Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.


Multiple Courses of Rituximab Produce Sustained Efficacy in Patients with Rheumatoid Arthritis with an Inadequate Response to One or More TNF Inhibitors.

Keystone6,  Edward C., Fleischmann5,  Roy M., Emery2,  Paul, Dougados3,  Maxime, Williams4,  Sarah, Linnik1,  Matthew D., Reynard4,  Mark

Biogen Idec, San Diego, San Diego, CA
Chapel Allerton Hospital, Leeds, United Kingdom
Hospital Cochin, Paris, France
Roche Products Ltd, Welwyn Garden City, UK
University of Texas Southwestern Medical Center, Dallas, Dallas, TX
University of Toronto, Toronto, ON, Canada

Objectives:

To assess the efficacy of repeat courses of rituximab (RTX) in patients (pts) with a prior inadequate response to TNF inhibitors (TNF-IR).

Methods:

Rheumatoid arthritis (RA) pts recruited into Phase II or III studies with RTX and who previously had an IR to a TNF inhibitor were permitted to receive further courses of RTX in open-label extensions. Eligibility for retreatment included a response to the initial course (at least 20% reduction in swollen and tender joint counts [SJC/TJC]) with subsequent courses given no more frequently than every 16 weeks. Criteria for retreatment included active disease defined as either >=8 SJC and TJC or DAS28 >=2.6 (depending on the study). Each course (C) consisted of 2 × 1000mg given as IV infusions 2 weeks (wks) apart. Efficacy was determined 24 wks following each course of RTX with outcomes assessed relative to the pts pre-RTX treatment baseline. Analyses were performed using observed data on all pts, and on all pts with efficacy data at 24 wks following each of their first five courses of RTX (the within pt-within visit [WW] population).

Results:

500 RA TNF-IR pts had been exposed to at least one course of RTX and had efficacy data at Week 24, with 119 evaluable at 24 wks following each course (WW population). Observed efficacy in all pts show higher responses for C2 onwards compared with C1. However, retreatment criteria may cause this population to become enriched for RTX responders, as pts were required to achieve a response to C1. Similar maintained or improved responses were seen in the WW population.

From C1 to C5, the proportion of pts in the WW population achieving DAS28 low disease activity (LDA) or remission doubled. Safety over repeat courses did not show any unexpected findings, with consistent rates of infection and serious infection.

Conclusion:

In TNF-IR pts with an initial response to RTX, repeated courses of RTX were associated with sustained levels of efficacy.

 All patientsWithin pt, within visit
 C1C2C3C4C5C1C2C3C4C5
ACR responses (n)500360289222153119119119119119
ACR20 (%)61.070.870.965.865.468.972.371.467.270.6
ACR50 (%)30.241.446.443.242.535.341.245.442.944.5
ACR70 (%)12.018.925.322.520.316.018.523.521.022.7
EULAR responses (n)489355288215149112112112112112
Good response (%)15.725.433.328.828.210.720.525.923.230.4
DAS28 LDA (%)16.225.633.728.828.211.620.525.923.230.4
DAS28 remission (%)8.414.417.717.216.16.38.99.815.215.2
Change in DAS28          
Mean change-2.15-2.64-2.93-2.88-2.93-2.29-2.63-2.83-2.85-3.08
SD1.431.431.461.591.731.321.461.461.671.66
LDA = DAS28 <=3.2; remission = DAS28 <2.6

To cite this abstract, please use the following information:
Keystone, Edward C., Fleischmann, Roy M., Emery, Paul, Dougados, Maxime, Williams, Sarah, Linnik, Matthew D., et al; Multiple Courses of Rituximab Produce Sustained Efficacy in Patients with Rheumatoid Arthritis with an Inadequate Response to One or More TNF Inhibitors. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :321
DOI: 10.1002/art.28090

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