Transcript Early Arthritis Clinic Jack Cush, MD What do I have to do to get this patient seen? • • • • 53 yoWM under evaluation for.

Early Arthritis Clinic
Jack Cush, MD
What do I have to do to get this patient seen?
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53 yoWM under evaluation for eosinophilia
No Meds; PMHx prostatitis; ROS negative
Only c/o R knee effusion/warmth x 12 weeks
Negative: CBC, BM Bx, Stool O/P, ANA, DNA, ESR,
UA, CXR (pending RF, CRP)
• Hematology W/U exhausted
– How to w/u the swollen R knee (maybe L too)?
• Next availalable rheumatology appt?
• Who you gonna call?
Early Arthritis
Diagnostic
Algorithm
No
Chronicity: Joint
swelling > 12 wks ?
Yes
Possible RA
Yes
Synovial
Swelling
Yes
>3 Joints
(Symmetric,
Typical)
Early arthritis:observe
Crystal arthritis
Reactive arthritis
Chlamydial arthritis
Viral arthritis
Palindromic Rheum.
Diff Dx < 3 jts
No
Undifferentiated
Polyarthritis
Psoriatic arthritis
Reactive arthritis
Spondyloarthropathy
Serum RF/CCP Positive? No
Pseudogout
Connective Tissue Dz
Assess Severity
Slowly
Polymyalgia Rheumatica
High titer RF
Progressive
Inflammatory OA
No
CCP+
RA
Hemochromatosis
Xray Erosions
RA
Many Swollen Jts
Nodules/Extra-artic
HLA-DRB1/SE
HAQ > 1.4
Yes
Aggressive RA
“High Risk Patient”
US City Populatoins and Expected NEW RA Cases every Year (28-56,000)
City
Population
Rheums
Pts/Rheum
New RA/yr
Ft. Smith, AR
81,518
2
8366
16
Ft Collins, CO
124,665
2
62,322
24
Little Rock, AR
184,055
22
8366
37
Huntsville, AL
162,536
5
32,507
32
Birmingham, AL
239,416
45(30)
5320
47
Toledo, OH
309,106
7
44,158
62
Omaha, NE
399,106
12
33,279
80
Denver, CO
560,415
40(29)
14,010
112
Charlotte, NC
580,597
14
36,328
116
Nashville, TN
648,882
25
29,955
138
Louisville, KY
698,080
18
38,782
140
SanAntonio, TX
1,194,222
30(24)
39,807
238
Dallas, TX
1,211,467
46 (29)
26,336
242
10.3 Million w/ Chronic Joint Symptoms
Have Never Seen an MD
• 2001 CDC, BRFSS adult
telephone survey (>18yrs)
• 2001 estimated 47.5 million
with CJS
• 10.3 million have not seen
MD (~2.0 million w/ activity
limitations). Risk Factors:
– < HS education, excellentgood health, no insurance, no
PCP, no activity limitation and
engaged in regular physical
activity
876,000
Early RA: Window of Opportunity
RA/Inflammatory Arthritis Continuom
MD? PCP
#’s? 800,000
Sxs? Wks-Mos
Rheums
725,000
Mos-Yrs
Few
Joints
Many
Normal
XRay
Erosive
Possible
Remission
Rare?
Full Time
Employed?
Disability
Early RA: A problematic diagnosis
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Most patients will not meet ACR criteria
Most patients will not be RF+ ( 19- 45%)
Most patients will not seek medical care
Most PCPs prefer to evaluate, rather than refer
Many patients will remit with symptomatic Rx
Histopathology similar: RA, ERA, UPA
Few features to distinguish RA vs UPA
• Duration, #Jts, RF+, CCP+, ESR/CRP
• Cost of diagnositic evaluation is higher in UPA
Early RA: Take Home Points
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Early RA defined as < 12 weeks; the earlier the better
Articular erosions/damage evident early
 Delay in Rx is Disastrous!
1st DMARD Choice is CRITICAL!
– Use Best DMARD First!
– Multiple Trials show signif. downstream effects
High Risk Early RA patients Can Be defined
RF and CCP are Predictive and OMINOUS together
DMARDs work, COMBOs and Biologics are Better!
Referral Rules: >3 jts, squeeze test, Sx 6-12 wks, RF+
Challenge: how to facillitate early referral
Short Delay of Therapy Affected
Radiographic Outcome
Sharp Score
14
12
10
Delayed Treatment = median 123 days
8
6
Early Treatment = median 15 days
4
2
0
0
6
12
Time (months)
Lard LR, et al. Am J Med. 2001;111:446-451.
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24
Early Referral, Early DMARD in VERA
Nell VP, Machold KP, Eberl G, et al. Rheumatology 2004
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Case-controlled, parallel study
Very early RA (VERA): dz duration 3 mos
Late early RA (LERA): <12 mos to DMARD
DMARDS: SSZ, MTX, CQ, CYA, LEF, Combo
Evaluated at 36 mos: DAS28, Larsen score
– At study end DAS28 improved 2.8±1.5 in the VERA vs.
1.7±1.2 in the LERA group (P<0.05)
– Larsen scores showed a statistically significant
retardation of progression in VERA vs. LERA
Percent of Patients Fulfilling ACR Response
Criteria After 36 Months of Follow-Up
% Patients With Fulfilled Criteria
100
90
LERA
VERA1
80
70
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60
*
50
40
30
20
10
0
20% response
* P<0.05
50% response
70% response
Nell V. et al., Rheumatology 2004; 43:906-14.
Radiographic Changes in LERA and
VERA1 Patients, Indicated by the Larsen Score
LERA
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VERA1
40
*
Larsen Score
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30
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20
10
0
0
* P<0.05
12
24
Months after DMARD initiation
36
Nell V. et al., Rheumatology 2004; 43:906-14.
4 Treatment Strategies in Early RA
Sequential
Monotherapy
n=125
Step-Up
Therapy
n=128
MTX
45%
MTX
41%
SSZ
21%
MTX + SSZ
30%
LEF
19%
MTX + SSZ +
HCQ
16%
MTX + biologic
15%
Initial
Combination
Therapy
n=133
Initial MTX +
Biologic
Therapy
n=128
MTX + SSZ +
PRED
81%
MTX + biologic
86%
MTX + CSA +
PRED
11%
SSZ
8%
LEF
6%
MTX + biologic
8%
MTX + SSZ
+ HCQ + PRED
13%
De Vries-Bouwstra JK, et al. Arthritis Rheum. 2003;48:3649.
Percentage of Patients in Remission:
DAS44 < 1.6
Percentage
80
70
I Monotherapy
II Step-up
Discontinuation of
Biologic
60
50
40
30
20
10
0
III Combination
IV Biologic
0
3
6
9
12
Time (months)
De Vries-Bouwstra JK, et al. Arthritis Rheum. 2003;48:3649.
Aggressive Therapy Example:
COBRA 1997
Double-blind, randomized study
Study
design
Population 155 early active RA patients
(no more than 2 years from ACR diagnosis)
Treatment
groups
• Prednisolone (607.5 mg/day step-down),
MTX (7.5 mg/week), SSZ (2 g/day) vs
SSZ (2 g/day)
• Prednisolone and MTX tapered and stopped
after 28 weeks and 40 weeks, respectively
Follow-up
56 weeks
ACR = American College of Rheumatology; COBRA = Combinatietherapie Bij Reumatoide
Artritis; MTX = methotrexate; SSZ = sulfasalazine.
Boers M, et al. Lancet. 1997;350:309-318.
Landewe R, et al. Arthritis Rheum. 2002:46:347-356.
COBRA Trial
Step-Down Therapy
Clinical Outcome
1.6
Pooled Index
Combined Treatment
Pooled Index Score
Sulphasalazine
1.2
0.8
Pr e d
Prednisolone
0.4
M TX
Methotrexate
SSZ
Sulfasalazine
COBRA Tr e atm e nt pr otocol
0.0
0
16
28
40
weeks
Time
(Weeks)
Adapted from: Boers M, et al. Lancet. 1997;350:309-318.
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Early Aggressive Therapy Provides for
Long-term Results
Damage Progression (Sharp/van der Heijde)
40
SSZ:
8.6 points/y
30
COBRA:
5.4 points/y
20
P=0.008
10
0
0
1
2
3
Years
Landewe RB, et al. Arthritis Rheum. 2002;46:347-356.
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Fin-RA Co Study
Short Delay of Therapy
Predicted Remission* at 2 Years
Study
2-year, open-label, parallel-group,
design
randomized trial
Population N=195; disease duration < 2 years;
prednisone and DMARD naive
Treatment
groups
Monotherapy
Sulfasalazine (2-3 g) ± prednisolone (5-10 mg)
initially, switching to methotrexate
(7.5 to 15 mg/week) if inadequate response
Combination therapy
Methotrexate
Hydroxychloroquine
Sulphasalazine
Prednisolone
7.5-15 mg
300 mg
1-2 g
5-10 mg
*ACR preliminary criteria for remission were used.
Mottonen T, et al. Lancet. 1999;353:1568-1573. Arthritis Rheum 46:894, 2002
Cumulative work disability days
Fin-Co-RA Work Disability Early RA
5 Yr Followup of Single vs Triple DMARD
600
550
500
450
400
350
300
250
200
150
100
50
0
GREATER
Sick Leave
Work Disability
Retirement
Combination Therapy
Single Therapy
ß=119
ß=79
0
1
2
3
4
5
Cumulative follow-up time (years)
ß=annual regression
coefficient
Puolakka, K. et al., Arthritis Rheum 2004;50:55-62.
Etanercept in Early RA:
ACR Response Rates at Year 2
100
% of Patients
80
60
MTX 20 mg
Etanercept 25 mg
P = 0.005
72
59
P = NS
49
42
40
P = NS
24
29
20
0
ACR-20
ACR-50
Genovese MC, et al. Arthritis Rheum. 2002;46:1443–1450.
ACR-70
Etanercept ERA Trial
Radiographic Change at Year 2
Mean Change
From Baseline
Total Sharp
Score
(p=0.001)
Erosions
(p=0.001)
4
2
Joint Space
Narrowing
(p=0.0163)
3.2
1.9
1.3
0.7
0.5
1.0
0
Etanercept 25 mg
Methotrexate
Adapted from: Genovese MC, et al. Arthritis Rheum. 2002;46:1443-1450.
ASPIRE: MTX & INFLIXIMAB IN EARLY RA
• 54 wk phase IV DBRPCT
– MTX vs MTX + Infliximab (3 or 6 mg/kg)
• Early RA < 3 yrs duration ( mean ~ 7 mos)
• N=1050; 125 centers worldwide; 4:5:5 random
• Inclusion
– 12 Tender & 10 Swollen (30 Tend & 19 Swoll)
– RF+ or CRP^ or XRAY erosion ( > 80%)
Presbyterian Hospital of Dallas
Early Arthritis Clinic
Tuesday Afternoons
Jack Cush, MD
Andres Quiceno, MD
Kathyrn Dao, MD
EARLY ARTHRITIS CLINIC REFERRAL
(Patients must have “arthrititis” for < 12 months)
Patient Name :
Age :___________________
Referring Physician
Phone #
Fax #
Previously Seen a Rheumatologist? NO
YES
Whom: __________
Symptoms Began:
Diagnosis Date: _________
Reason for Referral (Choose any that apply) ?
Acute Pain
Acute Swelling
Chronic Pain
Chronic Swelling
Widespread Pain
Affected Joints: Hand
Feet
Shoulder
Knee
Hip
Back Neck
+ANA (Result:
Pattern:
)
+RF
(Result:
)
High ESR or CRP
(Result:
)
Osteoarthritis
Lupus
Rheumatoid arthritis
Gout
Fibromyalgia
Low back pain
Sjogrens syndrome
Scleroderma
Polymyositis/dermatomyositis
Vasculitis
Please attach copies of recent labs, xrays, H&P or discharge summary
Results: Diagnoses 53 pts
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10 wrongfully referred > 12 mos
5 SLE (5 malar, 2dsDNA, 1 Sm, 3 pred)
1 ANA(+) arthralgia
5 RA/inflammatory polyarthritis (1 resolved)
3 SpA & 1 PsA
3 PSS and CREST (2 pred, 1 CTX)
3 Myositis and Myopathy NOS
3 Osteoarthritis
5 Fibromyalgia/myofascial pain syndrome
4 No known dx (dx pending)
1 each: Urticaria, sialadenitis, drug-induced lupus,
bursitis
Diagnosing Early Arthritis in the Community
PHD Early Arthritis Campaign (PEAK)
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Why Bother?
Who will benefit?
Are PCPs and Specialists interested?
What do PCPs want?
How will it work?
Goal: to identify > 90% of new onset RA patients
in the next year?
• Cooperating Clinics: Internal medicine, Family
practice, Emergency Departments, Orthopedics,
IM subspecialties, OBGYN
Multidisciplinary Awareness Campaign
• Goal: increase awareness, facillitate early referral
diagnosis of serious rheumatic diseases
• Cachement: PHD Community 1 million
• Outcome: diagnosis of Early RA (N= 40 240)
• Role Players: Rheums, PR, Marketing, Phone,
Administration, Managed Care, Study Coordinators
• Tools: Mailings, Signage, Publications, Local Ad
Campaign, DTC mailings
• Success depends on PCP community
PHD Rheumatologists are Alligned
• Convinced that early diagnosis and early
aggressive Rx will positively impact outcomes
• Can be accomplished without effecting patient
load/flow. (work smarter, not harder)
• Agree to study this Cooperative Effort
– Protocol for intake, testing, DMARDs, Data.
• Create access to Consultation for PCPs, Patients
– Secondarily educate: facillitate referrals
PCP Misconceptions
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Referrals are easy (how many? How prompt?)
Diagnosis can be made by lab tests, xrays
Response to therapy confirms diagnosis
Everyone responds to Steroids or NSAIDs
– Those that don’t cant be helped
Physician Education
• 3 Main Messages
– Rapid easy access to the Rheum of choice
– Prompt appointments with rapid diagnosis
and treatment
– Rapid notice of outcome and return of
patient
Whats the Motivation for PCPs
• LOVE (Patient Satisfaction)
• MONEY (Arthritis Patients are not time efficient)
– Time = Money
– Rheumatology = voodoo medicine (ANA1000)
• Access to Rheumatologists
Physician Education Programs
• PCPs don’t want Rheum Education
– They Want Access to Rheumatologists
• Dear Dr. Letter: informs of program, reminds
• RheumaKNOWLEDGY Cards (Pocket info)
• Referral Rules Card
• Broadcast Fax/Frequent Newsletters
• Group lunches/breakfasts with Rheums
– Invite PCPs, Orthos, NP/PA
• CME Forums
• BEST: Immediate Feedback on patients referred
EAC Models
• EAC Clinic (@PHD Tuesday is Early Arthritis day)
• Physician Extender (NP/PA) intake/screening
• Prescreen: Chart review, FAX requests, MD to MD
referral
• Flexible Scheduling (promote, hold, fill spots)
• Meet and Greet Rapid Slots
• Free Arthritis Screening Clinics
• Model Depends on the objective/setting
– Private solo, group, multispecialty group
– University, Academic, Clinical Trials
– Government/Municipal
Must There be A Patient Focused Effort?
• Most patients don’t seek medical care
• Most newly afflicted patients don’t know who to see
– PCP, Ortho, GYN, Chiropracter?
• Whats a Rheumatologist?
– Purveyor of Rumors
– Specializes in Interior Design
• How will PCP sector perceive a public advertising
campaign encouraging new onset joint complaints
to see PCP?
– To self refer to Early arthritis screening clinics?
• Currently: EAC plans to only accept referred pts
“If you build it….they will come”
• Goal: increase awareness, facillitate early referral
diagnosis of serious rheumatic diseases
• Target: Rheums, PCPs, Orthos, OBGYNs, NP, PA,
Chiropractors, Patients, Media, Managed Care
• Cachement: Your Community N = ?
• Outcome: diagnosis & earlier Rx
• Role Players: Rheums, PR, Marketing, Phone,
Administration, Managed Care, Study Coordinators
• Tools: Mailings, Signage, Publications, Ad
Campaign, DTC mailings
• PCP: Dear Dr., Rheum Education, Newletters
Guidelines for Referral to the
Early Arthritis Clinic
Emery P, et al. Ann Rheum Dis 2002 61:290-297
Refer when there is clinical suspicion!
• > 3 swollen Joints
• + MTP/MCP “squeeze test”
• AM stiffness > 30 minutes
• + Rheumatoid factor
• Elevated ESR or C-Reactive Protein
(NSAIDs/Prednisone may obscure findings)
Differential Diagnosis
Inflammatory
• RA
• UPA/USP
• Viral arthritis
• SpA
• Crystal arthritis
Autoimmune
• SLE/UCTD
• Behcets
• Vasculitis
• Cryoglobulinemia
Noninflammatory
• Osteoarthritis
• Hemochromatosis
Others
• Infectious arthritis
• PMR
• SBE
• Serum sickness