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

Journal of Rheumatology

Volumn 40, Issue 6, 2013, Pages 787-797

  Weinblatt, Michael E ^a   Moreland, Larry W ^b   Westhovens, Rene ^c   Cohen, Roger B ^d   Kelly, Sheila M ^e   Khan, Nader ^e   Pappu, Ramesh ^e   Delaet, Ingrid ^e   Luo, Allison ^e   Gujrathi, Sheila ^e   Hochberg, Marc C ^f  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c UNIVERSITY OF LEUVEN   (Belgium)

^d FOX CHASE CANCER CENTER   (United States)

^e BRISTOL MYERS SQUIBB   (United States)

^f UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

Author keywords

Arthritis T cells; Rheumatoid; Therapy; Tuberculosis

Indexed keywords

ABATACEPT; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ETANERCEPT; INFLIXIMAB; METHOTREXATE; PLACEBO;

APHTHOUS STOMATITIS; ARTICLE; ASTHENIA; AUTOIMMUNE DISEASE; BACKACHE; BIOLOGICAL THERAPY; BREAST CANCER; BRONCHITIS; CANCER RISK; CELLULITIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; COHORT ANALYSIS; CONGESTIVE HEART FAILURE; COUGHING; DIZZINESS; DRUG DOSE COMPARISON; DRUG ERUPTION; DRUG EXPOSURE; DRUG FATALITY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; HEART INFARCTION; HOSPITALIZATION; HUMAN; INCIDENCE; INFECTION; INFUSION RELATED REACTION; INTERSTITIAL LUNG DISEASE; LARGE CELL LYMPHOMA; LEUKOCYTOCLASTIC VASCULITIS; LEUKOPENIA; LUNG CANCER; LUNG EMBOLISM; LUNG TUMOR; LYMPHOMA; MARGINAL ZONE LYMPHOMA; NAUSEA; NON MELANOMA SKIN CANCER; PHASE 3 CLINICAL TRIAL (TOPIC); PLEURA EFFUSION; PNEUMONIA; PRIORITY JOURNAL; PSORIASIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RAYNAUD PHENOMENON; RESPIRATORY FAILURE; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SINUSITIS; SJOEGREN SYNDROME; STANDARDIZED INCIDENCE RATIO; THORAX PAIN; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; UVEITIS;

RHEUMATOID ARTHRITIS; T CELLS; THERAPY; TUBERCULOSIS;

ADMINISTRATION, INTRAVENOUS; ADULT; AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; FEMALE; HUMANS; IMMUNOCONJUGATES; MALE; MIDDLE AGED; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84878631800     PISSN: 0315162X     EISSN: 14992752     Source Type: Journal    
DOI: 10.3899/jrheum.120906     Document Type: Article

References (41)

1. 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.
2. 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.
3. Kremer JM, Westhovens R, Leon M, Di Giorgio E, Alten R, Steinfeld S, et al. Treatment of rheumatoid arthritis by selective inhibition of T-cell activation with fusion protein CTLA4Ig. N Engl J Med 2003;349:1907-15.
4. Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med 2005;353:1114-23.
5. 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.
6. Ruperto N, Lovell DJ, Quartier P, Paz E, Rubio-Perez N, Silva CA, et al. Abatacept in children with juvenile idiopathic arthritis: A randomised, double-blind, placebo-controlled withdrawal trial. Lancet 2008;372:383-91.
7. Westhovens R, Robles M, Ximenes AC, Nayiager S, Wollenhaupt J, Durez P, et al. Clinical efficacy and safety of abatacept in methotrexate-naive patients with early rheumatoid arthritis and poor prognostic factors. Ann Rheum Dis 2009;68:1870-7.
8. Wallis RS, Broder MS, Wong JY, Hanson ME, Beenhouwer DO. Granulomatous infectious diseases associated with tumor necrosis factor antagonists. Clin Infect Dis 2004;38:1261-5.
9. De Bandt M, Sibilia J, Le Loet X, Prouzeau S, Fautrel B, Marcelli C, et al. Systemic lupus erythematosus induced by anti-tumour necrosis factor alpha therapy: A French national survey. Arthritis Res Ther 2005;7:R545-51.
10. Ramos-Casals M, Brito-Zeron P, Munoz S, Soria N, Galiana D, Bertolaccini L, et al. Autoimmune diseases induced by TNF-targeted therapies: Analysis of 233 cases. Medicine 2007;86:242-51.
11. Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: Systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA 2006;295:2275-85.
12. Wolfe F, Michaud K. Biologic treatment of rheumatoid arthritis and the risk of malignancy: Analyses from a large US observational study. Arthritis Rheum 2007;56:2886-95.
13. Alonso-Ruiz A, Pijoan JI, Ansuategui E, Urkaregi A, Calabozo M, Quintana A. Tumor necrosis factor alpha drugs in rheumatoid arthritis: Systematic review and metaanalysis of efficacy and safety. BMC Musculoskelet Disord 2008;9:52.
14. 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.
15. 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.
16. 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.
17. 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 abatacept: The ARRIVE trial. Ann Rheum Dis 2009;68:1708-14.
18. Lacaille D, Anis AH, Guh DP, Esdaile JM. Gaps in care for rheumatoid arthritis: A population study. Arthritis Rheum 2005;53:241-8.
19. PharMetrics Integrated Database. Danbury, CT: IMS. [Internet. Accessed February 27, 2013.] Available from: http://www.imshealth.com/portal/site/ims/ menuitem.d248e29c8658 9c9c30e81c033208c22a/?vgnextoid=d6952a2e23264310VgnVCM1 00000ed152ca2RCRD&vgnextfmt=default
20. Wolfe F, Michaud K. The effect of methotrexate and anti-tumor necrosis factor therapy on the risk of lymphoma in rheumatoid arthritis in 19, 562 patients during 89, 710 person-years of observation. Arthritis Rheum 2007;56:1433-9.
21. Lawson DH, Sherman V, Hollowell J. The General Practice Research Database. Scientific and Ethical Advisory Group. QJM 1998;91:445-52.
22. National Cancer Institute. Surveillance, Epidemiology and End Results Program. SEER*Stat Database: Incidence - SEER 17, 2000-2007. Bethesda, MD: US Department of Health and Human Services. [Internet. Accessed February 27, 2013.] Available from: http://seer.cancer.gov/canques/incidence.html
23. Simon TA, Smitten AL, Franklin J, Askling J, Lacaille D, Wolfe F, et al. Malignancies in the rheumatoid arthritis abatacept clinical development programme: An epidemiological assessment. Ann Rheum Dis 2009;68:1819-26.
24. Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, et al. Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis. Mod Rheumatol 2011;21:343-51.
25. Komano Y, Tanaka M, Nanki T, Koike R, Sakai R, Kameda H, et al. Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: A report from the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety. J Rheumatol 2011;38:1258-64.
26. Singh JA, Wells GA, Christensen R, Tanjong Ghogomu E, Maxwell L, Macdonald JK, et al. Adverse effects of biologics: A network meta-analysis and Cochrane overview. Cochrane Database Syst Rev 2011;2:CD008794.
27. St. Clair EW, van der Heijde DM, Smolen JS, Maini RN, Bathon JM, Emery P, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: A randomized, controlled trial. Arthritis Rheum 2004;50:3432-43.
28. Burmester GR, Mease P, Dijkmans BA, Gordon K, Lovell D, Panaccione R, et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases. Ann Rheum Dis 2009;68:1863-9.
29. Leombruno JP, Einarson TR, Keystone EC. The safety of anti-tumour necrosis factor treatments in rheumatoid arthritis: Meta and exposure-adjusted pooled analyses of serious adverse events. Ann Rheum Dis 2009;68:1136-45.
30. 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.
31. Genovese MC, Cohen S, Moreland L, Lium D, Robbins S, Newmark R, 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.
32. Dixon WG, Hyrich KL, Watson KD, Lunt M, Galloway J, Ustianowski A, et al. Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: Results from the British Society for Rheumatology Biologics Register (BSRBR). Ann Rheum Dis 2010;69:522-8.
33. Schiff MH, Burmester GR, Kent JD, Pangan AL, Kupper H, Fitzpatrick SB, et al. Safety analyses of adalimumab (HUMIRA) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis. Ann Rheum Dis 2006;65:889-94.
34. Tubach F, Salmon D, Ravaud P, Allanore Y, Goupille P, Breban M, et al. Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance of Biotherapies registry. Arthritis Rheum 2009;60:1884-94.
35. Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Frequency of infection in patients with rheumatoid arthritis compared with controls: A population-based study. Arthritis Rheum 2002;46:2287-93.
36. Simon TA, Askling J, Lacaille D, Franklin J, Wolfe F, Covucci A, et al. Infections requiring hospitalization in the abatacept clinical development program: An epidemiological assessment. Arthritis Res Ther 2010;12:R67.
37. Smitten AL, Simon TA, Hochberg MC, Suissa S. A meta-analysis of the incidence of malignancy in adult patients with rheumatoid arthritis. Arthritis Res Ther 2008;10:R45.
38. Askling J, Baecklund E, Granath F, Geborek P, Fored M, Backlin C, et al. Anti-tumour necrosis factor therapy in rheumatoid arthritis and risk of malignant lymphomas: Relative risks and time trends in the Swedish Biologics Register. Ann Rheum Dis 2009;68:648-53.
39. Abrams JR, Kelley SL, Hayes E, Kikuchi T, Brown MJ, Kang S, et al. Blockade of T lymphocyte costimulation with cytotoxic T lymphocyte-associated antigen 4-immunoglobulin (CTLA4Ig) reverses the cellular pathology of psoriatic plaques, including the activation of keratinocytes, dendritic cells, and endothelial cells. J Exp Med 2000;192:681-94.
40. Bongartz T, Nannini C, Medina-Velasquez YF, Achenbach SJ, Crowson CS, Ryu JH, et al. Incidence and mortality of interstitial lung disease in rheumatoid arthritis. A population-based study. Arthritis Rheum 2010;62:1583-91.
41. Weinblatt ME, Genovese MC, Schiff MH, Westhovens R, Alten R, Delaet I, et al. Immunogenicity is low and transient with intravenous abatacept therapy. Ann Rheum Dis 2012;71 Suppl 3:377.