Olumiant ® (baricitinib)

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Can baricitinib be used with oral contraceptives in patients with severe alopecia areata?

Oral contraceptives were permitted during the BRAVE-AA clinical trials. However, no subgroup analysis of efficacy and safety has been conducted based on the concomitant use of oral contraceptives in the baricitinib BRAVE-AA clinical trials.

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Baricitinib information from the label

Baricitinib is contraindicated during pregnancy. Women of childbearing potential have to use effective contraception during and for at least 1 week after treatment.1

Overview of BRAVE-AA phase 3 placebo-controlled 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

Concomitant Medication use criteria in the BRAVE-AA phase 3 placebo-controlled clinical studies

Permitted concomitant medication

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

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.

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.

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 Populationa)3

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.

Drug-drug interactions with 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.

Potential for drug-drug interactions with baricitinib based on pharmacokinetic studies

Pharmacokinetic substrate studies

There were no clinically relevant effects on baricitinib pharmacokinetics (PK) when baricitinib was coadministered with

  • a CYP3A inhibitor (ketoconazole)
  • a CYP2C19/CYP2C9/CYP3A inhibitor (fluconazole)
  • a CYP3A inducer (rifampicin)
  • a P-glycoprotein (Pgp) inhibitor (cyclosporine), or
  • methotrexate (MTX).4

Coadministration with baricitinib had no clinically relevant effects on the PK of

  • a CYP3A substrate (simvastatin or Microgynon®)
  • a organic anion transporting polypeptide (OATP) 1B1 substrate (simvastatin acid)
  • a Pgp substrate (digoxin), or
  • an organic anion transporter (OAT)1, OAT3, and BCRP substrate (MTX).3,4

In clinical pharmacology studies, coadministration of baricitinib with ketoconazole (strong CYP3A inhibitor) resulted in no clinically meaningful effect on the PK of baricitinib.1

Coadministration of baricitinib with fluconazole (moderate CYP3A/CYP2C19/CYP2C9 inhibitor) or rifampicin (strong CYP3A inducer) resulted in no clinically meaningful changes to baricitinib exposure.1

Metabolism and elimination

In vitro, baricitinib is a cytochrome P450 enzyme (CYP)3A4 substrate although less than 10 % of the dose is metabolised via oxidation.1

Renal elimination is the principal mechanism for baricitinib’s clearance through glomerular filtration and active secretion via

  • OAT3,
  • Pgp,
  • BCRP and
  • MATE2-K.1

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 faeces.1

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


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