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Olumiant ® ▼ (baricitinib)
Olumiant® ▼ (baricitinib): Hypersensitivity Reactions in Patients With Atopic Dermatitis
Rash, urticaria, and facial swelling are adverse drug reactions with baricitinib. Based on data from the BREEZE-AD clinical program, there were no differences in hypersensitivity reactions between baricitinib and placebo.
UK_cFAQ_BAR119B_HYPERSENSITIVITY_REACTIONS_AD
en-GB
Baricitinib Label Information Related to Hypersensitivity
Contraindications, Warnings and Precautions
Baricitinib is contraindicated in case of hypersensitivity to the active substance or to any of the excipients.1
In post-marketing experience, cases of drug hypersensitivity associated with baricitinib administration have been reported.1
If any serious allergic or anaphylactic reaction occurs, baricitinib should be discontinued immediately.1
Adverse Drug Reactions: Rash, Urticaria, and Swelling of the Face
Rash was a common adverse drug reaction (≥1/100 to <1/10) in patients treated with BARI in clinical trials. Urticaria and swelling of the face were uncommon adverse drug reactions (≥1/1,000 to <1/100) in patients treated with BARI in clinical trials.1
Atopic Dermatitis Clinical Development Program Exclusion Criteria
In the BARI AD clinical trials, BARI was not to be used in patients with hypersensitivity to the active substance or to any of its excipients.2
Hypersensitivity in the Baricitinib Atopic Dermatitis Development Program
Patients with AD have an increased risk of general allergic reactions, including food and airborne allergens.
The risk of developing allergies is related to the epidermal permeability barrier defect and a genetic predisposition in patients with elevated serum Ig E and allergen-specific Ig E, facilitating allergen sensitization.3
Therefore, an assessment of allergic and hypersensitivity reactions was incorporated into the baricitinib development program.
Hypersensitivity - Definition of Terms
Data for hypersensitivity were searched based on the Hypersensitivity Standardized Medical Dictionary for Regulatory Authorities Queries (SMQ), which included the following MedDRA queries
- hypersensitivity SMQ (broad, narrow and [narrow] AD; see Standardized MedDRA Hypersensitivity Query (SMQ) Preferred Terms)
- angioedema SMQ (broad and narrow; see Standardized MedDRA Angioedema Query (SMQ) and Anaphylactic Query (SMQ) Preferred Terms)
- anaphylactic reaction SMQ (broad, narrow, and algorithm; see Standardized MedDRA Angioedema Query (SMQ) and Anaphylactic Query (SMQ) Preferred Terms).2
Dataset Description
The integrated datasets used to evaluate hypersensitivity reactions are described in Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials.
Treatment-Emergent Adverse Events Including Hypersensitivity, Angioedema, and Anaphylaxis
In the 16-week placebo-controlled period, there was no statistical difference p>.05) in hypersensitivity, angioedema, and anaphylactic events between the BARI 4 mg or BARI 2 mg compared to placebo. Additionally in the 16-week placebo-controlled period, no TEAEs of anaphylaxis were identified by the anaphylactic reaction SMQ (narrow search and algorithm; see Treatment-Emergent Adverse Events Including Anaphylactic, Angioedema, and Hypersensitivity in Atopic Dermatitis Trials).2
In the extended period across all 3 SMQs, the majority of the adjusted IRs for hypersensitivity, angioedema, and anaphylactic events following narrow and broad search approaches were not statistically different (p>.05) between the BARI 4 mg and BARI 2 mg groups. The angioedema broad search term was significantly higher (p<.05) in the BARI 4 mg group compared to BARI 2 mg in the extended period (see Treatment-Emergent Adverse Events Including Anaphylactic, Angioedema, and Hypersensitivity in Atopic Dermatitis Trials).2
Hyper-sensitivity Broad |
Hyper-sensitivity Narrow |
Hyper-sensitivity (Narrow) AD |
Angioedema Broad |
Angioedema Narrow |
Anaphylactic Reaction Broad |
Anaphylactic Reaction Narrow |
Anaphylactic Reaction Algorithm |
|
Placebo, n=889 |
73 (8.2) |
51 (5.7) |
19 (2.0) |
19 (2.1) |
10 (1.1) |
46 (5.0) |
0 |
0 |
BARI 2 mg, n=721 |
63 (8.6) |
42 (5.9) |
19 (2.4) |
14 (1.7) |
7 (0.9) |
38 (4.9) |
0 |
0 |
Placebo, n=743 |
62 (6.9) |
46 (5.1) |
16 (1.7) |
16 (1.7) |
8 (0.9) |
37 (4.0) |
0 |
0 |
BARI 4 mg, n=489 |
44 (7.6) |
30 (5.0) |
14 (2.2) |
12 (2.3) |
5 (1.0) |
24 (4.4) |
0 |
0 |
BARI 2 mg, n=576 |
53 (7.4) |
38 (5.5) |
17 (2.1) |
12 (1.5) |
7 (0.9) |
33 (4.4) |
0 |
0 |
BARI 4 mg, n=489 |
44 (7.6) |
30 (5.0) |
14 (2.2) |
12 (2.3) |
5 (1.0) |
24 (4.4) |
0 |
0 |
BARI 2 mg vs 4 mg extended, n (adj %)b [adj IR] |
||||||||
BARI 2 mg, n=576 |
78 (11.5) [19.5] |
54 (8.0) [13.1] |
25 (3.4) [5.6] |
18 (2.4) [3.9] |
12 (1.7) [2.6] |
47 (6.4) [10.6] |
0 |
0 |
BARI 4 mg, n=489 |
81 (14.3) [20.5] |
59 (10.2) [13.3] |
29 (4.9) [6.4] |
25 (4.5) [6.1]c |
16 (2.8) [3.5] |
46 (8.3) [11.6] |
0 |
1 (0.2) [0.2] |
All BARI AD, n (%), [IR] |
||||||||
All doses, N=2531 |
356 (14.1) [17.0] |
234 (9.2) [10.7] |
114 (4.5) [5.1] |
89 (3.5) [3.9] |
58 (2.3) [2.5] |
207 (8.2) [9.5] |
1 (0) [0] |
3 (0.1) [0.1] |
Abbreviations: AD = atopic dermatitis; adj = adjusted; BARI = baricitinib; IR = incidence rate.
aData through 16-week placebo-controlled period.
bFor 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.
cp<.05.
In the All BARI AD dataset, the hypersensitivity TEAEs using broad search terms led to
- a serious event in 42 (1.7%) patients
- interruption of treatment in 22 (0.9%) patients, and
- discontinuation of treatment in 28 (1.1%) patients.2
In the All BARI AD dataset, the angioedema TEAEs using broad search terms led to
- a serious event in 2 (0.1%) patients
- interruption of treatment in 1 (0%) patients, and
- discontinuation of treatment in 2 (0.1%) patients.2
In the All BARI AD dataset, the anaphylactic TEAEs using broad search terms led to
- a serious event in 9 (0.4%) patients
- interruption of treatment in 10 (0.4%) patients, and
- discontinuation of treatment in 7 (0.3%) patients.2
Integrated Safety Datasets Table
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
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
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
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
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 2 mg ADa Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, BREEZE-AD5, BREEZE-AD7, and extension studies BREEZE-AD3, BREEZE-AD6 |
No between-group comparisons Includes 1598 (total PYE=1434.2) patients with AD from 1 phase 2, 5 phase 3, and 2 phase 3 extension studies who received BARI 2 mg doses. Includes all patients who were exposed to BARI 2 mg at any time during the 8 studies, either from randomization or switch, or rescue to BARI 2 mg. Censoring of data at dose change in period 2 in BREEZE-AD3. |
All BARI AD Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, BREEZE-AD5, BREEZE-AD7, and extension studies BREEZE-AD3, BREEZE-AD6 |
No between-group comparisons Includes 2531 (total PYE=2247.4) 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.
aThe All BARI 2 mg AD analysis set uses an updated safety database with longer exposure time and with additional patients from 4 ongoing studies, compared to the All BARI AD analysis set.
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.
Hypersensitivity Standardized Medical Dictionary for Regulatory Authorities Queries
|
Hypersensitivity SMQ (20000214) a |
|
Search Type |
Category |
Preferred Term |
Narrow |
A |
Acquired C1 inhibitor deficiency |
Narrow |
A |
Acute generalised exanthematous pustulosis |
Narrow |
A |
Administration related reaction |
Narrow |
A |
Administration site dermatitis |
Narrow |
A |
Administration site eczema |
Narrow |
A |
Administration site hypersensitivity |
Narrow |
A |
Administration site rash |
Narrow |
A |
Administration site recall reaction |
Narrow |
A |
Administration site urticaria |
Narrow |
A |
Administration site vasculitis |
Narrow |
A |
Allergic bronchitis |
Narrow |
A |
Allergic colitis |
Narrow |
A |
Allergic cough |
Narrow |
A |
Allergic cystitis |
Narrow |
A |
Allergic eosinophilia |
Narrow |
A |
Allergic gastroenteritis |
Narrow |
A |
Allergic hepatitis |
Narrow |
A |
Allergic keratitis |
Narrow |
A |
Allergic oedema |
Narrow |
A |
Allergic otitis externa |
Narrow |
A |
Allergic otitis media |
Narrow |
A |
Allergic pharyngitis |
Narrow |
A |
Allergic reaction to excipient |
Narrow |
A |
Allergic respiratory disease |
Narrow |
A |
Allergic respiratory symptom |
Narrow |
A |
Allergic sinusitis |
Narrow |
A |
Allergic stomatitis |
Narrow |
A |
Allergic transfusion reaction |
Narrow |
A |
Allergy alert test positive |
Narrow |
A |
Allergy test positive |
Narrow |
A |
Allergy to immunoglobulin therapy |
Narrow |
A |
Allergy to surgical sutures |
Narrow |
A |
Allergy to vaccine |
Narrow |
A |
Anal eczema |
Narrow |
A |
Anaphylactic reaction |
Narrow |
A |
Anaphylactic shock |
Narrow |
A |
Anaphylactic transfusion reaction |
Narrow |
A |
Anaphylactoid reaction |
Narrow |
A |
Anaphylactoid shock |
Narrow |
A |
Anaphylaxis treatment |
Narrow |
A |
Angioedema |
Narrow |
A |
Antiallergic therapy |
Narrow |
A |
Antiendomysial antibody positive |
Narrow |
A |
Anti-neutrophil cytoplasmic antibody positive vasculitis |
Narrow |
A |
Application site dermatitis |
Narrow |
A |
Application site eczema |
Narrow |
A |
Application site hypersensitivity |
Narrow |
A |
Application site rash |
Narrow |
A |
Application site recall reaction |
Narrow |
A |
Application site urticaria |
Narrow |
A |
Application site vasculitis |
Narrow |
A |
Arthritis allergic |
Narrow |
A |
Aspirin-exacerbated respiratory disease |
Narrow |
A |
Atopic cough |
Narrow |
A |
Atopy |
Narrow |
A |
Blepharitis allergic |
Narrow |
A |
Blood immunoglobulin E abnormal |
Narrow |
A |
Blood immunoglobulin E increased |
Narrow |
A |
Bromoderma |
Narrow |
A |
Bronchospasm |
Narrow |
A |
Bullous haemorrhagic dermatosis |
Narrow |
A |
Catheter site dermatitis |
Narrow |
A |
Catheter site eczema |
Narrow |
A |
Catheter site hypersensitivity |
Narrow |
A |
Catheter site rash |
Narrow |
A |
Catheter site urticaria |
Narrow |
A |
Catheter site vasculitis |
Narrow |
A |
Chronic eosinophilic rhinosinusitis |
Narrow |
A |
Chronic hyperplastic eosinophilic sinusitis |
Narrow |
A |
Circulatory collapse |
Narrow |
A |
Circumoral oedema |
Narrow |
A |
Circumoral swelling |
Narrow |
A |
Conjunctival oedema |
Narrow |
A |
Conjunctivitis allergic |
Narrow |
A |
Contact stomatitis |
Narrow |
A |
Contrast media allergy |
Narrow |
A |
Contrast media reaction |
Narrow |
A |
Corneal oedema |
Narrow |
A |
Cutaneous vasculitis |
Narrow |
A |
Dennie-Morgan fold |
Narrow |
A |
Dermatitis |
Narrow |
A |
Dermatitis acneiform |
Narrow |
A |
Dermatitis allergic |
Narrow |
A |
Dermatitis atopic |
Narrow |
A |
Dermatitis bullous |
Narrow |
A |
Dermatitis contact |
Narrow |
A |
Dermatitis exfoliative |
Narrow |
A |
Dermatitis exfoliative generalised |
Narrow |
A |
Dermatitis herpetiformis |
Narrow |
A |
Dermatitis infected |
Narrow |
A |
Dermatitis psoriasiform |
Narrow |
A |
Device allergy |
Narrow |
A |
Dialysis membrane reaction |
Narrow |
A |
Distributive shock |
Narrow |
A |
Documented hypersensitivity to administered product |
Narrow |
A |
Drug eruption |
Narrow |
A |
Drug hypersensitivity |
Narrow |
A |
Drug provocation test |
Narrow |
A |
Drug reaction with eosinophilia and systemic symptoms |
Narrow |
A |
Eczema |
Narrow |
A |
Eczema infantile |
Narrow |
A |
Eczema nummular |
Narrow |
A |
Eczema vaccinatum |
Narrow |
A |
Eczema vesicular |
Narrow |
A |
Eczema weeping |
Narrow |
A |
Encephalitis allergic |
Narrow |
A |
Encephalopathy allergic |
Narrow |
A |
Eosinophilic granulomatosis with polyangiitis |
Narrow |
A |
Epidermal necrosis |
Narrow |
A |
Epidermolysis |
Narrow |
A |
Epidermolysis bullosa |
Narrow |
A |
Epiglottic oedema |
Narrow |
A |
Erythema multiforme |
Narrow |
A |
Erythema nodosum |
Narrow |
A |
Exfoliative rash |
Narrow |
A |
Eye allergy |
Narrow |
A |
Eye oedema |
Narrow |
A |
Eye swelling |
Narrow |
A |
Eyelid oedema |
Narrow |
A |
Face oedema |
Narrow |
A |
Fixed eruption |
Narrow |
A |
Giant papillary conjunctivitis |
Narrow |
A |
Gingival oedema |
Narrow |
A |
Gingival swelling |
Narrow |
A |
Gleich's syndrome |
Narrow |
A |
Haemorrhagic urticaria |
Narrow |
A |
Hand dermatitis |
Narrow |
A |
Henoch-Schonlein purpura |
Narrow |
A |
Henoch-Schonlein purpura nephritis |
Narrow |
A |
Heparin-induced thrombocytopenia |
Narrow |
A |
Hereditary angioedema |
Narrow |
A |
Hereditary angioedema with C1 esterase inhibitor deficiency |
Narrow |
A |
Hypersensitivity |
Narrow |
A |
Hypersensitivity myocarditis |
Narrow |
A |
Hypersensitivity pneumonitis |
Narrow |
A |
Hypersensitivity vasculitis |
Narrow |
A |
Idiopathic urticaria |
Narrow |
A |
Immediate post-injection reaction |
Narrow |
A |
Immune thrombocytopenia |
Narrow |
A |
Immune tolerance induction |
Narrow |
A |
Implant site dermatitis |
Narrow |
A |
Implant site hypersensitivity |
Narrow |
A |
Implant site rash |
Narrow |
A |
Implant site urticaria |
Narrow |
A |
Incision site dermatitis |
Narrow |
A |
Incision site rash |
Narrow |
A |
Infusion related hypersensitivity reaction |
Narrow |
A |
Infusion related reaction |
Narrow |
A |
Infusion site dermatitis |
Narrow |
A |
Infusion site eczema |
Narrow |
A |
Infusion site hypersensitivity |
Narrow |
A |
Infusion site rash |
Narrow |
A |
Infusion site recall reaction |
Narrow |
A |
Infusion site urticaria |
Narrow |
A |
Infusion site vasculitis |
Narrow |
A |
Injection related reaction |
Narrow |
A |
Injection site dermatitis |
Narrow |
A |
Injection site eczema |
Narrow |
A |
Injection site hypersensitivity |
Narrow |
A |
Injection site rash |
Narrow |
A |
Injection site recall reaction |
Narrow |
A |
Injection site urticaria |
Narrow |
A |
Injection site vasculitis |
Narrow |
A |
Instillation site hypersensitivity |
Narrow |
A |
Instillation site rash |
Narrow |
A |
Instillation site urticaria |
Narrow |
A |
Interstitial granulomatous dermatitis |
Narrow |
A |
Intestinal angioedema |
Narrow |
A |
Iodine allergy |
Narrow |
A |
Kaposi's varicelliform eruption |
Narrow |
A |
Kounis syndrome |
Narrow |
A |
Laryngeal oedema |
Narrow |
A |
Laryngitis allergic |
Narrow |
A |
Laryngospasm |
Narrow |
A |
Laryngotracheal oedema |
Narrow |
A |
Limbal swelling |
Narrow |
A |
Lip oedema |
Narrow |
A |
Lip swelling |
Narrow |
A |
Mast cell degranulation present |
Narrow |
A |
Medical device site dermatitis |
Narrow |
A |
Medical device site eczema |
Narrow |
A |
Medical device site hypersensitivity |
Narrow |
A |
Medical device site rash |
Narrow |
A |
Medical device site recall reaction |
Narrow |
A |
Medical device site urticaria |
Narrow |
A |
Mouth swelling |
Narrow |
A |
Mucocutaneous rash |
Narrow |
A |
Multiple allergies |
Narrow |
A |
Nephritis allergic |
Narrow |
A |
Nikolsky's sign |
Narrow |
A |
Nodular rash |
Narrow |
A |
Nutritional supplement allergy |
Narrow |
A |
Oculomucocutaneous syndrome |
Narrow |
A |
Oculorespiratory syndrome |
Narrow |
A |
Oedema mouth |
Narrow |
A |
Oral allergy syndrome |
Narrow |
A |
Oropharyngeal blistering |
Narrow |
A |
Oropharyngeal oedema |
Narrow |
A |
Oropharyngeal spasm |
Narrow |
A |
Oropharyngeal swelling |
Narrow |
A |
Palatal oedema |
Narrow |
A |
Palatal swelling |
Narrow |
A |
Palisaded neutrophilic granulomatous dermatitis |
Narrow |
A |
Palpable purpura |
Narrow |
A |
Pathergy reaction |
Narrow |
A |
Perioral dermatitis |
Narrow |
A |
Periorbital oedema |
Narrow |
A |
Periorbital swelling |
Narrow |
A |
Pharyngeal oedema |
Narrow |
A |
Pharyngeal swelling |
Narrow |
A |
Procedural shock |
Narrow |
A |
Pruritus allergic |
Narrow |
A |
Radioallergosorbent test positive |
Narrow |
A |
Rash |
Narrow |
A |
Rash erythematous |
Narrow |
A |
Rash follicular |
Narrow |
A |
Rash macular |
Narrow |
A |
Rash maculo-papular |
Narrow |
A |
Rash maculovesicular |
Narrow |
A |
Rash morbilliform |
Narrow |
A |
Rash neonatal |
Narrow |
A |
Rash papulosquamous |
Narrow |
A |
Rash pruritic |
Narrow |
A |
Rash pustular |
Narrow |
A |
Rash rubelliform |
Narrow |
A |
Rash scarlatiniform |
Narrow |
A |
Rash vesicular |
Narrow |
A |
Reaction to azo-dyes |
Narrow |
A |
Reaction to colouring |
Narrow |
A |
Reaction to excipient |
Narrow |
A |
Reaction to food additive |
Narrow |
A |
Reaction to preservatives |
Narrow |
A |
Red man syndrome |
Narrow |
A |
Rhinitis allergic |
Narrow |
A |
Scleral oedema |
Narrow |
A |
Scleritis allergic |
Narrow |
A |
Scrotal dermatitis |
Narrow |
A |
Scrotal oedema |
Narrow |
A |
Serum sickness |
Narrow |
A |
Serum sickness-like reaction |
Narrow |
A |
Shock |
Narrow |
A |
Shock symptom |
Narrow |
A |
SJS-TEN overlap |
Narrow |
A |
Skin necrosis |
Narrow |
A |
Skin reaction |
Narrow |
A |
Skin test positive |
Narrow |
A |
Solar urticaria |
Narrow |
A |
Solvent sensitivity |
Narrow |
A |
Stevens-Johnson syndrome |
Narrow |
A |
Stoma site hypersensitivity |
Narrow |
A |
Stoma site rash |
Narrow |
A |
Swelling face |
Narrow |
A |
Swelling of eyelid |
Narrow |
A |
Swollen tongue |
Narrow |
A |
Symmetrical drug-related intertriginous and flexural exanthema |
Narrow |
A |
Therapeutic product cross-reactivity |
Narrow |
A |
Tongue oedema |
Narrow |
A |
Toxic epidermal necrolysis |
Narrow |
A |
Toxic skin eruption |
Narrow |
A |
Tracheal oedema |
Narrow |
A |
Type I hypersensitivity |
Narrow |
A |
Type II hypersensitivity |
Narrow |
A |
Type III immune complex mediated reaction |
Narrow |
A |
Type IV hypersensitivity reaction |
Narrow |
A |
Urticaria |
Narrow |
A |
Urticaria cholinergic |
Narrow |
A |
Urticaria chronic |
Narrow |
A |
Urticaria contact |
Narrow |
A |
Urticaria papular |
Narrow |
A |
Urticaria physical |
Narrow |
A |
Urticaria pigmentosa |
Narrow |
A |
Urticaria vesiculosa |
Narrow |
A |
Urticarial dermatitis |
Narrow |
A |
Urticarial vasculitis |
Narrow |
A |
Vaccination site dermatitis |
Narrow |
A |
Vaccination site eczema |
Narrow |
A |
Vaccination site exfoliation |
Narrow |
A |
Vaccination site hypersensitivity |
Narrow |
A |
Vaccination site rash |
Narrow |
A |
Vaccination site recall reaction |
Narrow |
A |
Vaccination site urticaria |
Narrow |
A |
Vaccination site vasculitis |
Narrow |
A |
Vaccination site vesicles |
Narrow |
A |
Vaginal ulceration |
Narrow |
A |
Vasculitic rash |
Narrow |
A |
Vernal keratoconjunctivitis |
Narrow |
A |
Vessel puncture site rash |
Narrow |
A |
Vessel puncture site vesicles |
Narrow |
A |
Vulval eczema |
Narrow |
A |
Vulval ulceration |
Narrow |
A |
Vulvovaginal rash |
Narrow |
A |
Vulvovaginal ulceration |
Narrow |
A |
Vulvovaginitis allergic |
Broad |
A |
Acute respiratory failure |
Broad |
A |
Administration site photosensitivity reaction |
Broad |
A |
Airway remodelling |
Broad |
A |
Allergy to chemicals |
Broad |
A |
Allergy to fermented products |
Broad |
A |
Alpha tumour necrosis factor increased |
Broad |
A |
Alveolitis |
Broad |
A |
Antibody test abnormal |
Broad |
A |
Antibody test positive |
Broad |
A |
Anti-insulin antibody increased |
Broad |
A |
Anti-insulin antibody positive |
Broad |
A |
Anti-insulin receptor antibody increased |
Broad |
A |
Anti-insulin receptor antibody positive |
Broad |
A |
Application site photosensitivity reaction |
Broad |
A |
Asthma |
Broad |
A |
Asthma late onset |
Broad |
A |
Asthma-chronic obstructive pulmonary disease overlap syndrome |
Broad |
A |
Asthmatic crisis |
Broad |
A |
Auricular swelling |
Broad |
A |
Blister |
Broad |
A |
Blister rupture |
Broad |
A |
Blood immunoglobulin A abnormal |
Broad |
A |
Blood immunoglobulin A increased |
Broad |
A |
Blood immunoglobulin D increased |
Broad |
A |
Blood immunoglobulin G abnormal |
Broad |
A |
Blood immunoglobulin G increased |
Broad |
A |
Blood immunoglobulin M abnormal |
Broad |
A |
Blood immunoglobulin M increased |
Broad |
A |
Bronchial hyperreactivity |
Broad |
A |
Bronchial oedema |
Broad |
A |
Bullous impetigo |
Broad |
A |
Caffeine allergy |
Broad |
A |
Capillaritis |
Broad |
A |
Charcot-Leyden crystals |
Broad |
A |
Cheilitis |
Broad |
A |
Childhood asthma |
Broad |
A |
Choking |
Broad |
A |
Choking sensation |
Broad |
A |
Complement factor C1 decreased |
Broad |
A |
Complement factor C2 decreased |
Broad |
A |
Complement factor C3 decreased |
Broad |
A |
Complement factor C4 decreased |
Broad |
A |
Complement factor decreased |
Broad |
A |
Conjunctivitis |
Broad |
A |
Corneal exfoliation |
Broad |
A |
Cough variant asthma |
Broad |
A |
Cytokine release syndrome |
Broad |
A |
Cytokine storm |
Broad |
A |
Ear swelling |
Broad |
A |
Eosinophil count abnormal |
Broad |
A |
Eosinophil count increased |
Broad |
A |
Eosinophil percentage abnormal |
Broad |
A |
Eosinophil percentage increased |
Broad |
A |
Eosinophilia |
Broad |
A |
Eosinophilia myalgia syndrome |
Broad |
A |
Eosinophilic bronchitis |
Broad |
A |
Eosinophilic oesophagitis |
Broad |
A |
Eosinophilic pneumonia |
Broad |
A |
Eosinophilic pneumonia acute |
Broad |
A |
Eosinophilic pneumonia chronic |
Broad |
A |
Erythema |
Broad |
A |
Flushing |
Broad |
A |
Gastrointestinal oedema |
Broad |
A |
Generalised oedema |
Broad |
A |
Genital rash |
Broad |
A |
Genital swelling |
Broad |
A |
Haemolytic transfusion reaction |
Broad |
A |
Human leukocyte antigen marker study positive |
Broad |
A |
Human anti-hamster antibody increased |
Broad |
A |
Human anti-hamster antibody positive |
Broad |
A |
Immune complex level increased |
Broad |
A |
Immunoglobulins abnormal |
Broad |
A |
Immunoglobulins increased |
Broad |
A |
Immunology test abnormal |
Broad |
A |
Implant site photosensitivity |
Broad |
A |
Infusion site photosensitivity reaction |
Broad |
A |
Injection site panniculitis |
Broad |
A |
Injection site photosensitivity reaction |
Broad |
A |
Interstitial lung disease |
Broad |
A |
Laryngeal dyspnoea |
Broad |
A |
Laryngeal obstruction |
Broad |
A |
Leukotriene increased |
Broad |
A |
Lip exfoliation |
Broad |
A |
Localised oedema |
Broad |
A |
Macrophage inflammatory protein-1 alpha increased |
Broad |
A |
Mechanical urticaria |
Broad |
A |
Medical device site photosensitivity reaction |
Broad |
A |
Mesenteric panniculitis |
Broad |
A |
Monocyte chemotactic protein-2 increased |
Broad |
A |
Mouth ulceration |
Broad |
A |
Mucocutaneous ulceration |
Broad |
A |
Mucosa vesicle |
Broad |
A |
Mucosal erosion |
Broad |
A |
Mucosal exfoliation |
Broad |
A |
Mucosal necrosis |
Broad |
A |
Mucosal ulceration |
Broad |
A |
Nasal crease |
Broad |
A |
Necrotising panniculitis |
Broad |
A |
Neurodermatitis |
Broad |
A |
Neutralising antibodies positive |
Broad |
A |
Noninfective conjunctivitis |
Broad |
A |
Non-neutralising antibodies positive |
Broad |
A |
Occupational asthma |
Broad |
A |
Occupational dermatitis |
Broad |
A |
Oedema mucosal |
Broad |
A |
Oral mucosal exfoliation |
Broad |
A |
Orbital oedema |
Broad |
A |
Panniculitis |
Broad |
A |
Penile exfoliation |
Broad |
A |
Penile oedema |
Broad |
A |
Penile rash |
Broad |
A |
Penile swelling |
Broad |
A |
Perineal rash |
Broad |
A |
Perivascular dermatitis |
Broad |
A |
Photosensitivity reaction |
Broad |
A |
Pneumonitis |
Broad |
A |
Prurigo |
Broad |
A |
Pruritus |
Broad |
A |
Pulmonary eosinophilia |
Broad |
A |
Reactive airways dysfunction syndrome |
Broad |
A |
Respiratory arrest |
Broad |
A |
Respiratory distress |
Broad |
A |
Respiratory failure |
Broad |
A |
Respiratory tract oedema |
Broad |
A |
Reversible airways obstruction |
Broad |
A |
Rhinitis perennial |
Broad |
A |
Scrotal exfoliation |
Broad |
A |
Scrotal swelling |
Broad |
A |
Seasonal allergy |
Broad |
A |
Septal panniculitis |
Broad |
A |
Skin erosion |
Broad |
A |
Skin exfoliation |
Broad |
A |
Skin oedema |
Broad |
A |
Skin swelling |
Broad |
A |
Sneezing |
Broad |
A |
Status asthmaticus |
Broad |
A |
Stomatitis |
Broad |
A |
Streptokinase antibody increased |
Broad |
A |
Stridor |
Broad |
A |
Suffocation feeling |
Broad |
A |
Sunscreen sensitivity |
Broad |
A |
Throat tightness |
Broad |
A |
Tongue exfoliation |
Broad |
A |
Tracheal obstruction |
Broad |
A |
Tracheostomy |
Broad |
A |
Transplantation associated food allergy |
Broad |
A |
Upper airway obstruction |
Broad |
A |
Vaccination site photosensitivity reaction |
Broad |
A |
Vaginal oedema |
Broad |
A |
Visceral oedema |
Broad |
A |
Vulval oedema |
Broad |
A |
Vulvovaginal exfoliation |
Broad |
A |
Vulvovaginal swelling |
Broad |
A |
Wheezing |
Abbreviations: IV = intravenous; MedDRA = Medical Dictionary for Regulatory Activities; SMQ = standardized MedDRA query.
aThis search was modified to remove terms associated with the disease state being studied, including dermatitis atopic, eczema, blepharitis allergic, blood immunoglobulin E increased, conjunctivitis allergic, dermatitis, dermatitis acneiform, dermatitis exfoliative, dermatitis exfoliative generalized, dermatitis infected, eye allergy, Kaposi’s varicelliform eruption, multiple allergies, perioral dermatitis, rhinitis allergic, and vulval eczema.
|
|
|
|
|
|
Angioedema SMQ (20000024) |
Anaphylactic reaction SMQ (20000021)a |
||||
Search Type |
Category |
Preferred Term |
Search Type |
Category |
Preferred Term |
Narrow |
A |
Acquired C1 inhibitor deficiency |
Narrow |
A |
Anaphylactic reaction |
Narrow |
A |
Allergic oedema |
Narrow |
A |
Anaphylactic shock |
Narrow |
A |
Angioedema |
Narrow |
A |
Anaphylactic transfusion reaction |
Narrow |
A |
Circumoral oedema |
Narrow |
A |
Anaphylactoid reaction |
Narrow |
A |
Circumoral swelling |
Narrow |
A |
Anaphylactoid shock |
Narrow |
A |
Conjunctival oedema |
Narrow |
A |
Circulatory collapse |
Narrow |
A |
Corneal oedema |
Narrow |
A |
Dialysis membrane reaction |
Narrow |
A |
Epiglottic oedema |
Narrow |
A |
Kounis syndrome |
Narrow |
A |
Eye oedema |
Narrow |
A |
Procedural shock |
Narrow |
A |
Eye swelling |
Narrow |
A |
Shock |
Narrow |
A |
Eyelid oedema |
Narrow |
A |
Shock symptom |
Narrow |
A |
Face oedema |
Narrow |
A |
Type I hypersensitivity |
Narrow |
A |
Gingival oedema |
Broad |
B |
Acute respiratory failure |
Narrow |
A |
Gingival swelling |
Broad |
B |
Asthma |
Narrow |
A |
Gleich's syndrome |
Broad |
B |
Bronchial oedema |
Narrow |
A |
Hereditary angioedema |
Broad |
B |
Bronchospasm |
Narrow |
A |
Hereditary angioedema with C1 esterase inhibitor deficiency |
Broad |
B |
Cardio-respiratory distress |
Narrow |
A |
Idiopathic angioedema |
Broad |
B |
Chest discomfort |
Narrow |
A |
Idiopathic urticaria |
Broad |
B |
Choking |
Narrow |
A |
Intestinal angioedema |
Broad |
B |
Choking sensation |
Narrow |
A |
Laryngeal oedema |
Broad |
B |
Circumoral oedema |
Narrow |
A |
Laryngotracheal oedema |
Broad |
B |
Cough |
Narrow |
A |
Limbal swelling |
Broad |
B |
Cough variant asthma |
Narrow |
A |
Lip oedema |
Broad |
B |
Cyanosis |
Narrow |
A |
Lip swelling |
Broad |
B |
Dyspnoea |
Narrow |
A |
Mouth swelling |
Broad |
B |
Hyperventilation |
Narrow |
A |
Oculorespiratory syndrome |
Broad |
B |
Irregular breathing |
Narrow |
A |
Oedema mouth |
Broad |
B |
Laryngeal dyspnoea |
Narrow |
A |
Oropharyngeal oedema |
Broad |
B |
Laryngeal oedema |
Narrow |
A |
Oropharyngeal swelling |
Broad |
B |
Laryngospasm |
Narrow |
A |
Palatal oedema |
Broad |
B |
Laryngotracheal oedema |
Narrow |
A |
Palatal swelling |
Broad |
B |
Mouth swelling |
Narrow |
A |
Periorbital oedema |
Broad |
B |
Nasal obstruction |
Narrow |
A |
Periorbital swelling |
Broad |
B |
Oedema mouth |
Narrow |
A |
Pharyngeal oedema |
Broad |
B |
Oropharyngeal oedema |
Narrow |
A |
Pharyngeal swelling |
Broad |
B |
Oropharyngeal spasm |
Narrow |
A |
Scleral oedema |
Broad |
B |
Oropharyngeal swelling |
Narrow |
A |
Swelling face |
Broad |
B |
Pharyngeal oedema |
Narrow |
A |
Swelling of eyelid |
Broad |
B |
Pharyngeal swelling |
Narrow |
A |
Swollen tongue |
Broad |
B |
Respiratory arrest |
Narrow |
A |
Tongue oedema |
Broad |
B |
Respiratory distress |
Narrow |
A |
Tracheal oedema |
Broad |
B |
Respiratory failure |
Narrow |
A |
Urticaria |
Broad |
B |
Reversible airways obstruction |
Narrow |
A |
Urticaria cholinergic |
Broad |
B |
Sensation of foreign body |
Narrow |
A |
Urticaria chronic |
Broad |
B |
Sneezing |
Narrow |
A |
Urticaria papular |
Broad |
B |
Stridor |
Broad |
A |
Auricular swelling |
Broad |
B |
Swollen tongue |
Broad |
A |
Breast oedema |
Broad |
B |
Tachypnoea |
Broad |
A |
Breast swelling |
Broad |
B |
Throat tightness |
Broad |
A |
Choking |
Broad |
B |
Tongue oedema |
Broad |
A |
Choking sensation |
Broad |
B |
Tracheal obstruction |
Broad |
A |
Drug hypersensitivity |
Broad |
B |
Tracheal oedema |
Broad |
A |
Ear swelling |
Broad |
B |
Upper airway obstruction |
Broad |
A |
Endotracheal intubation |
Broad |
B |
Wheezing |
Broad |
A |
Gastrointestinal oedema |
Broad |
C |
Acquired C1 inhibitor deficiency |
Broad |
A |
Generalised oedema |
Broad |
C |
Allergic oedema |
Broad |
A |
Genital swelling |
Broad |
C |
Angioedema |
Broad |
A |
Hypersensitivity |
Broad |
C |
Circumoral swelling |
Broad |
A |
Laryngeal dyspnoea |
Broad |
C |
Erythema |
Broad |
A |
Laryngeal obstruction |
Broad |
C |
Eye oedema |
Broad |
A |
Localised oedema |
Broad |
C |
Eye pruritus |
Broad |
A |
Nasal obstruction |
Broad |
C |
Eye swelling |
Broad |
A |
Nasal oedema |
Broad |
C |
Eyelid oedema |
Broad |
A |
Nipple oedema |
Broad |
C |
Face oedema |
Broad |
A |
Nipple swelling |
Broad |
C |
Flushing |
Broad |
A |
Obstructive airways disorder |
Broad |
C |
Hereditary angioedema with C1 esterase inhibitor deficiency |
Broad |
A |
Oedema |
Broad |
C |
Injection site urticaria |
Broad |
A |
Oedema blister |
Broad |
C |
Lip oedema |
Broad |
A |
Oedema genital |
Broad |
C |
Lip swelling |
Broad |
A |
Oedema mucosal |
Broad |
C |
Nodular rash |
Broad |
A |
Oedema neonatal |
Broad |
C |
Ocular hyperaemia |
Broad |
A |
Oedema peripheral |
Broad |
C |
Oedema |
Broad |
A |
Orbital oedema |
Broad |
C |
Oedema blister |
Broad |
A |
Penile oedema |
Broad |
C |
Periorbital oedema |
Broad |
A |
Penile swelling |
Broad |
C |
Periorbital swelling |
Broad |
A |
Perinephric oedema |
Broad |
C |
Pruritus |
Broad |
A |
Peripheral oedema neonatal |
Broad |
C |
Pruritus allergic |
Broad |
A |
Peripheral swelling |
Broad |
C |
Rash |
Broad |
A |
Reversible airways obstruction |
Broad |
C |
Rash erythematous |
Broad |
A |
Scrotal oedema |
Broad |
C |
Rash pruritic |
Broad |
A |
Scrotal swelling |
Broad |
C |
Skin swelling |
Broad |
A |
Skin oedema |
Broad |
C |
Swelling |
Broad |
A |
Skin swelling |
Broad |
C |
Swelling face |
Broad |
A |
Soft tissue swelling |
Broad |
C |
Swelling of eyelid |
Broad |
A |
Stridor |
Broad |
C |
Urticaria |
Broad |
A |
Suffocation feeling |
Broad |
C |
Urticaria papular |
Broad |
A |
Swelling |
Broad |
D |
Blood pressure decreased |
Broad |
A |
Therapeutic product cross-reactivity |
Broad |
D |
Blood pressure diastolic decreased |
Broad |
A |
Throat tightness |
Broad |
D |
Blood pressure systolic decreased |
Broad |
A |
Tracheal obstruction |
Broad |
D |
Cardiac arrest |
Broad |
A |
Tracheostomy |
Broad |
D |
Cardio-respiratory arrest |
Broad |
A |
Type I hypersensitivity |
Broad |
D |
Cardiovascular insufficiency |
Broad |
A |
Upper airway obstruction |
Broad |
D |
Diastolic hypotension |
Broad |
A |
Vaginal oedema |
Broad |
D |
Hypotension |
Broad |
A |
Visceral oedema |
Broad |
D |
Hypotensive crisis |
Broad |
A |
Vulval oedema |
Broad |
D |
Post procedural hypotension |
Broad |
A |
Vulvovaginal swelling |
Broad |
C |
Acquired C1 inhibitor deficiency |
Broad |
A |
Wheezing |
NA |
NA |
NA |
Abbreviations: MedDRA = Medical Dictionary for Regulatory Activities; NA = not applicable; SMQ = standardized MedDRA query.
aAnaphylactic algorithm was defined as 1 or more events in the following categories a narrow term from the anaphylactic SMQ (Category A of the SMQ), or multiple terms from the SMQ, comprising terms from at least 2 of the following categories from the SMQ: Category B - (Upper Airway/Respiratory signs and symptoms) Category C - (Angioedema/Urticaria/Pruritus/Flush signs and symptoms), and Category D - (Cardiovascular/Hypotension signs and symptoms).
References
1Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Tham EH, Leung DY. Mechanisms by which atopic dermatitis predisposes to food allergy and the atopic march. Allergy Asthma Immunol Res. 2019;11(1):4-15. https://doi.org/10.4168/aair.2019.11.1.4
4Bieber 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
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
Glossary
AD = atopic dermatitis
BARI = baricitinib
Ig = immunoglobulin
MedDRA = Medical Dictionary for Regulatory Activities
SMQ = standardized MedDRA query
TEAE = treatment-emergent adverse event
▼ 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: July 13, 2020
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