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1 Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Protocol for: The Idiopathic Pulmonary Fibrosis Clinical Research Network. Prednisone, azathioprine, and N-acetylcysteine for pulmonary fibrosis. N Engl J Med 2012;366: DOI: /NEJMoa
2 Supplementary Appendix Supplement to: Raghu G, Anstrom KJ, King TE Jr, Lasky JA, Martinez FJ, on behalf of the IPFnet. A double blind, placebo controlled, randomized trial of combined prednisone, azathioprine and N acetyl cysteine in idiopathic pulmonary fibrosis. Contents Appendix A IPFnet Members... 2 Appendix B Table S1: Study drug adherence... 3 Appendix C Table S2: Patient characteristics, and primary and secondary endpoints 4 Appendix D Table S3: Non serious adverse events
3 Appendix A: Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet) Members: 1 The following IPFnet investigators participated in this study: Protocol Chairs University of Michigan: F.J. Martinez, University of Washington: G. Raghu. IPFnet Steering Committee Chairs University of Colorado: M. Schwarz; University of Michigan: G.B. Toews; University of Iowa: G. Hunninghake. Clinical Centers Beth Israel Deaconness: J. Zibrak, A. Demersky, M. Vey; Brigham and Women s: I.O. Rosas, P. Debrosse; Cleveland Clinic: D.A. Culver, J. Chapman, M. Olman, S. Lubell, R. Wehrmann; Duke University Medical Center: L.D. Morrison, M.P. Steele, T. Haram, R. Kidd; Highland Hospital: M. Kallay, E. Lyda; Mayo Clinic: J.H. Ryu, J.P. Utz, A.H. Limper, C.E. Daniels, K. Meiras, S. Walsh; Medical University of South Carolina: S. Sahn, N. O Banner, F. Stokes; National Jewish Health: K.K. Brown, C. Bair, D. Kervitsky; St. Luke s Hospital: N.A. Ettinger, S. Merli; Temple University: G. J. Criner. I.Q. Swift, A. Satti, F. Cordova, N. Patel, K. West, G. Jones; Tulane University: J.A. Lasky, S. Ditta; University of Alabama at Birmingham: J. de Andrade, V.J. Thannickal, M. Stewart; University of California at Los Angeles: J. Belperio, J.P. Lynch III, E. Calahan, P. Lopez; University of California at San Francisco: T.E. King, Jr., H.R. Collard, J. Golden, P. Wolters, A. Eller; University of Chicago: I. Noth, D.K. Hogarth, N. Sandbo, M.E. Strek, S. Maleckar, G. Rahimova, L. Sardin, ; University of Louisville: J. Roman, R. Perez, T. Perez; University of Miami Miller School of Medicine: M.K. Glassberg, E. Simonet; University of Michigan: F.J. Martinez, K. Baumann, K. Chan, A. Chughtai, B. Gross, K.R. Flaherty, M.L. Han, R. Hyzy, E. Kazerooni, B. Moore, J. Myers, G.B. Toews, E. White, D. Dahlgren, C. Majors; University of Pennsylvania: M. Rossman, M. Kreider, K. Le; University of Texas Southwestern: J. Fitzgerald, C. Glazer; University of Utah: M.B. Scholand, L. Brewster, A. Johnson; University of Washington: G. Raghu, P. Berry-Bell, A. Snydsman; Vanderbilt University: J.E. Loyd, L. Lancaster, W. Lawson, R. Greer, K. Kinser, R. Richardson, W. Mason; Weill Medical College of Cornell: R.J. Kaner, K. Bandong; Yale University: D. Antin-Ozerkis, C. Holm, J. Estrom. Core Lab Chairs Radiology: National Jewish Health: D.A. Lynch; Pathology: Mayo Clinic: T. Colby. Data Coordinating Center Duke Clinical Research Institute: K.J. Anstrom, E.L. Eisenstein, J.S. Sundy, L. Davidson-Ray, P. Dignacco Project Leader, R. Edwards, R. Anderson, R. Beci, S. Calvert, T. Gentry-Bumpass, D. Hill, K. Hwang, J. Kaur, C. Matti, A. Meredith, J. Pesarchick, S. Ramey, R.S. Roberts, A. Sharlow, J. Winsor, Q. Yang, E. Yow Lead Statistician. NHLBI G.G. Weinmann, H. Reynolds, B. Schmetter, X. Tian, J. Kiley. Data and Safety Monitoring Board G. S. Davis, R. Levine, S.D. Nathan, S. Rounds, B.T. Thompson, B. Thompson. Protocol Review Committee P.B. Bitterman, T.J. Franks, S. Idell, S. Piantadosi, W.N. Rom, M. Selman, D.S. Wilkes. 2
4 Appendix B. Table S1: Study Drug Adherence Azathioprine/prednisone/NAC N 77 At week 15 visit Taking azathioprine or placebo 38 /52 (73.1) Taking prednisone or placebo 43 / 52 (82.7) Taking NAC or placebo 45 / 52 (86.5) Taking all three study agents 38 / 52 (73.1) At week 30 visit Taking azathioprine or placebo 23 / 36 (63.9) Taking prednisone or placebo 28 / 36 (77.8) Taking NAC or placebo 28 / 36 (77.8) Taking all three study agents 23 / 36 (63.9) At week 45 visit Taking azathioprine or placebo 21 / 32 (65.6) Taking prednisone or placebo 25 / 32 (78.1) Taking NAC or placebo 26 / 32 (81.3) Taking all three study agents 21 / 32 (65.6) At week 60 visit Taking azathioprine or placebo 12 / 20 (60.0) Taking prednisone or placebo 15 / 20 (75.0) Taking NAC or placebo 15 / 20 (75.0) Taking all three study agents 12 / 20 (60.0) Numerator / denominator (percentage) Placebo 56 / 57 (98.2) 57 / 57 (100) 56 / 57 (98.2) 56 / 57 (98.2) 43 / 44 (97.7) 44 / 44 (100) 43 / 44 (97.7) 43 / 44 (97.7) 30 / 31 (96.8) 31 / 31 (100) 30 / 31 (96.8) 30 / 31 (96.8) 21 / 21 (100) 21 / 21 (100) 21 / 21 (100) 21 / 21 (100) P-values for Taking all three study agents at: Week 15 p value =.0001; Week 30 p- value <.0001; Week 45 p-value =.003; Week 60 p-value =.001 3
5 Appendix C. Table S2: Patient Characteristics, and Primary and Secondary Endpoints Patient Characteristics Age years Characteristic Azathioprine / prednisone / NAC N , 74.3 Matched placebos , 74.0 Female sex Caucasian* African American* Hispanic* History of smoking Current Past Never Time since diagnosis years , , 1.6 Concomitant illnesses Coronary artery disease Diabetes GERD
6 Azathioprine / prednisone / Matched placebos Characteristic NAC N 77 GERD therapy Physiology Forced vital capacity % of predicted value Carbon monoxide diffusion capacity corrected for hemoglobin % of predicted value Partial pressure of oxygen mm Hg Alveolar arterial oxygen gradient Arterial oxygen saturation % Composite physiological index 6 Minute walk distance meters 6 Minute walk O2 saturation area under the curve 6 Minute walk distance to saturation 80% meters , , , , , , , , , , , , , , , , , ,
7 Characteristic 6 Minute walk actual minutes walked Azathioprine / prednisone / NAC N , 6.0 Matched placebos , 6.0 Patient reported outcomes Score on Shortness of Breath Questionnaire range Total score on SGRQ range, Symptoms score on SGRQ range, Activity score on SGRQ range, Impacts score on SGRQ range, SF 36 Aggregate physical score range, SF 36 Aggregate mental score range, EuroQol score range, 0.59 to , , , , , , , , , , , , , , , , 1.0 6
8 Characteristic EuroQol thermometer response range, Hospital Anxiety Scale range, 0 21 Hospital Depression Scale range, 0 21 Azathioprine / prednisone / NAC N , , , 5.0 Matched placebos , , , 4.0 *Self reported Categorical variables resented as N % Continuous variables presented as mean SD and median 25 th, 75 th percentiles No statistical significance patient characteristics results were observed Indicates a better score GERD denotes gastroesophageal reflux disease; SGRQ denotes St George s respiratory questionnaire; EuroQol denotes EuroQol Group 5 Dimension; and SF 36 denotes the Medical Outcomes Study 36 Item Short Form Health Survey. 7
9 Primary endpoint Forced vital capacity liters Azathioprine/prednisone/NA C N 77 Matched Placebos Treatment Difference P value , , , Secondary endpoints DL CO corrected (-2.73, -0.71) (-2.65, -0.67) (-1.48, 1.35) Minute walk distance (-142.0, -44.1) (-118.4, -28.7) (-85.9, 46.9) 0.56 meters 6 Minute walk test O (-29.7, -9.6) (-22.1, -3.6) -6.8 (-20.4, 6.9) 0.33 desaturation AUC 6 Minute walk test distance to saturation 80% (-205.6, -80.8) (-86.8, 26.2) (-197.1, -28.6) Minute walk test minutes walked (-0.80, 0.22) (-1.12, -0.23) 0.39 (-0.29, 1.06) 0.26 CPI 6.72 (3.61, 9.83) 5.33 (2.37, 8.29) 1.39 (-2.90, 5.68) 0.52 UCSD SOBQ 10.6 (3.60, 17.6) 8.01 (1.67, 14.3) 2.57 (-6.87, 12.0) 0.59 SGRQ total score 4.29 (-1.14, 9.73) 7.50 (2.57, 12.4) (-10.5, 4.13) 0.39 SGRQ symptoms score , , , SGRQ activity score 7.33 (1.05, 13.6) 10.3 (4.66, 16.0) (-11.4, 5.46)
10 Azathioprine/prednisone/NA C N 77 Matched Placebos Treatment Difference SGRQ impacts score 5.23 (-0.80, 11.3) 5.80 (0.34, 11.27) (-8.71, 7.57) 0.89 P value SF 36 Aggregate physical (-7.40, -0.97) (-5.90, -0.02) (-5.58, 3.13) 0.58 score SF 36 Aggregate mental 0.96 (-2.51, 4.44) (-7.50, -1.20) 5.31 (0.62, 10.00) score EuroQol score (-0.14, -0.00) (-0.09, 0.04) (-0.14, 0.05) 0.31 EuroQol thermometer (-13.0, -0.67) (-12.4, -0.94) (-8.54, 8.24) 0.93 response Estimated change over 60 weeks, adjusted for age, sex, race, and height CPI denotes composite physiological index; UCSD SOBQ denotes University of California at San Diego Shortness of Breath Questionnaire; SGRQ denotes St George s respiratory questionnaire; EuroQol denotes EuroQol Group 5 Dimension; and SF 36 denotes the Medical Outcomes Study 36 Item Short Form Health Survey. 9
11 Appendix D. Table S3: Non-serious Adverse Events Azathioprine/prednisone/NAC N 77 Matched Placebos P value Any 68 (88.3%) 61 (78.2%) 0.09 Respiratory 35 (45.5%) 34 (43.6%) 0.82 Infectious 37 (48.1%) 28 (35.9%) 0.13 Gastrointestinal % % 0.69 General Disorders % % 0.03 Investigations % % 0.81 Nervous system 18 (23.4%) 12 (15.4%) 0.21 Musculoskeletal 10 (13.0%) 16 (20.5%) 0.21 Metabolism 14 (18.2%) 7 (9.0%) 0.09 Skin 13 (16.9%) 4 (5.1%) 0.02 Psychiatric 6 7.8% 7 9.0% 0.79 Renal and urinary % 1 1.3% Injury 6 7.8% 4 5.1% 0.53 Eye 6 7.8% 3 3.8% 0.33 Blood and lymphatic 5 6.5% 2 2.6% 0.28 Cardiac 4 (5.2%) 3 (3.8%) 0.72 Vascular 5 (6.5%) 2 (2.6%) 0.28 Ear 4 5.2% 2 2.6%
12 Azathioprine/prednisone/NAC Matched Placebos N 77 P value Immune 2 (2.6%) 3 (3.8%) 1.00 Neoplasms 4 (5.2%) 1 (1.3%) 0.21 Reproductive 2 (2.6%) 3 (3.8%) 1.00 Congenital or Genetic 0 0.0% 1 1.3% 1.00 Endocrine 0 0.0% 1 1.3% 1.00 Social Circumstances 1 (1.3%) 0 (0.0%)
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