Table 1 Provisional list of pathogens/presentations and MedDRA HLT term approved by consensus by the SAC
Opportunistic infections definitions/pathogens | MedDRA HLT |
|---|---|
Definition of definite opportunistic infection in children with JIA | |
 1. Generally does not occur in the absence of immunosuppression and whose presence suggests a severe alteration in host immunity OR |  |
 2. Can occur in patients without recognized forms of immunosuppression, but whose presence indicates a potential or likely alteration in host immunity |  |
List of definite pathogens and/or presentations of specific pathogens | Â |
  Aspergillosis (invasive disease only) | Aspergillus infections |
  Bartonellosis (disseminated disease only) | Bartonella infections |
  BK virus disease including PVAN | BK virus infection |
  Blastomycosis | Blastomyces infections |
  Candidiasis (invasive disease or pharyngeal) | Candida infections |
  Coccidioidomycosis | Coccidioides infections/Paracoccidioides infections |
  Cryptococcosis | Cryptococcal infections |
Cytomegalovirus disease with onset at age >  1 month: pneumonia (CMV in BAL), colitis, CNS disease (CMV in CSF), liver (biopsy), retina (confirmed by ophthalmologist), nephritis, myocarditis, pancreatitis | Cytomegaloviral infections |
  HBV reactivation | Hepatitis viral infections |
  Herpes simplex (invasive disease only) | Herpes viral infections |
  Herpes zoster (any form) | Herpes viral infections |
  Histoplasmosis | Histoplasma infections |
  Legionellosis | Legionella infections |
Listeria monocytogenes (invasive disease only) | Listeria infections |
  Nocardiosis | Nocardia infections |
  Non-tuberculous mycobacterium disease | Atypical mycobacterial infections |
  Other invasive fungi: Mucormycosis (zygomycosis) (Rhizopus, Mucor and Lichtheimia), Scedosporium /Pseudallescheria boydii, Fusarium | Fungal infections NEC |
Pneumocystis jirovecii | Pneumocystis infections |
  Post-transplant lymphoproliferative disorder (EBV) | Epstein-Barr viral infections |
  Progressive multifocal leucoencephalopathy | Polyomavirus infections |
  Salmonellosis (invasive disease only) | Salmonella infections |
  Strongyloides (hyperinfection syndrome and disseminated forms only) | Nematode infections |
Toxoplasmosis of central nervous system, onset at age ≥ 1 month; Disseminated toxoplasmosis, visceral toxoplasmosis | Toxoplasma infections |
  Tuberculosis | Tuberculous infections |
Definition of probable opportunistic infection | |
 Published data is currently lacking, but expert opinion believes that risk is likely elevated in the setting of DMARD therapy. In case of the unusually severe course of infection due to a common pathogen with usually mild disease the pathogen might tentatively be considered opportunistic in a patient with impaired immune function. Below there is a non-exhaustive list of possible pathogens |  |
List of probable pathogens and/or presentations of specific pathogens | |
  Campylobacteriosis (invasive disease only) | Campylobacter infections |
Cryptosporidium species (chronic disease only) | Cryptosporidia infections |
Enterovirus chronic encephalitis | Enteroviral infections NEC |
Giardia, Isospora: chronic (> 1 month) diarrhea | Giardia infections/Isospora infections |
  HCV progression | Hepatitis viral infections |
Human Herpes Virus (HHV6–7): pneumonia, encephalitis | Herpes viral infections |
Human Herpes Virus (HHV8): kaposi sarcoma | Herpes viral infections |
Human metapneumovirus (hMPV): pneumonia, ARDS | Viral infections NEC |
Human Papilloma Virus (HPV): extensive warts | Papilloma viral infections |
Human respiratory syncytial virus (RSV): pneumonia with onset > 6 months of age | Respiratory syncytial viral infections |
  Legionellosis | Legionella infections |
  Leishmaniasis (Visceral only) | Leishmania infections |
  Microsporidiosis | Protozoal infections NEC |
Molluscum contagiosum: chronic, disseminated | Molluscum contagiosum |
  Paracoccidioides infections | Paracoccidioides infections |
Parvovirus B19: pure red cell aplasia | Parvoviral infections |
Penicillium marneffei | Fungal infections NEC |
Rota-Arena-Norovirus: chronic (> 1 month) diarrhea | Rotaviral infections/Arenaviral infections/Caliciviral infections |
  Shigellosis (invasive disease only) | Shigella infections |
Sporothrix schenckii | Sporothrix infections |
  Trypanosoma cruzi infection (Chagas’ disease) (disseminated disease only) | Trypanosomal infections |
Varicella: encephalitis (excluding cerebellitis), hepatitis, pneumonia | Herpes viral infections |
  Vibriosis (invasive disease due to Vibrio vulnificus) | Vibrio infections |
West Nile, Usutu: chronic encephalitis | Flaviviral infections |