Safety issues and concerns of new immunomodulators in rheumatology

被引:34
作者
Selmi, Carlo [1 ,2 ,3 ]
Ceribelli, Angela [1 ,2 ]
Naguwa, Stanley M. [4 ]
Cantarini, Luca [5 ,6 ]
Shoenfeld, Yehuda [7 ]
机构
[1] Humanitas Res Hosp, Div Rheumatol & Clin Immunol, Milan, Italy
[2] Univ Milan, BIOMETRA Dept, Milan, Italy
[3] Humanitas Clin & Res Ctr, Div Rheumatol & Clin Immunol, I-20089 Milan, Italy
[4] Univ Calif Davis, Div Rheumatol Allergy & Clin Immunol, Davis, CA 95616 USA
[5] Univ Siena, Res Ctr Syst Autoinflammatory Dis, I-53100 Siena, Italy
[6] Behcets Dis Clin, Dept Med Sci Surg & Neurosci, Siena, Italy
[7] Chaim Sheba Med Ctr, Zabludowicz Ctr Autoimmune, IL-52621 Tel Hashomer, Israel
关键词
adverse event; biologic registry; cancer; infection; TNF-alpha inhibitor; TUMOR-NECROSIS-FACTOR; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; CHRONIC HEPATITIS-C; SYSTEMIC-LUPUS-ERYTHEMATOSUS; HUMAN-IMMUNODEFICIENCY-VIRUS; ANTI-TNF THERAPY; MYCOBACTERIUM-TUBERCULOSIS INFECTION; CONNECTIVE-TISSUE DISEASES; FACTOR-ALPHA; SERIOUS INFECTIONS;
D O I
10.1517/14740338.2015.993605
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Introduction: The development of biologic therapies has been an enormous leap in the management of patients with rheumatoid and psoriatic arthritis. Since the first anti-INF-alpha therapies, numerous molecules have been identified as targets of immunomodulatory therapies, such as IL-1 (anakinra, canakinumab), IL-6 (tocilizumab), CD20(+) B cells (rituximab), CTLA4 (abatacept) and two additional anti-TNF-alpha therapies (certolizumab pegol, golimumab). Areas covered: In the present review, we will describe the safety issues related to the immunosuppressive action of these biologic drugs that are mainly represented by infection and malignancy. The risk of infection should be identified before initiating a biologic treatment and markers checked over time, in particular for tuberculosis and hepatitis B and C viruses. Other infections (bacterial, viral, parasitic; opportunistic; surgery-related) and safety issues may require temporary interruption of the treatment until complete resolution. No significantly increased risk of malignancy, both hematological and solid, has been associated with the use of biologic agents. In all cases, it is difficult to dissect the risks related to biologics from those related to baseline treatments. Expert opinion: Detailed medical history and laboratory screening should be performed before starting biologic therapies. Clinicians should be aware of the different safety profiles associated with different molecules and they should follow up data coming out of the existing registries for biologics in regard to new or old side effects.
引用
收藏
页码:389 / 399
页数:11
相关论文
共 97 条
  • [31] Rates of, and risk factors for, severe infections in patients with systemic autoimmune diseases receiving biological agents off-label
    Diaz-Lagares, Candido
    Perez-Alvarez, Roberto
    Garcia-Hernandez, Francisco J.
    Ayala-Gutierrez, Maria M.
    Luis Callejas, Jose
    Martinez-Berriotxoa, Agustin
    Rascon, Javier
    Caminal-Montero, Luis
    Selva-O'Callaghan, Albert
    Oristrell, Joaquim
    Hidalgo, Carmen
    Gomez-de-la-Torre, Ricardo
    Saez, Luis
    Canora-Lebrato, Jesus
    Camps, Maria-Teresa
    Ortego-Centeno, Norberto
    Castillo-Palma, Maria-Jesus
    Ramos-Casals, Manuel
    [J]. ARTHRITIS RESEARCH & THERAPY, 2011, 13 (04)
  • [32] Predictors of infection in rheumatoid arthritis
    Doran, MF
    Crowson, CS
    Pond, GR
    O'Fallon, WM
    Gabriel, SE
    [J]. ARTHRITIS AND RHEUMATISM, 2002, 46 (09): : 2294 - 2300
  • [33] Occurrence of Plantar Pustular Psoriasis during Treatment with Infliximab
    English, Penny Lovell
    Vender, Ronald
    [J]. JOURNAL OF CUTANEOUS MEDICINE AND SURGERY, 2009, 13 (01) : 40 - 42
  • [34] Infection-related morbidity and mortality in patients with connective tissue diseases: a systematic review
    Falagas, Matthew E.
    Manta, Katerina G.
    Betsi, Gregoria I.
    Pappas, Georgios
    [J]. CLINICAL RHEUMATOLOGY, 2007, 26 (05) : 663 - 670
  • [35] Vaccines and biologics
    Ferreira, Isabel
    Isenberg, David
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2014, 73 (08) : 1446 - 1454
  • [36] Current treatment of hepatitis C-associated rheumatic diseases
    Ferri, Clodoveo
    Sebastiani, Marco
    Antonelli, Alessandro
    Colaci, Michele
    Manfredi, A.
    Giuggioli, Dilia
    [J]. ARTHRITIS RESEARCH & THERAPY, 2012, 14 (03)
  • [37] Infectious diseases in systemic lupus erythematosus: risk factors, management and prophylaxis
    Fessler, BJ
    [J]. BEST PRACTICE & RESEARCH IN CLINICAL RHEUMATOLOGY, 2002, 16 (02): : 281 - 291
  • [38] The risk of serious infections in patients receiving anakinra for rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register
    Galloway, James B.
    Hyrich, Kimme L.
    Mercer, Louise K.
    Dixon, William G.
    Watson, Kath D.
    Lunt, Mark
    Symmons, Deborah P. M.
    [J]. RHEUMATOLOGY, 2011, 50 (07) : 1341 - 1342
  • [39] Incidence and risk of hospitalisation due to shingles and chickenpox in patients with rheumatic diseases treated with TNF antagonists
    Garcia-Doval, Ignacio
    Perez-Zafrilla, Beatriz
    Descalzo, Miguel Angel
    Rosello, Rosa
    Hernandez, Ma Victoria
    Gomez-Reino, Juan J.
    Carmona, Loreto
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2010, 69 (10) : 1751 - 1755
  • [40] Gaylis N, 2003, J RHEUMATOL, V30, P407