ISSAS International Start TNFblocker Study in Ankylosing Spondylitis

1
ISSASInternational Start TNF-blocker Study in
Ankylosing Spondylitis
Robert Landewé, Désirée van der Heijde, Maxime
Dougados, Sjef van der Linden.
2
ISSAS Objectives

• Worldwide rheumatologists judgement
• Consecutive AS outpatients
• TNF-blockers treatment yes/no
• Given risk/benefit profile of the treatment

3
ISSAS Objectives

• To get insight in type of AS patients that
  physicians would like to treat with TNF-blockers.
  
• To test sensitivity and specificity of ASAS
  consensus statement recommendations on start of
  TNF-blockers in AS.

Braun J et al. ARD 2003
4
ISSAS Methods

• 13 countries
• 20 rheumatologists per country
• 10 AS patients per rheumatologist
• 200 patients per country
• 2600 patients expected

5
Participating Countries and principal
investigators

• Italy Ignacio Olivieri
• Mexico Rubens Burgos-Vargas
• Netherlands Irene van der Horst
• Spain Eduardo Collantes
• UK Paul Emery

• Australia John Edmonds
• Belgium Herman Mielants
• Canada Milicent Stone
• France Thao Pham
• Germany Martin Rudwaleit

6
Thanks to investigators for their active
participation
Thanks to investigators ingenuity ..

• Added questions
• Removed questions
• Re-numbered questions
• Several different CRFs in the same country

7
Results patientsLast update (17/01/04)

• Australia
• Belgium
• Canada
• France
• Germany
• Italy
• Mexico
• Netherlands
• Spain
• UK

120 100 200 139 202 105 130 104
187 47
1334
8
CRFs received before December 31st

• Australia
• Belgium
• France
• Germany
• Italy
• Spain

120 100 116 202 63 187
788
9
TNF-blockers initiation question 1

• Do you want to start therapy with TNF-blockers
  in this patient under the following assumptions
  
• the treatment gives an improvement of at least
  50 in at least 50 of the patients
• the drugs are available and fully reimbursed
• there may be an increased risk for (serious)
  infections and little information is available on
  long term safety.
• The judgment should be made independent of the
  patients wish to start TNF-blockers.

Yes
No
?
?
10
TNF-blockers initiation question 1

• Do you want to start therapy with TNF-blockers
  in this patient under the following assumptions
  
• the treatment gives an improvement of at least
  50 in at least 50 of the patients
• the drugs are available and fully reimbursed
• there may be an increased risk for (serious)
  infections and little information is available on
  long term safety.
• The judgment should be made independent of the
  patients wish to start TNF-blockers.

Yes
No
?
?
11
TNF-blockers initiation question 1

• Do you want to start therapy with TNF-blockers
  in this patient under the following assumptions
  
• the treatment gives an improvement of at least
  50 in at least 50 of the patients
• the drugs are available and fully reimbursed
• there may be an increased risk for (serious)
  infections and little information is available on
  long term safety.
• The judgment should be made independent of the
  patients wish to start TNF-blockers.

Yes
No
?
?
12
TNF-blockers initiation question 1

• Do you want to start therapy with TNF-blockers
  in this patient under the following assumptions
  
• the treatment gives an improvement of at least
  50 in at least 50 of the patients
• the drugs are available and fully reimbursed
• there may be an increased risk for (serious)
  infections and little information is available on
  long term safety.
• The judgment should be made independent of the
  patients wish to start TNF-blockers.

Yes
No
?
?
13
TNF-blockers initiation question 1
Preliminary results

• Do you want to start therapy with TNF-blockers
  in this patient under the following assumptions
  
• the treatment gives an improvement of at least
  50 in at least 50 of the patients
• the drugs are available and fully reimbursed
• there may be an increased risk for (serious)
  infections and little information is available on
  long term safety.
• The judgment should be made independent of the
  patients wish to start TNF-blockers.

Yes 53.3
No 46.7
n 777
14
TNF-blockers initiation
Preliminary results
15
Decision based on
Preliminary results
16
Predominant localization of symptoms
Preliminary results
17
Population description
Preliminary results
18
Population description
Preliminary results
19
Population description
Preliminary results
20
Concordance
Preliminary results
21
Concordance
Preliminary results
Sensitivity 47.1 Specificity 77.4
Accuracy 61.6 Concordance (Cohens kappa) 23.9
22
Conclusion

• ASAS clinical initiative
• Preliminary results (788 of 1334 patients)
• Great variability between countries
• Physicians opinion based on
• Disease activity
• Disease severity
• Biological inflammation
• Response to previous/present treatment
• High rate of willingness to treat with TNF
  blockers

23
Conclusion

• Analyses on the complete database
• The entire process should be repeated 1-2 years
  after the publication of the recommendations to
  test the implementation of the recommendations