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The Drug-Induced Cardiotoxicity Website and App

Frequency - Incidence

Incidence of cardiac 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 cardiac 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

XXXIV.e

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

Publications

Charpy F, Altwegg R, Debourdeau A

Disseminated Tuberculosis in a Patient Treated with Tofacitinib for Ulcerative Colitis.

Journal of Crohn's & colitis. 2022;16(4):685-686

Winthrop KL, Park SH, Gul A, Cardiel MH, Gomez-Reino JJ, Tanaka Y, Kwok K, Lukic T, Mortensen E, Ponce de Leon D, Riese R, Valdez H

Tuberculosis and other opportunistic infections in tofacitinib-treated patients with rheumatoid arthritis.

Annals of the rheumatic diseases. 2016;75(6):1133-8

van Vollenhoven RF, Fleischmann R, Cohen S, Lee EB, García Meijide JA, Wagner S, Forejtova S, Zwillich SH, Gruben D, Koncz T, Wallenstein GV, Krishnaswami S, Bradley JD, Wilkinson B, ORAL Standard Investigators

Tofacitinib or adalimumab versus placebo in rheumatoid arthritis.

The New England journal of medicine. 2012;367(6):508-19

Fleischmann R, Kremer J, Cush J, Schulze-Koops H, Connell CA, Bradley JD, Gruben D, Wallenstein GV, Zwillich SH, Kanik KS, ORAL Solo Investigators

Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis.

The New England journal of medicine. 2012;367(6):495-507

Maiga M, Lun S, Guo H, Winglee K, Ammerman NC, Bishai WR

Risk of tuberculosis reactivation with tofacitinib (CP-690550).

The Journal of infectious diseases. 2012;205(11):1705-8