1230 - Patient-Reported Disease Activity Including Joint Assessment: A Comparison of RADAI (Rheumatoid Arthritis Disease Activity Index) and RAPID3 (Routine Assessment of Patient Index Data 3) in Patients Treated with Certolizumab Pegol Over 12 Weeks

Monday, November 7, 2011: 9:00 AM-6:00 PM
Hall F2 - Poster Hall (McCormick Place West)
Michael E. Weinblatt, Department of Medicine, Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, Janet E. Pope, St. Joseph's Health Care, University of Western Ontario, London, ON, Roy M. Fleischmann, MCRC, University of Texas, Dallas, TX, Clifton O. Bingham, Johns Hopkins University, Baltimore, MD, Geoffroy Coteur, UCB, Brussels, Belgium and Maxime Dougados, Paris-Descartes University, Cochin Hospital, Paris, France
Presentation Number: 1230

Background/Purpose: Self-reported disease activity (DA) indices such as RAPID3 (Routine Assessment of Patient [pt] Index Data 3) and RADAI (Rheumatoid Arthritis [RA] DA Index)1 offer a pt-focused approach to clinical management. RAPID3 is an index without formal joint counts, whereas RADAI includes a self-assessment of tenderness in 16 joint areas. This post hoc analysis of the REALISTIC (RA EvALuation In Subjects receiving TNF Inhibitor Certolizumab pegol [CZP]) study2 assessed the performance of RAPID3 and RADAI to measure impact of treatment with CZP in a broad population of RA pts closely resembling routine clinical practice.

Method: During the 12-week (wk), double-blind phase of REALISTIC (NCT00717236) 1063 pts with inadequate response to ≥1 DMARD were randomized 4:1 to CZP 400 mg at Wks 0, 2, and 4, followed by 200 mg at Wks 6, 8, and 10, or placebo (PBO), added to their current treatment. 75% pts were from North America. The RADAI (summarized as a joint tenderness score [JS] or the total score [TS], both ranging 010, with 10 indicating highest DA) was administered at 0, 2, 6, and 12 wks. Mean change from baseline (BL) in RADAI-TS was assessed using ANCOVA applying LOCF (CZP vs PBO). The % of pts achieving a minimum clinically important difference (MCID) for the RADAI-TS was evaluated (defined as a 1-point decrease). Correlations between RADAI-TS, RADAI-JS, RAPID3, and clinical DA measures (including DAS28[ESR] and total and swollen joint counts [TJC, SJC]) were examined using Pearson coefficients.

Result: Mean BL RAPID3 and RADAI-TS were similar between groups (CZP vs PBO: RAPID3 14.75 vs 15.50, RADAI-TS 5.56 vs 5.68). Statistically significant improvements in RAPID3 and RADAI-TS were reported with CZP vs PBO from as early as Wk 2 up to Wk 12 (Figure). Significantly more CZP pts had improvements ≥MCID in RADAI and achieved RAPID3 low DA or remission from Wk 2 onward. Correlations between RADAI (TS and JS) or RAPID3 and DAS28(ESR) were high, while correlations between RADAI-TS and RAPID3 were very high (Table). Pt-reported scoring of the joint for tenderness in the RADAI highly correlated with physician-reported TJC and moderately with SJC. Responsiveness of RADAI and RAPID3 was good, especially in pts with moderate or high number of affected joints at BL.

Conclusion: Rapid and significant improvements in RAPID3 and RADAI were observed within the first 3 months of CZP treatment in a broad population of RA pts. RADAI and RAPID3 may represent reliable pt-reported measures of DA in RA pts.

References

1.    Uitz E, et al. Rheumatology 2000;39:542-549.

2.    Weinblatt ME, et al. Ann Rheum Dis 2011;70(Suppl. 3);414.

 


Keywords: certolizumab pegol, patient questionnaires and rheumatoid arthritis, treatment

Disclosure: M. E. Weinblatt, UCB Inc, 2, UCB Inc, 5 ; J. E. Pope, UCB Inc, 2, UCB Inc, 5 ; R. M. Fleischmann, UCB Inc, 5, UCB Inc, 2 ; C. O. Bingham, UCB Inc, 5, UCB Inc, 2 ; G. Coteur, UCB Inc, 3 ; M. Dougados, UCB Inc, 5, UCB Inc, 2 .