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The Drug-Induced Respiratory Disease Website and App

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.b

Pneumonitis (interstitial lung disease/ILD)

See: http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf

Publications

Oya K, Nakamura Y, Fujisawa Y, Endo R, Tanaka R, Ishitsuka Y, Maruyama H, Watanabe R, Okiyama N, Fujimoto M

Third-line pembrolizumab-induced immune-related interstitial pneumonitis after ipilimumab and nivolumab failure.

European journal of dermatology : EJD. 2018;28(1):129-130

Ali AK, Watson DE

Pharmacovigilance Assessment of Immune-Mediated Reactions Reported for Checkpoint Inhibitor Cancer Immunotherapies.

Pharmacotherapy. 2017;37(11):1383-1390

Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csőszi T, Fülöp A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR, KEYNOTE-024 Investigators

Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer.

The New England journal of medicine. 2016;375(19):1823-1833

Fragkou P, Souli M, Theochari M, Kontopoulou C, Loukides S, Koumarianou A

A Case of Organizing Pneumonia (OP) Associated with Pembrolizumab.

Drug target insights. 2016;10:9-12

Martin-Liberal J, Kordbacheh T, Larkin J

Safety of pembrolizumab for the treatment of melanoma.

Expert opinion on drug safety. 2015;14(6):957-64

Robert C, Ribas A, Wolchok JD, Hodi FS, Hamid O, Kefford R, Weber JS, Joshua AM, Hwu WJ, Gangadhar TC, Patnaik A, Dronca R, Zarour H, Joseph RW, Boasberg P, Chmielowski B, Mateus C, Postow MA, Gergich K, Elassaiss-Schaap J, Li XN, Iannone R, Ebbinghaus SW

Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial.

Lancet (London, England). 2014;384(9948):1109-17

Hamid O, Robert C, Daud A, Hodi FS, Hwu WJ, Kefford R, Wolchok JD, Hersey P, Joseph RW, Weber JS, Dronca R, Gangadhar TC, Patnaik A, Zarour H, Joshua AM, Gergich K, Elassaiss-Schaap J, Algazi A, Mateus C, Boasberg P, Tumeh PC, Chmielowski B, Ebbinghaus SW

Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma.

The New England journal of medicine. 2013;369(2):134-44