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Screening of Latent Tuberculosis before treatment with TNF  blockers. Ori Elkayam M.D Tel Aviv Medical Center. Guidelines of the Israeli association of Rheumatology for the prevention of tuberculosis in patients treated with TNF-alpha blocker. Screening includes :

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Screening of latent tuberculosis before treatment with tnf blockers l.jpg

Screening of Latent Tuberculosis before treatment with TNF  blockers

Ori Elkayam M.D

Tel Aviv Medical Center


Slide2 l.jpg
Guidelines of the Israeli association of Rheumatology for the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Screening includes :

  • Tuberculin Skin Test (TST)

  • Chest X-ray

  • Questionnaire about possible exposure to TB

Elkayam O, Balbir-Gurman A, Lidgi M, Rahav G, Weiler-Ravel D


Risk factor questionnaire l.jpg
Risk Factor Questionnaire the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Did you immigrate from a country with high TB prevalence ?

  • Have you ever been in close contact with TB?

  • Have you been offered to be treated for TB ?


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Criteria for Tuberculin positivity the prevention of tuberculosis in patients treated with TNF-alpha blocker

* >15 mg Prednisone for at least 1 monthor TNF blockers


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Immunocompromised patients the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Treated with Prednisone

  • Treatments with MTX, Imuran

  • Further studies are needed

  • Prone to infections and malignancies


Debate l.jpg
Debate the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Should TST≥5 mm considered positive for all candidates to anti-TNF therapy ?

  • Is the diagnosis of latent TB similar for RA patients, PsA and AS?


Topics of discussion l.jpg
Topics of discussion the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Milestones of TB in anti-TNFα therapy Era

  • Guidelines for screening of latent TB before anti-TNF therapy

  • PPD in different rheumatic diseases

  • Prevalence of TB in Israel

  • HIV, TNF  blockers and TB

  • Adverse consequences of over diagnosis of LTB


Tuberculosis and tnf alpha blockers l.jpg
Tuberculosis and TNF alpha blockers the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • 70 patients reported to the FDA, including from states with low incidence of TB

  • Extrapulmonary manifestations in 40 pts

  • Fatalities

  • Patients should be evaluated for latent tuberculosis infection with a tuberculin skin test.

Keane et al, NEJM 2001;345:1098-104

RA1301a


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BIOBADASER the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Treatment of RA with TNF inhibitors may predispose to significant increase in tuberculosis risk: a multicenter active-surveillance report. A&R2003

  • Effectiveness of recommendations to prevent reactivation of LTB in patients treated with TNF antagonists.A&R 2005

  • Risk of tuberculosis in patients treated with tumor necrosis factor antagonists due to incomplete prevention of reactivation of latent infection. A&R2007


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BIOBADASER (1) the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Registry based on the voluntary participation of hospital and community-based rheumatology Units

  • 1540 pts : 1265 RA, 89 PsA, 76 AS

  • 17 pts with TB; 65% extra-pulm, 2 deaths

  • 6 pts: PPD and X rays missing

  • 5 pts:prior X evidence of TB

  • Incidence :1100/100000

A&R2003


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Spanish Society of Rheumatology the prevention of tuberculosis in patients treated with TNF-alpha blocker

Recommendations

TST

<5 mm

≥5 mm

Re-test

<5 mm

≥5 mm

Chest X ray

Contact

Normal

INH 9 months

Suggestive


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BIOBADASER (2) the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • March 2002: data collected using standard forms

  • Since then, data reported by an electronic system.

  • Audit : 18% of the data reported are incomplete

  • 34 TB ( 28 RA)ׁ

  • 32 before March 2002

  • 2 pts after 03/02 fulfilled criteria for LTB

  • Decrease of >70 % in rate of TB

A&R 2005


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BIOBADASER (3) the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Following March 2002, 5,198 registered .

  • 15 ATB cases were noted (rate 172 per 100,000 patient-years).

  • Recommendations fully followed in 2,655 treatments.

  • Probability of ATB was 7 times higher when recommendations were not followed .

  • Two-step tuberculosis skin test for LTBI was the major failure in complying with recommendations.

R2007&A


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the prevention of tuberculosis in patients treated with TNF-alpha blockerThe recommendation that TST≥5 mm should be an indication for INH was established because of the high TB risk detected in this population. In populations with lower background rates , other strategies may be proposed “

Gomez-Reino et al


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Topics of discussion the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Milestones of TB in anti-TNFα therapy Era

  • Guidelines for screening of latent TB before anti-TNF therapy

  • PPD in different rheumatic diseases

  • Prevalence of TB in Israel

  • HIV, TNF  blockers and TB

  • Adverse consequences of over diagnosis of LTB


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Guidelines (USA) the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Gardam (2003) :

    TST :0-4 : Major immune suppression +risk factors

    5-9 : Epidemiologic risk factors ( Foreign born

    occupational, abnormal chest X ray, known contact)

    10 : all others

  • Winthrop (2005):

    Refer To CDC definitions of LTB

  • Furst D :

    CDC recommendations


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Guidelines (Europe) the prevention of tuberculosis in patients treated with TNF-alpha blocker

British Thoracic Society :

-Immunosuppressive therapy

No value of TST in pts

Risk stratification /Chest X ray

- No immunosuppressant therapy :

TST ≥15 for BCG +

TST ≥5 for BCG +

Risk stratification


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Guidelines (Europe) the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Greece Guidelines: Abnormal X ray

    TST≥10

  • French Guidelines: Abnormal X ray

    History

    TST≤10 mm


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Guidelines (Europe) the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Swiss Guidelines:TST not recommended

    History of exposure

    Country of Origin

    Interferon Gamma assays


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Topics of discussion the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Milestones of TB in anti-TNFα therapy Era

  • Guidelines for screening of latent TB before anti-TNF therapy

  • PPD in different rheumatic diseases

  • Prevalence of TB in Israel

  • HIV, TNF  blockers and TB

  • Adverse consequences of over diagnosis of LTB


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Attenuated response to PPD in RA the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • 112 RA patients vs 96 healthy controls

  • Similar background : age, sex, BCG vaccine

  • Median PPD : 4.5 in RA vs 11.5 in healthy

  • Negative PPD : 70% in RA vs 26% in healthy


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PPD in different rheumatic diseases the prevention of tuberculosis in patients treated with TNF-alpha blocker


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Infliximab treated : the prevention of tuberculosis in patients treated with TNF-alpha blocker

-USA : 50/100000

-EU :152/100000

-Spain:1100/100000

-Sweden :100/100000

Rate of TB in RA

-USA : 6.2/100000

-Spain : 90/100000

-Sweden: 10/100000

Incidence of MTB in Infliximab treated pts


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Prevalence the prevention of tuberculosis in patients treated with TNF-alpha blockerof TB in Israel (100000)

#

Dept. of TB & AIDS, MOH, Jerusalem


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Topics of discussion the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Milestones of TB in anti-TNF therapy Era

  • Guidelines for screening of latent TB before anti-TNF therapy

  • PPD in different rheumatic diseases

  • Prevalence of TB in Israel

  • HIV, TNF  blockers and TB

  • Adverse consequences of over diagnosis of LTB


Tnf blockers hiv and tb l.jpg
TNF the prevention of tuberculosis in patients treated with TNF-alpha blocker Blockers, HIV and TB

  • High frequency of extra-pulmonary manifestations

  • HIV impairs TNF mediated MG apoptotic response to MT

  • HIV + with TST≥5 mm are treated for LTB , independently of CD4 levels


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Infliximab treated : the prevention of tuberculosis in patients treated with TNF-alpha blocker

-USA : 50/100000

-EU :152/100000

-Spain:1100/100000

-Sweden :100/100000

HIV +

- South –Africa : 2.2/100

-Swiss : 1.6/100

20 ≤fold increase of reactivation

Incidence of MTB in Infliximab treated pts vs HIV +

Rate of TB in RA pts in USA : 6.2/100000

Rate of TB in RA pts in Sweden :10/100000

Rate of TB in RA pts in Spain : 90/100000


Topics of discussion29 l.jpg
Topics of discussion the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Milestones of TB in anti-TNF therapy Era

  • Guidelines for screening of latent TB before anti-TNF therapy

  • PPD in different rheumatic diseases

  • Prevalence of TB in Israel

  • HIV, TNF  blockers and TB

  • Adverse consequences of over diagnosis of LTB


Adverse consequences of over diagnosis and treatment ltb l.jpg
Adverse consequences of over diagnosis and treatment LTB the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Drug toxicity

  • Hepatotoxicity

  • Drug multi resistance


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Multi drug resistance in Southern Israel the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Overall INH resistance rate :16%

  • In former soviet union :INH resistance of 32%

  • Resistance to any drug observed in 29% overall and 50% of isolates among IFSU.

  • Multi drug-resistant tuberculosis was observed in 8.5% and 17%, respectively.


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Conclusions the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • Guidelines of diagnosis of LTB should take into consideration :

  • The prevalence of TB in the country

  • The immunosuppressive state of the patients

  • Adverse consequences of over diagnosis of latent TB


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Conclusions the prevention of tuberculosis in patients treated with TNF-alpha blocker

  • In RA patients :TST≥5 mm

  • In PsA and AS not treated with immunosuppressive drugs : TST ≥10 mm

  • Risk stratification and X chest ray


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