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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.
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.
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
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.
|
16-Week Placebo-controlled BARI ADa n (adj %) [adj IR] |
BARI 2 mg and 4 mg Extended ADba n [adj IR] |
n [IR] |
|||
Placebo |
BARI 2 mg |
BARI 4 mg |
BARI 2 mg |
BARI 4 mg |
All doses |
|
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.
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
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
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
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