Olumiant ® ▼ (baricitinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Olumiant Summary of Product Characteristics (SmPC)

Olumiant®▼ (baricitinib): Common Side Effects​ in Atopic Dermatitis

In the 16 week placebo-controlled period, the most common treatment-emergent adverse events reported in all treatment groups was nasopharyngitis and headache. Headache cases were significantly higher in the baricitinib treated group compared to placebo.

Common Treatment Emergent Adverse Events in the Atopic Dermatitis Clinical Trials

Most of the common TEAEs reported during the placebo-controlled period were of mild or moderate severity.1

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

  • herpes simplex

  • blood CPK increased

  • headache, and

  • upper respiratory tract infection.2

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

  • blood CPK increased

  • herpes simplex

  • UTI

  • abdominal pain upper

  • headache, and

  • influenza.1,2

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

  • blood CPK increased

  • diarrhea, and

  • UTI.2

The integrated datasets used to evaluate safety in the AD clinical trials are described in detail in Table 2.

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 Table 1.

Table 1. Treatment‑Emergent Adverse Events Occurring in ≥2% in Any Group by Preferred Term1,2

 

BARI 2 mg Placebo-Controlleda
n (adj %)
b

BARI 4 mg Placebo-Controlleda
n (adj %)
b

BARI 2 mg vs 4 mga
n (adj %)
b

 

Placebo
n=889

BARI 2 mg
n=721

Placebo
n=743

BARI 4 mg
n=489

BARI 2 mg
n=576

BARI 4 mg
n=489

Nasopharyngitis

93 (10.6)

74 (10.3)

83 (9.5)

67 (11.3)

67 (9.5)

67 (11.3)

Headache

30 (3.5)

40 (6.3)c

28 (3.3)

35 (6.3)d

37 (5.9)

35 (6.3)

Upper respiratory tract infection

23 (2.4)

34 (4.5)c

14 (1.4)

15 (2.5)

23 (3.2)

15 (2.5)

Nausea

11 (1.1)

19 (2.3)

8 (0.8)

4 (0.8)

14 (1.8)

4 (0.8)

Diarrhea

17 (2.0)

16 (2.0)

15 (1.8)

15 (2.7)

10 (1.3)

15 (2.7)

Folliculitis

11 (1.2)

15 (1.9)

11 (1.2)

10 (1.5)

14 (1.8)

10 (1.5)

Oral herpes

10 (1.3)

12 (1.5)

9 (1.2)

12 (2.0)

10 (1.2)

12 (2.0)

Influenza

10 (1.2)

13 (1.7)

8 (1.0)

12 (2.2)

13 (1.7)

12 (2.2)

Herpes simplex

8 (0.9)

13 (2.0)

8 (0.9)

15 (2.6)c

13 (2.0)

15 (2.6)

Urinary tract infection

11 (1.1)

14 (1.7)

8 (0.8)

11 (2.0)

9 (1.1)

11 (2.0)

Blood CPK increased

7 (0.9)

10 (1.3)

6 (0.8)

17 (2.9)e

8 (1.1)

17 (2.9)f

Upper abdominal pain

11 (1.3)

11 (1.7)

10 (1.2)

14 (2.5)

10 (1.6)

14 (2.5)

Abbreviations: adj = adjusted; BARI = baricitinib; CPK = creatine phosphokinase.

a Data through 16-week placebo-controlled period.

b For 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. 

c p≤.05 vs placebo.

d p≤.01 vs placebo.

e p≤.001 vs placebo.

f p≤.05 vs BARI 2 mg.

Baricitinib Label

Summary of Safety Profile

In placebo-controlled atopic dermatitis clinical trials, for up to 16 weeks, the most commonly reported ADRs occurring in ≥ 2 % of patients treated with baricitinib monotherapy or in combination with topical corticosteroids were similar to those observed in rheumatoid arthritis, except for

  • increased LDL cholesterol (13.2 %) and

  • herpes simplex (6.1 %).

In patients treated with baricitinib in the atopic dermatitis clinical trials, the frequency of herpes zoster was very rare.3

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.

Integrated Safety Datasets

Table 2. Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials1,2

Analysis Set

Description

BARI 2 mg Placebo-Controlled

Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE- AD4, BREEZE- AD5, and BREEZE-AD7

Compares BARI 2 mg vs placebo

Includes patients with AD from 1 phase 2 and 5 phase 3 studies who were randomized to

  • BARI 2 mg (n=721, PYE=210.6), or

  • placebo (n=889, PYE=252.7).

Treatment period was 0 to 16 weeks.

BARI 4 mg Placebo-Controlled

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

Compares BARI 4 mg vs placebo

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

  • BARI 4 mg (n=489, PYE=147.1), or

  • placebo (n=743, PYE=211.8).

Treatment period was 0 to 16 weeks.

BARI 2 mg vs 4 mg

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

Compares BARI 2 mg vs BARI 4 mg through 16 weeks

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), or

  • BARI 4 mg (n=489, PYE=147.1).

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

BARI 2 mg vs 4 mg Extended

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=576, PYE=425.5), or

  • BARI 4 mg (n=489, PYE=459.3).

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.

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

References

1. Bieber 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

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

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

Glossary

AD = atopic dermatitis

AE = adverse event

BARI = baricitinib

CPK = creatine phosphokinase

RA = rheumatoid arthritis

TEAE = treatment-emergent adverse event

UTI = urinary tract infection

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Date of Last Review: February 05, 2021


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