Skip to main content
  • Meeting abstract
  • Open access
  • Published:

Long-term efficacy and safety of biologics in rheumatoid arthritis

Biologic agents have been used for more that twelve years in treating rheumatoid arthritis (RA) and other rheumatic diseases. Long-term analysis for both efficacy/effectiveness and safety is now feasible for the first anti-TNF agents available, namely infliximab, etanercept and adalimumab. Open-label extension studies have shown that clinical improvement is maintained up to10 years. However, these studies include only the patients who have sustained efficacy without the development of significant adverse events that would cause the patient to exit the study prior to closure. Therefore, as with any completer analysis of efficacy, the results reported are generally positive. Furthermore, clinical trial patients may not be representative of the entire patient population since in the clinic setting the indications for treatment with biologic agents are not identical to the inclusion criteria for trials. Only a minority of the patients in the clinical setting would have been eligible for the major trials; ineligible patients have lower baseline disease activity, more comorbidity, lower functional status and lower response rates. Despite these data, long term evaluation of effectiveness and safety in observational studies and registers has shown that TNF inhibitors are still a good choice in treatment of RA and may be also associated with a reduced risk of cardiovascular events in patients with RA.

Author information

Authors and Affiliations


Rights and permissions

This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Cite this article

Montecucco, C. Long-term efficacy and safety of biologics in rheumatoid arthritis. Arthritis Res Ther 14 (Suppl 2), A12 (2012).

Download citation

  • Published:

  • DOI: