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Tumor necrosis factor inhibitor-induced pleuropericarditis: A retrospective evaluation using data from VigiBase
- Source :
- International immunopharmacology. 89
- Publication Year :
- 2020
-
Abstract
- Objective The aim of this study was to assess the causality of anti-TNFα agents-associated pleuropericarditis in VigiBase with a focus on its diverse types. Methods All variables contained in the pleuropericarditis reports were reviewed. Well-documented reports, vigiGrade completeness score ≥ 0.80 or with an informative narrative, were analyzed and with a focus on the clinical features of the cases. Bradford-Hill criteria were used in the case series assessment of causality. Results From 1968 up to 18 December 2019, there were 94 unique cases from 18 countries reporting pleuropericarditis with anti-TNFα agents as a suspected or interacting medicine. Among the 94 reports, 42 were identified as well-documented and further assessed for clinical features. Of the 42 cases, 39 were serious, including three fatal and seven life-threatening. In 35 cases, an anti-TNFα agent was the only suspected drug. Positive de- and re-challenge were reported in 95% and 17% of the 42 cases, respectively. The times to onset (TTO) varied greatly among individual cases, ranging from one month to 75 months (mean = 24 months). The most commonly involved anti-TNFα agents were adalimumab, infliximab and etanercept; and the mostly reported pleuropericarditis types were classified as autoimmune-related with (n = 17) or without (n = 15) co-reported drug-induced lupus (DIL), or infection-related (n = 8). While adalimumab was the most reported in the infection-related cases (7/8), infliximab was the most frequent in the autoimmune-related cases, in particular co-reported with DIL (9/17). There were four cases where the reaction occurred one to two months after the anti-TNFα agents (infliximab and adalimumab) were stopped. Based on the review of the case series using Bradford-Hill criteria the anti-TNFα agents associated pleuropericarditis are considered as a class effect. Conclusions To clinically recognize and manage these potentially life-threatening serious cardiopulmonary complications, health care professionals should be aware of this possible risk. Meanwhile, attention should be paid to the clinical features of pleuropericarditis cases, since they may cause diagnostic and therapeutic difficulties. Considering the long elimination time, clinicians need to be reminded to remain vigilant for the adverse reactions even after discontinuing anti-TNFα therapy.
- Subjects :
- 0301 basic medicine
Adult
Male
Pediatrics
medicine.medical_specialty
Adolescent
Immunology
Pleuropericarditis
Class effect
World Health Organization
Etanercept
03 medical and health sciences
Young Adult
0302 clinical medicine
medicine
Adalimumab
Immunology and Allergy
Adverse Drug Reaction Reporting Systems
Humans
Pericarditis
Aged
Retrospective Studies
Pharmacology
Aged, 80 and over
business.industry
Middle Aged
medicine.disease
Infliximab
030104 developmental biology
030220 oncology & carcinogenesis
Female
Tumor Necrosis Factor Inhibitors
business
Adverse drug reaction
medicine.drug
Subjects
Details
- ISSN :
- 18781705
- Volume :
- 89
- Database :
- OpenAIRE
- Journal :
- International immunopharmacology
- Accession number :
- edsair.doi.dedup.....328f4b3e6305883474dcc62f0e639217