Long-term safety of subcutaneous abatacept in rheumatoid arthritis: Integrated analysis of clinical trial data representing more than four years of treatment

Arthritis and Rheumatology

Volumn 66, Issue 8, 2014, Pages 1987-1997

  Alten, Rieke ^a   Kaine, Jeffrey ^b   Keystone, Edward ^c   Nash, Peter ^d   Delaet, Ingrid ^e   Genovese, Mark C ^f  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b Sarasota Arthritis Research Center   (United States)

^c MOUNT SINAI HOSPITAL   (Canada)

^d UNIVERSITY OF QUEENSLAND   (Australia)

^e BRISTOL MYERS SQUIBB   (United States)

^f STANFORD UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABATACEPT; ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CREATININE; DISEASE MODIFYING ANTIRHEUMATIC DRUG; METHOTREXATE; PREDNISONE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIBODY TITER; ARTHRITIS; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; B CELL LYMPHOMA; BACKACHE; BASAL CELL CARCINOMA; BREAST CANCER; BRONCHITIS; CREATININE BLOOD LEVEL; DERMATOMYOSITIS; DISEASE EXACERBATION; DIVERTICULITIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; ENDOMETRIUM CANCER; EPISCLERITIS; ERYTHEMA NODOSUM; FEMALE; GASTROENTERITIS; GASTROINTESTINAL DISEASE; HEMATOMA; HEPATOBILIARY DISEASE; HERPES ZOSTER; HUMAN; IMMUNOGENICITY; INCIDENCE; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE RASH; INJECTION SITE SWELLING; LEUKOCYTE COUNT; LOBAR PNEUMONIA; LONG TERM CARE; LUDWIG ANGINA; LUNG CANCER; LUNG TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MELANOMA; MULTIPLE SCLEROSIS; NEUROLOGIC DISEASE; NON MELANOMA SKIN CANCER; OPEN STUDY; OSTEOARTHRITIS; PAPULE; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMONIA; PRIORITY JOURNAL; PSORIASIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESPIRATORY TRACT DISEASE; RESPIRATORY TRACT INFECTION; RHEUMATOID ARTHRITIS; SIDE EFFECT; SJOEGREN SYNDROME; SQUAMOUS CELL CARCINOMA; STAPHYLOCOCCUS INFECTION; THORAX DISEASE; THROMBOCYTE COUNT; ULCERATIVE COLITIS; URINARY TRACT DISEASE; URINARY TRACT INFECTION; UTERUS CANCER; VASCULITIS; VERY ELDERLY;

AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; FEMALE; HUMANS; IMMUNOCONJUGATES; INJECTIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TIME FACTORS;

EID: 84904977067     PISSN: 23265191     EISSN: 23265205     Source Type: Journal    
DOI: 10.1002/art.38687     Document Type: Article

References (37)

1. Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, van Zeben D, Kerstens PJ, Hazes JM, et al. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum 2005; 52: 3381-90.
2. Dore RK, Mathews S, Schechtman J, Surbeck W, Mandel D, Patel A, et al. The immunogenicity, safety, and efficacy of etanercept liquid administered once weekly in patients with rheumatoid arthritis. Clin Exp Rheumatol 2007; 25: 40-6.
3. Bartelds GM, Krieckaert CL, Nurmohamed MT, van Schouwenburg PA, Lems WF, Twisk JW, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA 2011; 305: 1460-8.
4. Radstake TR, Svenson M, Eijsbouts AM, van den Hoogen FH, Enevold C, van Riel PL, et al. Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis. Ann Rheum Dis 2009; 68: 1739-45.
5. Curtis JR, Hobar C, Hansbrough K,. Injection-site burning and stinging in patients with rheumatoid arthritis using injectable biologics. Curr Med Res Opin 2011; 27: 71-8.
6. Combe B,. Early rheumatoid arthritis: strategies for prevention and management. Best Pract Res Clin Rheumatol 2007; 21: 27-42.
7. Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, 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 (Hoboken) 2012; 64: 625-39.
8. Yamada A, Salama A, Sayegh M,. The role of novel T cell costimulatory pathways in autoimmunity and transplantation. J Am Soc Nephrol 2002; 13: 559-75.
9. Buch MH, Boyle DL, Rosengren S, Saleem B, Reece RJ, Rhodes LA, et al. Mode of action of abatacept in rheumatoid arthritis patients having failed tumour necrosis factor blockade: a histological, gene expression and dynamic magnetic resonance imaging pilot study. Ann Rheum Dis 2009; 68: 1220-7.
10. Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor α inhibition. N Engl J Med 2005; 353: 1114-23.
11. Kremer JM, Dougados M, Emery P, Durez P, Sibilia J, Shergy W, et al. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase IIb, double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005; 52: 2263-71.
12. Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, et al. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med 2006; 144: 865-76.
13. Schiff M, Keiserman M, Codding C, Songcharoen S, Berman A, Nayiager S, et al. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis 2008; 67: 1096-103.
14. Schiff M, Pritchard C, Huffstutter JE, Rodriguez-Valverde V, Durez P, Zhou X, et al. The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial. Ann Rheum Dis 2009; 68: 1708-14.
15. Weinblatt M, Combe B, Covucci A, Aranda R, Becker JC, Keystone E,. Safety of the selective costimulation modulator abatacept in rheumatoid arthritis patients receiving background biologic and nonbiologic disease-modifying antirheumatic drugs: a one-year randomized, placebo-controlled study. Arthritis Rheum 2006; 54: 2807-16.
16. Weinblatt M, Schiff M, Goldman A, Kremer J, Luggen M, Li T, et al. Selective costimulation modulation using abatacept in patients with active rheumatoid arthritis while receiving etanercept: a randomised clinical trial. Ann Rheum Dis 2007; 66: 228-34.
17. Kremer JM, Russell AS, Emery P, Abud-Mendoza C, Szechinski J, Westhovens R, et al. Long-term safety, efficacy and inhibition of radiographic progression with abatacept treatment in patients with rheumatoid arthritis and an inadequate response to methotrexate: 3-year results from the AIM trial. Ann Rheum Dis 2011; 70: 1826-30.
18. Genovese MC, Schiff M, Luggen M, Le Bars M, Aranda R, Elegbe A, et al. Longterm safety and efficacy of abatacept through 5 years of treatment in patients with rheumatoid arthritis and an inadequate response to tumor necrosis factor inhibitor therapy. J Rheumatol 2012; 39: 1546-54.
19. Westhovens R, Kremer JM, Moreland LW, Emery P, Russell AS, Li T, et al. Safety and efficacy of the selective costimulation modulator abatacept in patients with rheumatoid arthritis receiving background methotrexate: a 5-year extended phase IIB study. J Rheumatol 2009; 36: 736-42.
20. Gottenberg J, Ravaud P, Bardin T,. Prospective follow-up of abatacept treatment in 682 patients with refractory rheumatoid arthritis: tolerance and efficacy data from the French ORA (Orencia and rheumatoid arthritis) registry. Joint Bone Spine 2009; 76: 980.
21. Nusslein H, Alten R, Galeazzi M, Lorenz HM, Boumpas D, Nurmohamed MT, et al. Real-world efficacy and safety of abatacept treatment for RA: 12-month interim analysis of the ACTION study [abstract]. Arthritis Rheum 2012; 64 Suppl: S199.
22. Weinblatt ME, Moreland LW, Westhovens R, Cohen RB, Kelly SM, Khan N, et al. Safety of abatacept administered intravenously in treatment of rheumatoid arthritis: integrated analyses of up to 8 years of treatment from the abatacept clinical trial program. J Rheumatol 2013; 40: 787-97.
23. Corbo M, Valencia X, Raymond R, Summerill R, Agrawal S, Shergy W, et al. A subcutaneous administration regimen for abatacept in patients with rheumatoid arthritis: pharmacokinetics, safety and immunogenicity [abstract]. Arthritis Rheum 2008; Suppl 58: S307.
24. Genovese MC, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, et al. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum 2011; 63: 2854-64.
25. Kaine J, Gladstein G, Strusberg I, Robles M, Louw I, Gujrathi S, et al. Evaluation of abatacept administered subcutaneously in adults with active rheumatoid arthritis: impact of withdrawal and reintroduction on immunogenicity, efficacy and safety (phase IIIb ALLOW study). Ann Rheum Dis 2012; 71: 38-44.
26. Keystone EC, Kremer JM, Russell A, Box J, Abud-Mendoza C, Elizondo MG, et al. Abatacept in subjects who switch from intravenous to subcutaneous therapy: results from the phase IIIb ATTUNE study. Ann Rheum Dis 2012; 71: 857-61.
27. Nash P, Nayiager S, Genovese M, Rodriguez C, Delaet I, Elegbe A, et al. Low immunogenicity, consistent safety and sustained clinical efficacy over 18 months of subcutaneous administration of abatacept with and without methotrexate in patients with rheumatoid arthritis-results from a phase III study. Ann Rheum Dis 2010; 69: iii97.
28. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988; 31: 315-24.
29. Hochberg MC, Chang RW, Dwosh I, Lindsey S, Pincus T, Wolfe F,. The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum 1992; 35: 498-502.
30. Genovese MC, Cobos AC, Leon G, Mysler EF, Keiserman MW, Valente RM, et al. Subcutaneous (SC) abatacept (ABA) versus intravenous (IV) ABA in patients (pts) with rheumatoid arthritis: long-term data from the ACQUIRE (Abatacept Comparison of sub[QU]cutaneous versus intravenous in Inadequate Responders to methotrexatE) trial [abstract]. Arthritis Rheum 2011; 63 Suppl: S150.
31. Nash P, Nayiager S, Genovese M, Kivitz A, Oelke K, Ludivico C, et al. Immunogenicity is not increased with subcutaneous administration of abatacept with and without methotrexate in patients with rheumatoid arthritis: results from a phase III study. Arthritis Rheum 2009; 60: S633-4.
32. Alten R, Kaine J, Keystone E, Nash P, Delaet I, Qi K, et al. Safety of SC abatacept in patients with RA: update from pooled clinical trial data. Ann Rheum Dis 2012; 71: 670.
33. Salliot C, Dougados M, Gossec L,. Risk of serious infections during rituximab, abatacept and anakinra treatments for rheumatoid arthritis: meta-analyses of randomised placebo-controlled trials. Ann Rheum Dis 2009; 68: 25-32.
34. Kaine J, Gladstein G, Strusberg I, Robles M, Pappu R, Delaet I, et al. Subcutaneous abatacept is effective and well tolerated, with low immunogenicity following temporary withdrawal and re-introduction in the long term extension of the ALLOW trial [abstract]. Arthritis Rheum 2011; Suppl 63: S853.
35. Westhovens R, Kremer JM, Moreland LW, Emery P, Russell AS, Li T, et al. Safety and efficacy of the selective costimulation modulator abatacept in patients with rheumatoid arthritis receiving background methotrexate: a 5-year extended phase IIB study. J Rheumatol 2009; 36: 736-42.
36. 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: 44-8.
37. Fries JF, Spitz P, Kraines RG, Holman HR,. Measurement of patient outcome in arthritis. Arthritis Rheum 1980; 23: 137-45.