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Abstract Number: 2101

How Much Can Patient Reported Outcomes Improve Among Rheumatoid Arthritis Patients Who Have a Clinical Response to Biologic Therapy but Have Not Attained Low Disease Activity?

Jeffrey R. Curtis1, Ying Shan, Jie Zhang1, Jeffrey D. Greenberg3 and George W. Reed4, 1Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, 2New York Hospital for Joint Disease, New York, NY, 3University of Massachusetts Medical School, Worcester, MA

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Rheumatoid arthritis (RA)

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Session Information

Title: Rheumatoid Arthritis - Clinical Aspects III: Infections/Risk Factors for Incident Rheumatoid Arthritis/Metrology/Classification/Biomarkers/Predictors of Rheumatolid Arthritis Activity & Severity

Session Type: Abstract Submissions (ACR)

Background/Purpose:

Current treat-to-target (T2T) recommendations suggest that rheumatoid arthritis (RA) patients should strive for remission or low disease activity (LDA) as a goal. Treatment changes as often as every 3 months are recommended if necessary. However, it is unclear whether patients that have had a good clinical response to anti-TNF therapy by 3 months but who are not yet in LDA or remission might experience further meaningful improvement in patient reported outcomes (PROs) if they subsequently achieve these T2T disease state targets.

Methods:

We used data from the Consortium of Rheumatology Researchers of North America (CORRONA) to study participants with RA (n = 31701 total) who initiating anti-TNF therapy with a subsequent follow-up visit approximately 3 months later. The analysis cohort was restricted to patients who had clinical improvement (CDAI improvement by >= 10 units) at three months. Subsequent clinical response for patients who remained on the same anti-TNF therapy was examined approximately 6 months later to assess whether PROs (global, pain, disability by mHAQ) improved more among those who improved their CDAI category (from LDA to remission, or moderate/high disease activity to low disease activity) compared to those who stayed in the same CDAI category.

Results:

A total of 293 patients who initiated anti-TNF therapy and who had an improvement in CDAI of >= 10 units three months later were identified. After excluding 61 patients in CDAI remission (CDAI <=2.8) at 3 months, there were 120 individuals in LDA (CDAI 2.8 – 10) and 112 in moderate/high CDAI (CDAI > 10) eligible for analysis. Among patients who achieved LDA at 3 months, 45 (38%) subsequently went on to achieve CDAI remission, 26 (22%) stayed in LDA; 49 (41%) worsened to moderate/high disease activity and were excluded. Among the 112 patients still in moderate/high disease activity patients at 3 months, 40 (36%) went on to achieve LDA (CDAI <= 10) and the remainder stayed in moderate/high disease activity. The mean change in PROs was compared. Patients who improved their CDAI disease activity category were significantly better for patient global and pain and no different for mHAQ versus those who stayed in the same disease CDAI activity category.

Conclusion:

Among patients with a clinical response to anti-TNF therapy at 3 months but who have not yet attained LDA or remission, the magnitude of further change in patient reported outcomes for those who achieve these disease states 6 months later was relatively small compared to those who stayed the same. Some improvement was observed for patient global and pain but not for disability. These results suggest that patients may not experience much additional benefit in their PROs from subsequently attaining the LDA or remission targets recommended in T2T guidelines as long as they have had a good clinical response.

 

Patient Reported Outcome

Adjusted* Mean Change (95% CI) for Patients Who Improved to a Better CDAI Disease Activity Category Compared to Those Who Stayed the Same

Adjusted* p value

Patient Global (0-100 scale)

-14.7 (-20.4, -8.9)

< 0.001

Patient Pain (0-100 scale)

-11.5 (-17.5, -5.6)

< 0.001

Disability (mHAQ)

-0.02 (-0.10, 0.07)

0.74

* adjusted for age, gender, duration of RA, CDAI at 3 months, and baseline PRO


Disclosure:

J. R. Curtis,

Roche/Genetech, UCB< Centocor, Corrona,Amgen, Pfizer, BMS, Crescendo, Abbott, 2, Roche/Genetech,UCB, Centocor, CORRONA, Amgen, Pfizer, BMS, Crescendo, Abbott, 5; Y. Shan,
None;

J. Zhang,
None;

J. D. Greenberg,

Corrona,

1,

AstraZeneca, Novartis, Pfizer, CORRONA,

5;

G. W. Reed,

Corrona,

2,

University of Massachusetts Medical School,

3,

Corrona,

5,

Harvard Medical School,

.

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