SNFGE SNFGE
 
Thématique :
- MICI
Originalité :
Très original
Solidité :
Très solide
Doit faire évoluer notre pratique :
Immédiatement
 
 
Nom du veilleur :
Professeur Philippe SEKSIK
Coup de coeur :
 
 
Journal of the American Medical Association (JAMA)
  2017/11  
 
  2017 Nov ;318(17):1679-1686.  
  doi: 10.1001/jama.2017.16071.  
 
  Association Between Use of Thiopurines or Tumor Necrosis Factor Antagonists Alone or in Combination and Risk of Lymphoma in Patients With Inflammatory Bowel Disease  
 
  Lemaitre M, Kirchgesner J, Rudnichi A, Carrat F, Zureik M, Carbonnel F, Dray-Spira R  
  https://www.ncbi.nlm.nih.gov/pubmed/29114832  
 
 

Abstract

IMPORTANCE:

An increased risk of lymphoma has been reported among patients receiving thiopurines for inflammatory bowel disease (IBD). The risk of lymphoma associated with anti-tumor necrosis factor (TNF) agents either alone or in combination with thiopurines is uncertain.

OBJECTIVE:

To assess the risk of lymphoma associated with thiopurines and anti-TNF agents, used alone or in combination, for the management of IBD.

DESIGN, SETTING, AND PARTICIPANTS:

Nationwide cohort study based on French National Health Insurance databases. Patients aged 18 years or older identified with IBD were included from January 1, 2009, through December 31, 2013, and followed up until December 31, 2015.

EXPOSURES:

At each time of the follow-up, patients were categorized as being exposed to thiopurine monotherapy, anti-TNF monotherapy, or combination therapy, or being unexposed.

MAIN OUTCOMES AND MEASURES:

The primary outcome was incident lymphoma.

RESULTS:

Among the 189 289 patients included (54% women; median age, 43 years [interquartile range, 32-56 years]) and followed up for a median of 6.7 years, 123 069 were never exposed during follow-up, 50 405 were exposed to thiopurine monotherapy, 30 294 to anti-TNF monotherapy, and 14 229 to combination therapy. Overall, 336 lymphoma cases occurred: 220 in unexposed patients (incidence rate [IR] per 1000 person-years, 0.26; 95% CI, 0.23-0.29), 70 in patients exposed to thiopurine monotherapy (IR, 0.54; 95% CI, 0.41-0.67), 32 in patients exposed to anti-TNF monotherapy (IR, 0.41; 95% CI, 0.27-0.55), and 14 in patients exposed to combination therapy (IR, 0.95; 95% CI, 0.45-1.45). In a multivariable Cox model, compared with unexposed patients, the risk of lymphoma was higher among those exposed to thiopurine monotherapy (adjusted hazard ratio [aHR], 2.60; 95% CI, 1.96-3.44; P < .001), anti-TNF monotherapy (aHR, 2.41; 95% CI, 1.60-3.64; P < .001), or combination therapy (aHR, 6.11; 95% CI, 3.46-10.8; P < .001). The risk was higher in patients exposed to combination therapy vs those exposed to thiopurine monotherapy (aHR, 2.35; 95% CI, 1.31-4.22; P < .001) or anti-TNF monotherapy (aHR, 2.53; 95% CI, 1.35-4.77; P < .001).

CONCLUSIONS AND RELEVANCE:

Among adults with IBD, the use of thiopurine monotherapy or anti-TNF monotherapy was associated with a small but statistically significant increased risk of lymphoma compared with exposure to neither medication, and this risk was higher with combination therapy than with each of these treatments used alone. These findings may inform decisions regarding the benefits and risks of treatment.

 
Question posée
 
Les thiopurines sont associées à un risque accru de lymphome. Ce risque existe-t-il aussi avec les anti-TNFα ?
 
Question posée
 
Oui.
 
Commentaires

Très belle étude française menée par l’ANSM en collaboration avec l’AP-HP, portant sur le risque de lymphome associé aux anti-TNFα publiée dans le JAMA qui montre que les anti-TNFα, utilisés seuls ou en combinaison avec les thiopurines, sont associés à un risque accru de lymphome. Ces données doivent être prises en compte dans nos stratégies thérapeutiques. Cette étude met une nouvelle fois en lumière l’intérêt des données du SNIIRAM pour la surveillance de la sécurité des produits de santé.

 
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