FG-3019 anti-connective tissue growth factor monoclonal antibody: Results of an open-label clinical trial in idiopathic pulmonary fibrosis

European Respiratory Journal

Volumn 47, Issue 5, 2016, Pages 1481-1491

  Raghu, Ganesh ^a   Scholand, Mary Beth ^b   De Andrade, João ^c   Lancaster, Lisa ^d   Mageto, Yolanda ^e   Goldin, Jonathan ^f   Brown, Kevin K ^g   Flaherty, Kevin R ^h   Wencel, Mark ⁱ   Wanger, Jack ^j   Neff, Thomas ^k   Valone, Frank ^k   Stauffer, John ^k   Porter, Seth ^k  

^a UNIVERSITY OF WASHINGTON   (United States)

^b UNIVERSITY OF UTAH   (United States)

^c UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^d VANDERBILT UNIVERSITY   (United States)

^e UNIVERSITY OF VERMONT   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g DEPARTMENT OF MEDICINE   (United States)

^h UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

ⁱ Via Christi Clinic ^*  (United States)

^j Pulmonary Function and Clinical Trial Consultant   (United States)

^k FIBROGEN INC   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PAMREVLUMAB; CONNECTIVE TISSUE GROWTH FACTOR; MONOCLONAL ANTIBODY;

ACUTE RESPIRATORY FAILURE; ADULT; AGED; ARTICLE; BRONCHITIS; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; COUGHING; DIARRHEA; DISEASE ASSOCIATION; DIZZINESS; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DYSPNEA; EPISTAXIS; FATIGUE; FEMALE; FIBROSING ALVEOLITIS; GASTROINTESTINAL DISEASE; HEADACHE; HEART DISEASE; HIGH RESOLUTION COMPUTER TOMOGRAPHY; HUMAN; HUMAN TISSUE; HYPOXIA; INFLUENZA; INTERSTITIAL PNEUMONIA; KIDNEY DISEASE; LUNG BIOPSY; LUNG FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; MEDIASTINUM DISEASE; MENTAL DISEASE; MIDDLE AGED; MULTICENTER STUDY; NAUSEA; NEUROLOGIC DISEASE; NOSE OBSTRUCTION; OUTCOME ASSESSMENT; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PULMONARY HYPERTENSION; QUANTITATIVE ANALYSIS; RESPIRATORY ARREST; RESPIRATORY FAILURE; RESPIRATORY TRACT DISEASE; RHINOPHARYNGITIS; THORAX DISEASE; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; UROGENITAL TRACT DISEASE; USUAL INTERSTITIAL PNEUMONIA; VASCULAR DISEASE; ANTAGONISTS AND INHIBITORS; BIOPSY; CLINICAL TRIAL; COHORT ANALYSIS; DIAGNOSTIC IMAGING; DIFFERENTIAL DIAGNOSIS; DISEASE EXACERBATION; INTERSTITIAL LUNG DISEASE; LUNG; PATHOLOGY; PATIENT SAFETY; PATIENT-REPORTED OUTCOME; TREATMENT OUTCOME; VERY ELDERLY; X-RAY COMPUTED TOMOGRAPHY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; BIOPSY; COHORT STUDIES; CONNECTIVE TISSUE GROWTH FACTOR; DIAGNOSIS, DIFFERENTIAL; DISEASE PROGRESSION; HUMANS; IDIOPATHIC PULMONARY FIBROSIS; LUNG; LUNG DISEASES, INTERSTITIAL; MIDDLE AGED; PATIENT REPORTED OUTCOME MEASURES; PATIENT SAFETY; RESPIRATORY FUNCTION TESTS; TOMOGRAPHY, X-RAY COMPUTED; TREATMENT OUTCOME;

EID: 84969799564     PISSN: 09031936     EISSN: 13993003     Source Type: Journal    
DOI: 10.1183/13993003.01030-2015     Document Type: Article

References (18)

1. Raghu G, Collard HR, Egan JJ, et al. An official ATS/ERS/JRS/ALAT statement: Idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med 2011; 183: 788-824.
2. Kim DS, Collard HR, King TE Jr. Classification and natural history of the idiopathic interstitial pneumonias. Proc Am Thorac Soc 2006; 3: 285-292.
3. Lipson KE, Wong C, Teng Y, et al. CTGF is a central mediator of tissue remodeling and fibrosis and its inhibition can reverse the process of fibrosis. Fibrogenesis Tissue Repair 2012; 5: Suppl. 1, S24.
4. Mori T, Kawara S, Shinozaki M, et al. Role and interaction of connective tissue growth factor with transforming growth factor-beta in persistent fibrosis: A mouse fibrosis model. J Cell Physiol 1999; 181: 153-159.
5. Wang Q, Usinger W, Nichols B, et al. Cooperative interaction of CTGF and TGF-beta in animal models of fibrotic disease. Fibrogenesis Tissue Repair 2011; 4: 4.
6. Lipson KE, Wirkner U, Sternlicht M, et al. Rapid reversal of radiation-induced murine pneumonitis by treatment with the anti-CTGF monoclonal antibody FG-3019. Eur Respir J 2011; 38: Suppl. 55, P668.
7. Mageto Y, Flaherty K, Brown K, et al. Safety and tolerability of human monoclonal antibody FG-3019, Anti-connective tissue growth factor, in patients with idiopathic pulmonary fibrosis. Chest 2004; 126: Suppl., 773S-a.
8. Chong D, Brown MS, Kim HJ, et al. Reproducibility of volume and densitometric measures of emphysema on repeat computed tomography with an interval of 1 week. Eur Radiol 2012; 22: 287-294.
9. Miller MR, Crapo R, Hankinson J, et al. General considerations for lung function testing. Eur Respir J 2005; 26: 153-161.
10. Brown MS, Kim HJ, Abtin F, et al. Reproducibility of lung and lobar volume measurements using computed tomography. Acad Radiol 2010; 17: 316-322.
11. Kim HJ, Brown MS, Elashoff R, et al. Quantitative texture-based assessment of one-year changes in fibrotic reticular patterns on HRCT in scleroderma lung disease treated with oral cyclophosphamide. Eur Radiol 2011; 21: 2455-2465.
12. Kim HJ, Li G, Gjertson D, et al. Classification of parenchymal abnormality in scleroderma lung using a novel approach to denoise images collected via a multicenter study. Acad Radiol 2008; 15: 1004-1016.
13. US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE-4.03-2010-06-14-QuickReference-8.5x11.pdf Date last updated: June 14, 2010.
14. Best AC, Meng J, Lynch AM, et al. Idiopathic pulmonary fibrosis: physiologic tests, quantitative CT indexes, and CT visual scores as predictors of mortality. Radiology 2008; 246: 935-940.
15. Maldonado F, Moua T, Rajagopalan S, et al. Automated quantification of radiological patterns predicts survival in idiopathic pulmonary fibrosis. Eur Respir J 2014; 43: 204-212.
16. Oda K, Ishimoto H, Yatera K, et al. High-resolution CT scoring system-based grading scale predicts the clinical outcomes in patients with idiopathic pulmonary fibrosis. Respir Res 2014; 15: 10.
17. Kim HJ, Brown MS, Chong D, et al. Comparison of the quantitative CT imaging biomarkers of idiopathic pulmonary fibrosis at baseline and early change with an interval of 7 months. Acad Radiol 2015; 22: 70-80.
18. Hansell DM, Goldin JG, King TE, et al. CT staging and monitoring of fibrotic interstitial lung diseases in clinical practice and treatment trials: A position paper from the Fleischner Society. Lancet Respir Med 2015; 3: 483-496.