to 2 mg, and
- 4.0 in patients randomized to 4 mg (see Incidence of Adverse Events of Special Interest by Baricitinib Dose in Patients ≥65 Years Old for confidence intervals).4
In the as-treated group, the IRs for MACE, VTE, and mortality were similar between the baricitinib 4-mg and 2-mg group. The IR for serious infections was higher in the 4-mg group than in the 2-mg group. However, the as-treated groups were markedly different in disease severity and no reliable comparison can be made.4
Incidence of Adverse Events of Special Interest by Baricitinib Dose in Patients ≥65 Years Old provides details on the number, incidence, and confidence intervals of the adverse events by dose for each group.4
Figure 4 description: In the randomized RA group, the number of MACE and VTE were low with both doses in patients ≥65 years old. The IR of serious infections was 6.0 in patients randomized to 2 mg 4.0 and in patients randomized to 4 mg. In the as-treated group, the IRs for MACE, VTE, and mortality were similar between the baricitinib 4-mg and 2-mg group. The IR for serious infections was higher in the 4-mg group than in the 2-mg group.
Abbreviations: MACE = major adverse cardiovascular event; VTE = venous thromboembolism.
Notes:
For MACE- Randomized dataset included 68 patients in the 2-mg group and 76 patients in the 4-mg group. As-treated dataset included 156 patients in the 2-mg group and 511 patients in the 4-mg group.
For malignancies, VTE, serious infection, and mortality- Randomized dataset included 82 patients in the 2-mg group and 87 patients in the 4-mg group. As-treated dataset included 170 patients in the 2-mg group and 563 patients in the 4-mg group.
Post Hoc Subgroup Analysis of Pooled RA-BEAM and RA-BUILD: Effect of Age on Efficacy and Safety
Each of the 4 phase 3 studies in the clinical program evaluated a distinct treatment population of patients with moderate-to-severe RA.
- RA-BEGIN compared baricitinib 4 mg monotherapy, baricitinib 4 mg plus methotrexate (MTX), and MTX monotherapy in patients who had limited or no prior treatment with MTX and were naïve to other disease-modifying antirheumatic drugs (DMARDs).5
- RA-BEAM compared baricitinib 4 mg vs placebo or adalimumab, with background MTX, in patients with inadequate response to MTX.6
- RA-BUILD compared baricitinib 2 mg and 4 mg vs placebo, with background conventional synthetic DMARD (csDMARD) therapy, in patients with inadequate response to csDMARDs.7
- RA-BEACON compared baricitinib 2 mg and 4 mg vs placebo, with background csDMARD therapy, in patients with an inadequate response to at least one TNF inhibitor, who may also have had an inadequate response to one or more non-TNF inhibitor biologic DMARDs.8
Overview of Pooled Analysis
A post hoc analysis of data from RA-BEAM and RA-BUILD was conducted to evaluate the efficacy and safety of using baricitinib in the elderly subpopulation, defined as patients 65 years or older. Combined data from both trials provided an overall sample of
- 714 patients in the baricitinib 4-mg group, and
- 716 patients in the placebo group.9
Efficacy and safety data are presented for patients aged <50, ≥50 and <65 years, and ≥65 years.9
Efficacy Results
Greater numerical improvements were seen for the efficacy endpoints in the baricitinib 4-mg group compared to the placebo group consistently across all age groups (Efficacy Outcomes in the Elderly Population Compared to Younger Patients at Week 24 in RA-BUILD and RA-BEAM).9
| Baricitinib 4 mg <50 years (n=259) | Baricitinib 4 mg ≥50 and <65 years | Baricitinib 4 mg ≥65 years | Placebo <50 years | Placebo ≥50 and <65 years | Placebo ≥65 years |
ACR20, % | ||||||
Week 12 | 69 | 66 | 68 | 37 | 41 | 43 |
Week 24 | 76 | 67 | 71 | 35 | 40 | 40 |
ACR50, % | ||||||
Week 12 | 41 | 41 | 42 | 15 | 16 | 14 |
Week 24 | 54 | 45 | 47 | 19 | 20 | 24 |
ACR70, % | ||||||
Week 12 | 18 | 17 | 24 | 5 | 4 | 4 |
Week 24 | 34 | 24 | 27 | 7 | 9 | 8 |
CDAI, week 24, % | ||||||
LDA (≤10) | 52 | 48 | 53 | 19 | 23 | 27 |
Remission (≤2.8) | 16 | 15 | 18 | 3 | 5 | 4 |
SDAI, week 24, % | ||||||
LDA (≤11) | 54 | 49 | 53 | 19 | 24 | 27 |
Remission (≤3.3) | 17 | 14 | 18 | 3 | 4 | 3 |
Abbreviations: ACR20 = American College of Rheumatology 20% response criteria; ACR50 = American College of Rheumatology 50% response criteria; ACR70 = American College of Rheumatology 70% response criteria; CDAI = Clinical Disease Activity Index; LDA = low disease activity; SDAI = Simplified Disease Activity Index.
Safety Results
In both the baricitinib 4-mg and placebo groups, elderly patients had more adverse events (AEs), serious adverse events (SAEs), and discontinuations due to AEs at week 24 (Safety Outcomes in the Elderly Population Compared to Younger Patients at Week 24 in RA-BUILD and RA-BEAM).9
| Baricitinib 4 mg <50 years | Baricitinib 4 mg ≥50 and <65 years | Baricitinib 4 mg ≥65 years | Placebo <50 years | Placebo ≥50 and <65 years | Placebo ≥65 years |
Patients with ≥1 AE, n (%) | 229 (88) | 296 (93) | 135 (99) | 212 (84) | 326 (93) | 111 (98) |
Discontinuation due to AE or death, n (%) | 6 (2) | 18 (6) | 12 (9) | 6 (2) | 14 (4) | 7 (6) |
Death, n (%) | 0 | 1 (<1) | 1 (1) | 0 | 2 (1) | 0 |
Serious AEs, n (%) | 8 (3) | 15 (5) | 12 (9) | 10 (4) | 11 (3) | 12 (11) |
Serious infections, n (%) | 3 (1) | 2 (1) | 4 (3) | 4 (2) | 5 (1) | 2 (2) |
Cardiac disorders, n (%) | 0 | 2 (1) | 2 (2) | 1 (<1) | 1 (<1) | 2 (2) |
Patients with ≥1 infection, n (%) | 99 (38) | 125 (39) | 48 (35) | 89 (35) | 86 (25) | 38 (34) |
Herpes zoster, n (%) | 2 (1) | 5 (2) | 3 (2) | 0 | 2 (1) | 0 |
Abbreviation: AE = adverse event.
Serious AEs requiring hospitalization were reported in
- 1 patient due to thrombophlebitis in the baricitinib 4-mg <50-year age group, and
- 6 patients due to fractures related to falls with 2 patients in the ≥65-year age group.9
None of these patients discontinued the study, and all of these events resolved.
There were 4 deaths in patients ≥50 years of age due to
- subarachnoid hemorrhage and renal failure in the placebo ≥50 and <65 group (n=2)
- circulatory failure in the baricitinib-4 mg ≥50 and <65 group (n=1), and
- pneumonia in the baricitinib 4-mg elderly group (n=1).9
Post Hoc Subgroup Analysis of Pooled RA-BEAM and RA-BUILD: Effect of Baseline Demographics on Efficacy
Overview of Post Hoc Analysis
This post hoc analysis assessed the effect of baseline demographics, including age, on the response to baricitinib treatment in patients with RA and an inadequate response to prior csDMARDs.10
Data was pooled from 2 phase 3 double-blind, randomized controlled trials for
- 714 patients who received baricitinib 4 mg, and
- 716 patients who received placebo.10
Efficacy Results
Patients in the baricitinib 4-mg group had improved efficacy compared with patients in the placebo group regardless of age group (Clinical Efficacy After 12 Weeks by Baseline Demographic Subgroups in RA-BEAM and RA-BUILD). None of the reported baseline demographic characteristics had a substantial effect on the reported efficacy outcomes.10
| ACR20 Response PBO | ACR20 Response BARI 4 mga | Change from Baseline in DAS28-hsCRP PBO | Change from Baseline in DAS28-hsCRP BARI 4 mga | Patients Achieving SDAI ≤11 PBO | Patients Achieving SDAI ≤11 BARI 4 mga |
Age group (years) | ||||||
<65 | 237/603 | 387/578 | -1.0 (0.05) | -2.1 (0.05) | 102/603 | 221/578 |
≥65 | 49/113 | 92/136 | -1.2 (0.11) | -2.4 (0.10) | 20/113 | 63/136 |
≥75 | 4/14 28.6% | 16/22 72.7% | 0.2 (0.67) | -1.6 (0.59) | 2/14 14.3% | 10/22 45.5% |
Abbreviations: ACR20 = American College of Rheumatology 20% response criteria; BARI = baricitinib; DAS28-hsCRP = 28-joint Disease Activity Score based on high-sensitivity C-reactive protein; LSM = least squares mean; PBO = placebo; SDAI = Simplified Disease Activity Index.
aOnly the baricitinib 4-mg dose was included in the subgroup analysis although baricitinib 2 mg was evaluated in RA-BUILD.
Safety Results
The proportions of patients ≥65 years of age and <65 years of age who reported AEs or SAEs or discontinued from the study due to an AE were similar in the baricitinib 4-mg and placebo groups.10
Pooled Analysis of Phase 2 and Phase 3 Studies: Effect of Baseline Demographics on Efficacy
Effect of Age on Efficacy of Baricitinib
Overview of Pooled Analysis
Demographic subgroups were also evaluated using pooled data from
- 3 phase 2 studies
- JADC
- JADA,
- JADN, and
- 2 phase 3 studies, RA-BEAM and RA-BUILD.11
Patients included in this analysis were
- inadequate responders to csDMARDs, and
- were administered baricitinib 4 mg (n=881) or placebo (n=803) on a background of csDMARD therapy.11
The objective was to assess the consistency of the BARI treatment effect across baseline demographic subgroups using a large pooled sample of patients with similar treatment history.11
Interaction p values ≤.10 were considered indicative of a possible interaction between treatment and subgroup.11
Efficacy Results
Efficacy outcomes were evaluated across several baseline demographics including age.11
Treatment with baricitinib 4 mg daily was associated with a treatment benefit compared with placebo across subgroups based on age (Efficacy Outcomes by Age at Week 12 for Phase 2 and 3 Pooled Analysis).11
| ACR50 Response PBO | ACR50 Response BARI 4 mg | ACR50 Response OR (95% CI) | DAS28-hsCRP ≤3.2 PBO | DAS28-hsCRP ≤3.2 BARI 4 mg | DAS28-hsCRP ≤3.2 OR (95% CI) | HAQ-DI Change From Baseline PBO | HAQ-DI Change From Baseline BARI 4 mg | HAQ-DI Change From Baseline LSMD (95% CI) |
Overall study population | 127/881 (14.4) | 330/803 (41.1) | 4.1 (3.3, 5.2)a | 146/881 (16.6) | 352/803 (43.8) | 4.2 (3.3, 5.3)a | -0.25 (0.03) [868] | -0.53 (0.03) [792] | -0.28 (-0.33, -0.23)a |
Age (years) | |||||||||
<65 | 109/750 (14.5) | 265/650 (40.8) | 4.03 (3.11, 5.23) | 122/750 (16.3) | 278/650 (42.8) | 4.07 (3.16, 5.25) | -0.24 (0.03) [739] | -0.53 (0.03) [641] | -0.28 (-0.34, -0.23) |
≥65 | 18/131 (13.7) | 65/153 (42.5) | 4.59 (2.53, 8.30) | 24/131 (18.3) | 74/153 (48.4) | 4.65 (2.61, 8.26) | -0.23 (0.06) [129] | -0.52 (0.06) [151] | -0.29 (-0.40, -0.17) |
<75 | 126/867 (14.5) | 319/779 (40.9) | NPb | 145/867 (16.7) | 337/779 (43.3) | NP | -0.25 (0.03) [854] | -0.54 (0.03) [769] | NP |
≥75 | 1/14 (7.1) | 11/24 (45.8) | NP | 1/14 (7.1) | 15/24 (62.5) | NP | -0.19 (0.16) [14] | -0.16 (0.12) [23] | NP |
Abbreviations: ACR50 = American College of Rheumatology 50% response criteria; BARI = baricitinib; DAS28-hsCRP = 28-joint Disease Activity Score based on high-sensitivity C-reactive protein; HAQ-DI = Health Assessment Questionnaire-Disability Index; LSM = least squares mean; N-obs = number observed; NP = not provided; PBO = placebo.
ap<.001 for BARI 4 mg vs placebo in overall pooled population
bWhen logistic regression sample size requirements are not met, odds ratio and 95% CI are not provided within a subgroup
Post Hoc Subgroup Analysis of RA-BEACON: Effect of Age on Efficacy
Overview of Post Hoc Subgroup Analysis
A subgroup analysis of data from RA-BEACON assessed the efficacy of baricitinib 2 mg or 4 mg daily by baseline characteristics including age at weeks 12 and 24. Interaction p values ≤.10 were considered indicative of a possible interaction between treatment and subgroup.12
The analysis did not assess the incidence of AEs by baseline age.12
Efficacy Results
The analysis did not find a significant consistent effect of baseline age for American College of Rheumatology 20% response criteria (ACR20) or Clinical Disease Activity Index ≤10 (CDAI ≤10) at week 12 or 24 between baricitinib 4 mg and placebo or baricitinib 2 mg and placebo (Effect of Baseline Age on Efficacy of Baricitinib in RA-BEACON).12
| Age, <65 yearsa | Age, ≥65 yearsa |
Percent of patients achieving ACR20, n/N (%) | ||
BARI 2 mg | ||
Week 12 | 67/139 (48) | 18/35 (51) |
Week 24 | 61/139 (44) | 17/35 (49) |
BARI 4 mg | ||
Week 12 | 70/136 (51) | 28/41 (68) |
Week 24 | 58/136 (43) | 24/41 (59) |
PBO | ||
Week 12 | 38/136 (28) | 10/40 (25) |
Week 24 | 35/136 (26) | 13/40 (30) |
Percent of patients achieving CDAI ≤10, n/N (%) | ||
BARI 2 mg | ||
Week 12 | 34/139 (24) | 7/35 (20) |
Week 24 | 30/139 (22) | 10/35 (29) |
BARI 4 mg | ||
Week 12 | 32/136 (24) | 17/41 (41) |
Week 24 | 35/136 (26) | 20/41 (49) |
PBO | ||
Week 12 | 16/136 (12) | 3/40 (8) |
Week 24 | 22/136 (16) | 5/40 (13) |
Abbreviations: ACR20 = American College of Rheumatology 20% response criteria; BARI = baricitinib; CDAI = Clinical Disease Activity Index; PBO = placebo.
ap=.043 for interaction of age for BARI 4 mg vs placebo at 24 weeks (p≤.01 was considered significant).
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
2Ytterberg SR, Bhatt DL, Mikuls TR, et al; ORAL Surveillance Investigators. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med. 2022;386(4):316-326. https://doi.org/10.1056/NEJMoa2109927
3Taylor 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
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5Fleischmann R, Schiff M, van der Heijde D, et al. Baricitinib, methotrexate, or combination in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. Arthritis Rheumatol. 2017;69(3):506-517. https://doi.org/10.1002/art.39953
6Taylor PC, Keystone EC, van der Heijde D, et al. Baricitinib versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2017;376(7):652-662. https://doi.org/10.1056/NEJMoa1608345
7Dougados M, van der Heijde D, Chen YC, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Ann Rheum Dis. 2017;76(1):88-95. https://doi.org/10.1136/annrheumdis-2016-210094
8Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med. 2016;374(13):1243-1252. https://doi.org/10.1056/NEJMoa1507247
9Fleischmann R, Alam J, Arora V, et al. Safety and efficacy of baricitinib in elderly patients with rheumatoid arthritis. RMD Open. 2017;3(2):1-5. https://doi.org/10.1136/rmdopen-2017-000546
10Kremer JM, Schiff M, Muram D, et al. Response to baricitinib therapy in patients with rheumatoid arthritis with inadequate response to csDMARDs as a function of baseline characteristics. RMD Open. 2018;4(1):e000581. https://doi.org/10.1136/rmdopen-2017-000581
11Dougados M, Rooney TP, Xie L, et al. Efficacy response to baricitinib based on baseline characteristics in patients who are inadequate responders to conventional DMARDs. Arthritis Rheumatol. 2017;69(suppl 10):512. American College of Rheumatology abstract 512. https://acrabstracts.org/abstract/efficacy-response-to-baricitinib-based-on-baseline-characteristics-in-patients-who-are-inadequate-responders-to-conventional-dmard/
12Genovese MC, Kremer JM, Kartman CE, et al. Response to baricitinib based on prior biologic use in patients with refractory rheumatoid arthritis. Rheumatology (Oxford). 2018;57(5):900-908. https://doi.org/10.1093/rheumatology/kex489
Date of Last Review: June 24, 2026