Pharmacokinetics and pharmacodynamics of monoclonal antibodies for asthma treatment

References

• Beasley R. The burden of asthma with specific reference to the United States. J Allergy Clin Immunol. 2002 May;109(5 Suppl):S482–9.
   Google Scholar
• GINA gudelines of asthma. [cited 2018 Sep 2]. Available from: http://ginasthma.org/2017-gina-report-global-strategy-for-asthma-245 management-and-prevention/
   Google Scholar
• Bagnasco D, Ferrando M, Caminati M, et al. Targeting interleukin-5 or interleukin-5Rα: safety considerations. Drug Saf. 2017;40(7):559–570.
   Google Scholar
• Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS 243 guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43:343–373.
   Google Scholar
• Godard P, Chanez P, Siraudin L, et al. Costs of asthma are correlated with severity: a 1-yr prospective study. Eur Respir J. 2002 Jan;19(1):61–67.
   Google Scholar
• Caminati M, Pham DL, Bagnasco D, et al. Type 2 immunity in asthma. World Allergy Organ J. 2018 Jun 26; 11(1):13.
   Google Scholar
• Lombardi C, Savi E, Ridolo E, et al. Is allergic sensitization relevant in severe asthma? Which allergens may be culprit? World Allergy Organ J. 2017 Jan 6;10(1):2.
   Google Scholar
• De Ferrari L, Chiappori A, Bagnasco D, et al. Molecular phenotyping and biomarker development: are we on our way towards targeted therapy for severe asthma? Expert Rev Respir Med. 2016;10:9–38.
   Google Scholar
• Wynn TA. Type 2 cytokines: mechanisms and therapeutic strategies. Nat Rev Immunol. 2015;15(5):271–282.
   Google Scholar
• Oliphant CJ, Barlow JL, McKenzie AN. Insights into the initiation of type 2 immune responses. Immunology. 2011;134(4):378–385.
   Google Scholar
• Chang TW, Wu PC, Hsu CL, et al. Anti-IgE antibodies for the treatment of IgE mediated allergic diseases. Adv Immunol. 2007;93:63–119.
   Google Scholar
• Luu M, Bardou M, Bonniaud P, et al. Pharmacokinetics, pharmacodynamics and clinical efficacy of omalizumab for the treatment of asthma. Expert Opin Drug Metab Toxicol. 2016 Dec;12(12):1503–1511.
   Google Scholar
• Hendeles L, Sorkness CA. Anti-immunoglobulin E therapy with omalizumab for asthma. Ann Pharmacother. 2007 Sep;41(9):1397–1410.
   Google Scholar
• European medicines agency - Xolair - product information. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000606/WC500057298.pdf
   Google Scholar
• Food and drug administration – Xolair Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/omalgen062003LB.pdf
   Google Scholar
• Bang LM, Plosker GL. Omalizumab: a review of its use in the management of allergic asthma. Treat Respir Med. 2004;3(3):183–199.
   Google Scholar
• MacGlashan DW, Bochner BS, Adelman DC, et al. Down-regulation of Fc(epsilon)RI expression on human basophils during in vivo treatment of atopic patients with anti-IgE antibody. J Immunol Baltim Md 1950. 1997 Feb 1;158(3):1438–1445.
   Google Scholar
• Noga O, Hanf G, Kunkel G, et al. Basophil histamine release decreases during omalizumab therapy in allergic asthmatics. Int Arch Allergy Immunol. 2008;146(1):66–70.
   Google Scholar
• Dodig S, Richter D, Cepelak I, et al. Anti-IgE therapy with omalizumab in asthma and allergic rhinitis. Acta Pharm. 2005;55:123–138.
   Google Scholar
• Varricchi G, Bagnasco D, Borriello F, et al. Interleukin-5 pathway inhibition in the treatment of eosinophilic respiratory disorders: evidence and unmet needs. Curr Opin Allergy Clin Immunol. 2016;16(2):186–200.
   Google Scholar
• Ortega HG, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371:1198–1207.
   Google Scholar
• Bagnasco D, Caminati M, Ferrando M, et al. Anti-IL-5 and IL-5Ra: efficacy and safety of new therapeutic strategies in severe uncontrolled asthma. Biomed Res Int. 2018 Nov 5;2018:5698212.
   Google Scholar
• Schofield JP. An open, randomized, parallel group study to assess the bioavailability following administration at 3 subcutaneous sites and 1 intramuscular site relative to intravenous administration of single 250 mg doses of SB-240563 to healthy volunteers. Brentford: GlaxoSmithKline; 2002. ( Data on file).
   Google Scholar
• Choi MS, Dixit D, Bridgeman MB. Mepolizumab (nucala) for severe eosinophilic asthma. P T. 2016 Oct;41(10):619–622.
   Google Scholar
• Waldmann TA, Strober W. Metabolism of immunoglobulins. Prog Allergy. 1969;13:1–110.
   Google Scholar
• Mould DR, Sweeney KR. The pharmacokinetics and pharmacodynamics of monoclonal antibodies-mechanistic modeling applied to drug development. Curr Opin Drug Discovery Dev. 2007;10(1):84–96.
   Google Scholar
• Smith D, Minthorn EA, Beerahee M. Pharmacokinetics and pharmacodynamics of mepolizumab, an anti-interleukin-5 monoclonal antibody . Clin Pharmacokinet. 2011;50(4):215–227.
   Google Scholar
• Leckie MJ, tenBrinke A, Khan J, et al. Effects of an interleukin-5 blocking monoclonal antibody on eosinophils, airway hyper-responsiveness, and the late asthma response. Lancet. 2000;356:2144–2148.
   Google Scholar
• Pouliquen IJ, Kornmann O, Barton SV, et al. Characterization of the relationship between dose and blood eosinophil response following subcutaneous administration of mepolizumab. Int J Clin Pharmacol Ther. 2015 Dec;53(12):1015–1027.
   Google Scholar
• Freestone S. A double-blind, placebo controlled, parallel group study to assess the tolerability and pharmacokinetics of three 250 mg subcutaneous doses of SB-240563 in male and female patients with asthma. Brentford: Glaxo- SmithKline; 2001. (Data on file).
   Google Scholar
• Ortega H, Yancey S, Cozens S. Pharmacokinetics and absolute bioavailability of mepolizumab following administration at subcutaneous and intramuscular sites. Clin Pharmacol Drug Dev. 2014 Jan;3(1):57–62.
   Google Scholar
• Freestone S. A double blind, placebo controlled, dose rising study to assess safety and pharmacokinetics of SB-240563 in male patients with mild asthma. Brentford: GlaxoSmithKline; 1998. (Data on file).
   Google Scholar
• Flood-Page PT, Menzies-Gow AN, Kay AB, et al. Eosinophil’s role remains uncertain as anti-interleukin-5 only partially depletes numbers in asthmatic airway. Am J Respir Crit Care Med. 2003;167(2):199–204.
   Google Scholar
• Matera MG, Calzetta L, Rinaldi B, et al. Pharmacokinetic/pharmacodynamic drug evaluation of benralizumab for the treatment of asthma. Expert Opin Drug Metab Toxicol. 2017 Sep;13(9):1007–1013.
   Google Scholar
• Ghazi A, Trikha A, Calhoun WJ. Benralizumab - a humanized mAb to IL-5Rα with enhanced antibody-dependent cell-mediated cytotoxicity - a novel approach for the treatment of asthma. Expert Opin Biol Ther. 2012;12(1):113–118.
   Google Scholar
• Passalacqua G, Matucci A, Vultaggio A, et al. The safety of monoclonal antibodies in asthma. Expert Opin Drug Saf. 2016;15(8):1087–1095.
   Google Scholar
• Broughton SE, Nero TL, Dhagat U, et al. The betac receptor family: structural insights and their functional implications. Cytokine. 2015;74:247–258.
   Google Scholar
• Busse WW, Katial R, Gossage D, et al. Safety profile, pharmacokinetics, and biologic activity of MEDI-563, an anti-IL-5 receptor antibody, in a phase I study of subjects with mild asthma. J Allergy Clin Immunol. 2010;125(6):1237–1244.
   Google Scholar
• Jin F, White W, Gossage D, et al. Multiple ascending subcutaneous (SC) dose study of MEDI-563: pharmacokinetics and immune response in adult asthmatics [abstract]. European Respiratory Society – 20th Annual Congress; 2010 Sept 18–22; Barcelona. P4553.
   Google Scholar
• Gossage D, Geba G, Gillen A, et al. A multiple ascending subcutaneous (SC) dose study of MEDI-563, a humanized anti-IL5Ra monoclonal antibody, in adult asthmatics [abstract]. European Respiratory Society – 20th Annual Congress; 2010 Sept 18–22; Barcelona. P1177.
   Google Scholar
• Wang B, Yan L, Yao Z, et al. Population pharmacokinetics and pharmacodynamics of benralizumab in healthy volunteers and patients with asthma. PT Pharmacometrics Syst Pharmacol. 2017;6(4):249–257.
   Google Scholar
• Pelaia C, Calabrese C, Vatrella A, et al. Benralizumab: from the basic mechanism of action to the potential use in the biological therapy of severe eosinophilic asthma. Biomed Res Int. 2018 May;10(2018):4839230.
   Google Scholar
• Dirks NL, Meibohm B. Population pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49:633–659.
   Google Scholar
• Laviolette M, Gossage DL, Gauvreau G, et al. Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia. J Allergy Clin Immunol. 2013;132:1086–1096.
   Google Scholar
• Available from: http://ir.tevapharm.com/mobile.view?c=73925&v=203&d=1&id=2327641
   Google Scholar
• Matera MG, Rogliani P, Calzetta L, et al. Pharmacokinetic/pharmacodynamic profile of reslizumab in asthma. Expert Opin Drug Metab Toxicol. 2018 Feb;14(2):239–245.
   Google Scholar
• Jaworowicz D, Fiedler-Kelly J, Rabinovich-Guilatt L, et al. The steady-state pharmacokinetic (PK) profile across a range of patient body weight categories supports weight-based dosing for intravenous (iv) reslizumab [abstract]. Am J Respir Crit Care Med. 2016;193:A1389.
   Google Scholar
• Deeks ED, Brusselle G. Reslizumab in eosinophilic asthma: a review. Drugs. 2017;77:777–784.
   Google Scholar
• Egan RW, Athwal D, Bodmer MW, et al. Effect of SCH55700, a humanized monoclonal antibody to human interleukin-5, on eosinophilic responses and bronchial hyperreactivity. Arzneimittelforschung. 1999;49:779–790.
   Google Scholar
• Zhang J, Kuvelkar R, Murgolo NJ, et al. Mapping and characterization of the epitope(s) of Sch 55700, a humanized mAb, that inhibits human IL-5. Int Immunol. 1999;11:1935–1944.
   Google Scholar
• Kipps JC, O’Connor BJ, Langley SJ, et al. Effect of SCH55700, a humanized antihuman interleukin-5 antibody, in severe persistent asthma. Am J Respir Crit Care Med. 2003;167:1655–1659.
   Google Scholar
• Mukherjee M, Paramo FA, Kjarsgaard M, et al. Weight-adjusted intravenous reslizumab in severe asthma with inadequate response to fixed-dose subcutaneous mepolizumab. Am J Respir Crit Care Med. 2018;197(1):38–46.
   Google Scholar
• Passalacqua G, Mincarini M, Colombo D, et al. IL-13 and idiopathic pulmonary fibrosis: possible links and new therapeutic strategies. Pulm Pharmacol Ther. 2017;45:95–100.
   Google Scholar
• Available from: https://ec.europa.eu/health/documents/community-register/2017/20170926138667/anx_138667_en.pdf
   Google Scholar
• Wenzel S, Castro M, Corren J, et al. Dupilumab effi cacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016;388:31–44.
   Google Scholar
• Castro M, Corren J, Pavord ID, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med. 2018 Jun 28;378(26):2486–2496.
   Google Scholar
• Humbert M, Taillé C, Mala L, et al. Omalizumab effectiveness in patients with severe allergic asthma according to blood eosinophil count: the STELLAIR study. Eur Respir J. 2018;51:5, May 10
   Google Scholar
• Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001 Aug;108(2):184–190.
   Google Scholar
• Solèr M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J. 2001 Aug;18(2):254–261.
   Google Scholar
• Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651–659.
   Google Scholar
• Chupp GL, Bradford ES, Albers FC, et al. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017 5;May(5):390–400.
   Google Scholar
• Bel EH, Wenzel SE, Thompson PJ, et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371(13):1189–1197.
   Google Scholar
• FitzGerald JM, Bleecker ER, Nair P, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2128–2141.
   Google Scholar
• Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115–2127.
   Google Scholar
• Castro M, Zangrilli J, Wechsler ME, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015;3:355–366.
   Google Scholar
• Castro M, Mathur S, Hargreave F, et al. Reslizumab for poorly controlled, eosinophilic asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2011;184:1125–1132.
   Google Scholar
• Corren J, Weinstein S, Janka L, et al. Phase 3 study of reslizumab in patients with poorly controlled asthma: effects across a broad range of eosinophil counts. Chest. 2016 Oct;150(4):799–810.
   Google Scholar
• Bjermer L, Lemiere C, Maspero J, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil levels: a randomized phase 3 study. Chest. 2016 Oct;150(4):789–798.
   Google Scholar
• Rabe KF, Nair P, Brusselle G, et al. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. N Engl J Med. 2018 Jun 28;378(26):2475–2485.
   Google Scholar
• Matucci A, Vultaggio A, Danesi R. The use of intravenous versus subcutaneous monoclonal antibodies in the treatment of severe asthma: a review. Respir Res. 2018 Aug 16;19(1):154.
   Google Scholar
• Morse BL, Kim RB. Is personalized medicine a dream or a reality? Crit Rev Clin Lab Sci. 2015 Feb;52(1):1–11.
   Google Scholar
• Lombardi C, Canonica GW, Passalacqua G. Allergen immunotherapy as add-on to biologic agents. Curr Opin Allergy Clin Immunol. 2018 Aug 24. DOI:10.1097/ACI.0000000000000479.
   Google Scholar
• Bagnasco D, Milanese M, Rolla G, et al. Anti-IL-5 therapy in real life. The North-Western Italian experience 3 and comparison with the regulatory trials. WAOJ-D. 2018;11:34.
   Google Scholar
• Galkin D, Liu MC, Chipps BE, et al. Efficacy and safety of mepolizumab in uncontrolled patients with severe eosinophilic asthma following a switch from omalizumab (osmo study): exacerbation and safety outcomes. DOI:10.1016/j.jaci.2017.12.965
   Google Scholar
• Chipps BE, Newbold P, Hirsch I, et al. Benralizumab efficacy by atopy status and serum immunoglobulin E for patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2018 May;120(5):504–511.e4.
   Google Scholar
• Casale TB, Pacou M, Mesana L et al.Reslizumab compared with benralizumab in patients with eosinophilic asthma: a systematic literature review and network meta-analysis. J Allergy Clin Immunol Pract. 2019 Jan;7(1):122-130.e1.
   Google Scholar