Tips for searching:
• You have to select a product and type at least 2 words to activate the search
• Use only words that are specific to the information you are looking for
• Avoid typing questions or sentences
Please do not use this field to report adverse events or product complaints. Adverse events and product complaints should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google play or Apple app store. Adverse events and product complaints should also be reported to Lilly: please call Lilly UK on 01256 315 000.
Olumiant ® (baricitinib)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
What is the effect of Olumiant® (baricitinib) on lipids in patients with rheumatoid arthritis?
Baricitinib was associated with increased lipid parameters in the rheumatoid arthritis (RA) clinical development program. Lipid analytes generally increased initially in patients treated with baricitinib and then plateaued afterwards.
Content overview
Information From the Label
Increased LDL cholesterol (26.0 %) was one of the most commonly reported adverse drug reactions with baricitinib.
The frequency of hypercholesterolaemia was very common (≥ 1/10). The frequency of hypertriglyceridaemia was uncommon (≥ 1/1 000 to < 1/100). 1
The frequencies are based on integrated data from1
- clinical trials and/or
- postmarketing setting
across
- rheumatoid arthritis,
- atopic dermatitis, and
- alopecia areata
indications unless stated otherwise; where notable differences in frequency between indications are observed, these are presented in the footnotes below the table.1
Special warnings and precautions for use
Dose dependent increases in blood lipid parameters were reported in patients treated with baricitinib.1
- Elevations in low density lipoprotein (LDL) cholesterol decreased to pre- treatment levels in response to statin therapy.
- Lipid parameters should be assessed approximately 12 weeks following initiation of therapy and thereafter patients should be managed according to international clinical guidelines for hyperlipidaemia.
Lipid Elevations
In the integrated data from rheumatoid arthritis, atopic dermatitis and alopecia areata clinical trials, baricitinib treatment was associated with dose-dependent increases in lipid parameters including total cholesterol, LDL cholesterol, and high density lipoprotein (HDL) cholesterol.1
- There was no change in the LDL/HDL ratio.
- Elevations were observed at 12 weeks and remained stable thereafter at a higher value than baseline including in the long-term extension study in rheumatoid arthritis.
- Mean total and LDL cholesterol increased through week 52 in patients with atopic dermatitis and alopecia areata.
In rheumatoid arthritis clinical trials, baricitinib treatment was associated with dose-dependent increases in triglycerides. There was no increase in triglycerides levels in atopic dermatitis and alopecia areata clinical trials.1
Elevations in LDL cholesterol decreased to pre-treatment levels in response to statin therapy.1
Treatment-Emergent Adverse Events Related to Lipids in the Rheumatoid Arthritis Clinical Development Program
Incidence of Hypercholesterolemia and Hyperlipidemia
7-Study Placebo Controlled Dataset
The proportion of patients who reported hyperlipidemia was
- 3.2% in the baricitinib 4-mg group (p=.003 vs placebo)
- 1.3% in the baricitinib 2-mg group, and
- 1.3% in the placebo group.2
Furthermore, the proportion of patients who reported hypercholesterolemia was
- 3.4% in the baricitinib 4-mg group (p=.002 vs placebo)
- 1.9% in the baricitinib 2-mg group, and
- 1.5% in the placebo group.2
There were no serious hyperlipidemia events or temporary or permanent discontinuations from study drug due to hyperlipidemia events up to week 24.2
All BARI RA Dataset
In the All BARI RA dataset consisting of 3770 patients treated with baricitinib with maximum exposure of 9.3 years (patient-years of exposure [PYE]=14,744), the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of
- hyperlipidemia was reported in 242 patients (6.4%; 1.60 exposure-adjusted incidence rate [EAIR]), and
- hypercholesterolemia was reported in 261 patients (6.9%; 1.73 EAIR).2
None of these events were considered serious; 1 hyperlipidemia event led to permanent discontinuation of study drug.2
The EAIR per 100 PYE of hypercholesterolemia was lower in the dataset with maximum exposure of 9.3 years compared with previous safety data analyses, which reflects the onset of hypercholesterolemia in the first months after starting baricitinib treatment and demonstrating no increase with longer exposure.2
Exposure-Adjusted Incidence Rates of Hypercholesterolemia and Hyperlipidemia in the Baricitinib 2-mg and Baricitinib 4-mg subsets of the All BARI RA Analysis Set presents events of hypercholesterolemia and hyperlipidemia in patients ever on baricitinib 2 mg and baricitinib 4 mg.2
|
Ever on Baricitinib 2 mg |
Ever on Baricitinib 4 mg |
Hypercholesterolemia (PT) |
34 (3.2) |
213 (6.3) |
Hyperlipidemia |
40 (3.7) |
196 (5.8) |
Abbreviations: EAIR = exposure-adjusted incidence rate; PT = preferred term.
Changes in Lipid Analytes
Mean Changes in Lipid Analytes From Baseline
A 5-study pooled placebo-controlled dataset was used to assess mean changes over time in lipid analytes, including
The 5-study pooled dataset included patients with RA randomized to baricitinib 4 mg or placebo from 1 phase 2 study and 4 phase 3 studies (RA-BEAM, RA-BUILD, RA-BEACON and RA-BALANCE). Data includes a long-term extension study (RA-BEYOND).2
Baricitinib 2 mg data is pooled from 3 of these studies in which both baricitinib 2 mg and baricitinib 4 mg were options during randomization (1 phase 2 study as well as RA-BUILD and RA-BEACON).2
Compared to placebo, treatment with baricitinib 2 mg and baricitinib 4 mg was associated with statistically significant percent increases from baseline through week 24 in
- LDL-C
- HDL-C, and
- total cholesterol (p≤.001 for all).2
Compared to placebo, treatment with baricitinib 4 mg was also associated with statistically significant percent increases from baseline through week 24 in triglycerides (p≤.001).2,3
The lipid elevations plateaued after week 12 (see Mean Change in LDL Over Time With Baricitinib in the 4-Study Dataset and Percent Change From Baseline in Lipid Analytes From the 5-Study Pooled Dataset).2,3
Lipid Analyte |
Placebo |
BARI 4 mg |
BARI 2 mg |
|||||||||
BL Mean ± SD |
LSM |
LSM |
BL Mean ± SD |
LSM |
LSM |
BL Mean ± SD |
LSM |
LSM |
||||
mmol/L |
mg/dL |
mmol/L |
mg/dL |
mmol/L |
mg/dL |
|||||||
TC |
4.99±1.06 |
193±41 |
0.3 |
0.0 |
4.96±1.06 |
192±41 |
13.4 |
13.7 |
4.99±0.96 |
193±37 |
8.1 |
9.4 |
LDL-C |
3.00±0.90 |
116±35 |
0.6 (0.6) |
0.1 (0.0) |
2.97±0.88 |
115±34 |
14.5 (0.8)a |
15.7 (0.9)a |
3.00±0.83 |
116±32 |
8.2 (1.1)a |
9.6 (1.2)a |
HDL-C |
1.54±0.41 |
59.6±16.0 |
0.5 (0.4) |
0.2 (0.1)b |
1.55±0.41 |
60.1 (15.7) |
16.6 (0.7)a |
15.6 (0.7)a |
1.55±0.42 |
59.8±16.2 |
11.3 (0.9)a |
12.4 (1.1)a |
TGs |
3.23±2.09 |
125±81 |
2.8 (1.0)c |
-0.2 (0.1) |
3.20±1.76 |
124±68 |
15.0 (1.4)a |
15.1 (1.4)a |
3.36±1.81 |
130±70 |
8.3 (1.9)a |
9.7 (2.2)a |
Abbreviations: ANOVA = analysis of variance; BARI = baricitinib; BL = baseline; HDL-C = high-density lipoprotein-cholesterol; LDL-C = low-density lipoprotein-cholesterol; LSM = least squares mean; TC = total cholesterol; TGs = triglycerides.
Note: Percentage change from baseline was based on the LSM calculated using the ANOVA model, including terms of baseline value, treatment and study.
ap=.001 vs baseline.
bp=.018 vs baseline.
cp=.005 vs baseline.
Figure 1 description: Mean low-density lipoprotein cholesterol increased in patients treated with baricitinib 2 mg and baricitinib 4 mg up to week 12 and then plateaued through week 204.
Abbreviations: BARI = baricitinib; LDL = low-density lipoprotein; PBO = placebo; RA = rheumatoid arthritis.
Notes: Baricitinib 2-mg, placebo censored at rescue or dose change, and BARI 4-mg censored at any dose change (including step-down) or rescue in JADY.
The 4-study pooled dataset included patients with RA randomized to BARI 4 mg or placebo from 4 phase 3 studies (RA-BEAM, RA-BUILD, RA-BEACON and RA-BALANCE). Data includes a long-term extension study (RA-BEYOND) with data through 13 February 2018. Baricitinib 2 mg data is pooled from 2 of these studies in which both BARI 2 mg and BARI 4 mg were options during randomization (RA-BUILD and RA-BEACON).
Treatment Emergent Shifts in Lipid Analytes
Over 24 weeks, there was a significant (p=.001) increase from baseline in the proportion of patients with LDL ≥130 mg/dL (3.36 mmol/L) and high-density lipoprotein (HDL) ≥60 mg/dL (1.55 mmol/L).4 The LDL levels generally increased during the first 12 weeks of treatment and then stabilized.2
7-Study Placebo Controlled Dataset
In the combined 7-study dataset, a treatment-emergent shift in LDL to ≥130 mg/dL (3.36 mmol/L) from baseline to 24 weeks was reported in
- 13.1% of patients in the placebo group
- 29.2% of patients in the baricitinib 2-mg group, and
- 39.3% of patients in the baricitinib 4-mg group (p=.001 vs placebo) (Treatment-Emergent Shifts in LDL, HDL, and Triglycerides).2
A treatment-emergent shift in HDL to ≥60 mg/dL (1.55 mmol/L) from baseline to 24 weeks was reported in
- 19.7% of patients in the placebo group
- 25.7% of patients in the baricitinib 2-mg group, and
- 51.1% of patients in the baricitinib 4-mg group (p=.001 vs placebo) (Treatment-Emergent Shifts in LDL, HDL, and Triglycerides).2
All BARI RA Dataset
In the All BARI RA dataset, a treatment-emergent shift
- in LDL to ≥130 mg/dL (3.4 mmol/L) from baseline was reported in 64.3% of patients, and
- in HDL to ≥60 mg/dL (1.6 mmol/L) from baseline was reported in 63.6% of patients.2
Lipid Analyte |
All BARI RA Dataset |
|||
Placebo |
BARI 2 mg |
BARI 4 mg |
All doses |
|
LDL ≥130 mg/dL (3.4 mmol/L) |
82/626 (13.1) |
77/264 (29.2) |
269/684 (39.3)c |
1345/2093 (64.3) |
HDL ≥60 mg/dL (1.6 mmol/L) |
104/528 (19.7) |
55/214 (25.7) |
277/542 (51.1)c |
1193/1876 (63.6) |
Triglycerides ≥500 mg/dL (5.65 mmol/L) |
7/1113 (0.6) |
5/444 (1.1) |
5/1081 (0.5) |
94/3589 (2.6) |
Abbreviations: BARI = baricitinib; HDL = high-density lipoprotein; LDL = low-density lipoprotein; NAR = number at risk; PYE = patient years of exposure; RA = rheumatoid arthritis.
aThe 7-study dataset through 13 February 2018 includes patients with RA from 3 phase 2 and 4 phase 3 studies who were randomized to BARI 4 mg (N=1142, [exposure through 24 weeks: PYE=471.8, median exposure=169 days, maximum exposure=211 days]), or placebo (N=1215, [exposure through 24 weeks: PYE=450.8, median exposure=166 days, maximum exposure=235 days]). Baricitinib 2 mg data is derived from 4 studies in which both BARI 2 mg (N=479, [exposure through 24 weeks: PYE=185.8, median exposure=168 days, maximum exposure=197 days]).
bOnly data collected using the same laboratory assay methodologies were used. Therefore, the number of patients at risk can differ across analytes.
cp<.05 vs placebo.
Changes in Lipid Particle Size
Pooled nuclear magnetic resonance (NMR) lipid panels were performed at 12 weeks in the RA-BEAM phase 3 study, which evaluated baricitinib vs placebo or adalimumab (ADA) in patients with inadequate response to methotrexate (MTX). All patients received background MTX therapy.3,5
In RA-BEAM, the NMR lipoprotein profile revealed similar changes for baricitinib and ADA treatment groups relative to the placebo group. Compared to placebo, baricitinib had statistically significant
- increases in
- total LDL (p≤.05) and large LDL (p≤.001) mean particle number
- total HDL (p≤.001) and all subfractions of HDL (p≤.05) mean particle number, and
- decreases in small, medium small, and very small LDL (p≤.01 for all) mean particle numbers.3
Compared to placebo, baricitinib had statistically significant
- increases in LDL (p≤.001) and very low-density lipoprotein (VLDL) (p≤.01) mean particle size, and
- modest decrease in HDL (p≤.05) mean particle size (NMR Lipoprotein Within-Group Changes From Baseline at Week 12 With Data From RA-BEAM).3
NMR analysis, least squares mean change from baseline (SD) |
|||
Placebo (N=488) |
Bari (N=487) |
ADA (N=330) |
|
Mean number of particles, nmol/L |
|||
Total number of LDL particles |
-21.31 (12.25) |
-36.64 (14.77) |
|
Large LDL particles |
-0.72 (8.20) |
39.49 (9.89)e |
|
Small LDL particles |
-21.86 (15.09) |
-80.26 (14.89)e |
-82.86 (18.18)e |
Medium small LDL particles |
-3.18 (3.15) |
-16.29 (3.11)e |
-15.47 (3.80)a |
Very small LDL particles |
-18.76 (12.07) |
-63.93 (11.91)e |
-67.37 (14.55)a |
Total number of HDL particles |
0.06 (0.22) |
1.93 (0.26)c |
|
Large HDL particles |
0.0 (0.12) |
0.41 (0.14)a |
|
Medium HDL particles |
0.13 (0.14) |
-0.30 (0.17)a |
|
Small HDL particles |
-0.08 (0.21) |
1.86 (0.25)c |
|
Mean particle size, nm |
|||
LDL particle size |
0.02 (0.03) |
0.25 (0.03)c |
0.23 (0.03)c |
HDL particle size |
0.01 (0.01) |
-0.02 (0.01)a |
-0.00 (0.01) |
VLDL particle size |
0.57 (0.40) |
2.34 (0.40)e |
1.19 (0.49) |
Abbreviations: ADA = adalimumab; Bari = baricitinib; HDL = high-density lipoprotein cholesterol; LDL = low-density lipoprotein cholesterol; NMR = nuclear magnetic resonance; VLDL = very low-density lipoprotein.
ap≤.05 vs placebo.
bp≤.01 vs ADA.
cp≤.001 vs placebo.
dp≤.001 vs ADA.
ep≤.01 vs placebo.
Effect of Statins in Combination With Baricitinib on Lipid Analytes
The effect of statin therapy on lipids for patients who initiated statins during the studies was evaluated
- in the 6-study dataset for patients randomized to placebo, and
- in the long-term cohort, consisting of baricitinib 2-mg data from RA-BUILD and RA-BEACON and baricitinib 4-mg data from RA-BEAM, RA-BUILD, and RA-BEACON, including data from RA-BEYOND.3
The 6-study dataset includes patients with RA from 3 phase 2 and 3 phase 3 studies who were randomized to baricitinib 4 mg or placebo, and includes data through 24 weeks of assigned treatment or until rescue in the phase 3 studies.2
The long-term baricitinib cohort included patients randomized to receive
- baricitinib 4 mg in RA-BEAM, RA-BUILD, and RA-BEACON, and
- baricitinib 2 mg in RA-BUILD and RA-BEACON.3
The dataset also included data from RA-BEYOND which was censored at dose change or rescue.3
The effect of baseline statin use on lipid levels was evaluated in the 6-study dataset with data presented as
- placebo, and
- baricitinib combined 2-mg and 4-mg groups.3
In the long-term baricitinib cohort, 25 patients receiving baricitinib 2 mg and 58 patients receiving baricitinib 4 mg initiated statin therapy after starting baricitinib. The effects of statin therapy were comparable between the baricitinib groups and placebo group (n=20) for
- LDL-C
- total cholesterol, and
- triglycerides.3
At week 24, in patients treated with baricitinib 2 mg and 4 mg, increases from baseline in both statin and non-statin users were seen for
- total cholesterol
- LDL-C
- HDL-C, and
- triglycerides.3
There were significant differences in the magnitude of lipid analyte change between the baricitinib 2-mg and 4-mg group and placebo group for both baseline statin users and non-statin users (Change in Lipid Analytes by Baseline Statin Use in Phase 3 Studies up to 24 Weeks From the 6-Study Dataset).3
Statin Use Group at Baseline |
LS Mean Change from Baseline (SE) |
|||||||
Total Cholesterol |
LDL-C |
HDL-C |
Triglycerides |
|||||
mmol/L |
mg/dL |
mmol/L |
mg/dL |
mmol/L |
mg/dL |
mmol/L |
mg/dL |
|
Nonusers |
||||||||
Placebo (N=704) |
-0.01 (0.03) |
-0.77 (1.14) |
-0.03 (0.02) |
-1.61 (0.90) |
0.00 (0.01) |
-0.12 (0.44) |
-0.01 (0.03) |
-1.29 (2.29) |
Bari 2/4 mg (N=1054) |
0.59 (0.02) |
22.75 (0.90) |
0.35 (0.02) |
13.63 (0.71) |
0.20 (0.01) |
7.90 (0.35) |
0.15 (0.02) |
12.87 (1.81) |
Users |
||||||||
Placebo (N=84) |
0.17 (0.11) |
6.07 (4.02) |
0.20 (0.10) |
7.70 (3.58) |
0.00 (0.03) |
0.00 (1.21) |
-0.01 (0.12) |
-0.02 (9.79) |
Bari 2/4 mg (N=137) |
0.63 (0.08) |
24.29 (3.16) |
0.41 (0.07) |
15.75 (2.81) |
0.24 (0.02) |
9.22 (0.95) |
0.14 (0.09) |
12.68 (7.68) |
Abbreviations: ANOVA = analysis of variance; Bari = baricitinib; HDL-C = high-density lipoprotein-cholesterol; LDL-C = low-density lipoprotein-cholesterol; LS = least squares.
Note: The LS mean change from baseline was calculated using the ANOVA model, including terms of baseline value, treatment, and study.
Twenty-five patients receiving baricitinib 2 mg and 58 patients receiving baricitinib 4 mg initiated statin therapy after starting baricitinib. The effects of statin therapy were comparable between the baricitinib groups and placebo group (n=20) for
- LDL-C
- total cholesterol, and
- triglycerides (Change in (A) Total Cholesterol, (B) Triglycerides, (C) LDL-C, and (D) HDL-C From Baseline to Initiation of Statin Therapy and End of Statin Use up to Week 24).3
Figure 2 description: Total cholesterol, triglycerides, low-density lipoprotein-cholesterol, and high-density lipoprotein-cholesterol increased in patients treated with baricitinib 2-mg and baricitinib 4-mg from baseline until statin initiation and decreased afterwards up to week 24.
Abbreviations: Bari = baricitinib; HDL-C = high-density lipoprotein-cholesterol; LDL-C = low-density lipoprotein-cholesterol.
Lipids in the Rheumatoid Arthritis Population
Compared to individuals without RA, patients with RA have lower
- total cholesterol
- HDL-C, and
- LDL-C.6
However, patients with RA are at increased risk for cardiovascular disease.6
Suppressing the inflammation in RA with disease-modifying antirheumatic drugs seems to increase levels of lipid fractions in RA, as response to therapy results in a normalization of lipid levels.7
The effects of baricitinib on lipid analytes are consistent with a pharmacologic effect of Janus kinase inhibition, which may be explained, in part, by the inhibition of interleukin-6 signaling.2,8
Appendix: Safety Dataset Descriptions
Analyses were conducted using integrated safety datasets including the
- 7-study placebo-controlled dataset, which compares the safety of baricitinib 4 mg or 2 mg vs placebo through 24 weeks, and
- All-BARI-RA dataset, the largest dataset that included 3770 patients with rheumatoid arthritis (RA) who received any dose of baricitinib from 9 randomized studies and 1 long-term extension study.9,10
More details on each dataset are provided in Integrated Analysis Datasets Used to Evaluate Safety in Rheumatoid Arthritis Clinical Trials.
This evaluation included a review of treatment-emergent adverse events (TEAEs) using a query for “hyperlipidemia” and "hypercholesterolemia."
Analysis Set |
Descriptiona |
7-Study Placebo-Controlled Dataset Studies: JADC, JADA, JADN, RA-BEAM, RA-BUILD, RA-BEACON, RA-BALANCE |
Compares BARI 4 mg vs placebo Includes patients with RA from 3 phase 2 and 4 phase 3 studies who were randomized to
Patients in the placebo group could have been taking
Evaluation time periods included
BARI 2 mg Analysis Set BARI 2 mg data is derived from 4 studies in which both BARI 2 mg (N=479, [exposure through 24 weeks: PYE=185.8, median exposure=168 days, maximum exposure=197 days]) and BARI 4 mg were options during randomization (JADA, JADN, RA-BUILD, RA-BEACON). |
All BARI RA Dataset Studies: JADB, JADC, JADA, JADN, RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON, RA-BALANCE, RA-BEYOND (extension) |
No between-group comparisons Includes patients with RA (N=3770, PYE=14,744 PY exposure to BARI and 15,114 PY overall observation including time on BARI and follow up, median exposure=4.6 yrs, maximum exposure=9.3 yrs) from 1 phase 1b, 3 phase 2, 5 phase 3 studies, and 1 phase 3 extension study who received BARI at a variety of doses, including
Patients had to have received at least 1 dose of BARI and could have received different doses throughout the trials. Evaluation time period is all exposure time points including after rescue or changes in study drug unless otherwise specified. |
Abbreviations: BARI = baricitinib; DMARD = disease-modifying antirheumatic drug; MTX = methotrexate; PY = patient-years; PYE = patient-years of exposure; QD = once daily; RA = rheumatoid arthritis.
aPatients with renal function impairment who were randomized to BARI 4 mg, but treated with the 2-mg dose were analyzed in the BARI 4-mg group.
References
1Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Taylor PC, Kremer JM, Emery P, et al. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018;77(7):988-995. http://dx.doi.org/10.1136/annrheumdis-2017-212461
4Smolen JS, Genovese MC, Takeuchi T, et al. Safety profile of baricitinib in patients with active rheumatoid arthritis with over 2 years median time in treatment. J Rheumatol. 2019;46(1):7-18. http://dx.doi.org/10.3899/jrheum.171361
5Taylor 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. http://dx.doi.org/10.1056/NEJMoa1608345
6Myasoedova E, Crowson CS, Kremers HM, et al. Lipid paradox in rheumatoid arthritis: the impact of serum lipid measures and systemic inflammation on the risk of cardiovascular disease. Ann Rheum Dis. 2011;70(3):482-487. http://dx.doi.org/10.1136%2Fard.2010.135871
7McGrath CM, Young SP. Lipid and metabolic changes in rheumatoid arthritis. Curr Rheumatol Rep. 2015;17(9):57. http://dx.doi.org/10.1007/s11926-015-0534-z
8Robertson J, Peters MJ, McInnes IB, Sattar N. Changes in lipid levels with inflammation and therapy in RA: a maturing paradigm. Nat Rev Rheumatol. 2013;9(9):513-523. http://dx.doi.org/10.1038/nrrheum.2013.91
9Genovese 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
10Taylor 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
11Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 8.4 years: an updated integrated safety analysis. Ann Rheum Dis. 2020;79(suppl 1):642-643. European League Against Rheumatism abstract FRI0123. https://ard.bmj.com/content/79/Suppl_1/642.1
Date of Last Review: 26 August 2022