Quantitative assessment of ESAT-6 and CFP-10 specific T-lymphocyte responses

• Research unit: SFOPH
• Project number: 02.001712

Key words (German)

Key words (English)

latent Mtb-infection
chronic inflammatory autoimmune condition
TNF a-inhibitor
standard immunosuppression

Short description (German)

Schaffen einer rationalen Grundlage zur Risikoabschätzung einer TNF -Inhibitor-Therapie bei autoimmunen Patientinnen und Patienten.

Short description (English)

The purpose of the project is to overcome the diagnostic dilemma of latent Mtb-infection in patients with chronic inflammatory autoimmune conditions, who are trated with TNF a-inhibitors or standard immunosuppression.

Project aims (German)

Validieren eines neuartigen Tuberkulose-Tests bei Patiententinnen und Patienten, welche mit immun-supprimierenden Antirheumatika behandelt werden.

Abstract (English)

Zwischenbericht 12/2003

Quantative assessment of ESAT-6 and CFP-10 specific T-lymphocyte responses for diagnosis of latent infection with Mycobacterium tuberculosis before and during TNFa-inhibitor treatment.

Since last year we have completed the pilot trial (phase I), which aimed at testing the QuantiFERON ELISA system in patients treated with various immunosuppressive drugs.

Results: Stimulation of memory T-lymphocytes in vitro using mitogen yielded detectable IFN-gamma production in all healthy controls and in all but one patient, when heparin was used as an anticoagulant. Remarkably, IFN-gamma production of healthy controls and patients was in the same range. Even patients treated with a combination of various drugs e.g. infliximab, prednisone and methotrexate could respond with high IFN-gamme secretion to mitogen stimulation. There was also no obvious difference between responses of young and elderly patients.

When EDTA was used as an anticoagulant, the QuantiFERON test yielded always negative results. EDTA-blood was taken from 6 patients treated with methotrexate (at the outpatient clinic), and from one patient treated with TNF-alpha inhibitor (at the day clinic).

The results of the pilot trial therefore strongly suggested, that the QuantiFERON ELISA system can be used in autoimmune immunosuppressed patients. In agreement with Cellestis we have therefore now started with Phase II of the study, in which we will test the latest generation QuantiFERON test - Quantiferon-TB Gold "in tube test". This test has two advantages over the second generation QuantiFERON test: Firstly, it has a higher sensitivity, and secondly it is easier to use. We now plan to approach other Rheumatology Centers for the recruitment of patients.

Preliminary results of the Phase II trial in 50 patients suggest, that the "in tube" QuantiFERON-TB Gold works well in immunesuppressed patients. The recruitment to the phase II trial has started well. We are therefore optimistic, that the study could be finished within the next year, i.e. one year short of the original layout.

Transfer and application (German)

Für allfällige Fragen wenden Sie sich bitte an das Sekretariat Eidg. Kommission zur Bekämpfung von Rheumaerkrankungen, 3003 Bern

Publications / Results (German)

keine