Dual inhibition of tumour necrosis factor and interleukin-17A with ABT-122: Open-label long-term extension studies in rheumatoid arthritis or psoriatic arthritis

Rheumatology (United Kingdom)

Volumn 57, Issue 11, 2018, Pages 1972-1981

  Genovese, Mark C ^a   Weinblatt, Michael E ^b   Mease, Philip J ^c   Aelion, Jacob A ^d,e   Peloso, Paul M ^f   Chen, Kun ^g   Li, Yihan ^g   Liu, John ^h   Othman, Ahmed A ⁱ   Khatri, Amit ⁱ   Mansikka, Heikki T ^f   Leszczynski, Piotr ^j  

^a STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

^d Arthritis Clinic   (United States)

^e UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^f Clinical Protocol Development   (United States)

^g Data and Statistical Sciences   (United States)

^h Medical Safety Evaluation Pharmacovigilance and Patient Safety   (United States)

ⁱ ABBVIE INC   (United States)

^j POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

more..

Author keywords

Bispecific blocking immunoglobulin; Interleukin 17; Psoriatic arthritis; Rheumatoid arthritis; Tumour necrosis factor

Indexed keywords

ADALIMUMAB; ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; C REACTIVE PROTEIN; HEMOGLOBIN; INTERLEUKIN 17; PLACEBO; REMTOLUMAB; TUMOR NECROSIS FACTOR; ABT-122; ANTIRHEUMATIC AGENT; IL17A PROTEIN, HUMAN; IMMUNOGLOBULIN; METHOTREXATE;

ADULT; ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASPARTATE AMINOTRANSFERASE LEVEL; BASAL CELL CARCINOMA; BILIRUBIN BLOOD LEVEL; BRONCHITIS; CLINICAL DISEASE ACTIVITY INDEX; CONTROLLED STUDY; CONTUSION; DAS28; DISEASE ACTIVITY SCORE; DISEASE DURATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; ENTEROCOLITIS; FATTY LIVER; FEMALE; HEART MUSCLE ISCHEMIA; HEMOGLOBINOPATHY; HEPATOBILIARY DISEASE; HERPES SIMPLEX; HUMAN; HUMERUS FRACTURE; IMMUNOGENICITY; INFECTION; INFLAMMATION; INFLUENZA; JOINT DISLOCATION; LIGAMENT DISEASE; LIGAMENT SPRAIN; LIMIT OF QUANTITATION; LIVER CYST; LIVER DISEASE; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MALIGNANCY; MENORRHAGIA; MIDDLE AGED; MOUTH INFECTION; MUSCLE STRAIN; OPEN STUDY; ORAL HERPES; PHARYNGITIS; PRIORITY JOURNAL; PSORIASIS AREA AND SEVERITY INDEX; PSORIATIC ARTHRITIS; RANDOMIZED CONTROLLED TRIAL; RASH; RHEUMATOID ARTHRITIS; RHINITIS; RHINOPHARYNGITIS; SIDE EFFECT; SKIN ULCER; SPRAIN; TONSILLITIS; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT DISEASE; WOUND; AGED; ANTAGONISTS AND INHIBITORS; COMBINATION DRUG THERAPY; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

ADULT; AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, PSORIATIC; ARTHRITIS, RHEUMATOID; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; IMMUNOGLOBULINS; INTERLEUKIN-17; MALE; METHOTREXATE; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 85054674482     PISSN: 14620324     EISSN: 14620332     Source Type: Journal    
DOI: 10.1093/rheumatology/key173     Document Type: Article

References (30)

1. McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med 2011;365:2205-19.
2. Mease PJ. Tumour necrosis factor (TNF) in psoriatic arthritis: pathophysiology and treatment with TNF inhibitors. Ann Rheum Dis 2002;61:298-304.
3. Choy E. Understanding the dynamics: pathways involved in the pathogenesis of rheumatoid arthritis. Rheumatology 2012;51:v3-11.
4. Furst DE, Emery P. Rheumatoid arthritis pathophysiology: update on emerging cytokine and cytokine-associated cell targets. Rheumatology 2014;53:1560-9.
5. Mease PJ. Inhibition of interleukin-17, interleukin-23 and the TH17 cell pathway in the treatment of psoriatic arthritis and psoriasis. Curr Opin Rheumatol 2015;27:127-33.
6. Raychaudhuri SP, Raychaudhuri SK, Genovese MC. IL-17 receptor and its functional significance in psoriatic arthritis. Mol Cell Biochem 2012;359:419-29.
7. de Vlam K, Gottlieb AB, Mease PJ. Current concepts in psoriatic arthritis: pathogenesis and management. Acta Derm Venereol 2014;94:627-34.
8. Aaltonen KJ, Virkki LM, Malmivaara A et al. Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis. PLoS One 2012;7:e30275.
9. Genovese MC, Greenwald M, Cho CS et al. A phase II randomized study of subcutaneous ixekizumab, an anti-interleukin-17 monoclonal antibody, in rheumatoid arthritis patients who were naive to biologic agents or had an inadequate response to tumor necrosis factor inhibitors. Arthritis Rheumatol 2014;66:1693-704.
10. Antoni C, Krueger GG, de Vlam K et al. Infliximab improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial. Ann Rheum Dis 2005;64:1150-7.
11. Kavanaugh A, McInnes I, Mease P et al. Golimumab, a new human tumor necrosis factor a antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: twenty-four-week efficacy and safety results of a randomized, placebo-controlled study. Arthritis Rheum 2009;60:976-86.
12. Mease PJ, Genovese MC, Greenwald MW et al. Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis. N Engl J Med 2014;370:2295-306.
13. Mease PJ, Gladman DD, Ritchlin CT et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005;52:3279-89.
14. Mease PJ, Kivitz AJ, Burch FX et al. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rheum 2004;50:2264-72.
15. Mease PJ, McInnes IB, Kirkham B et al. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N Engl J Med 2015;373:1329-39.
16. Mease PJ, van der Heijde D, Ritchlin CT et al. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis 2017;76:79-87.
17. Hsieh C-M, Cuff C, Tarcsa E, Hugunin M. FRI0303 Discovery and characterization of ABT-122, an anti-TNF/ IL-17 DVD-IG™ molecule as a potential therapeutic candidate for rheumatoid arthritis [abstract]. Ann Rheum Dis 2014;73 (Suppl 2):495.
18. Mansikka H, Ruzek M, Hugunin M et al. FRI0164 Safety, tolerability, and functional activity of ABT-122, a dual TNF- and IL-17A-targeted DVD-IG™, following single-dose administration in healthy subjects [abstract]. Ann Rheum Dis 2015;74 (Suppl 2):482-3.
19. Fleischmann RM, Wagner F, Kivitz AJ et al. Safety, tolerability, and pharmacodynamics of ABT-122, a TNF- and IL-17-targeted dual variable domain immunoglobulin, in patients with RA. Arthritis Rheumatol 2017;69:2283-91.
20. Khatri A, Goss S, Jiang P, Mansikka H, Othman AA. Pharmacokinetics of ABT-122, a TNFa- and IL-17A-targeted dual-variable domain immunoglobulin, in healthy subjects and patients with rheumatoid arthritis: results from three phase I trials. Clin Pharmacokinet 2018;57:613-23.
21. Genovese MC, Weinblatt M, Aelion JA et al. ABT-122, a bispecific DVD-immunoglobulin targeting TNF and IL-17A, in RA with inadequate response to methotrexate: a randomized, double-blind study. Arthritis Rheumatol 2018;doi:10.1002/art.40580.
22. Mease PJ, Genovese MC, Weinblatt M et al. Phase 2 study of ABT-122, a TNF- and IL-17A-targeted dual variable domain immunoglobulin, in psoriatic arthritis with inadequate methotrexate response. Arthritis Rheumatol 2018;doi:10.1002/art.40579.
23. Taylor W, Gladman D, Helliwell P et al. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum 2006;54:2665-73.
24. Woodworth T, Furst DE, Alten R et al. Standardizing assessment and reporting of adverse effects in rheumatology clinical trials II: the Rheumatology Common Toxicity Criteria v.2.0. J Rheumatol 2007;34:1401-14.
25. Weinblatt M, Schiff M, Goldman A et al. Selective costim-ulation modulation using abatacept in patients with active rheumatoid arthritis while receiving etanercept: a randomised clinical trial. Ann Rheum Dis 2007;66:228-34.
26. Genovese MC, Cohen S, Moreland L et al. Combination therapy with etanercept and anakinra in the treatment of patients with rheumatoid arthritis who have been treated unsuccessfully with methotrexate. Arthritis Rheum 2004;50:1412-9.
27. Greenwald MW, Shergy WJ, Kaine JL et al. Evaluation of the safety of rituximab in combination with a tumor necrosis factor inhibitor and methotrexate in patients with active rheumatoid arthritis: results from a randomized controlled trial. Arthritis Rheum 2011;63:622-32.
28. Curtis JR, Beukelman T, Onofrei A et al. Elevated liver enzyme tests among patients with rheumatoid arthritis or psoriatic arthritis treated with methotrexate and/or leflu-nomide. Ann Rheum Dis 2010;69:43-7.
29. Murdaca G, Spano F, Contatore M et al. Immunogenicity of infliximab and adalimumab: what is its role in hypersensitivity and modulation of therapeutic efficacy and safety? Expert Opin Drug Saf 2016;15:43-52.
30. Vultaggio A, Nencini F, Pratesi S et al. Manifestations of antidrug antibodies response: hypersensitivity and infusion reactions. J Interferon Cytokine Res 2014;34:946-52.