Safety issues and concerns of new immunomodulators in rheumatology

Expert Opin Drug Saf. 2015 Mar;14(3):389-99. doi: 10.1517/14740338.2015.993605. Epub 2014 Dec 18.


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.

Keywords: TNF-α inhibitor; adverse event; biologic registry; cancer; infection.

Publication types

  • Review

MeSH terms

  • Antirheumatic Agents / adverse effects*
  • Antirheumatic Agents / pharmacology
  • Arthritis, Psoriatic / drug therapy
  • Arthritis, Rheumatoid / drug therapy
  • Biological Therapy / adverse effects
  • Biological Therapy / methods
  • Humans
  • Immunologic Factors / adverse effects*
  • Immunologic Factors / pharmacology
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*


  • Antirheumatic Agents
  • Immunologic Factors
  • Tumor Necrosis Factor-alpha