Recombinant human pentraxin-2 therapy in patients with idiopathic pulmonary fibrosis: Safety, pharmacokinetics and exploratory efficacy

European Respiratory Journal

Volumn 47, Issue 3, 2016, Pages 889-897

  Van Den Blink, Bernt ^a   Dillingh, Marlous R ^b   Ginns, Leo C ^c   Morrison, Lake D ^d   Moerland, Matthijs ^b   Wijsenbeek, Marlies ^a   Trehu, Elizabeth G ^e   Bartholmai, Brian J ^f   Burggraaf, Jacobus ^b  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b CENTRE FOR HUMAN DRUG RESEARCH   (Netherlands)

^c MASSACHUSETTS GENERAL HOSPITAL   (United States)

^d DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e Promedior   (United States)

^f MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

INTERCELLULAR ADHESION MOLECULE 1; INTERLEUKIN 8; MATRILYSIN; PENTRAXIN 2; PLACEBO; SERUM AMYLOID P; UNCLASSIFIED DRUG; VASCULOTROPIN; HOMEODOMAIN PROTEIN; PRM-151; RECOMBINANT PROTEIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; BACKACHE; CLINICAL ARTICLE; CONTROLLED STUDY; COUGHING; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPHONIA; DYSPNEA; FATIGUE; FEMALE; FIBROSING ALVEOLITIS; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HEADACHE; HEMATOMA; HUMAN; HYPERTENSION; HYPOTENSION; LUNG FUNCTION; LUNG FUNCTION TEST; LUNG VOLUME; LYMPHADENOPATHY; MALAISE; MALE; MAXIMUM PLASMA CONCENTRATION; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; TREATMENT OUTCOME; VOMITING; WALKING; AGED; CLINICAL TRIAL; DOSE RESPONSE; EXERCISE TEST; IDIOPATHIC PULMONARY FIBROSIS; LUNG; MIDDLE AGED; MULTICENTER STUDY; NETHERLANDS; PATHOPHYSIOLOGY; UNITED STATES; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; EXERCISE TEST; FEMALE; HOMEODOMAIN PROTEINS; HUMANS; IDIOPATHIC PULMONARY FIBROSIS; LUNG; MALE; MIDDLE AGED; NETHERLANDS; RECOMBINANT PROTEINS; RESPIRATORY FUNCTION TESTS; SERUM AMYLOID P-COMPONENT; TREATMENT OUTCOME; UNITED STATES;

EID: 84959906529     PISSN: 09031936     EISSN: 13993003     Source Type: Journal    
DOI: 10.1183/13993003.00850-2015     Document Type: Article

References (23)

1. King TE Jr, Bradford WZ, Castro-Bernardini S, et al. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med 2014; 370: 2083-2092.
2. Richeldi L, du Bois RM, Raghu G, et al. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med 2014; 370: 2071-2082.
3. King TE Jr, Brown KK, Raghu G, et al. BUILD-3: a randomized, controlled trial of bosentan in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2011; 184: 92-99.
4. 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.
5. Wolters PJ, Collard HR, Jones KD. Pathogenesis of idiopathic pulmonary fibrosis. Annu Rev Pathol 2014; 9: 157-179.
6. Cox N, Pilling D, Gomer RH. Serum amyloid P: a systemic regulator of the innate immune response. J Leukoc Biol 2014; 96: 739-743.
7. Doni A, Musso T, Morone D, et al. An acidic microenvironment sets the humoral pattern recognition molecule PTX3 in a tissue repair mode. J Exp Med 2015; 212: 905-925.
8. Castaño AP, Lin SL, Surowy T, et al. Serum amyloid P inhibits fibrosis through FcγR-dependent monocyte-macrophage regulation in vivo. Sci Transl Med 2009; 1: 5ra13.
9. Pilling D, Roife D, Wang M, et al. Reduction of bleomycin-induced pulmonary fibrosis by serum amyloid P. J Immunol 2007; 179: 4035-4044.
10. Verna EC, Patel J, Bettencourt R, et al. Novel association between serum pentraxin-2 levels and advanced fibrosis in well-characterised patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther 2015; 42: 582-590.
11. Murray LA, Rosada R, Moreira AP, et al. Serum amyloid P therapeutically attenuates murine bleomycin-induced pulmonary fibrosis via its effects on macrophages. PLoS One 2010; 5: e9683.
12. Murray LA, Chen Q, Kramer MS, et al. TGF-beta driven lung fibrosis is macrophage dependent and blocked by serum amyloid P. Int J Biochem Cell Biol 2011; 43: 154-162.
13. Dillingh MR, van den Blink B, Moerland M, et al. Recombinant human serum amyloid P in healthy volunteers and patients with pulmonary fibrosis. Pulm Pharmacol Ther 2013; 26: 672-676.
14. van den Blink B, Burggraaf J, Morrison LB, et al. A phase I study of PRM-151 in patients with Idiopathic Pulmonary Fibrosis. American Thoracic Society International Conference, May 17-22, 2013, Philadelphia, PA, USA. 2013: 5707.
15. Zavaletta VA, Bartholmai BJ, Robb RA. High resolution multidetector CT-aided tissue analysis and quantification of lung fibrosis. Acad Radiol 2007; 14: 772-787.
16. Raghunath S, Rajagopalan S, Karwoski RA, et al. Quantitative stratification of diffuse parenchymal lung diseases. PLoS One 2014; 9: e93229.
17. 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.
18. Travis WD, Costabel U, Hansell DM, et al. An official American Thoracic Society/European Respiratory Society statement: update of the international multidisciplinary classification of the idiopathic interstitial pneumonias. Am J Respir Crit Care Med 2013; 188: 733-748.
19. Fell CD, Martinez FJ, Liu LX, et al. Clinical predictors of a diagnosis of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2010; 181: 832-837.
20. Raghu G, Chen SY, Yeh WS, et al. Idiopathic pulmonary fibrosis in US Medicare beneficiaries aged 65 years and older: incidence, prevalence, and survival, 2001-11. Lancet Respir Med 2014; 2: 566-572.
21. Pilling D, Buckley CD, Salmon M, et al. Inhibition of fibrocyte differentiation by serum amyloid P. J Immunol 2003; 171: 5537-5546.
22. Moore B, Lawson WE, Oury TD, et al. Animal models of fibrotic lung disease. Am J Respir Cell Mol Biol 2013; 49: 167-179.
23. Richards TJ, Kaminski N, Baribaud F, et al. Peripheral blood proteins predict mortality in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2012; 185: 67-76.