Rituxan Clinical Data
Care should be taken when interpreting these data, as they constitute the results of an uncontrolled observational study based on registry data.
While TNFi therapy is effective for many patients, up to 1/3 fail to respond. For those who need a different approach, consider Rituxan.1
In the pivotal placebo-controlled trial, a significantly higher proportion of patients treated with one course of Rituxan vs placebo achieved the primary end point of an ACR20 response at 6 months2
- ACR20*: 51% for Rituxan vs 18% for placebo*
*p<0.0001
Registry Data: Switching MOA vs subsequent TNFi therapy following TNFi nonresponse
Switching due to TNFi nonresponse1
The study was not powered to detect differences in efficacy between therapies. No comparison of safety and efficacy is intended with any specific TNFi agent.
![Longitudinal change in DAS28 in TNFi nonresponders after switching to Rituxan vs an alternative TNFi[1]](/ra/hcp/images/about/longitudinal-change.gif)
A prospective cohort study of 318 RA registry patients. The analysis included data collected from the Swiss RA registry (SCQM-RA) between January 1998 and the end of March 2008 for patients who discontinued at least one TNFi and subsequently received either Rituxan or an alternative TNFi. The primary end point was change in DAS28 over time, which was analyzed using multivariate regression models for longitudinal data and then adjusted for potential confounders. At 6 months in patients with a TNFi nonresponse, 61% of Rituxan patients had a DAS28 improvement of more than 1.2 units vs 37% of TNFi patients (p=0.001).1
Adapted from Finckh et al 2010.
Switching due to adverse events or other reasons1
![Longitudinal change in DAS after DAS28 after switching from a TNFi to Rituxan or an alternative TNFi due to adverse events or other reasons[1]](/ra/hcp/images/about/longitudinal-change2.gif)
Overall results were not significantly modified by the number of previous TNFi failures or the type of TNFi switch.1
Switching TNFi patients to subsequent MOA
Dr. Kevin Latinis gives a video presentation on Dr. Finckh's analysis of data that examines switching TNFi patients to an alternative MOA like Rituxan.
IMPORTANT SAFETY INFORMATION
Concomitant use with biologic agents and DMARDs other than methotrexate in RA:- Limited data are available on the safety of the use of biologic agents or DMARDs other than methotrexate in patients exhibiting peripheral B-cell depletion following treatment with rituximab
- Observe patients closely for signs of infection if biologic agents and/or DMARDs are used concomitantly
REFERENCES
- 1.
- Finckh A, Ciurea A, Brulhart L, et al; on the behalf of the doctors of the Swiss Clinical Quality Management Programme for Rheumatoid Arthritis. Which subgroup of patients with rheumatoid arthritis benefits from switching to rituximab versus alternative anti‐tumour necrosis factor (TNF) agents after previous failure of an anti-TNF agent? Ann Rheum Dis. 2010;69(2):387-393.
- 2.
- REFLEX Trial Group. Rituximab for rheumatoid arthritis refractory to anti‐tumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54(9):2793-2806. doi:10.1002/art.22025.
