Results from a Phase IIA Parallel Group Study of JNJ-40346527, an Oral CSF-1R Inhibitor, in Patients with Active Rheumatoid Arthritis despite Disease-modifying Antirheumatic Drug Therapy

REFERENCES

1. 1.↵
   1. McInnes IB,
   2. Schett G

   . The pathogenesis of rheumatoid arthritis. N Engl J Med 2011;365:2205–19.

   OpenUrlCrossRefPubMed
2. 2.↵
   1. Singh JA,
   2. Furst DE,
   3. Bharat A,
   4. Curtis JR,
   5. Kavanaugh AF,
   6. Kremer JM,
   7. et al.

   2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res 2012;64:625–39.

   OpenUrlCrossRef
3. 3.↵
   1. O’Dell JR,
   2. Mikuls TR,
   3. Taylor TH,
   4. Ahluwalia V,
   5. Brophy M,
   6. Warren SR,
   7. et al.

   Therapies for active rheumatoid arthritis after methotrexate failure. N Engl J Med 2013;369:307–18.

   OpenUrlCrossRefPubMed
4. 4.↵
   1. Burmester GR,
   2. Blanco R,
   3. Charles-Schoeman C,
   4. Wollenhaupt J,
   5. Zerbini C,
   6. Benda B,
   7. et al;
   8. ORAL Step investigators

   . Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. Lancet 2013;381:451–60.

   OpenUrlCrossRefPubMed
5. 5.↵
   1. Papagoras C,
   2. Voulgari PV,
   3. Drosos AA

   . Strategies after the failure of the first anti-tumor necrosis factor alpha agent in rheumatoid arthritis. Autoimmun Rev 2010;9:574–82.

   OpenUrlCrossRefPubMed
6. 6.↵
   1. Hamilton JA

   . Colony-stimulating factors in inflammation and autoimmunity. Nat Rev Immunol 2008;8:533–44.

   OpenUrlCrossRefPubMed
7. 7.↵
   1. Toh ML,
   2. Bonnefoy JY,
   3. Accart N,
   4. Cochin S,
   5. Pohle S,
   6. Haegel H,
   7. et al.

   Bone- and cartilage-protective effects of a monoclonal antibody against colony-stimulating factor 1 receptor in experimental arthritis. Arthritis Rheum 2014;66:2989–3000.

   OpenUrlCrossRef
8. 8.↵
   1. Arnett FC,
   2. Edworthy SM,
   3. Bloch DA,
   4. McShane DJ,
   5. Fries JF,
   6. Cooper NS,
   7. et al.

   The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315–24.

   OpenUrlCrossRefPubMed
9. 9.↵
   1. Fries JF,
   2. Spitz P,
   3. Kraines RG,
   4. Holman HR

   . Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23:137–45.

   OpenUrlCrossRefPubMed
10. 10.↵
    1. Felson DT,
    2. Anderson JJ,
    3. Boers M,
    4. Bombardier C,
    5. Furst D,
    6. Goldsmith C,
    7. et al.

    American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727–35.

    OpenUrlCrossRefPubMed
11. 11.↵
    1. Prevoo ML,
    2. van ‘t Hof MA,
    3. Kuper HH,
    4. van Leeuwen MA,
    5. van de Putte LB,
    6. van Riel PL

    . Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995;38:44–8.

    OpenUrlCrossRefPubMed
12. 12.↵
    1. Wells G,
    2. Becker JC,
    3. Teng J,
    4. Dougados M,
    5. Schiff M,
    6. Smolen J,
    7. 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.

    OpenUrlAbstract/FREE Full Text
13. 13.↵
    1. Kolodziejczyk K,
    2. Stappers AE,
    3. Teleha CA,
    4. Weerts KJH

    . United States patent application US 2014/0045789 A1. Process for the preparation of C-FMS kinase inhibitors. Washington, DC: US Patent Office; 2014.
14. 14.↵
    1. Sadis S,
    2. Mukherjee A,
    3. Olson S,
    4. Dokmanovich M,
    5. Maher R,
    6. Cai CH,
    7. et al.

    Safety, pharmacokinetics, and pharmacodynamics of PD-0360324, a human monoclonal antibody to monocyte/macrophage colony stimulating factor, in healthy volunteers. Arthritis Rheum 2009;60 Suppl 10:408.

    OpenUrlCrossRefPubMed
15. 15.↵
    1. Radi ZA,
    2. Koza-Taylor PH,
    3. Bell RR,
    4. Obert LA,
    5. Runnels HA,
    6. Beebe JS,
    7. et al.

    Increased serum enzyme levels associated with sr cell reduction with no signs of hepatic or skeletal muscle injury. Am J Pathol 2011;179:240–7.

    OpenUrlCrossRefPubMed
16. 16.↵
    1. Kawanaka N,
    2. Yamamura M,
    3. Aita T,
    4. Morita Y,
    5. Okamoto A,
    6. Kawashima M,
    7. et al.

    CD14+, CD16+ blood monocytes and joint inflammation in rheumatoid arthritis. Arthritis Rheum 2002;46:2578–86.

    OpenUrlCrossRefPubMed
17. 17.↵
    1. Korkosz M,
    2. Bukowska-Strakova K,
    3. Sadis S,
    4. Grodzicki T,
    5. Siedlar M

    . Monoclonal antibodies against macrophage colony-stimulating factor diminish the number of circulating intermediate and nonclassical (CD14(++)CD16(+)/CD14(+)CD16(++)) monocytes in rheumatoid arthritis patient. Blood 2012;119:5329–30.

    OpenUrlFREE Full Text
18. 18.↵
    1. Kremer JM,
    2. Cohen S,
    3. Wilkinson BE,
    4. Connell CA,
    5. French JL,
    6. Gomez-Reino J,
    7. et al.

    A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid arthritis and an inadequate response to methotrexate alone. Arthritis Rheum 2012;64:970–81.

    OpenUrlCrossRefPubMed
19. 19.↵
    1. Rahman MU,
    2. Buchanan J,
    3. Doyle MK,
    4. Hsia EC,
    5. Gathany T,
    6. Parasuraman S,
    7. et al.

    Changes in patient characteristics in anti-tumour necrosis factor clinical trials for rheumatoid arthritis: results of an analysis of the literature over the past 16 years. Ann Rheum Dis 2011;70:1631–40.

    OpenUrlAbstract/FREE Full Text
20. 20.↵
    1. de Hair MJ,
    2. Harty LC,
    3. Gerlag DM,
    4. Pitzalis C,
    5. Veale DJ,
    6. Tak PP

    . Synovial tissue analysis for the discovery of diagnostic and prognostic biomarkers in patients with early arthritis. J Rheumatol 2011;38:2068–72.

    OpenUrlAbstract/FREE Full Text
21. 21.↵
    1. Burmester GR,
    2. Weinblatt ME,
    3. McInnes IB,
    4. Porter D,
    5. Barbarash O,
    6. Vatutin M,
    7. et al.

    Efficacy and safety of mavrilimumab in subjects with rheumatoid arthritis. Ann Rheum Dis 2013;72:1445–52.

    OpenUrlAbstract/FREE Full Text
22. 22.↵
    1. Lenzo JC,
    2. Turner AL,
    3. Cook AD,
    4. Vlahos R,
    5. Anderson GP,
    6. Reynolds EC,
    7. et al.

    Control of macrophage lineage populations by CSF-1 receptor and GM-CSF in homeostasis and inflammation. Immunol Cell Biol 2012;90:429–40.

    OpenUrlCrossRefPubMed
23. 23.↵
    1. Davies LC,
    2. Rosas M,
    3. Jenkins SJ,
    4. Liao CT,
    5. Scurr MJ,
    6. Brombacher F,
    7. et al.

    Distinct bone marrow-derived and tissue-resident macrophage lineages proliferate at key stages during inflammation. Nat Commun 2013;4:1886.

    OpenUrlCrossRefPubMed
24. 24.↵
    1. Lacey DC,
    2. Achuthan A,
    3. Fleetwood AJ,
    4. Dinh H,
    5. Roiniotis J,
    6. Scholz GM,
    7. et al.

    Defining GM-CSF- and macrophage-CSF-dependent macrophage responses by in vitro models. J Immunol 2012;188:5752–65.

    OpenUrlAbstract/FREE Full Text
25. 25.↵
    1. Iwata Y,
    2. Boström EA,
    3. Menke J,
    4. Rabacal WA,
    5. Morel L,
    6. Wada T,
    7. et al.

    Aberrant macrophages mediate defective kidney repair that triggers nephritis in lupus-susceptible mice. J Immunol 2012;188:4568–80.

    OpenUrlAbstract/FREE Full Text