vectra da: a better measure for predicting radiographic ... 2014... · vectra® da: a better...

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Vectra® DA: A Better Measure for

Predicting Radiographic Progression in

Rheumatoid Arthritis?

Ronald F. van Vollenhoven, MD, PhD

Jonathan Kay, MD

Andrew Laster MD, FACR

Eric Sasso, MD

Crescendo Bioscience® is the sponsor of the presentation.

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Agenda • Introduction:

- Eric Sasso, MD, Crescendo Bioscience

• The Role of CRP and ESR in Assessing RA Disease Activity:

- Jonathan Kay, MD, UMass Medical School

• Vectra® DA and Radiographic Progression:

- Eric Sasso, MD, Crescendo Bioscience

- Ronald van Vollenhoven, MD, PhD, Karolinska Institute

• Clinical Applications of Vectra DA:

- Andrew Laster, MD, FACR, Arthritis & Osteoporosis Consultants of the

Carolinas

• Q&A

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Vectra® DA Intended Use

• Vectra DA, a multi-biomarker blood test, was validated to

measure disease activity in adults diagnosed with

rheumatoid arthritis

• Test results are intended to

– Aid in the assessment of disease activity in RA patients

– Help inform patient management decisions when used in

conjunction with standard clinical assessment

• This test is not intended or validated to:

– Diagnose RA

– Guide therapy selection

• Interpretation of individual biomarker results has not

been validated

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Vectra® DA Biomarkers: Twelve biomarkers reflect the

heterogeneity of RA

Biomarker Biomarker Category Primary Role

VCAM-1 Adhesion Molecules Cellular influx and tissue expansion

EGF

VEGF-A

Growth Factors

IL-6

TNF-RI

Cytokine-related Proteins Local inflammation and destruction

MMP-1

MMP-3

Matrix Metalloproteinases Cartilage degradation and joint

damage

YKL-40 Skeletal-related Proteins Stromal activity & regulation

(fibroblasts, chondrocytes, vascular

cells)

Leptin

Resistin

Hormones

Systemic Inflammatory Response

SAA

CRP

Acute Phase Proteins

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An algorithm is applied to the concentrations of individual

biomarkers to calculate a Vectra® DA score from 1 to 100

* The range reflects the precision of the score based on repeat measurements.

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The Role of CRP and ESR in Assessing

RA Disease Activity

Jonathan Kay, MD

UMass Medical School


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Disclosures

Research Support: AbbVie Inc.; Ardea Biosciences, Inc.; Eli Lilly and

Company; Fidia Farmaceutici, SpA; Roche Laboratories, Inc.

Consultant: AbbVie Inc.; Amgen, Inc.; AstraZeneca; Bristol-Myers

Squibb Company; Celgene Corp.; Crescendo Bioscience, Inc.; Eli Lilly

and Company; EPIRUS Biopharmaceuticals, Inc.; Genentech Inc.;

Hospira, Inc.; Janssen Biotech, Inc.; medac pharma Inc.; PanGenetics,

B.V.; Pfizer Inc.; Roche Laboratories, Inc.; Sun Pharmaceutical

Industries Ltd.; UCB, Inc.

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Background

1Sokka T, Pincus T. Arthritis Rheum. 2003; 48: 313-318.

• Patients with active RA often have elevated tender &

swollen joint counts and patient & MD global assessment,

yet have normal ESR and/or CRP

• These discordances imply that when ESR and CRP are in

the normal range, they may be uninformative in clinical

practice, especially for patients with active RA

• These discordances also imply that patients may fail to

meet clinical trial APR entry criteria despite having active

disease.1

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Study Overview

• Observational study

• CORRONA database

• October 1, 2001 through February 27, 2011

• 9135 RA patients with active disease

– All had CDAI >2.8 at a visit

– ESR and CRP obtained at visit

– 4,031 (44.1%) were biologic-naïve

Kay J, Morgacheva O, Messing S, et al. Arthritis Research & Therapy 2014; 16(1)

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Baseline Characteristics by APR Levels

Neither APR

elevated

n=2520

APR levels

discordant

n=1058

Both APR

elevated

n=650

P-Value

Age (years) 59.29± 13.22 62.21±13.21 62.71± 13.34 <0.0001

Duration of RA (years) 11.01± 9.83 11.93± 10.68 10.91± 10.27 0.0406

CDAI 12.89 ± 10.15 15.18 ± 11.16 20.47 ± 14.68 <0.0001

Tender Joints 3.73 ± 5.24 4.29 ± 5.40 6.30 ± 7.21 <0.0001*

Swollen Joints 4.04 ± 5.13 4.80 ± 5.49 6.64 ± 6.42 <0.0001*

Patient Global Assessment 30.91 ± 23.82 36.35 ± 25.45 42.90 ± 27.56 <0.0001

MD Global Assessment 20.21 ± 16.61 24.67 ± 19.06 32.42 ± 22.50 <0.0001

Prednisone Use 680 (26.98%) 341 (32.23%) 275 (42.31%) <0.0001

Methotrexate Use 1668 (66.19%) 698 (65.97%) 417 (64.15%) 0.6166

Biologic Use 1263 (50.12%) 447 (42.25%) 224 (34.46%) <0.0001

* Log-linear model (Poisson) - χ² test


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• Data from 9,135 patients with active RA (CDAI >2.8) from the

CORRONA registry

ESR and CRP were each low in ~70% of patients

* Units of CRP are mg/dL; Units of ESR are mm/hr

71% CRP ≤0.8*

n = 6,507

29% CRP >0.8*

n = 2,628

70% ESR ≤28*

n = 6,416

30% ESR >28*

n = 2,719


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CRP and ESR were both low in 58% of patients with

active RA

• Data from 9,135 patients with active RA (CDAI >2.8) from the

CORRONA registry

58% ESR ≤28*

and

CRP ≤0.8* n = 5,295

42% ESR >28*

and/or

CRP >0.8* n = 3,840



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66% CRP ≤0.8*

n = 2,674

68% ESR ≤28*

n = 2,756

Similar levels of low CRP and ESR were seen among the

4,031 biologic-naïve patients with active RA (CDAI >2.8)

32% ESR >28*

n = 1,275

34% CRP >0.8*

n = 1,357



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Similar levels of low CRP and ESR were seen among the

4,031 biologic-naïve patients with active RA (CDAI >2.8)

54% CRP ≤0.8*

and

ESR ≤28* n = 2,164

46% ESR >28*

and/or

CRP >0.8* n = 1,867



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67% 57%

46%

23%

27%

28%

10% 16%

26%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

CDAI LDA CDAI MDA CDAI HAD

Both CRP andESR elevated

Either CRP orESR elevated

Neither CRP orESR elevated

In both moderate and high CDAI Disease Activity Levels,

both ESR and CRP were low in ~50% of patients

LDA = Low Disease Activity, MDA = Moderate Disease Activity, HDA = High Disease Activity

(>2.8 & ≤10) (>10 & ≤22) (>22)

LDA MDA HDA CDAI


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Summary

• Patients with active RA often have elevated tender &

swollen joint counts and patient & MD global assessment,

yet have normal ESR and/or CRP

• These discordances imply that when ESR and CRP are in

the normal range, they may be uninformative in clinical

practice, especially for patients with active RA

• These discordances also imply that patients may fail to

meet clinical trial APR entry criteria despite having active

disease.1

1Sokka T, Pincus T. Arthritis Rheum. 2003; 48: 313-318.

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7%

33%

51% 34%

54%

36% 59%

13% 13%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

SWEFOT eRAPre-MTX

Leiden StableDMARDs

Stable TherapyBRASS

High (>44)

Mod (30-44)

Low (<30)

Perc

en

tag

e o

f A

ssessm

en

ts

Vectra DA

algorithm score

N = 71/235

30.2%

N = 158/235

67.2%

N = 184/235

78.3%

Multiple Cohorts

SWEFOT eRA Pre-MTX

BRASS Stable Therapy

Leiden Stable DMARDs

Vectra® DA algorithm scores were frequently moderate

or high when CRP was low (≤1 mg/dL)

Hambardzumyan K, Bolce R, Saevarsdottir S, et al. Annals of the Rheumatic Diseases 2014. doi:10.1136/annrheumdis-2013-204986;

Lee, YC. et al, ACR 2013, Arthritis Rheum 2013;65 Suppl 10:2683; Li W, et al, EULAR 2013, poster # FRI0098; Data on File

* The Vectra DA algorithm and biomarkers were used in a study performed in Crescendo’s R&D lab

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7% 7%

34% 26%

59% 68%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

SWEFOT eRAPre-MTX

Leiden StableDMARDs

BRASS StableTherapy

High (>44)

Mod (30-44)

Low (<30)

Perc

en

tag

e o

f A

ssessm

en

ts

Vectra DA

algorithm score


; Crescendo Data on File

SWEFOT: CRP groups are based on CRP values from clinical laboratory

N = 71/235

30.2%

SWEFOT

SWEFOT eRA Pre-MTX

Vectra® DA algorithm scores were also frequently

moderate or high when ESR was low (≤25)

N = 74/235

31.5%

SWEFOT eRA Pre-MTX

Low

CRP

Low

ESR

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Vectra® DA and Radiographic

Progression

Eric Sasso, MD

Crescendo Bioscience


Karolinska Institute


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Disclosures • Dr. Eric Sasso is an employee of Crescendo

Bioscience, a wholly-owned subsidiary of Myriad

Genetics, Inc.

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Leiden


Stable DMARDs

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Leiden study

Clinic visit

On DMARDs

Clinical data

Vectra® DA

1 year

X-ray #1 X-ray #2 Radiographic progression

N=271 visits for 163 patients

van der Helm-van Mil, et al. Rheumatology. 2013. 52 (5): 839-846.

Stable DMARDS / Leiden

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Vectra® DA algorithm score discriminated risk for

radiographic progression better than DAS28-CRP

van der Helm-van Mil, et al. Rheumatology. 2013. doi:10.1093/rheumatology/kes378

7%

20% 15%

27%

18%

24%

43%

37%

0%

10%

20%

30%

40%

50%

Vectra DA Algorithm Score (Remission ≤25; High >44)

DAS28CRP(Remission <2.32; High >4.1)

Δ S

HS

> 3

in

a

12

mo

nth

pe

rio

d

Remission Low Moderate High

3/43 47/110 17/83 23/63

RR = 1.8 RR = 6.1

P<0.05

2/13 19/105 8/30 23/95

Vectra DA Algorithm Score DAS28-CRP

n = n =

The Vectra DA algorithm and biomarkers were used in a study performed in Crescendo’s R&D lab

≤25 26-29 30-44 >44 <2.3 ≥2.3 to

≤2.7

>4.1 >2.7 to

≤4.1


N = 271 visits,

163 patients

Range =

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Definition of

Remission Remission

Non-

remission P-value PLR

DAS28-CRP

<2.32

80%

(66/83)

71%

(134/188) 0.18 1.38

ACR/EULA

R

83

(25/30)

73

(175/241) 0.27 1.78

Vectra® DA

≤25

93

(40/43)

70

(160/228) 0.001 4.73


Good radiographic outcome (ΔSHS ≤3) for

patients in remission versus non-remission


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Definition of

Remission Remission

Non-


DAS28-CRP

<2.32

80%

(66/83)

71%

(134/188) 0.18 1.38

ACR/

EULAR

83%

(25/30)

73%

(175/241) 0.27 1.78

Vectra® DA

≤25

93

(40/43)

70

(160/228) 0.001 4.73





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Definition of

Remission Remission

Non-


DAS28-CRP

<2.32

80%

(66/83)

71%

(134/188) 0.18 1.38

ACR/

EULAR

83%

(25/30)

73%

(175/241) 0.27 1.78

Vectra® DA

≤25

93%

(40/43)

70%

(160/228) 0.001 4.73





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Definition of

Remission Remission

Non-


DAS28-CRP

<2.32

80%

(66/83)

71%

(134/188) 0.18 1.38

ACR/

EULAR

83%

(25/30)

73%

(175/241) 0.27 1.78

Vectra® DA

≤25

93%

(40/43)

70%

(160/228) 0.001 4.73





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Vectra® DA and Radiographic

Progression


Karolinska Institute


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Disclosures

Research support, consultancy: AbbVie, Biotest, BMS, Crescendo,

GSK, Janssen, Lilly, Merck, Pfizer, Roche, UCB, Vertex

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R = Responders

NR = Non Responders

MTX/H/S = Methotrexate with sulfasalazine and hydroxychloroquine

MTX/Inf = Methotrexate with infliximab

eRA / SWEFOT

SWEFOT Vectra® DA Analysis Overview

month 3

ΔSHS

R

NR

MTX

MTX/H/S

MTX/Inf

Start MTX

year 1 BL

X-ray #1

Clinical Data

Vectra DA

(N = 235) Assess

Response

X-ray #2

• Patients from 15 rheumatology units in Sweden

• Early rheumatoid arthritis (eRA) patients with disease duration <1 year, DMARD naive


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0%

3%

21%

0%

5%

10%

15%

20%

25%

30%

35%

0/5 1/29 42/201 n =

High

(>44)

Moderate

(30-44)

% R

ap

id R

ad

iog

rap

hic

Pro

gre

ss

ors

(Δ

SH

S >

5

BL

to

year

1)

Low

(<30)

Vectra® DA categories predicted risk of rapid radiographic

progression (ΔSHS >5) over 1 year

eRA / SWEFOT


_____________

Vectra DA Score at Baseline (Total N = 235)

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0%

3%

21%

0%

5%

10%

15%

20%

25%

30%

35%

0/5 1/29 42/201 n =

High

(>44)

Moderate

(30-44)

7x Relative Risk

Low

(<30)

Vectra DA Score at Baseline (Total N = 235)

p = 0.008

Vectra® DA categories predicted risk of rapid radiographic

progression (ΔSHS >5) over 1 year

eRA / SWEFOT


Data on File

The p value 0.008 represents low/moderate vs. high Vectra DA score. The p value for moderate vs. high Vectra DA score is 0.021 (figure 2D)

_____________

% R

ap

id R

ad

iog

rap

hic

Pro

gre

ss

ors

(Δ

SH

S >

5

BL

to

year

1)

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Baseline Vectra® DA score categories differentiated

radiographic progressors at 1 year

ΔSHS>5

21%

3%

0%

5

eRA / SWEFOT


BL Vectra DA Levels Δ

To

tal

Sh

arp

-va

n d

er

Heijd

e S

co

re

Cumulative % of Patients

Low (< 30), n = 5

High (> 44), n = 201

Moderate (30 – 44), n = 29

ΔSHS>5

N=235

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Baseline Vectra® DA score differentiated radiographic progressors

at year 1 better than baseline CRP, ESR, or DAS28-ESR

5


eRA / SWEFOT

Δ T

ota

l S

HS

Δ

To

tal

SH

S

Δ T

ota

l S

HS

Δ

To

tal

SH

S

SHS = Sharp-van der Heijde Score

High (> 44), n = 201

Moderate (30 – 44), n = 29

Low (< 30), n = 5 Low (≤ 1 mg/dL), n = 71

Moderate (> 1-3 mg/dL), n = 75

High (> 3 mg/dL), n = 89

N=235

Moderate (>3.2-5.1), n = 68

Low (≤ 3.2), n = 0

High (>5.1), n = 167 2nd Tertile (>25-45 mm/h), n = 81

1st Tertile (≤ 25 mm/h), n = 74

3rd Tertile (>44 mm/h), n = 80





ΔSHS>5

DAS28-ESR category ΔSHS>5

ΔSHS>5

ΔSHS>5

Vectra DA category CRP category

ESR category

High (> 44), n = 201

Moderate (30 – 44), n = 29

Low (< 30), n = 5

21%

3%

0%

High (> 3 mg/dL), n = 89

Moderate (> 1-3 mg/dL), n = 75

Low (≤ 1 mg/dL), n = 71

25%

15%

14%

High (>5.1), n = 167

Moderate (>3.2-5.1), n = 68

Low (≤ 3.2), n = 0

20%

15%

3rd Tertile (>44 mm/h), n = 80

2nd Tertile (>25-45 mm/h), n = 81

1st Tertile (≤ 25 mm/h), n = 74

26%

15%

14%

5 5

5 5

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Rapid radiographic progression at 1 year in patients with high

Vectra® DA (>44) was observed across CRP categories at baseline

Baseline CRP (mg/dL)

Baseline Vectra DA


n = 71 n = 75 n = 89

10

11

21

eRA Pre-MTX / SWEFOT

10

11

21

ΔSHS >5 (n = 43)

High (>44)

5 0 0

24

4 1

0

10

20

30

40

50

60

70

80

90

100

Low (≤1) Mod (>1 – 3) High (>3)

Low (<30)

Mod (30 – 44) 42

71

88

Nu

mb

er

of

Pa

tie

nts

ΔSHS >5 at 1 year

Baseline Vectra DA

Score

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4% 6%

35%

0%

10%

20%

30%

40%

DAS28CRP(Remission <2.32; High >4.1)

51 31 34 n =

Low Moderate High

eRA / SWEFOT

Ra

pid

Ra

dio

gra

ph

ic P

rog

res

so

rs

(Δ S

HS

> 5

) fr

om

Ye

ar

1 t

o 2

Patients had high Vectra DA score at BL and were MTX non-responders at

Month 3. Rapid radiographic progression is defined as ΔSHS >5 in one year. Hambardzumyan, K. Ann Rheum Dis 2014;73(Suppl2).

Persistence of a high Vectra® DA score at Year 1 was associated

with rapid progression from Year 1 to Year 2 (ΔSHS >5)

Vectra DA Score at Year 1

N=

Among Patients with High Vectra DA at Baseline

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Vectra DA is not validated to guide therapy selection.

The statements/conclusions provided herein are based

on a secondary analysis of the SWEFOT trial

data. Additional validation studies would be required to

support use of Vectra DA as a predictor of therapy

response.

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Vectra DA is not validated to guide therapy selection. The statements/conclusions provided herein are based on a secondary analysis of the

SWEFOT trial data. Additional validation studies would be required to support use of Vectra DA as a predictor of therapy response.

0%

10%

20%

30%

40%

50%

60%

70%

80%

67%

43%

37%

57%

Response to triple therapy was best following a large decrease in

Vectra® DA score (>20) on MTX monotherapy

Hambardzumyan, K. Ann Rheum Dis 2014;73(Suppl2).

eRA / SWEFOT

Pa

tie

nts

wit

h D

AS

28

≤ 3

.2 a

t ye

ar

1

Triple therapy Anti-TNF

Δ Vectra DA at month 3 of MTX

12/18 19/44 6/16 29/51 n =

Δ >20 Δ ≤20 Δ >20 Δ ≤20

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Clinical Applications of Vectra® DA

Andrew Laster MD, FACR

Arthritis & Osteoporosis Consultants of the

Carolinas

Charlotte, NC


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Disclosures • Advisory board: Amgen, Crescendo Bioscience,

Genentech/ Roche, Lilly, UCB

• Speakers Bureau: Abbvie, Amgen, Crescendo

Bioscience, Genentech/ Roche, GSK, Lilly, UCB

• Consultant: Augmedix, Hologic, Medimaps

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• Community based independent rheumatology practice in

Charlotte, NC (pop.1.5 x 106)

• 6 rheumatologists / 2 NPs / 41 total staff

• Single office

• Full capability with X ray and U/S

• MRI not available in office without CON in NC

Arthritis & Osteoporosis Consultants of the

Carolinas

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Use of Vectra® DA in My Practice

• Number of RA patients in practice: 456

• Tested with Vectra DA in Last 12 Months: 322 (71%)

– Single test 52%

– > 1 test 48%

Score Composite for Last

12 Months Score Distribution for

Last 12 Months

10 20 30 40 50 60 70 80 90 100 0%

5% 10%

15%

20% 25%

30%

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• 12-30% of patients with apparent clinical remission have

evidence of radiographic progression 1,2,3

– Advanced imaging with U/S or MRI:

• has superior sensitivity compared to clinical evaluation for

detecting synovitis

• correlates with subsequent X ray damage and functional

outcome

• ~ 60% of patients not in clinical remission do not progress

radiographically 2

1Brown et al Arthritis Rheum 2008; 58(10):2958-2967. 2Lillegraven et al Ann Rheum Dis 2012; 71(50):681-686. 3van der Helm-van Mil et al Rheumatology 2013; 52 (5):839-846.

Why Not Just Rely on the Clinical Exam?

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Clinical Exam Role of Vectra Comments

Normal joint exam

Rule out subclinical

synovitis

If ESR/CRP are normal,

an elevated Vectra DA

score may lead to U/S or

MRI to confirm active RA

Synovitis on exam and no

radiographic abnormalities

(erosions/JSN)

Assess likelihood of

radiographic progression

Low Vectra DA score

means lower risk of

progression.

High Vectra DA score

means higher risk of

progression.

Synovitis on exam +

erosions and/or JSN

Helps assess adequacy of

response to therapy

Clinical measures and

ESR/CRP may not be

sufficient in assessing

LDA or remission.

Tender joints without

obvious synovitis

Helps assess patients with

co-morbidities

(Fibromyalgia / OA)

Low Vectra DA means

active RA is less likely

Vectra® DA: How I incorporate into practice

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Other Possible Roles for Vectra® DA

• Monitor response to drug therapy:

– MTX +/- corticosteroids

– Biologic therapy: abatacept, adalimumab, etanercept,

golimumab, infliximab, tocilizumab*

– tofacitinib

• Insurance approval:

– Biologic dosing: adalimumab, tofacitinib

– Assessment of disease activity in single joint instead of

MRI

* Change in Vectra DA score during tocilizumab treatment may underestimate the

change in clinical response

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Summary: Clinical Utility of Vectra® DA in My Practice

• Vectra DA has had a significant impact on my ability to better

assess disease activity in RA patients with a variety of

presentations (there is not one ideal patient type where Vectra

DA is best suited):

– Identify patients with sub-clinical synovitis

– Exclude active RA in setting of co-morbidities

– Assess early in disease course, likelihood of progression with

radiographic damage

• Vectra DA has resulted in more selective utilization of advanced

diagnostic imaging in my practice

• Vectra DA has allowed me to more confidently manage drug

therapy in a treat-to-target approach

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Q&A


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Oral Presentations Wednesday, Nov. 19; Room 258B

9:30–9:45 AM

2973 The Multi-Biomarker Disease Activity Score as a Predictor of Radiographic Progression in a Registry of

Patients with Rheumatoid Arthritis; E.H. Sasso, G. Wu, C.C. Hwang, M.E. Weinblatt, N.A. Shadick,C. Alexander, O.G.

Segurado

9:45–10:00 AM

2974 Multi-Biomarker Disease Activity Score is Associated with Power Doppler Ultrasound in Patients with

Rheumatoid Arthritis in Low Disease Activity State; M.H. Ma, T. Garrood, W. Li, N.A. Defranoux, G.H. Kingsley, A.P.

Cope, D. Scott

Poster Presentations

Sunday, Nov 16, 9:00–11:00 AM; Exhibit Hall B

364 In Early Rheumatoid Arthritis, the Multi-Biomarker Disease Activity Score at Different Time-Points is

Predictive of Subsequent Radiographic Progression; K. Hambardzumyan R.J. Bolce, S. Saevarsdottir, K. Forslind,

I.F. Petersson, P. Geborek, E.H. Sasso, D. Chernoff, S. Cruickshank, R.F. van Vollenhoven

367 In Early Rheumatoid Arthritis Patients with Non-Response to Methotrexate Monotherapy the Change in Multi-

Biomarker Disease Activity Score is Differentially Associated with Subsequent Response to Non-Biological

Versus Biological Therapy; K. Hambardzumyan, R.J. Bolce, S. Saevarsdottir, K. Forslind, I.F. Petersson, P. Geborek,

E.H. Sasso, D. Chernoff, S. Cruickshank, R.F. van Vollenhoven

376 Using the Multi-Biomarker Disease Activity Score as a Complementary Inclusion Criterion for Clinical Trials

in Rheumatoid Arthritis May Enhance Recruitment; R.F. van Vollenhoven, R. Bolce, K. Hambardzumyan, S.

Saevarsdottir, K. Forslind, I.F. Petersson, E.H. Sasso, C.C Hwang, O.G. Segurado, P. Geborek

Tuesday, Nov. 18; 9:00–11:00 AM Exhibit Hall B

2615 Preliminary Assessment of a Multi-Biomarker Disease Activity Test for Axial Spondyloarthritis; W.P. Maksymowych, S. Wichuk, P.S. Eastman, E.H. Sasso

Vectra® DA Posters and Presentations at ACR

vectra da: a better measure for predicting radiographic ... 2014... · vectra® da: a better...

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