Olumiant ® (baricitinib) tabletter

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Olumiant® (baricitinib): Överkänslighetsreaktioner hos patienter med atopisk dermatit

Utslag, urtikaria och svullnad i ansiktet är biverkningar med baricitinib. Baserat på data från BREEZE-AD fanns det inga skillnader i överkänslighetsreaktioner mellan baricitinib och placebo.

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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

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 significant difference 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 significantly different between the BARI 4 mg and BARI 2 mg groups. The angioedema broad search term was significantly higher in the BARI 4 mg group compared to the BARI 2 mg group in the extended period (p<.05; see Treatment-Emergent Adverse Events Including Anaphylactic, Angioedema, and Hypersensitivity in Atopic Dermatitis Trials).2

Treatment-Emergent Adverse Events Including Anaphylactic, Angioedema, and Hypersensitivity in Atopic Dermatitis Trials2

Hyper-sensitivity Broad

Hyper-sensitivity Narrow

Hyper-sensitivity (Narrow) AD

Angioedema Broad

Angioedema Narrow

Anaphylactic Reaction Broad

Anaphylactic Reaction Narrow

Anaphylactic Reaction Algorithm

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

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

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

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 vs 4 mga, n (adj %)b

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

Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials2,4

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.

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

  • BARI 1 mg (n=538, PYE=245.9)
  • BARI 2 mg (n=1580, PYE=1129.5), and
  • BARI 4 mg (n=914, PYE=872.8).

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.

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

Standardized MedDRA Hypersensitivity Query (SMQ) Preferred Terms2

 

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.

Standardized MedDRA Angioedema Query (SMQ) and Anaphylactic Query (SMQ) Preferred Terms2

 

 

 

 

 

 

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. Published online September 14, 2020. https://doi.org/10.1111/jdv.16948

Glossary

AD = atopic dermatitis

BARI = baricitinib

Ig = immunoglobulin

MedDRA = Medical Dictionary for Regulatory Activities

SMQ = standardized MedDRA query

TEAE = treatment-emergent adverse event

Datum fӧr senaste ӧversyn 2020 M07 13


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