Efficacy and safety of mavrilimumab in subjects with rheumatoid arthritis

Annals of the Rheumatic Diseases

Volumn 72, Issue 9, 2013, Pages 1445-1452

  Burmester, Gerd R ^a   Weinblatt, Michael E ^b   McInnes, Iain B ^c   Porter, Duncan ^d   Barbarash, Olga ^e   Vatutin, Mykola ^f   Szombati, Istvan ^g   Esfandiari, Ehsanollah ^h,j   Sleeman, Matthew A ^h   Kane, Christopher D ^h,m   Cavet, Guy ^i,l   Wang, Bing ^h   Godwood, Alex ^h   Magrini, Fabio ^h,k  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c UNIVERSITY OF GLASGOW   (United Kingdom)

^d GARTNAVEL GENERAL HOSPITAL   (United Kingdom)

^e Kemerovo Regional Clinical Psychiatric Hospital   (Russian Federation)

^f DONETSK NATIONAL MEDICAL UNIVERSITY   (Ukraine)

^g Óbudai Egészségügyi Centrum OEC   (Hungary)

^h MEDIMMUNE   (United States)

ⁱ Crescendo Bioscience Inc   (United States)

^j IMPERIAL COLLEGE LONDON   (United Kingdom)

^k ELI LILLY AND COMPANY   (United States)

^l GOOGLE INC   (United States)

^m UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; MAVRILIMUMAB; METHOTREXATE; PLACEBO;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALLERGIC REACTION; AMENORRHEA; AMERICAN COLLEGE OF RHEUMATOLOGY; AMINOTRANSFERASE BLOOD LEVEL; ANAPHYLAXIS; ANEMIA; ARTICLE; BRONCHITIS; CONTROLLED STUDY; COUGHING; DISEASE ACTIVITY SCORE; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ERUPTION; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HEALTH ASSESSMENT QUESTIONNAIRE; HEALTH ASSESSMENT QUESTIONNAIRE DISABILITY INDEX; HERPETIC STOMATITIS; HUMAN; HUMERUS FRACTURE; HYPERCHOLESTEROLEMIA; HYPERTENSION; INFLUENZA; INJECTION SITE PAIN; INJECTION SITE REACTION; INTERVERTEBRAL DISK DISEASE; MALE; MONOCYTOPENIA; MONONUCLEAR PHAGOCYTE; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; NEUTROPENIA; OPPORTUNISTIC INFECTION; PATELLA FRACTURE; PHARYNGITIS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SIDE EFFECT; SKIN EXFOLIATION; TREATMENT DURATION; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION;

DISEASE ACTIVITY; RHEUMATOID ARTHRITIS; TREATMENT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DISABILITY EVALUATION; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; GLUCOCORTICOIDS; HEALTH STATUS; HUMANS; LEUKOCYTES, MONONUCLEAR; MALE; METHOTREXATE; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84881479459     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2012-202450     Document Type: Article

References (44)

1. Campbell J, Lowe D, Sleeman MA. Developing the next generation of monoclonal antibodies for the treatment of rheumatoid arthritis. Br J Pharmacol 2011;162:1470-84.
2. Cornish AL, Campbell IK, McKenzie BS, et al. G-CSF and GM-CSF as therapeutic targets in rheumatoid arthritis. Nat Rev Rheumatol 2009;5:554-9.
3. Mulherin D, Fitzgerald O, Bresnihan B. Synovial tissue macrophage populations and articular damage in rheumatoid arthritis. Arthritis Rheum 1996;39:115-24. (Pubitemid 26036386)
4. Bresnihan B, Gerlag DM, Rooney T, et al. Synovial macrophages as a biomarker of response to therapeutic intervention in rheumatoid arthritis: standardization and consistency across centers. J Rheumatol 2007;34:620-2. (Pubitemid 46364021)
5. de Hair MJ, Harty LC, Gerlag DM, et al. Synovial tissue analysis for the discovery of diagnostic and prognostic biomarkers in patients with early arthritis. J Rheumatol 2011;38:2068-72.
6. Haringman JJ, Gerlag DM, Zwinderman AH, et al. Synovial tissue macrophages: a sensitive biomarker for response to treatment in patients with rheumatoid arthritis. Ann Rheum Dis 2005;64:834-8. (Pubitemid 40733904)
7. Bell AL, Magill MK, McKane WR, et al. Measurement of colony-stimulating factors in synovial fluid: potential clinical value. Rheumatol Int 1995;14:177-82.
8. Fiehn C, Wermann M, Pezzutto A, et al. (Plasma GM-CSF concentrations in rheumatoid arthritis, systemic lupus erythematosus and spondyloarthropathy). Z Rheumatol 1992;51:121-6.
9. Davis JM III, Knutson KL, Strausbauch MA, et al. Analysis of complex biomarkers for human immune-mediated disorders based on cytokine responsiveness of peripheral blood cells. J Immunol 2010;184:7297-304.
10. Hazenberg BP, Van Leeuwen MA, Van Rijswijk MH, et al. Correction of granulocytopenia in Felty's syndrome by granulocyte-macrophage colony-stimulating factor. Simultaneous induction of interleukin-6 release and flare-up of the arthritis. Blood 1989;74:2769-70. (Pubitemid 20007805)
11. Pereira J, Velloso ED, Loterio HA, et al. Long-term remission of neutropenia in Felty's syndrome after a short GM-CSF treatment. Acta Haematol 1994;92:154-6.
12. de Vries EG, Willemse PH, Biesma B, et al. Flare-up of rheumatoid arthritis during GM-CSF treatment after chemotherapy. Lancet 1991;338:517-18.
13. Burmester GR, Feist E, Sleeman MA, et al. Mavrilimumab, a human monoclonal antibody targeting GM-CSF receptor-{alpha}, in subjects with rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase I, first-in-human study. Ann Rheum Dis 2011;70:1542-9.
14. Wang B, Lau YY, Liang M, et al. Mechanistic modeling of antigen sink effect for mavrilimumab following intravenous administration in patients with rheumatoid arthritis. J Clin Pharmacol 2011;52:1150-61.
15. Smolen JS, Breedveld FC, Schiff MH, et al. A simplified disease activity index for rheumatoid arthritis for use in clinical practice. Rheumatology (Oxford) 2003;42:244-57. (Pubitemid 36305610)
16. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315-24. (Pubitemid 18091653)
17. Wells G, Becker JC, Teng J, et al. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis 2009;68:954-60.
18. Fries JF, Spitz P, Kraines RG, et al. Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23:137-45. (Pubitemid 10164318)
19. Bakker MF, Cavet G, Jacobs JW, et al. Performance of a multi-biomarker score measuring rheumatoid arthritis disease activity in the CAMERA tight control study. Ann Rheum Dis 2012;71:1692-7.
20. Curtis JR, van der Helm-van Mil AH, Knevel R, et al. Validation of a novel multi-biomarker test to assess rheumatoid arthritis disease activity. Arthritis Care Res 2012;(accessed 6 Nov 2012). accepted article.
21. Crescendo Bioscience I. Vectra DA disease activity test. 2012. http://www.vectra-da.com/ (accessed 12 Apr 2012).
22. Kitamura T, Tanaka N, Watanabe J, et al. Idiopathic pulmonary alveolar proteinosis as an autoimmune disease with neutralizing antibody against granulocyte/macrophage colony-stimulating factor. J Exp Med 1999;190: 875-80. (Pubitemid 29451632)
23. Trapnell BC, Carey BC, Uchida K, et al. Pulmonary alveolar proteinosis, a primary immunodeficiency of impaired GM-CSF stimulation of macrophages. Curr Opin Immunol 2009;21:514-21.
24. Suzuki T, Sakagami T, Rubin BK, et al. Familial pulmonary alveolar proteinosis caused by mutations in CSF2RA. J Exp Med 2008;205:2703-10.
25. Seymour JF, Presneill JJ. Pulmonary alveolar proteinosis: progress in the first 44 years. Am J Respir Crit Care Med 2002;166:215-35. (Pubitemid 34765459)
26. Seymour JF, Doyle IR, Nakata K, et al. Relationship of anti-GM-CSF antibody concentration, surfactant protein A and B levels, and serum LDH to pulmonary parameters and response to GM-CSF therapy in patients with idiopathic alveolar proteinosis. Thorax 2003;58:252-7. (Pubitemid 36308005)
27. Inoue Y, Trapnell BC, Tazawa R, et al. Characteristics of a large cohort of patients with autoimmune pulmonary alveolar proteinosis in Japan. Am J Respir Crit Care Med 2008;177:752-62. (Pubitemid 351490562)
28. Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J Roy Statist Soc Ser B (Methodological) 1995;57:289-300.
29. Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, et al. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum 2005;52:3381-90. (Pubitemid 41612204)
30. Breedveld FC, Weisman MH, Kavanaugh AF, et al. The PREMIER study: A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum 2006;54:26-37. (Pubitemid 43122183)
31. St Clair EW, van der Heijde DM, Smolen JS, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum 2004;50:3432-43. (Pubitemid 39488667)
32. McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med 2011;365:2205-19.
33. Mease PJ. The potential roles for novel biomarkers in rheumatoid arthritis assessment. Clin Exp Rheumatol 2011;29:567-74.
34. Johansen JS, Stoltenberg M, Hansen M, et al. Serum YKL-40 concentrations in patients with rheumatoid arthritis: relation to disease activity. Rheumatology (Oxford) 1999;38:618-26. (Pubitemid 29507329)
35. Recklies AD, White C, Ling H. The chitinase 3-like protein human cartilage glycoprotein 39 (HC-gp39) stimulates proliferation of human connective-tissue cells and activates both extracellular signal-regulated kinase-and protein kinase B-mediated signalling pathways. Biochem J 2002;365(Pt 1):119-26. (Pubitemid 34756146)
36. Knudsen LS, Klarlund M, Skjodt H, et al. Biomarkers of inflammation in patients with unclassified polyarthritis and early rheumatoid arthritis. Relationship to disease activity and radiographic outcome. J Rheumatol 2008;35:1277-87. (Pubitemid 352000771)
37. Tanaka T, Narazaki M, Kishimoto T. Therapeutic targeting of the interleukin-6 receptor. Annu Rev Pharmacol Toxicol 2012;52:199-219.
38. Sonderegger I, Iezzi G, Maier R, et al. GM-CSF mediates autoimmunity by enhancing IL-6-dependent Th17 cell development and survival. J Exp Med 2008;205:2281-94.
39. El-Behi M, Ciric B, Dai H, et al. The encephalitogenicity of T(H)17 cells is dependent on IL-1-and IL-23-induced production of the cytokine GM-CSF. Nat Immunol 2011;12:568-75.
40. Codarri L, Gyulveszi G, Tosevski V, et al. RORgammat drives production of the cytokine GM-CSF in helper T cells, which is essential for the effector phase of autoimmune neuroinflammation. Nat Immunol 2011;12:560-7.
41. Kavanaugh A, Klareskog L, van der Heijde D, et al. Improvements in clinical response between 12 and 24 weeks in patients with rheumatoid arthritis on etanercept therapy with or without methotrexate. Ann Rheum Dis 2008;67:1444-7.
42. Miyata M, Sakuma F, Fukaya E, et al. Detection and monitoring of methotrexate-associated lung injury using serum markers KL-6 and SP-D in rheumatoid arthritis. Intern Med 2002;41:467-73. (Pubitemid 34727578)
43. Ohnishi H, Yokoyama A, Kondo K, et al. Comparative study of KL-6, surfactant protein-A, surfactant protein-D, and monocyte chemoattractant protein-1 as serum markers for interstitial lung diseases. Am J Respir Crit Care Med 2002;165:378-81. (Pubitemid 34118512)
44. Oyama T, Kohno N, Yokoyama A, et al. Detection of interstitial pneumonitis in patients with rheumatoid arthritis by measuring circulating levels of KL-6, a human MUC1 mucin. Lung 1997;175:379-85. (Pubitemid 27431215)