Abstract
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-TNF-α 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-α 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.
| Original language | English |
|---|---|
| Pages (from-to) | 389-399 |
| Number of pages | 11 |
| Journal | Expert Opinion on Drug Safety |
| Volume | 14 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Mar 1 2015 |
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Keywords
- Adverse event
- Biologic registry
- Cancer
- Infection
- TNF-α inhibitor
ASJC Scopus subject areas
- Pharmacology (medical)
- Medicine(all)
Cite this
Safety issues and concerns of new immunomodulators in rheumatology. / Selmi, Carlo; Ceribelli, Angela; Naguwa, Stanley M.; Cantarini, Luca; Shoenfeld, Yehuda.
In: Expert Opinion on Drug Safety, Vol. 14, No. 3, 01.03.2015, p. 389-399.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Safety issues and concerns of new immunomodulators in rheumatology
AU - Selmi, Carlo
AU - Ceribelli, Angela
AU - Naguwa, Stanley M.
AU - Cantarini, Luca
AU - Shoenfeld, Yehuda
PY - 2015/3/1
Y1 - 2015/3/1
N2 - 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-TNF-α 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-α 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.
AB - 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-TNF-α 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-α 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.
KW - Adverse event
KW - Biologic registry
KW - Cancer
KW - Infection
KW - TNF-α inhibitor
UR - http://www.scopus.com/inward/record.url?scp=84923319847&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84923319847&partnerID=8YFLogxK
U2 - 10.1517/14740338.2015.993605
DO - 10.1517/14740338.2015.993605
M3 - Article
C2 - 25518908
AN - SCOPUS:84923319847
VL - 14
SP - 389
EP - 399
JO - Expert Opinion on Drug Safety
JF - Expert Opinion on Drug Safety
SN - 1474-0338
IS - 3
ER -