P.P. Tak1, P. Mease 2 , S. Bombardieri 3 , C. Lue 4 , J.D. Isaacs 5 , J. Schechtman 6 , D. Gray 7 , M. Cravets 8 , S. Safa-leathers 9. 1Div. of Clinical Immunology and Rheumatology, University of Amsterdam, Amsterdam, Netherlands, 2Seattle Rheumatology Associates, XXX, Seattle, WA, United States, 3Dept of Rheumatology, International Medical Centre, Pisa, Italy, 4Little Rock Diagnostic Clinic, XXX, Arkansas, United States, 5Dept of Rheumatology, University School of Clinical Sciences, Newcastle Upon Tyne, United Kingdom, 6Sun Valley Arthritis Center Ltd, XXX, Glendale, AZ, United States, 7Medical Sciences, Roche Products Ltd, Roche Products Ltd, United Kingdom, 8Biogen Idec, San Diego, CA, United States, 9Medical Sciences, Roche Products Ltd, Welwyn Garden City, United Kingdom

Objectives: To investigate the effect of a repeated course of rituximab (RTX) treatment on physical function and quality of life in patients (pts) with rheumatoid arthritis (RA) and an inadequate response to TNF inhibitors.
Methods: All pts included in this analysis had received prior treatment with TNF inhibitors and had participated in a Phase II or III trial in the RTX clinical trial programme. Pts were eligible to receive additional open-label courses of RTX via an extended repeat treatment protocol to these trials. All pts had received a single course of two RTX 1000 mg infusions 2 weeks apart within the initial study. The second treatment course consisted of the same regimen (described previously). Pts' quality of life was assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI) and the Short Form Health Survey 36 (SF-36) at 24 weeks' follow-up.
Results: As of October 2005, a total of 156 pts with an inadequate response to prior treatment with TNF inhibitors had received two courses of RTX and had 24-week data available relative to both their initial and repeat treatment course. All comparisons of change were made relative to pts' baseline values prior to treatment with RTX. Of this group, 72% and 69% of pts had a clinically meaningful change in physical function, as defined by a decrease in the HAQ DI score of >0.22, following both the initial and repeated treatment courses, respectively (Table). SF-36 data were available from 119 pts with 24 weeks' follow-up. Within this group, a mean change of 8.7 in the mental component was observed following the second course of treatment, compared to a mean change of 4.8 following the first course of treatment, suggesting that the effect on the mental component is further improved following repeat treatment. Mean changes in the physical component were 6.4 and 7.8 at 24 weeks following the first and second treatment courses, respectively, also suggesting that pts continue to improve with repeated treatment.

1st treatment course:2nd treatment course:
24-week follow-up24-week follow-up
% of pts with a decrease in HAQ-DI >0.22 after course (n=156)*72%69%
Mean change in SF-36 mental component after course standard deviation (SD) (n=119)*4.8 (11.6)8.7 (11.4)
Mean change in SF-36 physical component after course (SD) (n=119)*6.4 (8.3)7.8 (9.4)

*n represents pts treated at least 24 weeks prior to data cut.
Conclusion: These results indicate that repeat treatment with RTX in pts with active RA can lead to a continued improvement in pts' physical function and an enhanced improvement in both mental and physical components of pts' quality of life.
Citation: Ann Rheum Dis 2006;65(Suppl II):503

Session: Rheumatic arthritis – treatment biologics


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