TRU-015, a fusion protein derived from an anti-CD20 antibody, for the treatment of rheumatoid arthritis

Current Opinion in Molecular Therapeutics

Volumn 12, Issue 1, 2010, Pages 115-123

  Rubbert Roth, Andrea ^a  

^a UNIVERSITY OF COLOGNE   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIHISTAMINIC AGENT; CD20 ANTIBODY; CORTICOSTEROID; DIPHENHYDRAMINE; HYBRID PROTEIN; LORATADINE; METHOTREXATE; METHYLPREDNISOLONE; OCRELIZUMAB; PARACETAMOL; PLACEBO; PREDNISONE; RITUXIMAB; TRU 015; UNCLASSIFIED DRUG;

ACUTE CHOLECYSTITIS; APPENDICITIS; ARTHRALGIA; AUTOIMMUNE DISEASE; B CELL LYMPHOMA; B LYMPHOCYTE; BACKACHE; BRONCHITIS; BRONCHOSPASM; BURKITT LYMPHOMA; CELL LINE; CLINICAL TRIAL; COUGHING; DELIRIUM TREMENS; DRUG METABOLISM; DRUG SAFETY; ECCHYMOSIS; EDEMA; ENTERITIS; FACE ERYTHEMA; FATIGUE; FEBRILE NEUTROPENIA; FLUSHING; GASTRIC ULCER BLEEDING; HEADACHE; HEART PALPITATION; HUMAN; HYPERSENSITIVITY; IN VITRO STUDY; INFLUENZA VIRUS; INSOMNIA; INTERVERTEBRAL DISK HERNIA; KIDNEY CARCINOMA; LIVER CANCER; MEMBRANOUS GLOMERULONEPHRITIS; MYALGIA; MYOSITIS; NAUSEA; NEPHRITIS; NONHODGKIN LYMPHOMA; NONHUMAN; PAIN; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRURITUS; RASH; REVIEW; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE DRUG DOSE; SINUSITIS; SYNOVIAL CYST; SYSTEMIC LUPUS ERYTHEMATOSUS; TICK BORNE ENCEPHALITIS; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; URTICARIA; VASCULITIS;

ANTIBODIES, ANTI-IDIOTYPIC; ANTIBODIES, MONOCLONAL; ANTIGENS, CD20; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; CLINICAL TRIALS AS TOPIC; HUMANS; RECOMBINANT FUSION PROTEINS;

EID: 76749140818     PISSN: 14648431     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (55)

1. Endocytosis and degradation of monoclonal antibodies targeting human B-cell malignancies. Press OW, Farr AG, Borroz KI, Anderson SK, Martin PJ CANCER RES 1989 49 17 4906-4912
2. CD16-mediated antibody dependent cellular cytotoxicity is required for B cell depletion by a small modular immunopharmaceutical specific for CD20. Hayden-Ledbetter M, Magaletti D, Mohler K, Thompson PA, Clark EA, Ledbetter JA, Byrd JC BLOOD 2003 102 11 Abs 2388
3. TRU-015, a novel CD20-directed biologic therapy, demonstrates significant anti-tumor activity in human tumor xenograft models. Barone D, Nilsson C, Ledbetter J, Hayden-Ledbetter M, Mohler K PROC AM SOC CLIN ONCOL 2005 24 Abs 2549
4. Prolonged depletion of circulating B cells in cynomolgus monkeys after a single dose of TRU-015, a novel CD20 directed therapeutic. Barone D, Burge DJ, Baum P, Ledbetter J, Hayden-Ledbetter M, Mohler K ANN RHEUM DIS 2005 64 Suppl 3 159-160
5. Wyeth announces strategic collaboration with Trubion Pharmaceuticals. Wyeth PRESS RELEASE 2006 January 03
6. Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. Edwards JC, Szczepanski L, Szechinski J, Filipowicz-Sosnowska A, Emery P, Close DR, Stevens RM, Shaw T N ENGL J MED 2004 350 25 2572-2581 (Pubitemid 38758544)
7. The comparative efficacy and safety of biologics for the treatment of rheumatoid arthritis: A systematic review and meta analysis. Gartlehner G, Hansen RA, Jonas BL, Thieda P, Lohr KN J RHEUMATOL 2006 33 12 2398-2408
8. Risk and prevention of tuberculosis and other serious opportunistic infections associated with the inhibition of tumor necrosis factor. Winthrop KL NAT CLIN PRACT RHEUMATOL 2006 2 11 602-610
9. Trubion Pharmaceuticals Inc reports second quarter and first half 2007 financial results. Trubion Pharmaceuticals Inc PRESS RELEASE 2007 August 13
10. Safety and pharmacodynamics of repeat administration of TRU-015, a CD20-directed SMIP therapeutic, in subjects with rheumatoid arthritis. Burge D, Martin R, Wallace D, Little-John T, Bookbinders S, Bannink J, Shub C ARTHRITIS RHEUM 2007 56 9 Suppl S168-S169
11. TRU-015 improves rheumatoid arthritis disease activity in a randomized, double-blind, placebo-controlled, multi-center phase 2 dose ranging trial. Burge D, Chopiak V, Dvoretskiy L, Koshukova G, Nasonov E, Povoroznyuk V, Stanislavchuk M, Shu C, Bass D ARTHRITIS RHEUM 2007 56 12 4234-4235
12. Trubion initiates phase 1/2 study of TRU-016 in CLL, announces next-generation product candidate for RA and provides product pipeline update. Trubion Pharmaceuticals Inc PRESS RELEASE 2008 March 27
13. B cells: A fundamental role in the pathogenesis of rheumatoid arthritis? Panayi GS RHEUMATOLOGY 2005 44 Suppl 2 ii3-ii7
14. Phase 1 study of TRU-015, a CD20 directed small modular immunopharmaceutical (SMIP) protein therapeutic, in subjects with rheumatoid arthritis. Burge DJ, Bookbinder SA, Kivitz AJ, Fleischmann RM, Shu C, Bannink J, Barone D ARTHRITIS RES THER 2007 9 S3 Abs P31
15. Rituximab in rheumatoid arthritis following anti-TNF-associated tuberculosis. Burr ML, Malaviya AP, Gaston JH, Carmichael AJ, Ostor AJK RHEUMATOLOGY 2008 47 5 738-739
16. Trubion Pharmaceuticals announces extension of research period under its Wyeth collaboration. Trubion Pharmaceuticals Inc. PRESS RELEASE 2008 June 19
17. TRU-015 administered every 24 weeks for 2 years is well tolerated and maintains consistent pharmacodynamic effects in rheumatoid arthritis patients. Burge D, Martin RW, Bookbinder S, Littlejohn T, Wallace D, Kirsch T, Bass D, Shu C ARTHRITIS RHEUM 2008 58 9 S306-S307
18. Pharmacokinetic and pharmacodynamic properties of TRU-015, a CD20-directed small modular immunopharmaceutical protein therapeutic, in patients with rheumatoid arthritis: A phase I, open-label, dose-escalation clinical study. Burge DJ, Bookbinder SA, Kivitz AJ, Fleischmann RM, Shu C, Bannink J CLIN THER 2008 30 10 1806-1816
19. TRU-015, a small modular immunopharmaceutical (SMIP) drug candidate directed against CD20, demonstrates clinical improvement in subjects with rheumatoid arthritis. Burge DJ, Shu C, Martin RW, Littlejohn TW, Wallace DJ, Taborn J, Palmer WR, Kivitz A ARTHRITIS RES THER 2007 9 Suppl 3 Abs P32
20. Rituximab inhibits structural joint damage in patients with rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitor therapies. Keystone E, Emery P, Peterfy CG, Tak PP, Cohen S, Genovese MC, Dougados M, Burmester GR, Greenwald M, Kvien TK, Williams S et al ANN RHEUM DIS 2009 68 2 216-221
21. Trubion Pharmaceuticals: Website. Trubion Pharmaceuticals Inc COMPANY WORLD WIDE WEB SITE 2009 April 23
22. CD20-directed small modular immunopharmaceutical, TRU-015, depletes normal and malignant B cells. Hayden-Ledbetter MS, Cerveny CG, Espling E, Brady WA, Grosmaire LS, Tan P, Bader R, Slater S, Nilsson CA, Barone DS, Simon A et al CLIN CANCER RES 2009 15 8 2739-2746
23. Population pharmacokinetic analysis of TRU-015 in patients with active rheumatoid arthritis. Shu C, Zhou Y, Bass D, Kirsch T, Gourly I, Raible D, Palmisano M, Burge D J CLIN PHARMACOL 2008 48 9 1128
24. The efficacy and tolerability of newer biologics in rheumatoid arthritis: Best current evidence. Siddiqui MA CURR OPIN RHEUMATOL 2007 19 3 308-313
25. B-cell targeted therapies in rheumatoid arthritis and systemic lupus erythematosus. Eisenberg R, Albert D NAT CLIN PRACT RHEUMATOL 2006 2 1 20-27
26. The therapeutic potential of anti-CD20 "what do B-cells do" Eisenberg R, Looney RJ CLIN IMMUNOL 2005 117 3 207-213
27. Drug insight: The mechanism of action of rituximab in autoimmune disease-The immune complex decoy hypothesis. Taylor RP, Lindorfer MA NAT CLIN PRACT RHEUMATOL 2007 3 2 86-95
28. Therapeutic strategies for rheumatoid arthritis. O'Dell JR N ENGL J MED 2004 350 25 2591-2602
29. Inflammatory arthritis: An overview for primary care physicians. Brent LH J POSTGRAD MED 2009 121 2 148-162
30. TRU-015 improves rheumatoid arthritis disease activity after first course of retreatment following phase 2b study. Stromatt S, Chopiak V, Dvoretskiy L, Koshukova G, Nasonov E, Povoroznyuk V, Stanislavchuk M, Shu C, Bass D EUR LEAGUE AGAINST RHEUMATISM (EULAR) ANN MEET 2009 Abs OP-0028
31. Repeated therapy with TRU-015 is well tolerated and results in consistent pharmacodynamic effects in rheumatoid arthritis patients. Burge D, Martin RW, Wallace D, Bookbinder SA, Kirsch T, Bass D, Shu C, Littlejohn TW ANN RHEUM DIS 2008 67 Suppl 2 Abs OP-0252
32. T cell activation in rheumatoid synovium is B cell dependent. Takemura S, Klimiuk PA, Braun A, Goronzy JJ, Weyand CM J IMMUNOL 2001 167 8 4710-4718
33. Effective use of TNF antagonists. Yocum D ARTHRITIS RES THER 2004 6 Suppl 2 S24-S30
34. Abatacept in the treatment of rheumatoid arthritis. Buch MH, Vital EM, Emery P ARTHRITIS RES THER 2008 10 Suppl 1 S5
35. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor α inhibition. Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, Birbara C, Box J, Natarajan K, Nuamah I, Li T et al N ENGL J MED 2005 353 11 1114-1123
36. Anakinra: Review of recombinant human interleukin-I receptor antagonist in the treatment of rheumatoid arthritis. Furst DE CLIN THER 2004 26 12 1960-1975
37. New and future drug therapies for rheumatoid arthritis. Simon LS, Yocum D RHEUMATOLOGY (OXFORD) 2000 39 Suppl 1 36-42
38. Systematic review: Comparative effectiveness and harms of disease-modifying medications for rheumatoid arthritis. Donahue KE, Gartlehner G, Jonas DE, Lux LJ, Thieda P, Jonas BL, Hansen RA, Morgan LC, Lohr KN ANN MED INTERNE 2008 148 2 124-134
39. Levels of expression of CD19 and CD20 in chronic B cell leukaemias. Ginaldi L, De Martinis M, Matutes E, Farahat N, Morilla R, Catovsky D J CLIN PATHOL 1998 51 5 364-369
40. Mechanisms of killing by anti-CD20 monoclonal antibodies. Glennie MJ, French RR, Cragg MS, Taylor RP MOL IMMUNOL 2007 44 16 3823-3837
41. TRU-015, a small modular immunopharmaceutical (SMI) drug candidate directed against CD20, demonstrates clinical improvement in subjects with rheumatoid arthritis. Burge DJ, Shu C, Martin RW, Littlejohn TW, Wallace DJ, Tabom J, Palmer WR, Kivitz A ARTHRITIS RHEUM 2006 54 9 S230
42. Phase 1 study of TRU-015, a CD20 directed small modular immunopharmaceutical (SMIP) protein therapeutic, in subjects with rheumatoid arthritis. Burge DJ, Bookbinder SA, Kivitz AJ, Fleischmann RM, Shu C, Bannink J, Barone D ANN RHEUM DIS 2006 65 Suppl 2 Abs THU0210
43. Pfizer and Wyeth become one: Working together for a healthier world. Pfizer Inc PRESS RELEASE 2009 October 16
44. Trubion Pharmaceuticals Inc reports third quarter and nine months 2009 financial results. Trubion Pharmaceuticals Inc PRESS RELEASE 2009 November 05
45. Sustained safety and efficacy of TRU-015 with continued retreatment of rheumatoid arthritis subjects following a phase 2b study. Stromatt S, Chopiak V, Dvoretskiy L, Koshukova G, Nasonov E, Povoroznyuk V, Stanislavchuk M, Leith P, Alvarez D ARTHRITIS RHEUM 2009 60 10 Suppl Abs 403
46. Autoantibody-positive rheumatoid arthritis (RA) patients (pts) have enhanced clinical response to rituximab (RTX) when compared with seronegative patients. Isaacs JD, Olech E, Tak PP, Deodhar A, Keystone E, Emery P, Yocum D, Hessey E, Read S ANN RHEUM DIS 2009 68 Suppl 3 Abs FRI0256
47. Emerging therapeutics for rheumatoid arthritis. Bingham CO BULL NYU HOSP JT DIS 2008 66 3 210-215
48. Rituximab in combination with methotrexate (MTX) significantly inhibits joint damage and improves clinical outcomes in patients with early active RA who are naive to MTX: A randomized active comparator placebo-controlled trial (IMAGE). Tak PP, Rigby WFC, Rubbert-Roth A, Peterfy CG, van Vollenhoven RF, Stohl W, Hessey E, Chen AC, Tyrrell H, Shaw TM ANN RHEUM DIS 2009 68 Suppl 3 Abs 636
49. Patterns of radiological progression in early rheumatoid arthritis: Results of an 8 year prospective study. Plant MJ, Jones PW, Saklatvala J, Ollier WER, Dawes PT J RHEUMATOL 1998 25 3 417-426
50. Progressive multifocal leukoencephalopathy in patients on immunomodulatory therapies. Major EO ANNU REV MED 2009 61 doi:10.1146/annurev. med.080708.082655
51. Efficacy and safety of rituximab in patients with moderately to severely active systemic lupus erythematosus (SLE): Results from the randomized, double-blind phase II/III study EXPLORER. Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, Utset TO, Gordon C, Isenberg DA, Hsieh HJ, Zhang D et al AM COLL RHEUMATOL 2008 Abs L12
52. Efficacy and safety of rituximab in subjects with active proliferative lupus nephritis (LN): Results from the randomized, double-blind phase III LUNAR study. Furie R, Looney RJ, Rovin B, Latinis KM, Appel G, Sanchez-Guerrero J, Fervenza FC, Maciuca R, Brunetta P, Zhang D, Garg J AM COLL RHEUMATOL 2009 Abs 1149
53. Efficacy and safety of rituximab in a patient with active rheumatoid arthritis and chronic disseminated pulmonary aspergillosis and history of tuberculosis. Jung N, Owczarczyk K, Hellmann M, Lehmann C, Fatkenheuer G, Hallek M, Rubbert A RHEUMATOLOGY 2008 47 6 932-933
54. Progressive multifocal leukoencephalopathy after natalizumab monotherapy. Linda H, von Heijne A, Major EO, Ryschkewitsch C, Berg J, Olsson T, Martin C N ENGL J MED 2009 361 11 1081-1087
55. Immune suppressive therapy in dermatology and PML. Sterry W, Bagot M, Ferrandiz C, Kragballe K, Papp K, Stingl G J DTSCH DERMATOL GES 2009 7 1 5-5