ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1362

Impact of Rapid Attainment of Stringent Measures of Efficacy in Rheumatoid Arthritis on Patient-Reported Outcomes

EA Alemao1, S Joo2, S Banerjee1, P Emery3 and M Weinblatt4, 1Bristol-Myers Squibb, Princeton, NJ, 2Bristol-Myers Squibb, Hopewell, NJ, 3University of Leeds, Leeds, United Kingdom, 4Brigham and Women's Hospital, Boston, MA

Meeting: ACR/ARHP Annual Meeting 2014

Keywords: ,

Session Information

Title: Rheumatoid Arthritis - Clinical Aspects (ACR): Comorbidities, Treatment Outcomes and Mortality

Session Type: Abstract Submissions (ACR)

Background/Purpose: Treatment guidelines in RA recommend that therapies aim to reach a target of remission or low disease activity (LDA) and that these targets should be reached in 3–6 months (mths). This timeframe is based on ‘expert opinion’ rather than empirical data. Our objective was to evaluate the benefits of rapid (within 3 mths) vs later attainment of stringent measures of efficacy (SME) such as ACR/EULAR remission criteria (SDAI ≤3.3, CDAI ≤2.8), LDA (DAS <2.6), and ACR70 on pt-reported outcomes (PROs) in pts with RA in a randomized controlled trial. Methods: Data were analyzed from a Phase IIb study evaluating SC anti-IL-6 monoclonal antibody clazakizumab (CLZ) with or without MTX in pts with moderate-to-severe RA and inadequate response to MTX. Pts were randomized equally to CLZ 25, 100 or 200 mg with MTX every 4 wks; CLZ 100 or 200 mg monotherapy every 4 wks; MTX alone; or adalimumab with MTX every 2 wks. ‘Rapid’ attainment of SME (DAS28 [CRP] <2.6, ACR70, SDAI ≤3.3 and CDAI ≤2.8) was based on attaining SME within 3 mths. Pts attaining SME between 3 to 6 mths and after 6 mths were considered ‘intermediate' and ‘late' respectively. PROs evaluated during the 12-mth follow-up period included physical functioning using HAQ-DI, quality of life (QoL) using the Short Form-36 Health Survey (SF-36) (physical component summary [PCS] and mental component summary [MCS]), and pain and fatigue using visual analog scales. Mixed models were used to estimate both fixed and random effects of independent variables on the outcome measures. Results: A total of 418 pts were included in the analysis; average age was 50.4 yrs and 83.5% were females. At 12 wks (‘rapid’ group), 33.3%, 22.7%, 12.2% and 11.2% had attained DAS28 (CRP) <2.6, ACR70, SDAI ≤3.3 and CDAI ≤2.8, respectively. Between 12 and 24 wks (‘intermediate' group) these values were 17.5%, 16.0%, 12.4% and 12.7%, respectively; and after 24 wks (‘late' group) they were 18.2%, 20.8%, 19.6% and 18.9%, respectively. Baseline characteristics between groups were similar. Pts who attained DAS28 (CRP) <2.6 or ACR70 early (‘rapid' group) had significantly better HAQ, SF-36 PCS, pain and fatigue scores at Wk 48 than those who attained DAS28 (CRP) <2.6 or ACR70 later (‘late' group); the mean differences (delta) between the ‘rapid' vs ‘late' group were higher than the thresholds for minimum clinically important differences for these outcomes. Directionally similar results were observed for those attaining SDAI ≤3.3 and CDAI ≤2.8 rapidly vs late, although the results did not meet statistical significance due to small numbers of pts. There was no consistent pattern in PROs between the ‘rapid' vs ‘intermediate' group (Table).
Outcome D DAS28 (CRP) <2.6 ‘rapid’ vs ‘late’ p-value D ACR70 ‘rapid’ vs ‘late’ p-value
HAQ –0.37 0.0085 –0.60 <0.0001
SF-36 PCS 3.5 0.0007 3.4 0.0011
SF-36 MCS 2.2 0.1073 2.2 0.1261
Pain –16.4 <0.0001 –14.4 <0.0001
Fatigue –15.5 <0.0001 –13.6 <0.0001
D DAS28 (CRP) <2.6 ‘rapid’ vs ‘intermediate’ p-value D ACR70 ‘rapid’ vs ‘intermediate’ p-value
HAQ 0.02 0.8731 –0.10 0.4489
SF-36 PCS 0.5 0.6113 0.2 0.8336
SF-36 MCS 1.5 0.2963 –1.0 0.4942
Pain –6.8 0.0046 –4.0 0.0939
Fatigue –6.6 0.0113 –4.1 0.1192

Conclusion: Pts with rapid attainment of SME (including treatment guideline targets) tend to benefit more in the longer term in physical functioning, QoL, pain and fatigue than those attaining these measures much later; the findings are mixed for those attaining SME in the intermediate 3–6 mths time period.  

Disclosure:

E. Alemao,

BMS,

1,

BMS,

3;

S. Joo,

BMS,

3,

BMS,

1;

S. Banerjee,

BMS,

1,

BMS,

3;

P. Emery,

AbbVie, BMS, Merck, Pfizer, Roche, Takeda,

5,

AbbVie, BMS, Merck, Pfizer, Roche,

2;

M. Weinblatt,

BMS, Crescendo Bioscience, UCB, Abbvie, Roche, Janssen,

5,

BMS, Crescendo Bioscience, UCB,

2.

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