Efficacy and safety of pateclizumab (anti-lymphotoxin-α) compared to adalimumab in rheumatoid arthritis: A head-to-head phase 2 randomized controlled study (The ALTARA Study)

Arthritis Research and Therapy

Volumn 16, Issue 1, 2014, Pages

  Kennedy, William P ^a   Simon, J Abraham ^b   Offutt, Carolyn ^a   Horn, Priscilla ^a   Herman, Ann ^a   Townsend, Michael J ^a   Tang, Meina T ^a   Grogan, Jane L ^a   Hsieh, Frank ^a   Davis, John C ^a  

^a GENENTECH INC   (United States)

^b DEPARTAMENTO DE FÍSICA APLICADA   (Mexico)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ALANINE AMINOTRANSFERASE; CXCL13 CHEMOKINE; PATECLIZUMAB; PLACEBO; ANTIRHEUMATIC AGENT; C REACTIVE PROTEIN; CORTICOSTEROID; CXCL13 PROTEIN, HUMAN; LYMPHOTOXIN; MONOCLONAL ANTIBODY; NONSTEROID ANTIINFLAMMATORY AGENT;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; CONTROLLED STUDY; DAS28; DIARRHEA; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; ERYTHROCYTE SEDIMENTATION RATE; FEMALE; GASTROENTERITIS; HEADACHE; HUMAN; LUNG TUBERCULOSIS; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; PHARYNGITIS; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SIDE EFFECT; TREATMENT DURATION; TREATMENT OUTCOME; URINARY TRACT INFECTION; ADOLESCENT; ADULT; AGED; ANTAGONISTS AND INHIBITORS; ARTHRITIS, RHEUMATOID; CHEMICALLY INDUCED; CLINICAL TRIAL; COMBINATION DRUG THERAPY; COMPARATIVE STUDY; DRUG ADMINISTRATION; GENETICS; METABOLISM; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; PHASE 2 CLINICAL TRIAL; SEVERITY OF ILLNESS INDEX; SUBCUTANEOUS DRUG ADMINISTRATION; YOUNG ADULT;

ADALIMUMAB; ADOLESCENT; ADRENAL CORTEX HORMONES; ADULT; AGED; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BLOOD SEDIMENTATION; C-REACTIVE PROTEIN; CHEMOKINE CXCL13; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; HEADACHE; HUMANS; INJECTIONS, SUBCUTANEOUS; LYMPHOTOXIN-ALPHA; MALE; MIDDLE AGED; PHARYNGITIS; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84990967249     PISSN: 14786354     EISSN: 14786362     Source Type: Journal    
DOI: 10.1186/s13075-014-0467-3     Document Type: Article

References (29)

1. Smolen JS, Landewé R, Breedveld FC, Buch M, Burmester G, Dougados M, Emery P, Gaujoux-Viala C, Gossec L, Nam J, Ramiro S, Winthrop K, de Wit M, Aletaha D, Betteridge N, Bijlsma JW, Boers M, Buttgereit F, Combe B, Cutolo M, Damjanov N, Hazes JM, Kouloumas M, Kvien TK, Mariette X, Pavelka, van Riel PL, Rubbert-Roth A, Scholte-Voshaar M, Scott DL, et al: EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 2014, 73:492-509.
2. Browning JL: Inhibition of the lymphotoxin pathway as a therapy for autoimmune disease. Immunol Rev 2008, 223:202-220.
3. Ware CF: Network communications: lymphotoxins, LIGHT, and TNF. Annu Rev Immunol 2005, 23:787-819.
4. Chiang EY, Kolumam GA, Yu X, Francesco M, Ivelja S, Peng I, Gribling P, Shu J, Lee WP, Refino CJ, Balazs M, Paler-Martinez A, Nguyen A, Young J, Barck KH, Carano RA, Ferrando R, Diehl L, Chatterjea D, Grogan JL: Targeted depletion of lymphotoxin-alpha-expressing TH1 and TH17 cells inhibits autoimmune disease. Nat Med 2009, 15:766-773.
5. Takemura S, Braun A, Crowson C, Kurtin PJ, Cofield RH, O'Fallon WM, Goronzy JJ, Weyand CM: Lymphoid neogenesis in rheumatoid synovitis. J Immunol 2001, 167:1072-1080.
6. Humby F, Bombardieri M, Manzo A, Kelly S, Blades MC, Kirkham B, Spencer J, Pitzalis C: Ectopic lymphoid structures support ongoing production of class-switched autoantibodies in rheumatoid synovium. PLoS Med 2009, 13:e1.
7. Rangel-Moreno J, Hartson L, Navarro C, Gaxiola M, Selman M, Randall TD: Inducible bronchus-associated lymphoid tissue (iBALT) in patients with pulmonary complications of rheumatoid arthritis. J Clin Invest 2006, 116:3183-3194.
8. Baldassare A, Fiechtner J, Filipowicz-Sosnowska A, Jeka S, O'Gorman J, Weaver M, Beckman E: Preliminary safety and efficacy of baminercept (LTBR-Ig, BG9924) in the treatment of rheumatoid arthritis. Arthritis Rheum 2007, 56:S394.
9. Genovese MC, Greenwald MW, Alloway JA, Baldassare AR, Chase W, Newman C, Weaver ML: Efficacy and safety of baminercept in the treatment of rheumatoid arthritis (RA) results of the phase 2B study in the TNF-IR population. Arthritis Rheum 2009, 60:417.
10. van Vollenhoven R, Harju A, Brannemark S, Klareskog L: Treatment with infliximab (Remicade) when etanercept (Enbrel) has failed or vice versa: data from the STURE registry showing that switching tumour necrosis factor alpha blockers can make sense. Ann Rheum Dis 2003, 62:1195-1198.
11. Laas K, Peltomaa R, Kautiainen H, Leirisalo-Repo M: Clinical impact of switching from infliximab to etanercept in patients with rheumatoid arthritis. Clin Rheumatol 2008, 27:927-932.
12. Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP: Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther 2008, 117:244-279.
13. Chatzidionysiou K, van Vollenhoven R: TNF switch after failure of one or more TNF inhibitors: results of an observational study. Arthritis Rheum 2010, 62:S177.
14. Buch MH, Conaghan PG, Quinn MA, Bingham SJ, Veale D, Emery P: True infliximab resistance in rheumatoid arthritis: a role for lymphotoxin alpha? Ann Rheum Dis 2004, 63:1344-1346.
15. Neregård P, Krishnamurthy A, Revu S, Engström M, af Klint E, Catrina A: Etanercept decreases synovial expression of tumour necrosis factor-a and lymphotoxin-α in rheumatoid arthritis. Scand J Rheumatol 2013, 43:85-90.
16. Emu B, Luca D, Offutt C, Grogan JL, Rojkovich B, Williams MB, Tang MT, Xiao J, Lee JH, Davis JC: Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin a: results of a phase I randomized, placebo-controlled trial. Arthritis Res Ther 2012, 144:R6.
17. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS, Medsger TA Jr, Mitchell DM, Neustadt DH, Pinals RS, Schaller JG, Sharp JT, Wilder RL, Hunder GG: The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988, 31:315-324.
18. Mazurek GH, Jereb J, Vernon A, LoBue P, Goldberg S, Castro K, IGRA Expert Committee; Centers for Disease Control and Prevention (CDC): Updated guidelines for using interferon gamma release assays to detect mycobacterium tuberculosis infection-United States, 2010. MMWR Recomm Rep 2010, 59(RR-5):1-25.
19. Prevoo ML, van't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, 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, 38:444-448.
20. Fries JF, Spitz P, Kraines RG, Holman HR: Measurement of patient outcome in arthritis. Arthritis Rheum 1980, 23:137-145.
21. Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992, 30:473-483.
22. Rioja I, Hughes FJ, Sharp CH, Warnock LC, Montgomery DS, Akil M, Wilson AG, Binks MH, Dickson MC: Potential novel biomarkers of disease activity in rheumatoid arthritis patients: CXCL13, CCL23, transforming growth factor alpha, tumor necrosis factor receptor superfamily member 9, and macrophage colony-stimulating factor. Arthritis Rheum 2008, 58:2257-2267.
23. Boers M: A new design for registration trials in rheumatoid arthritis allowing secondary head-to-head comparisons with standard of care treatment including biologicals. Ann Rheum Dis 2010, 69:4-6.
24. Boers M: The time has come to limit the placebo period in rheumatoid arthritis trials to 3 months: a systematic comparison of 3-and 6-month response rates in trials of biological agents. Ann Rheum Dis 2010, 69:186-192.
25. Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, Teoh LA, Fischkoff SA, Chartash EK: Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum 2003, 48:35-45.
26. Furst DE, Schiff MH, Fleischmann RM, Strand V, Birbara CA, Compagnone D, Fischkoff SA, Chartash EK: Adalimumab, a fully human anti tumor necrosis factor-alpha monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis). J Rheumatol 2003, 30:2563-2571.
27. van de Putte LB, Atkins C, Malaise M, Sany J, Russell AS, van Riel PL, Settas L, Bijlsma JW, Todesco S, Dougados M, Nash P, Emery P, Walter N, Kaul M, Fischkoff S, Kupper H: Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed. Ann Rheum Dis 2004, 63:508-516.
28. O'Rourke KP, O'Donoghue G, Adams C, Mulcahy H, Molloy C, Silke C, Molloy M, Shanahan F, O'Gara F: High levels of Lymphotoxin-Beta (LT-Beta) gene expression in rheumatoid arthritis synovium: clinical and cytokine correlations. Rheumatol Int 2008, 28:979-986.
29. Isaacs JD, Genovese MC, Emery P, Scheinberg MA, Spindler AJ, Newman C, Weaver ML, Browning J, O'Gorman J, Cravets M, Hagerty D, Beckman EM, Nirula A: Efficacy and safety of baminercept in the treatment of rheumatoid arthritis (RA). Preliminary results of the phase 2B study in the DMARD-IR population. [abstract]. Arthritis Rheum 2009, 60:416.