Olumiant ® (baricitinib)

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What were the common adverse events reported in Olumiant® (baricitinib) alopecia areata clinical trials?

The most common adverse events ≥2% in the alopecia areata clinical trials were upper respiratory tract infections, nasopharyngitis, headache, acne, increased CPK, and urinary tract infections.

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Common treatment-emergent adverse events in the alopecia areata clinical trials

The baricitinib alopecia areata (AA) clinical trial program includes

Assessments of common treatment-emergent adverse events (TEAEs) in the BRAVE-AA trials were reported in 3 integrated safety datasets including the

  • 36-week placebo-controlled BARI AA dataset with patients exposed to placebo, baricitinib 2 mg, and baricitinib 4 mg from randomization to week 36
  • extended BARI AA dataset with patients exposed to baricitinib 2 mg or 4 mg from randomization to dose or treatment change, or data cut-off, and
  • All-BARI-AA dataset with all patients exposed to any baricitinib dose (1-mg, 2-mg, or 4-mg) at any time during the studies.4

Safety data were integrated from the BRAVE-AA1 Phase 2 and 3 cohorts (data cut-off March 31, 2021) and from BRAVE-AA2 (data cut-off March 24, 2021).4

More details on patient exposure and censoring rules in each dataset are provided in Integrated Analysis Datasets Used to Evaluate Safety in Alopecia Areata Clinical Trials .

Note: BARI 1 mg was studied in pivotal trials, however it is not approved. Please refer to section 4.2 of the Olumiant Summary of Product Characteristics for approved dosage.

Common TEAEs are defined as those reported at a frequency of ≥2% before the rounding of patients in any treatment group, including placebo.5

Across all analysis sets, the most common TEAEs were

  • upper respiratory tract infection
  • nasopharyngitis
  • headache
  • acne
  • blood creatine phosphokinase (CPK) increased, and
  • urinary tract infection (UTI).4

The most common TEAEs reported in ≥2% of any group in the baricitinib AA clinical trial program can be seen in Common Treatment-Emergent Adverse Events Occurring in ≥2% in Any Group.

Common Treatment-Emergent Adverse Events Occurring in ≥2% in Any Group4,5

 

36-Week Placebo-Controlled BARI AA

Extended BARI AA

All BARI AA

Treatment-emergent adverse event, n (%) [IR]

Placebo
N=371
PYE=243.2

BARI 2 mg
N=365
PYE=240.6

BARI 4 mg
N=540
PYE=363.4

BARI 2 mg
N=365
PYE=371.5

BARI 4 mg
N=540
PYE=624.3

All Doses
N=1244
PYE=1362.2

Upper respiratory tract infection

26 (7.0)
[11.2]

24 (6.6)
[10.3]

41 (7.6)
[11.8]

33 (9.0)
[9.0]

51 (9.4)
[8.5]

101 (8.1)
[7.8]

Nasopharyngitis

19 (5.1)
[8.0]

16 (4.4)
[6.8]

37 (6.9)
[10.7]

22 (6.0)
[5.8]

44 (8.1)
[7.3]

77 (6.2)
[5.8]

Headache

20 (5.4)
[8.4]

20 (5.5)
[8.5]

36 (6.7)
[10.4]

26 (7.1)
[7.0]

43 (8.0)
[7.1]

79 (6.4)
[5.9]

Acnea

4 (1.1)
[1.6]

21 (5.8)
[9.0]

30 (5.6)
[8.5]

24 (6.6)
[6.4]

34 (6.3)
[5.5]

73 (5.9)
[5.5]

Blood CPK increasedb

5 (1.3)
[2.0]

3 (0.8)
[1.2]

23 (4.3)
[6.4]

3 (0.8)
[0.8]

31 (5.7)
[5.0]

47 (3.8)
[3.4]

Urinary tract infection

6 (1.6)
[2.5]

14 (3.8)
[5.9]

18 (3.3)
[5.0]

19 (5.2)
[5.0]

26 (4.8)
[4.1]

57 (4.6)
[4.2]

Hypertension

9 (2.4)
[3.7]

2 (0.5)
[0.8]

14 (2.6)
[3.9]

2 (0.5)
[0.5]

18 (3.3)
[2.8]

27 (2.2)
[2.0]

Influenza

7 (1.9)
[2.9]

6 (1.6)
[2.5]

14 (2.6)
[3.9]

7 (1.9)
[1.8]

16 (3.0)
[2.5]

25 (2.0)
[1.8]

Pruritus

8 (2.2)
[3.3]

1 (0.3)
[0.4]

13 (2.4)
[3.6]

4 (1.1)
[1.0]

16 (3.0)
[2.5]

23 (1.8)
[1.7]

Cough

7 (1.9)
[2.9]

5 (1.4)
[2.1]

12 (2.2)
[3.3]

6 (1.6)
[1.5]

13 (2.4)
[2.0]

23 (1.8)
[1.7]

Fatigue

4 (1.1)
[1.6]

3 (0.8)
[1.2]

12 (2.2)
[3.3]

4 (1.1)
[1.0]

16 (3.0)
[2.5]

24 (1.9)
[1.7]

Folliculitis

3 (0.8)
[1.2]

5 (1.4)
[2.1]

12 (2.2)
[3.3]

6 (1.6)
[1.5]

15 (2.8)
[2.4]

30 (2.4)
[2.2]

Nausea

6 (1.6)
[2.5]

10 (2.7)
[4.2]

11 (2.0)
[3.1]

12 (3.3)
[3.1]

13 (2.4)
[2.1]

38 (3.1)
[2.8]

Back pain

12 (3.2)
[5.0]

6 (1.6)
[2.5]

10 (1.9)
[2.8]

8 (2.2)
[2.1]

16 (3.0)
[2.5]

27 (2.2)
[2.0]

Arthralgia

8 (2.2)
[3.3]

7 (1.9)
[2.9]

9 (1.7)
[2.5]

14 (3.8)
[3.6]

14 (2.6)
[2.2]

31 (2.5)
[2.3]

Diarrhea

8 (2.2)
[3.3]

2 (0.5)
[0.8]

9 (1.7)
[2.5]

3 (0.8)
[0.8]

12 (2.2)
[1.9]

17 (1.4)
[1.2]

Viral upper respiratory tract infection

6 (1.6)
[2.5]

8 (2.2)
[3.4]

8 (1.5)
[2.2]

8 (2.2)
[2.1]

10 (1.9)
[1.6]

20 (1.6)
[1.5]

Oral herpes

9 (2.4)
[3.7]

6 (1.6)
[2.5]

7 (1.3)
[1.9]

7 (1.9)
[1.8]

13 (2.4)
[2.0]

25 (2.0)
[1.8]

Vulvovaginal candidiasisc

0

6 (2.6)
[4.0]

4 (1.2)
[1.8]

6 (2.6)
[2.4]

6 (1.8)
[1.5]

16 (2.1)
[1.9]

COVID-19

2 (0.5)
[0.8]

1 (0.3)
[0.4]

1 (0.2)
[0.3]

5 (1.4)
[1.3]

18 (3.3)
[2.8]

44 (3.5)
[3.2]

Dermatitis contact

4 (1.1)
[1.6]

7 (1.9)
[2.9]

4 (0.7)
[1.1]

8 (2.2)
[2.1]

9 (1.7)
[1.4]

21 (1.7)
[1.5]

Dyslipidemia

3 (0.8)
[1.2]

0

9 (1.7)
[2.5]

0

12 (2.2)
[1.9]

16 (1.3)
[1.2]

Gastroenteritis

6 (1.6)
[2.5]

6 (1.6)
[2.5]

4 (0.7)
[1.1]

8 (2.2)
[2.1]

5 (0.9)
[0.8]

18 (1.4)
[1.3]

Abbreviations: AA = alopecia areata; BARI = baricitinib; COVID-19 = coronavirus disease 2019; CPK = creatine phosphokinase; IR = incidence rate; PYE = patient-years of exposure; PYR = patient-years at risk.

Note: IRs are calculated based on PYR.

aIn the 36-week placebo-controlled period, p<.001 vs placebo in BARI 2 mg and BARI 4 mg.

bIn the 36-week placebo-controlled period, p=.012 in BARI 4 mg vs placebo; p=.002 in BARI 4 mg vs BARI 2 mg.

cDenominator and IR adjusted because event is gender specific.

36-week placebo-controlled period

Treatment-emergent adverse events that were more frequent in the baricitinib 2-mg and baricitinib 4-mg group compared with placebo were

  • acne
  • UTI, and
  • vulvovaginal candidiasis.4,5

The TEAEs that were reported more frequently in baricitinib 4-mg compared with placebo were

  • blood CPK increased
  • fatigue, and
  • folliculitis.5

Extended BARI AA analysis set

Higher incidence rates (IRs) observed for the baricitinib 4-mg group compared with the baricitinib 2-mg group included

  • CPK increased
  • coronavirus disease 2019
  • hypertension
  • fatigue
  • pruritus
  • diarrhea, and
  • dyslipidemia.5

All-BARI-AA analysis set

With longer exposure, most IRs of TEAEs were similar or decreased in the All-BARI-AA analysis set compared with the placebo-controlled period.5

Adverse drug reactions with baricitinib treatment

The most commonly reported adverse drug reactions with baricitinib are6

  • increased LDL cholesterol (26.0 %),
  • upper respiratory tract infections (16.9 %) 
  • headache (5.2 %)
  • herpes simplex (3.2 %), and
  • urinary tract infections (2.9 %).

Serious pneumonia and serious herpes zoster occurred uncommonly in patients with rheumatoid arthritis.6

Please refer to section 4.8 of the Olumiant Summary of Product Characteristics for the tabulated list of adverse reactions and description of selected adverse reactions.

Common (≥1% and <10%) Baricitinib Adverse Drug Reactions5

Clinical Trial Dataa

Body System

Adverse Drug Reaction Terms

Gastrointestinal disorders

  • Nausea
  • Abdominal pain

Infections and infestations

  • Upper respiratory tract infectionsb
  • Herpes simplex
  • Herpes zoster
  • Urinary tract infection

Nervous system disorders

  • Headache

Skin and subcutaneous tissue disorders

  • Acne

Clinical chemistry

  • Creatine phosphokinase >5x ULN
  • LDL cholesterol ≥130 mg/dL (≥3.36 mmol/L)b
  • ALT ≥3x ULN

Hematology

  • Thrombocytosis >600,000 cells/mm3

Postmarketing datac

Skin and subcutaneous tissue disorders

  • Rashd (≥1% and <10%)
  • Swelling of the face (≥0.1% and <1%)
  • Urticaria (≥0.1% and <1%)

Abbreviations: AA = alopecia areata; AD = atopic dermatitis; ADR = adverse drug reaction; ALT = alanine aminotransferase; BARI = baricitinib; LDL = low-density lipoprotein; RA = rheumatoid arthritis; ULN = upper limit of normal.

aThe existing BARI safety profile contains ADRs based on the integrated safety data from the RA, AD, and AA clinical trial programs.

bVery common ≥10%.

cSpontaneous reporting has limitations due to bias in reporting including incomplete information concerning the patient. Active follow-up is undertaken to try and get additional information for any report received post approval. When verification of product manufactured by Eli Lilly and Company is not obtainable, these cases are included in the spontaneous database.

dIncludes rash, dermatitis, dermatitis contact, eczema, dermatitis allergic, rash maculo-papular, rash pruritic, rash pustular, drug eruption, rash erythematous, rash macular.

Integrated safety datasets

Integrated Analysis Datasets Used to Evaluate Safety in Alopecia Areata Clinical Trials4,5 

Analysis Set

Description

36-Week placebo-controlled BARI AA

Assesses BARI 4 mg, BARI 2 mg, and placebo.

Includes patients from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 studies who were randomized to

  • BARI 4 mg (n=540, PYE=363.4)
  • BARI 2 mg (n=365, PYE=240.6), or
  • placebo (n=371, PYE=243.2).

Evaluation time period included randomization to week 36.

Extended BARI AA

Assesses BARI 4 mg and BARI 2 mg including extended evaluations.

Includes patients from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 studies who were randomized to

  • BARI 4 mg (n=540, PYE=624.3), or
  • BARI 2 mg (n=365, PYE=371.5).

Evaluation time period included randomization up to data cutoff, March 24, 2021 for BRAVE-AA2 and March 31, 2021 for BRAVE-AA1. Data were censored after a patient was switched to another dose or treatment.

All BARI AA

No between-group assessments.

Includes 1244 (total PYE=1362.2) patients from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 studies who were exposed to any BARI dose, including

  • BARI 4 mg (n=938, PYE=858.9)
  • BARI 2 mg (n=564, PYE=488.9), or
  • BARI 1 mg (n=28, PYE=14.6).

Evaluation time period included any time points during the studies either from randomization or from switch or rescue from placebo.

Abbreviations: AA = alopecia areata; BARI = baricitinib; PYE = patient-years of exposure.

References

1King 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

2A study of baricitinib (LY3009104) in adults with severe or very severe alopecia areata (BRAVE-AA2). ClinicalTrials.gov identifier: NCT03899259. Updated January 26, 2022. Accessed March 4, 2022. https://clinicaltrials.gov/ct2/show/NCT03899259

3A study of baricitinib (LY3009104) in participants with severe or very severe alopecia areata (BRAVE-AA1). ClinicalTrials.gov identifier: NCT03570749. Updated February 3, 2022. Accessed March 4, 2022. https://clinicaltrials.gov/ct2/show/study/NCT03570749

4King B, Mostaghimi A, Shimomura Y, et al. Integrated safety analysis of baricitinib in adults with severe alopecia areata from two randomized clinical trials. Poster presented at: Annual Meeting of the American Academy of Dermatology Association (AAD); March 25-29, 2022; Boston, MA. Accessed April 29, 2022. https://aad-eposters.s3.amazonaws.com/AM2022/poster/33966/Integrated+safety+analysis+of+baricitinib+in+adults+with+severe+alopecia+areata+from+two+randomized+clinical+trials.pdf

5Data on file, Eli Lilly and Company and/or one of its subsidiaries.

6Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Date of Last Review: 13 June 2022


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