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Drug Approval Reports

Progressive fibrosing interstitial lung diseases: A new concept and indication of nintedanib

Pages 13-19 | Received 01 Jul 2020, Accepted 13 Sep 2020, Published online: 21 Dec 2020

References

  • Mikolasch TA, Porter JC. Transbronchial cryobiopsy in the diagnosis of interstitial lung disease: a cool new approach. Respirology. 2014;19(5):623–4.
  • Flaherty KR, Brown KK, Wells AU, Clerisme-Beaty E, Collard HR, Cottin V, et al. Design of the PF-ILD trial: a double-blind, randomised, placebo-controlled phase III trial of nintedanib in patients with progressive fibrosing interstitial lung disease. BMJ Open Respir Res. 2017;4(1):e000212.
  • Cottin V, Hirani NA, Hotchkin DL, Nambiar AM, Ogura T, Otaola M, et al. Presentation, diagnosis, and clinical course of the spectrum of progressive-fibrosing interstitial lung disease. Eur Respir Rev. 2018;27(150):180076.
  • Kim EJ, Elicker BM, Maldonado F, Webb WR, Ryu JH, van Uden JH, et al. Usual interstitial pneumonia in rheumatoid arthritis-associated interstitial lung disease. Eur Respir J. 2010;35(6):1322–8.
  • Wollin L, Wex E, Pautsch A, Schnapp G, Hostettler KE, Stowasser S, et al. Mode of action of nintedanib in the treatment of idiopathic pulmonary fibrosis. Eur Respir J. 2015;45(5):1434–45.
  • Taniguchi H, Ebina M, Kondoh Y, Ogura T, Azuma A, Nukiwa T, Pirfenidone Clinical Study Group in Japan, et al. Pirfenidone in idiopathic pulmonary fibrosis. Eur Respir J. 2010;35(4):821–9.
  • King TE, Jr, Bradford WZ, Castro-Bernardini TR, Fagan EA, Glaspole I, Glassberg MK, et al. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014;370(22):2083–92.
  • Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, et al. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014;370(22):2071–82.
  • Kuwana M, Azuma A. Nintedanib: new indication for systemic sclerosis-associated interstitial lung diseases. Mod Rheumatol. 2020;30(2):225–31.
  • Distler O, Highland KB, Gahlemann M, Azuma A, Fischer A, Mayes MD, SENSCIS Trial Investigators, et al. Nintedanib for systemic sclerosis-associated interstitial lung diseases. N Engl J Med. 2019;380(26):2518–28.
  • Flaherty KR, Wells AU, Cottin V, Devaraj A, Walsh SLF, Inoue Y, et al. Nintedanib in progressive fibrosing interstitial lung diseases. N Engl J Med. 2019;381(18):1718–27.
  • Richeldi L, Varone F, Bergna M, de Andrade J, Falk J, Hallowell R, et al. Pharmacological management of progressive-fibrosing interstitial lung diseases: a review of the current evidence. Eur Respir Rev. 2018;27(150):180074.
  • Walsh SLF, Devaraj A, Enghelmayer JI, Kishi K, Silva RS, Patel N, et al. Role of imaging in progressive-fibrosing interstitial lung diseasese. Eur Respir Rev. 2018;27(150):180073.
  • Kolb M, Bondue B, Pesci A, Miyazaki Y, Song JW, Bhatt NY, et al. Acute exacerbations of progressive-fibrosing interstitial lung diseasese. Eur Respir Rev. 2018;27(150):180071.
  • Olson AL, Gifford AH, Inase N, Fernández Pérez ER, Suda T. The epidemiology of idiopathic pulmonary fobrosis and interstitial lung diseasese at risk of a progressive-fibrosing phenotype. Eur Respir Rev. 2018;27(150):180077.
  • Swigris JJ, Brown KK, Abdulqawi R, Buch K, Dilling DF, Koschel D, et al. Patients’ perceptions and patient-reported outcomes in progressive-fibrosing interstitial lung diseasese. Eur Respir Rev. 2018;27(150):180075.
  • Harari S. Beyond idiopathic pulmonary fobrosis: the world of progressive fibrosing interstitial lung diseases. Eur Respir Rev. 2018;27(150):180110.
  • Inoue Y, Kaner RJ, Guiot J, Maher TM, Tomassetti S, Brown KK, et al. Diagnostic and prognostic biomarkers for chronic fibrosing interstitial lung diseases with a progressive phenotype. Chest. 2020;158(2):646–59.
  • Travis WD, Costabel U, Hansell DM, King TE, Jr, Lynch DA, Nicholson AG, ATS/ERS Committee on Idiopathic Interstitial Pneumonias, et al. An official American Thoracic Society/European Respiratory Society Statements: update of the International Multidisciplinary Classification of the Idiopathic Interstitial Pneumonias. Am J Respir Crit Care Med. 2013;188(6):733–48.
  • Fischer A, Antoniou KM, Brown KK, Cadranel J, Corte TJ, du Bois RM, “ERS/ATS Task Force on Undifferentiated Forms of CTD-ILD”, et al. An official European Respiratory Society/American Thoracic Society research statement: interstitial pneumonia with autoimmune features. Eur Respir J. 2015;46(4):976–85.
  • Travis WD, Hunninghake G, King TE, Jr, Lynch DA, Colby TV, Galvin JR, et al. Idiopathic nonspecific interstitial pneumonia: report of an American Thoracic Society project. Am J Respir Crit Care Med. 2008;177(12):1338–47.
  • Belloli EA, Beckford R, Hadley R, Flaherty KR. Idiopathic non-specific interstitial pneumonia. Respirology. 2016;21(2):259–68.
  • Sverzellati N, Lynch DA, Hansell DM, Johkoh T, King TE, Jr, Travis WD. Idiopathic nonspecific interstitial pneumonia: report of an American Thoracic Society-European Respiratory Society classificattion of the idiopathic interstitial pneumonia: advances in knowledge since 2002. Radiographics. 2015;35(7):1849–71.
  • Bjoraker JA, Ryu JH, Edwin MK, Myers JL, Tazelaar HD, Schroeder DR, et al. Prognostic significance of histopathologic subsets in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 1998;157(1):199–203.
  • Waseda Y, Johkoh T, Egashira R, Sumikawa H, Saeki K, Watanabe S, et al. Antisynthetase syndrome: pulmonary computed tomography findings of adult patients with antibodies to aminoacyl-tRNA synthetases. Eur J Radiol. 2016;85(8):1421–6.
  • . Alarco/n GS, Kremer JM, Macalso M, Weinblatt ME, Cannon GW, Palmer WR, et al. Risk factors for methotrexate-induced lung injury in patients with rheumatoid arthritis: a multicenter, case-control study. Methotrexate-Lung Study Group. Ann Intern Med. 1997;127(5):356–64.
  • Assayag D, Lee JS, King TE. Jr., Rheumatoid arthritis associated interstitial lung disease. Medicina (B Aires). 2014;74(2):158–65.
  • Gabbay E, Tarala R, Will R, Carroll G, Adler B, Cameron D, et al. Interstitial lung disease in recent onset rheumatoid arthritis. Am J Respir Crit Care Med. 1997;156(2):528–35.
  • Gochuico BR, Avila NA, Chow CK, Novero LJ, Wu HP, Ren P, et al. Progressive preclinical interstitial lung disease in rheumatoid arthritis. Arch Intern Med. 2008;168(2):159–66.
  • Kelly CA, Saravanan V, Nisar M, Arthanari S, Woodhead FA, Price-Forbes AN, British Rheumatoid Interstitial Lung (BRILL) Network, et al. Rheumatoid arthritis-related interstitial lung disease: association, prognostic factors and physiological and radiological characteristics-a large multicentre UK study. Rheumatology (Oxford). 2014;53(9):1676–82.
  • Tsuchiya Y, Takayanagi N, Sugiura H, Miyahara Y, Tokunaga D, Kawabata Y, et al. Lung diseases directly associated with rheumatoid arthritis and their relationship to outcome. Eur Respir J. 2011;37(6):1411–7.
  • Yunt ZX, Chung JH, Hobbs S, Fernandez Perez ER, Olson AL, Huie TJ, et al. High resolution computed tomography pattern of usual interstitial pneumonia in rheumatoid arthritis-associated interstitial lung disease: relationship to survival. Respir Med. 2017;126:100–4.
  • Hozumi H, Nakamura Y, Johkoh T, Sumikawa H, Colby TV, Kono M, et al. Acute exacerbations in rheumatoid arthritis-associated interstitial lung diseasese: a retrospective case control study. BMJ Open. 2013;3(9):e003132.
  • Suda T, Kaida Y, Nakamura Y, Enomoto N, Fujisawa T, Imokawa S, et al. Acute exacerbations of interstitial pneumonia associated with collagen vascular diseases. Respir Med. 2009;103(6):846–53.
  • Denton CP, Khanna D. Systemic sclerosis. Lancet. 2017;390(10103):1685–99.
  • Nihtyanova SI, Denton CP. Autoantibodies as a predictive tools in systemic sclerosis. Nat Rev Rheumatol. 2010;6(2):112–6.
  • Walker UA, Tyndall A, Czirják L, Denton C, Farge-Bancel D, Kowal-Bielecka O, et al. Clinical risk assessment of organ manifestations in systemic sclerosis: a report from EULAR scleroderma trials and research group database. Ann Rheum Dis. 2007;66(6):754–63.
  • Bouros D, Wells AU, Nicholson AG, Colby TV, Polychronopoulos V, Pantelidis P, et al. Histopathologic subsets of fibrosing alveolitis in patients with in systemic sclerosis and their relationship to outcome. Am J Respir Crit Care Med. 2002;165(12):1581–6.
  • Berezne A, Valeyre D, Ranque B, Guillevin L, Mouthon L. Interstitial lung disease associated with systemic sclerosis: What is the evidence for efficacy of cyclophosphamide? Ann N Y Acad Sci. 2007;1110(1):271–84.
  • Hamaguchi Y, Hasegawa M, Fujimoto M, Matsushita T, Komura K, Kaji K, et al. The clinical relevance of serum antinuclear antibodies in Japanese patients with systemic sclerosis. Br J Dermatol. 2008;158(3):487–95.
  • Gilson M, Zerkak D, Wipff J, Dusser A, Dinh-Xuan T, Abitbol V, et al. Prognostic factors for lung function in systemic sclerosis: prospective study of 105 cases. Eur Respir J. 2010;35(1):112–7.
  • Steen VD, Powell DL, Medsger TA Jr. Clinical correlation and prognosis based on serum autoantibodies in patients with systemic sclerosis. Arthritis Rheum. 1988;31(2):196–203.
  • LeRoy EC, Black C, Fleischmajer R, Jablonska S, Krieg T, Medsger TA, Jr, et al. Scleroderma (systemic sclerosis): classification, subsets and pathogenesis. J Rheumatol. 1988;15(2):202–5.
  • Nicholson AG, Colby TV, Wells AU. Histopathological approach to patterns of interstitial pneumonia in patients with connective tissue disorders. Sarcoidosis Vasc Diffuse Lung Dis. 2002;19(12):10–7.
  • Latsi PI, Wells AU. Evaluation and management of alveolitis and interstitial lung disease in scleroderma. Curr Opin Rheumatol. 2003;15(6):748–55.
  • Kim DS, Yoo B, Lee JS, Kim EK, Lim CM, Lee SD, et al. The major histopathologic patterns of pulmonary fibrosis in scleroderma is nonspecific interstitial pneumonia. Sarcoidosis Vasc Diffuse Lung Dis. 2002;19(2):121–7.
  • Tyndall AJ, Bannert B, Vonk M, Airò P, Cozzi F, Carreira PE, et al. Causes and risk factors for death in systemic sclerosis: a study from the EULAR scleroderma trials and research (EUSTAR) database. Ann Rheum Dis. 2010;69(10):1809–15.
  • Steen VD, Medsger TA. Changes in causes of death in systemic sclerosis, 1972-2002. Ann Rheum Dis. 2007;66(7):940–4.
  • Castelino FV, Dellaripa PF. Recent progress in systemic sclerosis-interstitial lung disease. Curr Opin Rhumatol. 2018;30(6):570–5.
  • Man A, Davidyock T, Ferguson LT, Ieong M, Zhang Y, Simms RW. Change in forced vital capacity over time in systemic sclerosis: application of group-based trajectory modelling. Rheumatology (Oxford). 2015;54(8):1464–71.
  • Goh NSL, Desai SR, Veeraraghavan S, Hansell DM, Copley SJ, Maher TM, et al. Interstitial lung disease in systemic sclerosis: a simple staging system. Am J Respir Crit Care Med. 2008;177(11):1248–54.
  • Sontheimer RD. Would a new name hasten the acceptance of amyopathic dermatomyositis(dermatomyositis sine myositis) as a distinct subset within the idiopathic inflammatory dermatomyopathies spectrum of clinical illeness? J Am Acad Dermatol. 2002;46(4):626–36.
  • Nakashima R, Hosono Y, Mimori T. Clinical significance and new detection system of autoantibodies in myositis with interstitial lung disease. Lupus. 2016;25(8):925–33.
  • Sato S, Hirakata M, Kuwana M, Suwa A, Inada S, Mimori T, et al. Autoantibodies to a 140 kd polypeptide, CADM-140, in Japanese patients with clinically amyopathic dermatomyositis. Arthritis Rheum. 2005;52(5):1571–6.
  • Gono T, Kawaguchi Y, Ozeki E, Ota Y, Satoh T, Kuwana M, et al. Serum ferritin correlates with activity of anti-MDA-5 antibody-associated acute interstitial lung disease as a complication of dermatomyositis. Mod Rheumatol. 2011;21(2):223–7.
  • Fujimoto M, Hamaguchi Y, Kaji K, Matsushita T, Ichimura Y, Kodera M, et al. Myositis-specific anti-155/140 autoantibodies target transcription intermediary factor 1 family proteins. Arthritis Rheum. 2012;64(2):513–22.
  • Fujimoto M, Murakami A, Kurei S, Okiyama N, Kawakami A, Mishima M, et al. Enzyme-linked immunosorbent assays for detection of anti-transcriptional intermediary factor-1 gamma and anti-Mi2 autoantibodies in dermatomyositis. J Dermatol Sci. 2016;84(3):272–81.
  • . De Souza FHC, Miossi R, Shinjo SK. Necrotizing myopathy associated with anti-signal recognition particle(anti-SRP) antibody. Clin Exp Rheumatol. 2017;35(6):766–71.
  • Zhang L, Wu G, Gao D, Liu G, Pan L, Ni L, et al. Associated with interstitial lung disease in patients with polymyosisis and dermatomyositis: a systemic review and meta-analysis. PLos One. 2016;11(5):e0155381.
  • Debray MP, Borie R, Revel MP, Naccache JM, Khalil A, Toper C, et al. Interstitial lung disease in polymyositis and dermatomyositis. Clinical features and prognosis as correlated with histologic findings. Eur J Radiol. 2015;84(3):516–23.
  • Cottin V, Thivolet-Bejui F, Reynaud-Gaubert M, Cadranel P, Delavel PJ, Ternamian JF, Groupe d'Etudes et de Recherche sur les Maladies "Orphelines" Pulmonaires, et al. Interstitial lung disease in amyopathic dermatomyositis, dermatomyositis and polymyositis. Eur Respir J. 2003;22(2):245–50.
  • Sato S, Masui K, Nishina N, Kawaguchi Y, Kawakami A, Tamura M, JAMI investigators, et al. Initial predictors of poor survival in myositis-associated interstitial lung disease: a multicenter cohort of 497 patients. Rheumatology(Oxford). 2018;57(7):1212–521.
  • Tanizawa K, Handa T, Nakashima R, Kubo T, Hosono Y, Watanabe K, et al. The long-term outcome of interstitial lung diseasese with anti-aminoacyl-tRNA synthetase antibodies. Respir Med. 2017;127:57–64.
  • Fujimoto S, Watts RA, Kobayashi S, Suzuki K, Jayne DRW, Scott DGI, et al. Comparison of the epidemiology of anti-neutrophil cytoplasmic antibody associated vasculitis between Japan and the U.K. Rheumatology(Oxford) 2011;50(10):1916–20.
  • Harper L, Savage COS. Pathogenesis of ANCA-associated systemic vasculitis. J Pathol. 2000;190(3):349–59.
  • Suzuki A, Sakamoto S, Kurosaki A, Kurihara Y, Satoh K, Usui Y, for Japan Research Committee of the Ministry of Health, Labour, and Welfare for Intractable Vasculitis and Research Committee of Intractable Renal Disease of the Ministry of Health, Labour, and Welfare of Japan, et al. Chest high-resolution CT findings of microscopic polyangitis: a Japanese first nationwide prospective cohort study. AJR Am J Roentgenol. 2019;213(1):104–14.
  • Sebastiani M, Manfredi A, Vacchi C, Cassone G, Faverio P, Cavazza A, et al. Epidemiology and management of interstitial lung diseasese in ANCA-associated vasculitis. Clin Exp Rheumatol. 2020;124(2):221–31.
  • Haupt HM, Moore GW, Hutchins GM. The lung in systemic lupus erythematosus analysis of the pathologic changes in 129 patients. Am J Med. 1981;71(5):791–8.
  • Niklas K, Niklas A, Mularek-Kubzdela T, Puszczewicz M. Prevalence of pulmonary hypertension in patients with systemic sclerosis and mixed connective tissue disease. Medicine (Baltimore). 2018;97(28):e11437.
  • Ramos-Casals M, Brito-Zero/n P, Seror R, Bootsma H, Bourman SJ, Dorner T, EULAR Sjögren Syndrome Task Force, et al. Characterization of systemic disease in primary Sjo.gren’s syndrome: EULAR-SS task force recommendations for articular, cutaneous, pulmonary and renal involvements. Rheumatology (Oxford). 2015;54(12):2230–8.
  • Strimlan CV, Rosenow EC 3rd, Divertie MB, Harrison EG Jr. Pulmonary manifestations of Sjo.gren’s syndrome. Chest. 1976;70(3):354–61.
  • Dong X, Zhou J, Guo X, Li Y, Xu Y, Fu Q, et al. A retrospective analysis of distinguishing feature of the chest HRCT and clinical manifestation in primary Sjögren’s syndrome-related interstitial lung diseases in a Chinese population. Clin Rheumatol. 2018;37(11):2981–8.
  • Gao H, Zhang XW, He J, Zhang J, An Y, Sun Y, et al. Prevalence, risk factors, and prognosis of interstitial lung disease in a large cohort of Chinese primary Sjögren’s syndrome patients: a case-control retrospective study. Medicine (Baltimore). 2018;97(24):e11003.
  • Kramer M, Melzer E, Nesher G, Sonnenblick M. Pulmonary manifestations of temporal arteritis. Eur J Respir Dis. 1987;71(5):430–3.
  • Wells AU, Flaherty KR, Brown KK, Inoue Y, Devaraj A, Richeldi L, INBUILD Trial Investigators, et al. Nintedanib in patients with progressive fibrosing interstitial lung diseases-subgroup analysis by interstitial lung disease diagnosis, in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial. Lancet Respir Med. 2020;8(5):453–60.
  • Kreuter M, Koegler H, Trampisch M, Geier S, Richeldi L. Differing severities of acute exacerbations of idiopathic pulmonary fibrosis(IPF) insights from the INPULSIS trials. Respir Res. 2019;20(1):71.