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Olumiant ® (baricitinib)
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Can baricitinib be used with oral contraceptives in patients with severe alopecia areata?
The risk of venous thromboembolic events needs further consideration. In the alopecia areata clinical trials, some patients treated with baricitinib were taking concomitant oral contraceptives.
Content overview
How to manage the risk of venous thromboembolism?
Baricitinib is contraindicated during pregnancy. Women of childbearing potential have to use effective contraception during and for at least 1 week after treatment.1
Deep vein thrombosis (DVT) and pulmonary embolism (PE) are uncommon adverse events of baricitinib, both affects ≥ 1/1 000 to < 1/100 patients (incidences are based on results from clinical trials in rheumatoid arthritis, or rheumatoid arthritis and atopic dermatitis, respectively).1
In a retrospective observational study of baricitinib in rheumatoid arthritis patients, a higher rate of venous thromboembolic events (VTE) was observed compared to patients treated with TNF inhibitors.1
In a large randomized active‑controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a dose dependent higher rate of VTE including deep venous thrombosis (DVT) and pulmonary embolism (PE) was observed with tofacitinib compared to TNF inhibitors.1
In patients with cardiovascular or malignancy risk factors (see also section 4.4 “Major adverse cardiovascular events (MACE)” and “Malignancy”) baricitinib should only be used if no suitable treatment alternatives are available.1
In patients with known VTE risk factors other than cardiovascular or malignancy risk factors, baricitinib should be used with caution.1
VTE risk factors other than cardiovascular or malignancy risk factors include1
- previous VTE,
- patients undergoing major surgery,
- immobilisation,
- use of combined hormonal contraceptives or hormone replacement therapy, and
- inherited coagulation disorder.
Patients should be re‑evaluated periodically during baricitinib treatment to assess for changes in VTE risk.1
Promptly evaluate patients with signs and symptoms of VTE and discontinue baricitinib in patients with suspected VTE, regardless of dose or indication.1
What is the experience from pivotal clinical trials?
What are the pivotal clinical trials?
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.2
Were patients using oral contraceptives included in the trial?
Treatments for other medical conditions, including oral contraceptives, were permitted during the BRAVE-AA clinical program.2
Women of childbearing potential were excluded from baricitinib clinical studies if they did not agree to use 2 forms of birth control (including 1 classified as "highly effective") when engaging in sexual intercourse with male partners while enrolled in the study and for at least 4 weeks following the last dose.2
Female patients of child-bearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same-sex relationship (as part of their preferred and usual lifestyle) must agree to either remain abstinent or stay in a same-sex relationship without sexual relationships with males.2
How many patients used concomitant oral contraceptive?
Summary of Concomitant Sex Hormones and Modulators of the Genital System in the Combined Analysis of the Pivotal Phase 3 BRAVE-AA1 and BRAVE-AA2 Trials (Integrated Analysis Set Population) presents the percentages of patients with concomitant use of oral contraceptives in the BRAVE-AA placebo-controlled clinical trials.
Categorized by ATC Level 2 Classification, n (%) |
Placebo (n=345) |
BARI 2 mg (n=340) |
BARI 4 mg (n=515) |
Sex hormones and modulators of the genital system |
52 (15.1) |
49 (14.4) |
71 (13.8) |
Ethinylestradiol; levonorgestrel |
5 (1.4) |
8 (2.4) |
9 (1.7) |
Ethinylestradiol; iron; norethisterone |
2 (0.6) |
4 (1.2) |
7 (1.4) |
Ethinylestradiol; norethisterone |
4 (1.2) |
2 (0.6) |
7 (1.4) |
Ethinylestradiol; norgestimate |
6 (1.7) |
5 (1.5) |
7 (1.4) |
Drospirenone; ethinylestradiol |
7 (2.0) |
3 (0.9) |
6 (1.2) |
Etonogestrel |
1 (0.3) |
6 (1.8) |
6 (1.2) |
Desogestrel; ethinylestradiol |
4 (1.2) |
3 (0.9) |
5 (1.0) |
Estradiol |
2 (0.6) |
3 (0.9) |
4 (0.8) |
Estradiol; norethisterone |
0 |
1 (0.3) |
3 (0.6) |
Medroxyprogesterone |
5 (1.4) |
3 (0.9) |
3 (0.6) |
Levonorgestrel |
3 (0.9) |
0 |
2 (0.4) |
Norethisterone |
5 (1.4) |
2 (0.6) |
2 (0.4) |
Testosterone |
1 (0.3) |
0 |
2 (0.4) |
Chorionic gonadotropin |
0 |
0 |
1 (0.2) |
Cyproterone; ethinylestradiol |
1 (0.3) |
2 (0.6) |
1 (0.2) |
Dienogest |
0 |
0 |
1 (0.2) |
Dienogest; estradiol |
0 |
1 (0.3) |
1 (0.2) |
Drospirenone; ethinylestradiol; levomefolic acid |
0 |
0 |
1 (0.2) |
Estradiol; progesterone |
0 |
0 |
1 (0.2) |
Estrogens conjugated |
0 |
1 (0.3) |
1 (0.2) |
Ethinylestradiol |
0 |
1 (0.3) |
1 (0.2) |
Ethinylestradiol; gestodene |
1 (0.3) |
1 (0.3) |
1 (0.2) |
Ethinylestradiol; iron; levonorgestrel |
0 |
1 (0.3) |
1 (0.2) |
Ethinylestradiol; norelgestromin |
0 |
0 |
1 (0.2) |
Tibolone |
0 |
0 |
1 (0.2) |
Ulipristal |
0 |
0 |
1 (0.2) |
Chlormadinone; ethinyestradiol |
1 (0.3) |
0 |
0 |
Desogestrel |
1 (0.3) |
2 (0.6) |
0 |
Drospirenone |
0 |
2 (0.6) |
0 |
Dydrogesterone; estradiol |
1 (0.3) |
0 |
0 |
Estradiol; levonorgestrel |
0 |
1 (0.3) |
0 |
Estrogen NOS; testosterone |
1 (0.3) |
0 |
0 |
Ethinylestradiol; etynodiol |
1 (0.3) |
0 |
0 |
Oral contraceptive NOS |
3 (0.9) |
0 |
0 |
Progesterone |
1 (0.3) |
0 |
0 |
Abbreviations: AA = alopecia areata; ATC = Anatomic Therapeutic Chemical; BARI = baricitinib; NOS = not otherwise specified.
aBased on the pooled week 36 efficacy population.
What was the efficacy and safety of baricitinib in patients with concomitant oral contraceptive?
Subgroup analyses of efficacy and safety have not been conducted in patients with concomitant use of oral contraceptives.
Is there a potential for drug-drug interactions between baricitinib and oral contraceptives?
Oral contraceptives are not included in the drug-drug interaction information specific to baricitinib, and drug-drug interaction studies were not performed specifically for baricitinib and oral contraceptives.
Coadministration with baricitinib had no clinically relevant effects on the pharmacokinetics of Microgynon®, a CYP3A4 substrate.3,4
For full information on interactions of baricitinib with other medicinal products please refer to the summary of product characteristics, section 4.5 and 5.2.
Clinical use of oral contraceptives and baricitinib
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. The treating physician should consider potential risks and benefits of treatment options, and monitor appropriately.
References
1Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2King 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
3Data on file, Eli Lilly and Company and/or one of its subsidiaries.
4Payne 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. http://dx.doi.org/10.1136/annrheumdis-2015-eular.1627
Date of Last Review: 04 May 2022