INTERSTITIAL LUNG DISEASES Recent Advances That Change Practice
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1 INTERSTITIAL LUNG DISEASES Recent Advances That Change Practice Talmadge E. King, Jr., M.D. Krevins Distinguished Professor of Medicine Chair, Department of Medicine University of California San Francisco (UCSF) San Francisco, CA
2 Conflict of interest disclosure I have the following, real or perceived conflicts of interest that relate to this presentation. - InterMune (Drug Study Steering committees) - Actelion (Drug Study Steering Committees) - ImmuneWorks (Scientific Advisory Committee) - Daiichi Sankyo Pharma (Consultant) - NIH IPFnet (principal investigator) Talmadge E. King, Jr., MD Professor & Chair
3 OVERVIEW Screening CT scans HRCT in diagnosis of IPF 2013 Revised ATS/ERS IIP Consensus Statement Role of acute exacerbations in the IIPs PANTHER TRIAL Chronic microaspiration in IPF Value of marginal declines in lung function Scoring system to predict outcome in IPF Causes of death in IPF
4 Screen-detected Subclinical Interstitial Lung Abnormalities are Common Elderly Smokers mabels.org.uk
5 Subclinical Interstitial Lung Abnormalities are Common in the Elderly -- HRCT Lung morphology in the elderly: comparative CT study of subjects over 75 years old versus those under 55 years old. Copley SJ, Wells AU, Hawtin KE, Gibson DJ, Hodson JM, Jacques AE, et al. Radiology 2009; 251: ILD present in over half of asymptomatic elderly individuals who have no pulmonary function deficit, and these CT findings are absent in younger individuals.
6 Subclinical Interstitial Lung Abnormalities are Common in Smokers -- HRCT Am J Respir Crit Care Med 2009;180: , Respir Med 2010;104: ILA found in 194/2416 subjects (8%) Decreased TLC Lower likelihood of meeting COPD criteria Decreased quantitative % emphysema N Engl J Med 2011;364:
7 Screen-detected lung fibrosis: 0.5-1% David Lynch
8 Subclinical Interstitial Lung Common in Smokers -- PATHOLOGY Human Pathology (2010) 41,
9 N Engl J Med 2011;364: HRCT Pattern Centrilobular or peribronchial ground glass opacities sparing the peripheral lung parenchyma (19%) Potential Implications Respiratory bronchiolitis Subpleural reticular, nodular, or ground-glass opacities (55%), A predominant age-related finding Centrilobular and subpleural, or mixed, findings (20%) Radiologic interstitial lung disease (6%) Combined pulmonary fibrosis and emphysema
10 Subclinical HRCT Interstitial Lung Abnormalities in Smokers Limited data suggest that many of the subclinical changes in the lungs in smokers are reversible in their natural clinical course or after smoking cessation, and that persistence or worsening is largely confined to those who continue to smoke or are found to have a defined interstitial lung disease. Is this an opportunity to prevent IPF?
11 HRCT is an essential component of the diagnostic pathway in IPF
12 Am J Respir Crit Care Med 2011; 183:
13 Diagnostic criteria for UIP UIP pattern Subpleural, basal predominance Reticular abnormality Honeycombing with or without traction bronchiectasis Absence of features inconsistent with UIP pattern ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management. AJRCCM, 2011; 183: David Lynch
14 Diagnostic criteria for UIP UIP pattern Subpleural, basal predominance Reticular abnormality Honeycombing with or without traction bronchiectasis Absence of features inconsistent with UIP pattern ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management. AJRCCM, 2011; 183: David Lynch
15 Diagnostic criteria for UIP Possible UIP pattern Subpleural, basal predominance Reticular abnormality Absence of features inconsistent with UIP pattern ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management. AJRCCM, 2011; 183: David Lynch
16 Diagnostic criteria for UIP Possible UIP pattern Subpleural, basal predominance Reticular abnormality Absence of features inconsistent with UIP pattern ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management. AJRCCM, 2011; 183: David Lynch
17 Honeycombing in UIP Present in 70-80% of cases of UIP Strongest indicator of UIP on CT Median survival UIP with honeycombing: 2.1 years UIP without honeycombing: 5.8 years Hunninghake GW, et al. Chest 2003;124: Elliot TL. J Comput Assist Tomogr 2005;29: Flaherty KR, et al. Thorax 2003;58: David Lynch
18 Inconsistent with UIP pattern Upper or midlung predominance Peribronchovascular predominance Extensive ground glass abnormality (>reticular) Profuse micronodules (bilateral, predominantly upper lobes) Discrete cysts (multiple, bilateral, away from areas of honeycombing) Diffuse mosaic attenuation (bilateral, in three or more lobes) Consolidation in segments or lobes ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management. AJRCCM, 2011; 183: David Lynch
19 UIP Honeycomb Pattern UIP: usual interstital pneumonia
20 Honeycombing in UIP Present in 70-80% of cases of UIP Strongest indicator of UIP on CT Median survival UIP with honeycombing: 2.1 years UIP without honeycombing: 5.8 years Hunninghake GW, et al. Chest 2003;124: Elliot TL. J Comput Assist Tomogr 2005;29: Flaherty KR, et al. Thorax 2003;58: David Lynch
21 Definition of honeycombing 22 Clustered cysts
22 Definition of honeycombing Clustered cysts Single layer of subpleural cysts
23 Definition of honeycombing 24 Clustered cysts
24 Honeycombing
25 Predictive value of CT diagnosis of UIP Study Correctness of first choice diagnosis of UIP Correctness of confident first choice diagnosis % cases of UIP without confident CT diagnosis Mathieson 89% 95% 72% Hunninghake 85% 96% 52% Flaherty 100% 100% 63% Tsubamoto 100% 91% 9% Elliot 88% 88% 50% Silva 84% 100% 67% David Lynch
26 2013 Revised ATS/ERS IIP Classification
27 2013 Revised ATS/ERS IIP Classification MAJOR IDIOPATHIC INTERSTITIAL PNEUMONIAS Idiopathic pulmonary fibrosis Idiopathic nonspecific interstitial pneumonia Respiratory bronchiolitis interstitial lung disease Desquamative interstitial pneumonia Cryptogenic organizing pneumonia Acute interstitial pneumonia RARE IDIOPATHIC INTERSTITIAL PNEUMONIAS Idiopathic lymphoid interstitial pneumonia Idiopathic pleuropulmonary fibroelastosis UNCLASSIFIABLE IDIOPATHIC INTERSTITIAL PNEUMONIAS
28 Idiopathic interstitial pneumonia (IIPs) Non-familial (> 80%) Familial (2-20%) Chronic Fibrosing Acute/Subacute Fibrosing Smoking-related Idiopathic pulmonary fibrosis Idiopathic nonspecific interstitial pneumonia Cryptogenic organizing pneumonia Acute interstitial pneumonia Respiratory bronchiolitis interstitial lung disease Desquamative interstitial pneumonia
29 2013 Revised ATS/ERS IIP Consensus Statement Rare IIPs described: Idiopathic lymphoid interstitial pneumonia (LIP) Idiopathic pleuropulmonary fibroelastosis (PPFE) Acute fibrinous and organizing pneumonia (AFOP) Interstitial pneumonias with a bronchiolocentric distribution
30 Adults (median age of 57 years) w ith no sex predilection. ~50% experienced recurrent infections. Familial ILD and nonspecific auto-antibodies. HRCT = dense subpleural consolidation w ith traction bronchiectasis, architectural distortion and upper lobe volume loss. Fibrosis involving the pleura and subpleural lung parenchyma Disease progression in 60% of patients; death from disease in 40%. Idiopathic Pleuropulmonary Fibroelastosis (PPFE)
31 Acute fibrinous and organizing pneumonia (AFOP) Path: intra-alveolar fibrin deposition and associated organizing pneumonia (hyaline membranes absent). HRCT = bilateral basal opacities and areas of consolidation. May represent a histologic pattern that can occur in the clinical spectrum of DAD and OP or it may reflect a tissue sampling issue. Idiopathic or associated with CVD, HP or drug reaction.
32 GERD - Not just heartburn
33 American Journal of Medicine, Vol 123, April 2010
34 HH is more common in IPF than COPD or asthma. HH correlated with higher DeMeester scores, confirming abnormal acid GER. Presence of HH alone was not associated with decreased lung function.
35 Gastroesophageal reflux is prevalent in patients with IPF. However, significance is unclear. Tobin RW, Pope CE II, Pellegrini CA, Emond MJ, Sillery J, Raghu G. Increased prevalence of gastroesophageal reflux in patients with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 1998;158: Patti MG, Tedesco P, Golden J, Hays S, Hoopes C, Meneghetti A, Damani T, Way LW. Idiopathic pulmonary fibrosis: How often is it really idiopathic? J Gastrointest Surg 2005;9: Raghu G, Freudenberger TD, Yang S, Curtis JR, Spada C, Hayes J, Sillery JK, Pope CE II, Pellegrini CA. High prevalence of abnormal acid gastro-oesophageal reflux in idiopathic pulmonary fibrosis. Eur Respir J 2006;27: Salvioli B, Belmonte G, Stanghellini V, Baldi E, Fasano L, Pacilli AM, De Giorgio R, Barbara G, Bini L, Cogliandro R, et al. Gastrooesophageal reflux and interstitial lung disease. Dig Liver Dis 2006;38: Sweet MP, Patti MG, Leard LE, Golden JA, Hays SR, Hoopes C, Theodore PR. Gastroesophageal reflux in patients with idiopathic pulmonary fibrosis referred for lung lung transplantation. J Thorac Cardiovasc Surg 2007;133:
36 Stabilization of Pulmonary Function With Medical or Surgical Treatment Of GER Raghu G, Yang ST, Spada C, Hayes J, Pellegrini CA. Sole treatment of acid gastroesophageal reflux in idiopathic pulmonary fibrosis: a case series. Chest 2006;129: Linden PA, Gilbert RJ, Yeap BY, Boyle K, Deykin A, Jaklitsch MT,Sugarbaker DJ, Bueno R. Laparoscopic fundoplication in patients with end-stage lung disease awaiting transplantation. J Thorac Cardiovasc Surg 2006;131:
37 Am J Respir Crit Care Med 2011; 184: Confirms GER-related findings are common in IPF Suggests that the reported use of GER medications is associated with less radiologic fibrosis and longer survival time in these patients. Although preliminary, these findings further support the hypothesis that GER and silent microaspiration may play a role in the pathobiology of IPF.
38 GER Symptoms Am J Respir Crit Care Med 2011; 184: GER Diagnosis no yes yes no GER Medication Use Nissen Fundoplication yes yes no no
39 % Alive Causes of Death in IPF NSIP Others NSIP 20 UIP 20 UIP Years Daniil ZD et al. Am J Respir Crit Care Med. 1999;160: Years Bjoraker JA et al. Am J Respir Crit Care Med. 1998;157:199.
40 Am J Respir Crit Care Med 2011; 183: CAUSES OF DEATH IN IPF Most deaths (77%) due to a respiratory cause. 61% of respiratory deaths occur as a subacute process. 39% occur as acute process (<4 weeks after onset of acute worsening). Causes: progression of IPF, acute exacerbations, acute lung injury, pneumonia, and cor pulmonale. Nonrespiratory deaths due to cardiac causes, sepsis, gastrointestinal conditions, stroke, cancer, and other causes.
41 Acute exacerbations are major cause of death in the IIPs Baseline 5 months later
42 Acute exacerbation of IIP Bilateral ground glass attenuation Peripheral Multifocal Diffuse ± consolidation Superimposed on background reticular abnormality/ honeycombing Collard HR, et al. Am J Respir Crit Care Med. 2007;176(7): Akira M, et al. Am J Respir Crit Care Med. 2008;178(4): Huie TJ, et al. Respirology Aug;15(6): David Lynch
43 Am J Physiol Lung Cell Mol Physiol 299: L3 L7, 2010 Plasma from patients with acute exacerbation of IPF showed significant elevations in markers of type II alveolar epithelial cell injury and/or proliferation, endothelial cell injury, and coagulation. This profile differed from the biomarker profile in patients with acute lung injury. These findings support the hypothesis that type II alveolar epithelial cells are centrally involved in the pathobiology of acute exacerbation of IPF. Furthermore, they suggest that acute exacerbation of IPF has a distinct plasma biomarker profile from that of acute lung injury.
44 Am J Respir Crit Care Med 2011; 183: This study uses the most current genomics-based technologies to investigate the possible infectious etiology of acute exacerbations of IPF. Most cases demonstrate no evidence of viral infection. Torque teno virus was present in a significant minority of cases, and cases of acute lung injury.
45 Respiration 2012;83:28 35 Acute exacerbation of IPF occurred more frequently between December and May (75.7%) than between June and November (24.3%) (p = 0.01). In-hospital mortality was 27% and median survival was 4.2 months (range ). Longer time between admission and initiation of treatment is poor prognostic factor
46 Intern Med 50: , 2011
47 Respiratory Medicine (2012) Background: Clinical significance of circulating autoantibodies in IPF is unclear Methods: Prevalence of circulating autoantibodies compared between IPF patients and healthy controls (n = 52). Results: Positive autoantibodies: IPF = 22%; healthy controls = 21. Conclusions: The frequency of circulating autoantibodies in patients with idiopathic pulmonary fibrosis is no different compared to healthy controls, but may be associated with longer survival.
48 Why Did We Use Corticosteroids to Treat IPF? Rationale: treat inflammation, slow fibroblastic proliferation and prevent irreversible fibrosis Some patients experience a precipitous decline when steroids were stopped, so, they appeared to be working No other therapy available If you remember I did mention possible side effects.
49 Treatment of IPF With Combination Therapy Corticosteroids + Cytotoxic Drugs
50
51 % Still alive Cyclophosphamide Appears to Improve Survival in IPF 100 Prednisolone + Cyclophosphamide (n=21) Prednisolone (n=22) p = N.S Y e a r s Johnson, Thorax 44:280, 1989
52 Chest. 2004; 125:
53 Am J Respir Crit Care Med 2000; 161:
54 Am J Respir Crit Care Med 2000; 161:
55 IFIGENIA Trial (Idiopathic pulmonary Fibrosis International Group Exploring NAC I Annual) N Engl J Med 2005;353:
56 VC (% Predicted) IFIGENIA Trial (Idiopathic pulmonary Fibrosis International Group Exploring NAC I Annual) 2 0 Baseline Endpoint 6m Endpoint 12m Mortality -2 9% % -8 NAC Placebo -10 Pred/Aza/NAC (n=) Pred/Aza/Placebo (n=) NEJM 2005; 353:
57 IFIGENIA Trial: Conclusion Addition of NAC to low-dose prednisone and azathioprine may help to preserve pulmonary function in patients with IPF. However, a drop-out rate of 30% (including deaths) raised concerns regarding the clinical relevance and robustness of the treatment effect.
58 Commonly used agents* for IPF (survey of pulmonologists in US) The percentage of respondents who to prefer to use each of the commonly used agents for patients with mild or advanced IPF Peikert T et al. Respir Med 2008; 102:
59 IPFnet trials IPFnet is a network of ~26 medical centers across the U.S.A. dedicated to the study of IPF
60 PANTHER-IPF Trial Prednisone, Azathioprine, and N - Acetylcysteine: A Study That Evaluates Response in Idiopathic Pulmonary Fibrosis N Engl J Med 2012; 366:
61 PANTHER Randomization IPF patients (N = 236) Pred + Aza + NAC (N = 77) NAC + Placebo (N = 81) Placebo (N = 78)
62 Primary Endpoints Change in serial measurements of FVC over 60 weeks. The study was designed to detect a 0.15 L difference between groups over the 60 weeks.
63 PANTHER Randomization October 14, 2011 NHLBI stops arm based on DSMB review mean 32 weeks of follow-up IPF patients (N = 236) Pred + Aza + NAC (N = 77) NAC + Placebo (N = 81) Placebo (N = 78)
64 Selected Patient Characteristics Characteristic Triple Therapy (n=77) Matched Placebo (n=78) Age Female sex 23% 27% History of smoking 70.1% 74.3% FVC (% pred) DLCO (% pred) CPI
65 Primary Endpoints: FVC Triple Therapy Matched Placebo P- value FVC (liters) (-0.33, -0.15) (-0.32, -0.14) 0.85
66 Safety End Points. The Idiopathic Pulmonary Fibrosis Clinical Research Network. N Engl J Med 2012;366:
67 Kaplan Meier Curve for the Time until Death HR 9.26 (95% CI ) P = 0.01 The Idiopathic Pulmonary Fibrosis Clinical Research Network. N Engl J Med 2012;366:
68 Kaplan Meier Curve For The Time Until A Composite Of Death or Disease Progression (Decrease in Forced Vital Capacity of 10%) HR 1.46 (95% CI: ) P = 0.30 The Idiopathic Pulmonary Fibrosis Clinical Research Network. N Engl J Med 2012;366:
69 Kaplan Meier Curve For The Time Until A Composite Of Death Or Hospitalization 9.26 ( ) 0.01 HR: 3.74 (95% CI: ) p<0.001 The Idiopathic Pulmonary Fibrosis Clinical Research Network. N Engl J Med 2012;366:
70 Study Drug Adherence Azathioprine or placebo Triple Therapy N=52 At Week 15 At Week 30 Matched Placebo N=57 Triple Therapy N=36 Matched Placebo N=44 73% 98% 64% 98% Prednisone or placebo 83% 100% 78% 100% NAC or placebo 87% 98% 78% 98% All three study agents 73% 98% 64% 98% P-values for All three study agents ; Week 15 p value =.0001; Week 30 p-value <.0001
71 Conclusions Increased risks of death and hospitalization were observed in patients with IPF who were treated with a combination of prednisone, azathioprine, and NAC, as compared with placebo. These findings provide evidence against the use of this combination in such patients. N Engl J Med 2012; 366:
72 Goals of effective IPF management Relieve symptoms Improve exercise tolerance Improve health status Prevent and treat complications Prevent and treat exacerbations Prevent disease progression Cough, Depression, Sleep Pulmonary rehab. Oxygen New approaches needed?? Experimental therapy in a RCT Reduce mortality Lung transplantation These goals should be reached with a minimum of side effects from treatment
73 RCTs That Give Hope Pirfenidone N-acetylcysteine (Fluimucil ) Sildenafil (advanced disease) BIBF 1120 (oral, potent angiokinase inhibitor
74 THANK YOU FOR YOU ATTENTION.
75 Am J Respir Crit Care Med 2012; 185: For patients with IPF, there are currently no validated surrogate endpoints. IPF We argue that it is fundamentally flawed and unfair to patients with IPF to hold their disease(s) to a threshold that is not feasible. In summary, we are vehemently opposed to the idea that mortality data should be required for drug registration in IPF.
76 Efficacy and Safety of Sirolimus in Lymphangioleiomyomatosis Francis X. McCormack, M.D., Yoshikazu Inoue, M.D., Ph.D., Joel Moss, M.D., Ph.D., Lianne G. Singer, M.D., Charlie Strange, M.D., Koh Nakata, M.D., Ph.D., Alan F. Barker, M.D., Jeffrey T. Chapman, M.D., Mark L. Brantly, M.D., James M. Stocks, M.D., Kevin K. Brown, M.D., Joseph P. Lynch, III, M.D., Hilary J. Goldberg, M.D., Lisa R. Young, M.D., Brent W. Kinder, M.D., Gregory P. Downey, M.D., Eugene J. Sullivan, M.D., Thomas V. Colby, M.D., Roy T. McKay, Ph.D., Marsha M. Cohen, M.D., Leslie Korbee, B.S., Angelo M. Taveira-DaSilva, M.D., Ph.D., Hye-Seung Lee, Ph.D., Jeffrey P. Krischer, Ph.D., Bruce C. Trapnell, M.D., for the National Institutes of Health Rare Lung Diseases Consortium and the MILES Trial Group N Engl J Med 2011; 364: Sirolimus stabilized lung function, reduced serum VEGF-D levels, and was associated with a reduction in symptoms and improvement in quality of
77 Recent Articles Key Findings Screening CT scans = ILAs, especially in elderly smokers HRCT = diagnostic of IPF Honeycombing = critical features Chronic microaspiration seen in IPF and treatment may improve survival Gene mutations and polymorphisms in IPF Marginal declines in FVC predict survival Scoring system to predict outcome in IPF Causes of death in IPF = respiratory (subacute & acute) Acute exacerbations seen in many forms of ILD (e.g., IIPs and HSP) Viral infections may play role in some New Treatment for lymphangioleiomyomatosis - sirolimus
78 Gene mutations and polymorphisms have been shown in both sporadic IPF and familial pulmonary fibrosis. There are no genetic factors consistently associated with sporadic IPF.
79 N Engl J Med 2011;364: MUC5B is a gel-forming mucin expressed by bronchial epithelial Dense accumulation of MUC5B observed in areas of microscopical honeycombing and involved patchy staining of the metaplastic epithelia lining the honeycomb cysts. Accumulation also observed in the mucous plugs within the cysts.
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