Routine Assessment of Patient Index Data 3 (RAPID3)-Defined Remission Is As Stringent As ACR/EULAR Boolean-Defined Remission in a Clinical Trial of Patients with Early Rheumatoid Arthritis Treated with Abatacept

Yusuf Yazici¹, KK Gandhi², E Alemao² and Daniel E. Furst³, ¹NYU Hospital for Joint Diseases, New York, NY, ²Bristol-Myers Squibb, Princeton, NJ, ³Medicine, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: abatacept and remission, Early Rheumatoid Arthritis

Session Information

Date: Monday, November 9, 2015

Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose:
Routine Assessment of Patient Index Data 3 (RAPID3) comprises the
three patient-reported ACR RA Core Data Set measures: function (HAQ-DI), pain
and patient global estimate of status (10-cm visual analog scale). These can be
scored in <10 seconds, making RAPID3 suitable for use in routine clinical
practice where it provides quantitative data to supplement qualitative
assessments. Significant correlations between RAPID3 scores and DAS28 (CRP) and
CDAI have been reported previously.^1,2 In this analysis, we examined
time to first RAPID3 remission compared with time to first remission, as
defined by other disease activity measures (DAS28 [CRP], CDAI, SDAI, Boolean). Methods: We
performed post hoc analyses of data from AVERT, a Phase IIIb,
randomized, active-controlled trial of 24 months, with a 12-month, double-blind
treatment period, in which patients were randomized 1:1:1 to subcutaneous
abatacept (ABA) + MTX, ABA monotherapy or MTX alone.³ RAPID3 scores
were calculated at baseline and 3-monthly intervals thereafter, up to 12
months. Definitions of remission were RAPID3 ≤3 (scale of 0–30), DAS28
(CRP) <2.6, CDAI ≤2.8, SDAI
≤3.3 and Boolean: TJC28 ≤1,
SJC28 ≤1, patient global assessment of disease
activity (0–10 cm) ≤1 and high-sensitivity CRP ≤1 mg/dL. Proportions of patients in RAPID3, DAS28 (CRP),
CDAI, SDAI and ACR/EULAR Boolean remission at each time point were calculated.
Proportions at 3, 6, 9 and 12 months were compared using cross-tabulation
analysis. Agreement between RAPID3 disease activity states and those of other
measures were assessed using kappa statistics. Time to first RAPID3 remission
was compared with time to first remission, as defined by other disease activity
measures (DAS28, CDAI, SDAI, Boolean) using Kaplan–Meier plots. Results: Among
the total AVERT population, the percentages of patients in remission according
to each measure at Month 12 were: RAPID3, 29.3%; Boolean, 28.8%; SDAI, 32.2%;
CDAI, 33.6%; and DAS28 (CRP), 50.1%. For each treatment arm, good agreement was
observed between RAPID3 and Boolean, SDAI and CDAI remission at Month 12 (0.45–0.67);
these kappa correlations were higher than those with DAS28 (CRP) (0.19–0.48). The
patterns of time to RAPID3 remission were most similar to Boolean and show that
ABA + MTX and ABA monotherapy lead to a faster onset of remission than MTX
alone (Figure).

Conclusion: RAPID3-defined
remission may be as stringent as ACR/EULAR Boolean-defined remission and agrees
well with SDAI and CDAI remission criteria. RAPID3 may be used in clinical
trials in addition to routine clinical care in early RA. In agreement with
other remission criteria, abatacept results in a high rate of RAPID3-defined
remission in early RA, with a faster time to remission than MTX.

1.
Pincus T, et al. J Rheumatol 2011;38:2565–71.

2.
Pincus T, et al. J Rheumatol 2008;35:2136–47.

3.
Emery P, et al. Ann Rheum Dis 2015;74:19–26.

Disclosure: Y. Yazici, Bristol-Myers Squibb, Celgene, Genentech, 5,NYU, Samumed, 3; K. Gandhi, Bristol-Myers Squibb, 1,Bristol-Myers Squibb, 3; E. Alemao, Bristol-Myers Squibb, 3,Bristol-Myers Squibb, 1; D. E. Furst, Gilead, 2,GlaxoSmithKline, 2,NIH, 2,Novartis Pharmaceutical Corporation, 2,Pfizer Inc, 2,Roche Pharmaceuticals, 2,Genentech and Biogen IDEC Inc., 2,UCB, 2,Abbvie, 5,Actelion Pharmaceuticals US, 5,Amgen, 5,Bristol-Myers Squibb, 5,Cytori, 5,Janssen Pharmaceutica Product, L.P., 5,Gilead, 5,GlaxoSmithKline, 5,NIH, 5,Novartis Pharmaceutical Corporation, 5,Pfizer Inc, 5,Roche Pharmaceuticals, 5,Genentech and Biogen IDEC Inc., 5,UCB, 5,Abbvie, 8,Actelion Pharmaceuticals US, 8,Bristol-Myers Squibb, 2,Amgen, 2,Actelion Pharmaceuticals US, 2,Abbvie, 2,UCB, 8.

To cite this abstract in AMA style:

Yazici Y, Gandhi K, Alemao E, Furst DE. Routine Assessment of Patient Index Data 3 (RAPID3)-Defined Remission Is As Stringent As ACR/EULAR Boolean-Defined Remission in a Clinical Trial of Patients with Early Rheumatoid Arthritis Treated with Abatacept [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/routine-assessment-of-patient-index-data-3-rapid3-defined-remission-is-as-stringent-as-acreular-boolean-defined-remission-in-a-clinical-trial-of-patients-with-early-rheumatoid-arthritis-treated-wit/. Accessed .

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