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<sup>+</sup> 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.

Safety issues and concerns of new immunomodulators in rheumatology / C. Selmi, A. Ceribelli, S.M. Naguwa, L. Cantarini, Y. Shoenfeld. - In: EXPERT OPINION ON DRUG SAFETY. - ISSN 1474-0338. - 14:3(2015), pp. 389-399.

Safety issues and concerns of new immunomodulators in rheumatology

C. Selmi
Primo
;
A. Ceribelli
Secondo
;
2015

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.
Adverse event; Biologic registry; Cancer; Infection; TNF-α inhibitor; Antirheumatic Agents; Arthritis, Psoriatic; Arthritis, Rheumatoid; Biological Therapy; Humans; Immunologic Factors; Tumor Necrosis Factor-alpha; Pharmacology (medical); Medicine (all)
Settore MED/16 - Reumatologia
Settore MED/09 - Medicina Interna
Article (author)
File in questo prodotto:
File Dimensione Formato  
2014-EODS-biologics.pdf

accesso riservato

Tipologia: Publisher's version/PDF
Dimensione 6.78 MB
Formato Adobe PDF
6.78 MB Adobe PDF   Visualizza/Apri   Richiedi una copia
Pubblicazioni consigliate

Caricamento pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/353511
Citazioni
  • ???jsp.display-item.citation.pmc??? 8
  • Scopus 30
  • ???jsp.display-item.citation.isi??? 30
social impact