Philippe Camus, M.D.

Dijon, France

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Etanercept

For those ILD cases exposed to methotrexate concomitantly, drug causality assessment can be extremely difficult

Frequency - Incidence

Incidence of respiratory adverse event(s) due to the specific drug as assessed by number of reported/published cases in the literature. Red digits in stars indicate: 0 = Very rare, questionable signal · 1 = < 10 cases · 2 = 10-50 cases · 3 = 50–100 cases · 4 = 100-200 cases · 5 = >200 cases

Evidence level/grade

Evidence level for respiratory adverse event(s) due to the specific drug as estimated using Hill’s (1965), Naranjo’s (1981), and Bégaud’s (1985) criteria applied to published cases. Blue digits in stars indicate: 0 = Questionable · 1 = Low · 2 = Moderate · 3 = Robust · 4 = Definite · 5 = Unquestionable, pathognomonic

I - Interstitial/parenchymal lung disease

I.a

Pneumonitis (ILD)
I.e

Organizing pneumonia pattern (an area or areas of consolidation on imaging)
I.g

Pulmonary fibrosis
I.n

ILD with a granulomatous component
I.r

Pulmonary nodulosis
I.x

Rapidly progressive ILD/pulmonary fibrosis (Hamman-Rich syndrome)
I.z

Progression, acceleration or exacerbation of preexisting ILD/fibrosis

III - Pulmonary/alveolar./airway hemorrhage/bleeding

III.a

Alveolar hemorrhage (AH), diffuse AH (DAH)

IV - Airway involvement

IV.a

Bronchospasm - Wheezing - Asthma

V - Central-large-upper airway (incl. pharyngeal-nasal) involvement

V.a

Angioedema (may cause UAO, asphyxia and death)

VI - Pleural and/or pericardial involvement

VI.d

Pleural/pericardial effusion, ANA positive (DI lupus)
VI.f

Pneumothorax
VI.m

Pleuropericarditis - Pleuropericardial effusion (ANA unknown or negative)

VII - Pulmonary vasculopathy

VII.a

Pulmonary embolism - Venous thrombosis/thromboembolism
VII.d

Pulmonary vasculitis or capillaritis

VIII - Mediastinal involvement

VIII.a

Lymphadenopathy (intrathoracic)

IX - Neuromuscular / CNS involvement - Disordered breathing (during sleep)

IX.q

Obstructive sleep apnea

X - Systemic/Distant conditions, syndromes and reactions

X.b

Antiphospholipid antibodies w/wo the APL syndrome
X.d

Lupus - Lupus syndrome (see also Vd)
X.e

Autoimmunity-Autoimmune conditions (+ANA, +anti-ds-DNA, +ANCAs, other auto-Abs)
X.f

Anaphylaxis-Anaphylactoid reaction (can be fatal)
X.l

Myopathy-Myositis-Polymyositis (see also under Xba)
X.m

Sarcoid-like granulomatosis (endo-/extrathoracic)
X.o

Vascultis (pulmonary, extrathoracic or systemic)-ANCA status unknown or negative)
X.u

Vasculitis, pulmonary (w/wo AH), extrapulmonary, systemic: ANCA-positive
X.ae

Anti-GBM antibody disease (Goodpasture-like or flare of preexisting GS)
X.at

Relapse/flare/onset of Crohn's disease

XI - Miscellaneous

XI.aa

Granulomas on tattoo edges

XII - Cardiovascular involvement / toxicity

XII.d

Myocarditis (can be fulminant)

XIX - Pathology

XIX.a

Path: NSIP-cellular pattern (see also Ia, Ib)
XIX.d

Path: Organizing pneumonia (OP/BOOP) pattern (see also Id)
XIX.f

Path: ILD with a granulomatous component (see also Im)
XIX.bx

Path: Granulomatous lymphadenopathy

XX - Infections & related conditions

XX.a

Respiratory tract infection incl. pneumonia
XX.b

Opportunistic pulmonary/systemic infections
XX.f

Tuberculosis, miliary
XX.g

Tuberculosis (pulmonary, pulmonary, extrapulmonary or disseminated). Reactivation or de novo
XX.h

Nontuberculous pulmonary mycobacterial infection/superinfection
XX.aa

Protozoan infection (incl. leishmaniasis)