Article Text

THU0186 Safety of Tofacitinib Compared to Biological Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate: Overview of Systematic Review
  1. J.M. Reyes Sanchez1,
  2. A.E. Rodriguez2,
  3. V. Prieto3
  1. 1Pfizer SAS, Bogota
  2. 2Universidad Nacional
  3. 3Pfizer SAS, Bogotá, Colombia


Background Tofacitinib is an oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA). Use of this new molecule is indicated in RA patients when non biological disease modifying antirheumatic drugs (bDMARDs) have failed. One of the advantages offered by tofacitinib is its oral administration; patient compliance with this therapy is expected to be greater.

Objectives To compare the safety of tofacitinib to bDMARDs for the treatment of RA patients with an inadequate response to methotrexate.

Methods We performed a systematic review that evaluated bDMARDs (adalimumab, certolizumab, infliximab, etanercept, golimumab, rituximab, tocilizumab and abatacept) or tofacitinib for the treatment of RA patients with an inadequate response to methotrexate. The search was performed using Medline, EMBASE, Cochrane, LILACS, DARE and HTA databases and was restricted to systematic reviews published within the last five years. The search strategy was the similar to the RA guidelines of the Ministry of Health from Colombia. Two researchers independently selected the studies and extracted the data. The risk of bias of systematic review was assessed with AMSTAR and ISPOR tools. Clinical trials that included in the systematic reviews were extracted and evaluated for methodological quality using the Cochrane checklist. Bayesian mixed treatment comparison method was applied for the pairwise comparison of treatments, where the common comparator was methotrexate. The outcomes were occurrence of serious adverse events, serious infections and withdrawal due to adverse event.

Results 27 systematic reviews and health technology assessments were included, from which 30 clinical trials were extracted in which the control and intervention arms were treated with methotrexate. The results of the mixed treatment comparison revealed that tofacitinib demonstrated a similar safety profile to the bDMARDs approved for the treatment of moderate-to-severe RA in that the rates of serious adverse events and serious infections were not statistically significantly different. Regarding withdrawal due to adverse events, etanercept was the only bDAMRD which demonstrated a lower probability of withdrawal due to adverse event compared to tofacitinib (odds ratio 2.21; 95% confidence interval 1.02-4.03) The remaining bDMARDs demonstrated a similar risk of withdrawal due to adverse events as tofacitinib.

Conclusions The results of mixed treatment comparison indicated that tofacitinib has a similar safety profile with bDMARDs for both serious adverse events and serious infections.

Disclosure of Interest This research was sponsored by Pfizer, Colombia.


  1. Ministry of Health and Social Protection (Colombia). Guia de practica clinica para la detecciόn temprana, diagnόstico y tratamiento de la artritis reumatoide. (Cited 2014 November). Available from: www://

Disclosure of Interest J. Reyes Sanchez Employee of: Pfizer SAS, A. Rodriguez Grant/research support from: Pfizer SAS, V. Prieto Employee of: Pfizer SAS

Statistics from

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.