Olumiant ® (baricitinib)

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What are the common adverse events of Olumiant® (baricitinib) in patients with atopic dermatitis?

The most common adverse events occurring in ≥2% in the atopic dermatitis clinical trials were nasopharyngitis, headache, upper respiratory tract infection, oral herpes, influenza, herpes simplex, folliculitis, diarrhea, and urinary tract infection.

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UK_cFAQ_BAR101B_COMMON_SIDE_EFFECTS_AD
en-GB

Common adverse drug reactions with baricitinib

The most commonly reported adverse drug reactions with baricitinib are1

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

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.

Please note that the frequencies of the adverse reactions are based on integrated data from1

  • clinical trials and/or
  • postmarketing setting

across

  • rheumatoid arthritis, 
  • atopic dermatitis, and
  • alopecia areata

indications unless stated otherwise. 1

Common treatment-emergent adverse events in the atopic dermatitis clinical trials

Most of the common treatment-emergent adverse events (TEAEs) reported during the placebo-controlled period were mild or moderate.2

The common TEAEs reported more frequently in baricitinib 2 mg treated patients compared to placebo included

  • herpes simplex
  • blood creatine phosphokinase (CPK) increased
  • headache, and
  • upper respiratory tract infection.3

The TEAEs reported more frequently in the baricitinib 4 mg group compared to placebo included

  • blood CPK increased
  • herpes simplex
  • urinary tract infection (UTI)
  • abdominal pain upper
  • headache, and
  • influenza.2,3

In the 16-week placebo-controlled period, dose-dependent increases with events occurring more frequently in the baricitinib 4 mg treated patients compared to 2 mg treated patients for

  • blood CPK increased
  • diarrhea, and
  • UTI.3

The integrated datasets used to evaluate safety in the atopic dermatitis (AD) clinical trials are described in detail in Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials.

The most common TEAEs reported in ≥2% of any group during the 16-week placebo-controlled period in the BARI AD clinical trial program are reported in Most Common Treatment‑Emergent Adverse Events Occurring in ≥2% Patients in the Placebo-Controlled Datasets.

Most Common Treatment‑Emergent Adverse Events Occurring in ≥2% Patients in the Placebo-Controlled Datasets3,4

 

16-Week Placebo-controlled BARI ADa

n (adj %) [adj IR]

BARI 2 mg and 4 mg Extended ADba

n [adj IR]

All BARI ADbc

n [IR]


Placebo
n=743

BARI 2 mg
n=576

BARI 4 mg
n=489

BARI 2 mg
n=584

BARI 4 mg
n=497

All doses
N=2636

Nasopharyngitis

83 (9.5) [34.9]

67 (9.5) [34.1]

67 (11.3) [40.8]

121 [21.0]

129 [22.3]

530 [13.8]

Headache

28 (3.3) [11.9]

37 (5.9) [21.1]

35 (6.3) [21.4]

58 [8.6]

55 [7.4]

216 [4.9]

Upper respiratory tract infection

14 (1.4) [4.8]

23 (3.2) [11.0]

15 (2.5) [8.3]

34 [5.1]

45 [5.8]

206 [4.7]

Nausea

8 (0.8) [2.7]

14 (1.8) [5.8]

4 (0.8) [2.5]

18 [2.3]

9 [1.1]

61 [1.3]

Diarrhea

15 (1.8) [6.2]

10 (1.3) [4.3]

15 (2.7) [9.0]

18 [2.3]

25 [3.3]

107 [2.3]

Folliculitis

11 (1.2) [4.0]

14 (1.8) [6.2]

10 (1.5) [4.9]

28 [3.9]

19 [2.4]

109 [2.4]

Oral herpes

9 (1.2) [4.1]

10 (1.2) [4.2]

12 (2.0) [6.7]

21 [2.9]

33 [4.7]

140 [3.1]

Influenza

8 (1.0) [3.4]

13 (1.7) [5.7]

12 (2.2) [7.2]

33 [4.4]

30 [4.7]

135 [3.0]

Herpes simplex

8 (0.9) [3.2]

13 (2.0) [7.1]

15 (2.6) [8.6]

22 [3.1]

36 [4.9]

120 [2.6]

Urinary tract infection

8 (0.8) [2.6]

9 (1.1) [3.8]

11 (2.0) [6.5]

17 [2.4]

21 [2.9]

104 [2.3]

Blood CPK increased

6 (0.8) [2.7]

8 (1.1) [3.5]

17 (2.9) [9.6]

15 [2.0]

27 [3.3]

90 [1.9]

Upper abdominal pain

10 (1.2) [4.1]

10 (1.6) [5.3]

14 (2.5) [8.5]

18 [2.4]

18 [2.5]

55 [1.2]

Abbreviations: AD = atopic dermatitis; adj = adjusted; BARI = baricitinib; IR = incidence rate; CPK = creatine phosphokinase.

aFor the integrated controlled analysis sets where the randomized ratio of patients receiving BARI to placebo or BARI to active control is not the same across all the integrated studies (example 2:1:1:1 vs 1:1:1:1), the study-size adjusted percentages were calculated for the adverse events to provide appropriate direct comparisons between treatment groups. 

bData up to 3.9 years.

cAll-BARI AD includes BARI 1-mg, 2-mg, and 4-mg.

Integrated Safety Datasets

Please find an overview of the integrated analysis datasets of atopic dermatitis in Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials

Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials2-5

Analysis Set

Description

16-Week Placebo-Controlled BARI AD

Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, and BREEZE-AD7

Compares BARI 2 mg, BARI 4 mg and placebo.

Includes patients with AD from 1 phase 2 and 4 phase 3 studies who were randomized to

  • BARI 2 mg (n=576, PYE=169.1)
  • BARI 4 mg (n=489, PYE=147.1), or
  • placebo (n=743, PYE=211.8).

Treated for 0 to 16 weeks during the placebo-controlled period.

BARI 2 mg and 4 mg Extended ADa

Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, BREEZE-AD7, and extension study BREEZE-AD3

Compares BARI 2 mg vs BARI 4 mg including extended evaluations

Includes patients with AD from 1 phase 2 and 4 phase 3 studies and any further exposure for those patients in the phase 3 extension study, BREEZE-AD3, who were randomized to

  • BARI 2 mg (n=584, PYE=727.1), or
  • BARI 4 mg (n=497, PYE=800.1).

Data censored at dose or treatment change (rescue, dose switch, or re-randomization to a different BARI dose or placebo) for BREEZE-AD4 and BREEZE-AD3.

All BARI ADb

Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, BREEZE-AD5, BREEZE-AD7, and extension studies BREEZE-AD3, BREEZE-AD6

No between-group comparisons

Includes 2636 (total PYE=4628.4) patients with AD from 1 phase 2, 5 phase 3, and 2 phase 3 extension studies who received BARI at a variety of doses, including

  • BARI 1 mg (n=605, PYE=441.5)
  • BARI 2 mg (n=1703, PYE=2420.9), and
  • BARI 4 mg (n=1012, PYE=1766.8).

Includes all patients who were exposed to any BARI dose at any time during the studies, either from randomization or from switch or rescue from placebo.

 No censoring of data at dose change.

Abbreviations: AD = atopic dermatitis; BARI = baricitinib; PYE = patient-years of exposure.

aData cut as of November 3, 2021 for BREEZE-AD3 and December 15, 2021 for BREEZE-AD4

bData cut as of November 3, 2021 for BREEZE-AD3, December 15, 2021 for BREEZE-AD4, and December 21, 2021 for BREEZE AD6

References

1Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2Bieber T, Thyssen JP, Reich K, et al. Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials. J Eur Acad Dermatol Venereol. 2021;35(2):476-485. https://doi.org/10.1111/jdv.16948

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

4Bieber T, Katoh N, Simpson EL, et al. Safety of baricitinib for the treatment of atopic dermatitis over a median of 1.6 and up to 3.9 years treatment: an updated integrated analysis of 8 clinical trials. Poster presented at: 31st Annual European Academy of Dermatology and Venereology Congress; September 7-10, 2022; Milan, Italy.

5King B, Maari C, Lain E, et al. Extended safety analysis of baricitinib 2 mg in adult patients with atopic dermatitis: an integrated analysis from eight randomized clinical trials. Am J Clin Dermatol. 2021;22(3):395-405. https://doi.org/10.1007/s40257-021-00602-x

Date of Last Review: 28 July 2022


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