1. XVI Congreso Panamericano de Reumatología Latin American biologics registries: Building on the European Experience
Prof. David Cezar Titton
Hospital de Clínicas – University of Paraná - Brazil
Coordenator of BiobadaBrasil

2. Results from BiobadaBrasil:
Rationale for the registry
Construct of registry
Patientes included
Results to date
Next steps

3. Why a brazilian registry?
DATASUS:

4. Why a brazilian registry
No included data about:
Judicial actions
Other diseases or biologic medicaments
No data about “health plans”
No data about:
Effectiveness
Adverse events

5. Definition
“Brazilian Control Registry of Biological Therapy in Rheumatic Diseases”
A prospective and observational trial, with indeterminate duration;
Promoted by Brazilian Society of Rheumatology (SBR), supported by Spanish Society of Rheumatology (SER) and BIOBADASER registry.

7. Cronogram 2007 2008 2009 Training Meeting EthicalComitee PANLAR
trimester
1st
trimester
2nd
trimester
3rd
trimester
4th
trimester
1st
trimester
2nd
trimester
Training
Meeting
EthicalComitee
PANLAR
Traduction
Data analysis
Portuguese System
CONOSUR training
Natal: Brazil
Implementation
Presentation in Maceió:
BiobadaBrasil initiation
Labour
agreement
BIOBADABRASIL

8. Brazilian Biologic Registry: the implementation process and preliminary BiobadaBrasil results* (dates 28 feb 2010)
*Submited to Rheumatology

9. Brazilian Biologic Registry: the implementation process and preliminary BiobadaBrasil results*
*Submited to Rheumatology

10. Brazilian Biologic Registry: the implementation process and preliminary BiobadaBrasil results*
*Submited to Rheumatology

11. Brazilian Biologic Registry: the implementation process and preliminary BiobadaBrasil results*
*Submited to Rheumatology

12. Brazilian Biologic Registry: the implementation process and preliminary BiobadaBrasil results
*Submited to Rheumatology

13. Table 4: Serious and non-serious infections in patients using biological agents included in BiobadaBrasil

14. EULAR2010-AB0299: BIOLOGIC REGISTER: EXPERIENCE WITH IMPLEMENTATION AND FIRST PRACTICAL OUTCOMES
Results: In 850 patients included (31/12/2009), 603 RA and 188 Espondiloarthritis:
66.46% of the patients were treated with Methotrexate but only 32.3% with concomitant folic acid supplementation.
Similarly 68.9% of the patients were receiving corticosteroids however only 33% were using calcium and vitamin D and only 10.45% were using bisphophonates.
All patients that received treatment for latent TB presented positive PPD or Chest x-rays abnormalities.No patient was treated (chemoprophylaxis) based on history of previous contact.

15. Regarding the biologic register (BiobadaBrasil):
EULAR2010-SCIE-4246: SURVEY REPORTS MAY NOT REFLECT ACTUAL CLINICAL PRACTICE: THE CASE OF METHOTREXATE AND FOLIC ACID
Results: questionnaires were submitted to 1491 rheumatologists, 491 (33%) were returned (3E Initiative in Rheumatology):
Conceptual agreement with recommendation of FA use with MTX was high, 94% of the responses. Self-reported application was also high (93.4%).
5% mentioned that supplementation with FA was prescribed only in case of adverse events.
Regarding the biologic register (BiobadaBrasil):
The data showed that 66.46% of the patients were receiving MTX but FA was added only in 32.3%, significantlyless than the reported use in the survey.

16. EULAR2010- AB0958: BIOLOGIC REGISTER IN A DEVELOPING COUNTRY: SAFETY IS DIFFERENT FROM EUROPEAN REGISTRIES? THE BIOBADABRASIL FIRST RESULTS.
Results: In a total of 850 patients, reports of 232 AEs were filed, 27% of all patients in the BiobadaBrasil register.
The most frequent AE was infection in 48% (urinary tract, upper respiratory tract and skin and soft tissue infections);
Fifteen per cent of all AEs were classified as serious AEs.
One death occurred in the biological therapy by Influenza A H1N1 Pneumonia. Another patient in our registry died from myocardial infarction in the control group. Nine cases of Herpes zoster were described.
Three cases of tuberculosis active were detected in the group of anti-TNF treatment: one pulmonary and 2 disseminated.
All these patients had been evaluated by tuberculin skin test (TST) and chest x-ray with negative results.
In 649 anti-TNF treatments, TST had not been done in 6,8%.

17. Conclusion Facilities: Difficulties:
It’s na easy and appliable record in all of Brazilian regions and Latin America)
Low cost registry
Unmeasurable return
Difficulties:
Patients / study subjects;
Medical registers;
Access to the Rheumatologist and to the biological medication;
Catch attention and keep the investigators interested

18. BiobadaBrasil on 20/APR/2010
Number of active centers: 24
Number of patients: 1153
Biológics = 833
Controls = 320
Number of treatments: 1292
Number of adverse events: 549

19. biobadaser.ser.es/biobadamerica/Brasil

20. Thank you: biobadabrasil@terra.com.br