Efficacy and safety of mavrilimumab in Japanese subjects with rheumatoid arthritis: Findings from a phase iia study

Modern Rheumatology

Volumn 25, Issue 1, 2015, Pages 21-30

  Takeuchi, Tsutomu ^a   Tanaka, Yoshiya ^b   Close, David ^c   Godwood, Alex ^c   Wu, Chi Yuan ^c   Saurigny, Didier ^a  

^a KEIO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

^c MEDIMMUNE   (United States)

Author keywords

Granulocyte macrophage colony stimulating factor; Mavrilimumab; Phase II; Rheumatoid arthritis

Indexed keywords

C REACTIVE PROTEIN; FOLIC ACID; MAVRILIMUMAB; METHOTREXATE; PLACEBO; ANTIRHEUMATIC AGENT; MONOCLONAL ANTIBODY;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; DAS28; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; FOLLOW UP; HEALTH ASSESSMENT QUESTIONNAIRE; HUMAN; HYPERSENSITIVITY; JAPANESE (PEOPLE); MAJOR CLINICAL STUDY; MALE; NEUTROPHIL COUNT; PHARMACOKINETIC ASSAY; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; TREATMENT RESPONSE; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; DOSE RESPONSE; DRUG COMBINATION; JAPAN; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; JAPAN; MALE; METHOTREXATE; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84983421796     PISSN: 14397595     EISSN: 14397609     Source Type: Journal    
DOI: 10.3109/14397595.2014.896448     Document Type: Article

References (32)

1. Scott DL, Wolfe F, Huizinga TW. Rheumatoid arthritis. Lancet. 2010; 376(9746): 1094-108
2. Gibofsky A. Overview of epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis. Am J Manag Care. 2012; 18(13): 295-302
3. Yamanaka H, Sugiyama N, Inoue E, Taniguchi A, Momohara S. Estimates of the prevalence of and current treatment practices for rheumatoid arthritis in Japan using reimbursement data from health insurance societies and the IORRA cohort (I). Mod Rheumatol. 2014; 24(1): 33-40
4. Upchurch K S, Kay J. Evolution of treatment for rheumatoid arthritis. Rheumatology (Oxford). 2012; 51 6: 28-36.
5. Koike R, Takeuchi T, Eguchi K, Miyasaka N, Japan College of Rheumatology. Update on the Japanese guidelines for the use of infl iximab and etanercept in rheumatoid arthritis. Mod Rheumatol. 2007; 17(6): 451-8
6. Koike R, Harigai M, Atsumi T, Amano K, Kawai S, Saito K, et al. Japan College of Rheumatology 2009 guidelines for the use of tocilizumab, a humanized anti-interleukin-6 receptor monoclonal antibody, in rheumatoid arthritis. Mod Rheumatol. 2009; 19(4): 351-7.
7. Takeuchi T, Kameda H. The Japanese experience with biologic therapies for rheumatoid arthritis. Nat Rev Rheumatol. 2010; 6(11): 644-52.
8. C ornish A L, C ampbell I K, M cKenzie B S, C hatfi eld S, Wicks IP. G-CSF and GM-CSF as therapeutic targets in rheumatoid arthritis. Nat Rev Rheumatol. 2009; 5(10): 554-9
9. van Nieuwenhuijze A, K oenders M, R oeleveld D, S leeman M A, van den Berg W, Wicks IP. GM-CSF as a therapeutic target in infl ammatory diseases. Mol Immunol. 2013; 56(4): 675-82
10. Field M, Clinton L. Expression of GM-CSF receptor in rheumatoid arthritis. Lancet. 1993; 342(8881): 1244
11. Berenbaum F, Rajzbaum G, Amor B, Toubert A. Evidence for GM-CSF receptor expression in synovial tissue. An analysis by semi-quantitative polymerase chain reaction on rheumatoid arthritis and osteoarthritis synovial biopsies. Eur Cytokine Netw. 1994; 5(1): 43-6
12. Bell AL, Magill MK, McKane WR, Kirk F, Irvine AE. Measurement of colony-stimulating factors in synovial fluid: potential clinical value. Rheumatol Int. 1995; 14(5): 177-82
13. Davis JMII, Knutson K L, Strausbauch M A, Crowson C S, Therneau TM, Wettstein PJ, et al. Analysis of complex biomarkers for human immune-mediated disorders based on cytokine responsiveness of peripheral blood cells. J Immunol. 2010; 184(12): 7297-304
14. Fiehn C, Wermann M, Pezzutto A, Hufner M, Heilig B. Plasma GM-CSF concentrations in rheumatoid arthritis, systemic lupus erythematosus and spondyloarthropathy. Z Rheumatol. 1992; 51(3): 121-126
15. de Vries EG, Willemse PH, Biesma B, Stern AC, Limburg PC, Vellenga E. Flare-up of rheumatoid arthritis during GM-CSF treatment after chemotherapy. Lancet. 1991; 338(8765): 517-8
16. Hazenberg BP, Van Leeuwen MA, Van Rijswijk MH, Stern AC, Vellenga E. Correction of granulocytopenia in Felty’ s syndrome by granulocyte-macrophage colony-stimulating factor. Simultaneous induction of interleukin-6 release and fl are-up of the arthritis. Blood. 1989; 74(8): 2769-70
17. Pereira J, Velloso E D, Loterio H A, Laurindo I M, Chamone D A. Long-term remission of neutropenia in Felty ’ s syndrome after a short GM-CSF treatment. Acta Haematol. 1994; 92(3): 154-6.
18. Minter RR, Cohen ES, Wang B, Liang M, Vainshtein I, Rees G, et al. Protein engineering and preclinical development of a GMCSF receptor antibody for the treatment of rheumatoid arthritis. Br J Pharmacol. 2013; 168(1): 200-11
19. Burmester GR, Feist E, Sleeman M A, Wang B, White B, Magrini F. Mavrilimumab, a human monoclonal antibody targeting GMCSF receptor- a, in subjects with rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase I, first-in-human study. Ann Rheum Dis. 2011; 70(9): 1542-9
20. Burmester GR, Weinblatt ME, McInnes IB, Porter D, Barbarash O, Vatutin M, et al. Efficacy and safety of mavrilimumab in subjects with rheumatoid arthritis. Ann Rheum Dis. 2013; 72(9): 1445-52.
21. Smolen J S, Breedveld F C, Schiff MH, Kalden JR, Emery P, Eberl G, et al. A simplified disease activity index for rheumatoid arthritis for use in clinical practice. Rheumatology (Oxford). 2003; 42(2): 244-57.
22. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classifi cation of rheumatoid arthritis. Arthritis Rheum. 1988; 31(3): 315-24
23. Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen 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(6): 954-60
24. Fries J F, Spitz P, Kraines R G, H olman H R. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980; 23(2): 137-45
25. Kitamura T, Tanaka N, Watanabe J, Uchida, Kanegasaki S, Yamada Y, Nakata K. Idiopathic pulmonary alveolar proteinosis as an autoimmune disease with neutralizing antibody against granulocyte/macrophage colony-stimulating factor. J Exp Med. 1999; 190(6): 875-80
26. Trapnell BC, Carey BC, Uchida K, Suzuki T. Pulmonary alveolar proteinosis, a primary immunodefi ciency of impaired GM-CSF stimulation of macrophages. Curr Opin Immunol. 2009; 21(5): 514-21.
27. Ohnishi H, Yokoyama A, Kondo K, Hamada H, Abe M, Nishimura 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(3): 378-81
28. Wang B, Lau YY, Liang M, Vainshtein I, Zusmanovich M, Lu H, et al. Mechanistic modeling of antigen sink effect for mavrilimumab following intravenous administration in patients with rheumatoid arthritis. J Clin Pharmacol. 2012; 52(8): 1150-61
29. Wang B, Kowalski K, White W, Wu C, Chapel S, Chen X, et al. Population pharmacokinetics and pharmacodynamics of mavrilimumab in rheumatoid arthritis patients [Abstr 2611]. PAGE Abstracts of the Annual Meeting of the Population Approach Group in Europe. 2012: 21
30. Khan M A. H LA-B27 and its subtypes in world populations. Curr Opin Rheumatol. 1995; 7(4): 263-9.
31. Saeki Y, Matsui T, Saisho K, Tohma S. Current treatments of rheumatoid arthritis: from the ‘NinJa ’ registry. Expert Rev Clin Immunol. 2012; 8(5): 455-65
32. Harigai M, Koike R, Miyasaka N, Pneumocystis Pneumonia under Anti-Tumor Necrosis Factor Therapy (PAT) Study Group. Pneumocystis pneumonia associated with infliximab in Japan. N Engl J Med. 2007; 357(18): 1874-6