Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
A Comparison of RAPID3 Response Criteria and EULAR-DAS28 Response Criteria in the DANCER and REFLEX Rituximab Clinical Trials.
Bergman1, Martin J., Turpcu2, Adam, Wong2, Pamela, Chung2, Carol, Reiss2, William
Taylor Hospital, Ridley Park, PA
Genentech, South San Francisco, CA
Background/Purpose:
In an effort to improve patient outcomes, an increasing number of physicians are treating Rheumatoid Arthritis (RA) patients to a disease activity target. Targets are typically based on composite indices of core data set measures such as the DAS28 (which is comprised of the TJC, SJC, ESR/CRP, and patient global) and the RAPID3 (which is comprised of the patient pain, patient global, and HAQ). However, there is no consensus as to which index should be used. It is important to understand how different targets compare.
Objectives:
To compare EULAR response criteria with proposed RAPID3 response criteria in the REFLEX1 and DANCER2 clinical trials.
Methods:
Patients treated with rituximab (1000mg) were classified as having EULAR good, moderate or no responses at the time of primary endpoint analysis (week24) in both trials. EULAR response categories3 are defined in terms of reduction in DAS28-ESR and final DAS28-ESR attained as follows:
Good = decrease >1.2 units AND final <3.2;
Moderate = decrease >1.2 AND final >=3.2, OR decrease of 0.6–1.2 AND final <=5.1;
No response = decrease <0.6, OR decrease of 0.6–1.2 AND final >5.1.
Proposed RAPID3 response categories are defined as follows:
Good = decrease >3.6 units AND final <6;
Moderate = decrease >3.6 AND final >=6, OR decrease of 1.8–3.6 AND final <=12;
Poor = decrease <1.8, OR decrease of 1.8–3.6 AND final >12.
Responses were pooled across both trials. Comparisons involved cross-tabulations and weighted kappa statistics.
Results:
Moderate agreement4 was observed between the EULAR-DAS28 response criteria and the proposed RAPID3 response criteria (weighted Kappa = 0.50). A greater proportion of patients achieved a good response on the RAPID3 (30.3%) relative to the DAS28 (19.9%) with roughly half (49.6%) of the good RAPID3 responders being defined as moderate responders by the DAS28. A similar proportion of patients were classified as being poor responders by both the DAS28 and the RAPID3.
Table. EULAR Response Criteria vs RAPID3 Response Criteria in the DANCER and REFLEX clinical trials at 24 weeks.
| Good Response | Poor Response | RAPID3 Moderate Response | DAS28 Totals by Response Category | ||
|---|---|---|---|---|---|
| DAS28 | Good Response | 67 (14.8%) | 18 (4.0%) | 5 (1.1%) | 90 (19.9%) |
| Moderate Response | 68 (15.0%) | 117 (25.9%) | 47 (10.4%) | 232 (51.3%) | |
| No Response | 2 (0.4%) | 34 (7.5%) | 94 (20.8%) | 130 (28.8%) | |
| RAPID3 Totals by Response Category | 137 (30.3%) | 169 (37.4%) | 146 (32.3%) | 452 (100%) | |
| Each box displays the number of patients meeting RAPID3 response criteria and the corresponding EULAR-DAS28 response criteria. For example, the top-left box illustrates that 67 patients were classified as good responders by both RAPID3 and EULAR-DAS28 criteria. | |||||
Conclusion:
Our findings suggest that patients are more likely to be classified as good responders under proposed RAPID3 response criteria relative to the EULAR response criteria. Substantive differences may exist between targets derived from different indices. To enable accurate between-patient and within-patient comparisons, it is important that practices maintain consistent targets where possible.
References:
1.Emery, P, Fleischmann, R & Filipowicz-Sosnowska, A et al. Arthritis Rheum 2006;54:1390-1400.
2.Cohen, SB, Emery, P & Greenwald, MW et al. Arthritis Rheum 2006;54:2793-2806.
3.Fransen, J & van, RielPLCM. Clin Exp Rheumatol 2005;23:S93–9.
4.Landis, JR & Koch, GG. Biometrics 1977;33:159–74
To cite this abstract, please use the following information:
Bergman, Martin J., Turpcu, Adam, Wong, Pamela, Chung, Carol, Reiss, William; A Comparison of RAPID3 Response Criteria and EULAR-DAS28 Response Criteria in the DANCER and REFLEX Rituximab Clinical Trials. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :142
DOI:
