Abstract
IntroductionInfliximab (IFX) was the first anti-tumor necrosis factor (TNFα) antibody to be used in the treatment of severe chronic inflammatory diseases, such as Crohn’s disease and rheumatoid arthritis. A number of serious adverse drug reactions are known to be associated with IFX use; they include infections, malignancies, and injection site reactions. Although a few case reports have described potential psychiatric adverse events (including suicide attempts and manic episodes), the latter are barely mentioned in IFX’s summary of product characteristics. The objective of the present retrospective study was to detect potential psychiatric adverse events associated with IFX treatment by analyzing a national discharge abstract database.Materials and MethodsWe performed an historical cohort study by analyzing data from the French national hospital discharge abstract database (PMSI) between 2008 and 2014. All patients admitted with one of the five diseases treated with IFX were included.ResultsOf the 325,319 patients included in the study, 7,600 had been treated with IFX. The proportion of hospital admissions for one or more psychiatric events was higher among IFX-exposed patients (750 out of 7,600; 9.87%) than among non-exposed patients (17,456 out of 317,719; 5.49%). After taking account of potential confounders in the cohort as a whole, a semi-parametric Cox regression analysis gave an overall hazard ratio (HR) [95% confidence interval] (CI) of 4.5 [3.95; 5.13] for a hospital admission with a psychiatric adverse event during treatment with IFX. The HR (95%CI) for a depressive disorder was 4.97 (7.35; 6.68). Even higher risks were observed for certain pairs of adverse events and underlying pathologies: psychotic disorders in patients treated for ulcerative colitis (HR = 5.43 [2.01; 14.6]), manic episodes in patients treated for severe psoriasis (HR = 12.6 [4.65; 34.2]), and suicide attempts in patients treated for rheumatoid arthritis (HR = 4.45 [1.11; 17.9]).DiscussionThe present retrospective, observational study confirmed that IFX treatment is associated with an elevated risk of psychiatric adverse events. Depending on the disease treated, physicians should be aware of these potential adverse events.
Highlights
Infliximab (IFX) was the first anti-tumor necrosis factor (TNFa) antibody to be used in the treatment of severe chronic inflammatory diseases, such as Crohn’s disease and rheumatoid arthritis
Each discharge report contains the following information: the primary and associated diagnoses coded according to the International Classification of Diseases, 10th revision (ICD-10) (WHO, 2020), the therapeutic and diagnostic procedures coded according to the French Classification commune des Actes Mé dicaux (CCAM) terminology [L'Assurance Maladie (Ameli), 2020], and the dispensation of certain expensive drugs coded according to the French Unité Commune de Dispensation (UCD) classification (Unites communes de dispensation prises en charge en sus Publication Agence Technique de l'information sur l'Hospitalisation (ATIH))
After taking into account all the psychiatric outcomes for the entire cohort, we found that the following variables were significantly associated with a higher risk of experiencing a psychiatric event: sex, disease treated, IFX exposure, the Rheumatoid arthritis n=118,528
Summary
Infliximab (IFX) was the first anti-tumor necrosis factor (TNFa) antibody to be used in the treatment of severe chronic inflammatory diseases, such as Crohn’s disease and rheumatoid arthritis. A few case reports have described suicide attempts (Roblin et al, 2006; Eshuis et al, 2010) and manic episodes (Elisa and Beny, 2010; Austin and Tan, 2012) associated with the use of IFX or other TNFa inhibitors (Kaufman, 2005; Ghossoub et al, 2016; Jafri and Sammut, 2018) These psychiatric adverse events have been reported in other types of study (Quartier et al, 2003; Mendes et al, 2013; Mendes et al, 2014; Lafay-Chebassier et al, 2015; Pastore et al, 2018; Smith et al, 2018), they are barely mentioned in each TNFa-inhibitor’s summary of product characteristics (SPC) [Agence Nationale de sécurité du médicament et des produits de santé (ANSM), 2020]. The characterization of these psychiatric adverse events is essential for adequately assessing the riskbenefit ratio and improving the management of these events when they occur
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