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IPF Disease Management Strategies: Surveying the Landscape of Therapeutic Options

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Title: IPF Disease Management Strategies: Surveying the Landscape of Therapeutic Options


1
  • IPF Disease Management Strategies Surveying the
    Landscape of Therapeutic Options

2
Learning Objectives
  • Employ the contemporary principles of
    evidence-based medicine to formulate practical
    patient management strategies and optimize
    outcomes
  • Critically evaluate current body of evidence
    regarding conventional and emerging therapies
  • Review and discuss current options for clinical
    trial enrollment
  • Examine the implications of the new lung
    transplant guidelines

3
Evolution of Evidence-Based Medicine
Haynes RB, et al. BMJ. 20023241350.
Guyatt G, et al. Chest. 2006129174-181.
4
Weighing the Research Evidence
  • Type of Study
  • Strength of Result
  • Adverse Events

Human RCT gt Retrospective, Subgroup gt
Observational
Statistically significant gt Trend gt Not
Significant
None gt Predictable gt Spontaneous gt Target Mediated
Guyatt G, et al. Chest. 2006129174-181.
5
Evidence-Based Medicine
Clinical state and circumstance
Clinical expertise
Research evidence
Patient preference
Haynes RB, et al. BMJ. 20023241350.
6
Patient Management Strategies
  • Clinical trial enrollment
  • Evidence-based therapeutic management
  • No therapywatch and wait
  • Lung transplantation
  • Supportive care

Bouros D, et al. Eur Respir J. 200526693-702.
7

Azathioprine Prednisone vs Prednisone Alone in
IPF
P 0.02 (age adjusted)
P 0.16
Raghu G, et al. Am Rev Respir Dis.
1991144291-296.
8
Combined Corticosteroid and Cyclophosphamide
Treatment Does Not Improve Survival in IPF
Patients
1.00
Expected
P 0.58
0.75
0.50
Probability of Survival
Untreated (n 82)
Median survival 1431 days
0.25
Treated (n 82)
Median survival 1665
0.00
3500
2500
3000
0
500
1000
1500
2000
4000
Days of Follow Up
Collard HR, et al. Chest. 20041252169-2174.
9
Interferon g-1b
GIPF-001 Trial
Raghu G, et al. N Engl J Med. 2004350125-133.
10
GIPF-001 Trial Overall Survival
Lung Function (FVC)2
Survival1
N 330
1.0
75
70
0.8
65
P 0.08
Probability of Survival
60
0.6
IFN ?-1b
16 IFN ?-1b and 28 placebo deaths (41
relative reduction)
55
Placebo
0.4
50
0
100
200
300
400
500
600
0
12
24
36
48
60
72
Day
Week
1. Raghu G, et al. N Engl J Med.
2004350125-133. 2. Data on file with InterMune.
11
GIPF-001 Trial Survival
Raghu G, et al. N Engl J Med. 2004350125-133. D
ata on file with InterMune.
12
INSPIRE Trial
Interferon g-1b
www.inspiretrial.com. Accessed June 2006.
13
N-acetylcysteine
IFIGENIA Trial
Demedts M, et al. N Engl J Med.
20053532229-2242.
14
IFIGENIA Study Results
DLCO
FVC
2
2
P 0.02
P 0.003
0
0
-2
-2
Acetylcysteine
-4
-4
Vital Capacity ( of predicted value)
Acetylcysteine
DLco ( predicted value)
-6
-6
-8
-8
Placebo
Placebo
-10
-10
12 Months
6 Months
Baseline
6 Months
Baseline
12 Months
No. of Patients Acetylcysteine Placebo
80 75
55 51
79 74
58 59
55 51
63 60
Demedts M, et al. N Engl J Med.
20053532229-2242.
15
Etanercept Trial
Raghu G, et al. Chest. 2005128496S-497S.
16
Bosentan
BUILD 1 Trial
Salani D, et al. Am J Pathol. 20001571703-1711.
OCallaghan D, Gaine SP. Int J Clin Pract.
20045869-73.
17
Pirfenidone
Azuma A, et al. Am J Respir Crit Care Med.
20051711040-1047.
18
Pirfenidone Phase 2 Trial Results
36
40
33
35
30
24
Placebo
25
Pirfenidone
18
of Patients
20
13
15
9
6
10
0
5
0
Declined
Improved
Improved
Declined
Min SpO2
FVC
Data based upon 9-month assessment due to early
discontinuation of the trial.
Azuma A, et al. Am J Respir Crit Care Med.
20051711040-1047.
19
Pirfenidone
CAPACITY Trials
www.capacitytrials.com. Accessed August 2006.
20
Imatinib Mesylate
Buchdunger E, et al. Eur J Cancer. 200238(Suppl
5)S28-S36. Daniels CE, et al. J Clin Invest.
20041141308-1316.
21
Anticoagulation Therapy
1
With Anticoagulant Therapy
0.8
n 23
0.6
Probability of Survival
n 33
0.4
Without Anticoagulant Therapy
N 56 P lt 0.05
0.2
0
600
800
1000
1200
0
200
400
Time (Days)
Kubo H, et al. Chest. 20051281475-1482.
22
Recent and Ongoing Trials for IPF
www.clinicaltrials.gov. Accessed May
2006 www.coalitionforpf.org. Accessed April
2006 National Heart, Lung, and Blood Institute
Strategic Plan. FY 2005-2009.
23
Idiopathic Pulmonary Fibrosis Clinical Research
Centers
Mayo Clinic Foundation
University of Washington
University of Chicago
University of Michigan
Cornell University
University of California, San Francisco
Vanderbilt University
Duke University (Data Coordinating Center)
University of California, Los Angeles
Emory University
University of Colorado
Louisiana State University and University of
Alabama, Birmingham
NIH-sponsored Research Centers
Non-NIH Current Research Centers
24
Nonpharmacologic Therapies
  • Lung transplantation
  • Supplemental oxygen
  • Pulmonary rehabilitation
  • Improvement in general and disease-specific
    health status
  • Increased exercise tolerance
  • End-of-life care
  • Screen for pulmonary hypertension, obstructive
    sleep apnea, cough, gastroesophageal reflux
    disease, coronary artery disease, and depression

ATS/ERS Consensus Statement. Am J Respir Crit
Care Med. 2000161646-664. Khalil N, et al.
CMAJ. 2004171153-160.
25
Adult Lung Transplantation
Kaplan-Meier Survival for IPF (Transplants
January 1990 June 2003)
100
Survival Comparisons
1990-1995 vs 1996-1996 P 0.77
1990-1995 vs 2000-6/2003 P 0.18
75
1996-1999 vs 2000-6/2003 P 0.0292
Survival ()
50
1990-1995 (N 577)
25
1996-1999 (N 681)
2000-6/2003 (N 591)
0
0
1
2
3
4
5
6
7
8
9
10
Years
Adapted from Web site www.ishlt.org. Accessed
June 2006. Trulock EP, et al. J Heart Lung
Transplant. 200625880-892.
26
Lung Transplant Guidelines
  • Old model based on first-come/first-served basis
  • New transplant guidelines are based on a lung
    allocation score (LAS)
  • LAS projected pretransplant 1-year survival vs
    projected posttransplant 1-year survival
  • Consider referral for transplant evaluation at
    time of diagnosis for appropriate patients

www.unos.org. Accessed June 2006.
27
Take Home Messages
  • Little quality evidence supports the safety and
    efficacy of conventional therapies for IPF
  • Randomized clinical trials should be discussed as
    an option for all appropriate patients
  • The principles of evidence-based medicine should
    be employed to identify optimal approaches to
    managing patients
  • Early referral and evaluation for lung
    transplantation are recommendednew guidelines
    may shorten the wait time for IPF patients
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