BRASS BRIGHAM AND WOMENS RHEUMATOID ARTHRITIS SEQUENTIAL STUDY - - PowerPoint PPT Presentation

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BRASS BRIGHAM AND WOMENS RHEUMATOID ARTHRITIS SEQUENTIAL STUDY - - PowerPoint PPT Presentation

BRASS BRIGHAM AND WOMENS RHEUMATOID ARTHRITIS SEQUENTIAL STUDY BRASS Registry Enrollment Began in March 2003 Prospective follow-up for 15 years 1468 recruited to date 30 rheumatologists have contributed patients > 90%


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SLIDE 1

BRIGHAM AND WOMEN’S RHEUMATOID ARTHRITIS SEQUENTIAL STUDY

BRASS

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SLIDE 2
  • Prospective follow-up for 15 years
  • 1468 recruited to date
  • 30 rheumatologists have contributed patients
  • > 90% approached will sign up
  • 6 month follow-up (86%)
  • 1 year follow-up (>80%)
  • 680 still enrolled

BRASS Registry Enrollment Began in March 2003

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SLIDE 3

Original Scientific Aims

  • Identify markers of disease progression
  • Monitor markers for drug response
  • Examine pathogenic mechanisms via hypothesis driven

experiments

  • Broaden our understanding of the epidemiology of RA
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SLIDE 4

Structure of the BRASS Registry

Registry Structure Data/Specimens Collected

BRASS

1461 RA patient (15% new onset RA) Physician data (annually) Patient reported data (6 months) DNA (twice) RNA (annually) Serum (annually) Plasma (annually)

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SLIDE 5

BRASS Protocol

Baseline enrollment Before BRASS 1 Year 3 Years 2 Years

Patient Data Collection Occurs Every 6 months Physician Domains and Labs Measured at Baseline and Yearly

Recall Recall Recall Recall Recall Recall Recall

If annual visit and semi-annual mailing will overlap (with-in 2 months), in-person visit takes priority and mailing will not be done. (-3 mos/+6 mos) (-3 mos/+6 mos) (-3 mos/+6 mos) (-2 wks/+3 mos)

6 Months mailed 18 Months mailed 30 Months mailed

Hand X-rays done at baseline, 2yr, 5yr, 7yr, 10yr, 12yr, and 15yr (±3 months)

(-2 wks/+3 mos) (-2 wks/+3 mos)

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SLIDE 6

Data Collection (over 2000 variables)

  • Demographics
  • General Health
  • Current Medications
  • Past Medications
  • Validated Scales

MDHAQ, SF-12, MHI-5, PHQ-9, EQ-5D, RADAI, Arthritis Self-Efficacy, MOS Sleep Scale, Widespread Pain, Dyspnea Questionnaire

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SLIDE 7

Brass Physician Domains

Physician Domains Baseline Annual Inclusion Criteria  Health & Symptoms Morning Stiffness   VAS   Infection/Opportunistic Infections   Extra-Articular Manifestations   Co-morbidities/drug toxicities   28 Joint Count   Medication Changes Start   Stop/reason   Change/reason  

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SLIDE 8

Annual Study Blood Draw

  • DNA (visits 1-2 only)
  • Serum
  • Plasma
  • Pax Gene Tubes (RNA)
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SLIDE 9

Radiographs

  • Collected at study baseline, year 2, year 5, year 7, year 10,

year 12 and year 15

  • Sharp scores are available on

Baseline (N = 1175) Year 2 (N = 786) Year 5 (N= 438) Year 7 (N = 210) Year 10 (N = 111)

  • ICC
  • Total Sharp Score = 0.975
  • Erosions = 0.962
  • Joint Space Narrowing = 0.977
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SLIDE 10

Sharp Score Data

15 30 45 60 75 90 105 120 135 150 165 180 195 210 225 240 255 270

total_sharp_score_A

10 20 30 40 50 60

Percent

Distribution of total_sharp_score_A

N = 1175; Mean = 25.9 (±45.0); Median = 5 (IQR 0-28)

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SLIDE 11

Year 2 Sharp Score Data

15 30 45 60 75 90 105 120 135 150 165 180 195 210 225 240 255 270

total_sharp_score_B

10 20 30 40 50 60

Percent

Distribution of total_sharp_score_B

N = 786; Mean = 27.9 (±46.1); Median = 6.5 (IQR 0-32)

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SLIDE 12

Year 5 Sharp Score Data

15 30 45 60 75 90 105 120 135 150 165 180 195 210 225 240 255 270

total_sharp_score_C

10 20 30 40 50 60

Percent

Distribution of total_sharp_score_C

N = 438; Mean = 31.8 (±46.7); Median = 10 (IQR 1-41)

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SLIDE 13

Distribution of Change in Sharp Score between Baseline and Year 2

  • 7.5
  • 6.0
  • 4.5
  • 3.0
  • 1.5

0.0 1.5 3.0 4.5 6.0 7.5 9.0 10.5 12.0 13.5 15.0 16.5 18.0

Change between 1st and 2nd Sharp Score per Year

20 40 60 80 100

Percent

Distribution of diff_ab

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SLIDE 14

Distribution of Change in Sharp Score Between Year 2 and Year 5

  • 7.5
  • 6.0
  • 4.5
  • 3.0
  • 1.5

0.0 1.5 3.0 4.5 6.0 7.5 9.0 10.5 12.0 13.5 15.0 16.5 18.0

Change between 2nd and 3rd Sharp Score per Year

20 40 60 80 100

Percent

Distribution of diff_bc

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SLIDE 15

Distribution of Annual Change in Sharp Score Between Baseline and Year 5