Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement

The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.


A Faster Clinical Response to Certolizumab Pegol (CZP) Treatment Is Associated with Better 52-Week Outcomes in Patients with Rheumatoid Arthritis (RA)

Keystone1,  Edward C., Curtis2,  Jeffrey R., Fleischmann3,  Roy, Mease4,  P., Khanna5,  D., Smolen6,  J. S., Furst7,  D. E.

Professor of Medicine/University of Toronto, Toronto, ON
Univ of Alabama at Birmingham, Birmingham, AL
Metroplex Clinical Research Center, Dallas, TX
Seattle Rheumatology Associates, Seattle, WA
UCLA, Los Angeles, CA
Medical Univ Vienna, Vienna, Austria
David Geffen School of Medicine at UCLA, Los Angeles, CA
UCB, Brussels, Belgium
Immuno-Rheumatology, Montpellier, France

Purpose:

CZP, the only PEGylated anti-TNF approved for the treatment of RA, provides rapid improvements in the signs and symptoms of RA, physical function and relief of pain and fatigue when added to methotrexate (MTX). The objective of our analysis was to determine if a more rapid response to CZP treatment was associated with better long-term outcomes in patients with active RA.

Methods:

In the RAPID1 clinical trial, patients treated with CZP 200 mg + MTX who had an ACR20 response or DAS28 change of >=1.2 points from baseline (BL) at Wk 12 were divided into 2 subgroups depending on response at Wk 6: Wk 6 responders and WK 6 non-responders (who responded at Wk 12). ACR20/50/70 response rates at Wk 52 were compared between responder subgroups using logistic regression; HAQ-DI, Pain-VAS and Fatigue Assessment Scale (FAS) at Wk 52 were compared using ANCOVA, adjusted for BL.

Results:

BL characteristics were similar between the 2 subgroups in both analyses. Overall, response to CZP treatment was rapid with the majority of Wk 52 responders achieving a DAS28 or ACR20 responses by Wk 6 (Table). Wk 6 DAS28 and ACR20 responders had higher ACR20/50/70 response rates at Wk 52 than Wk 12 responders (Table). At Wk 52, Wk 6 DAS28 responders also had a significantly greater improvement in Pain VAS than Wk 12 responders, but not in HAQ-DI or FAS. Wk 6 ACR20 responders also reported significantly greater improvements in HAQ-DI and Pain VAS, but not FAS, than Wk 12 responders.

Table. Wk 52 Outcomes in Wk 6 versus Wk 12 responders

Responder definitionACR20ACR50ACR70HAQ (0–3)Pain VAS (0–100)FAS (0–100)
Change in DAS28 >=1.2      
Wk 6 responder (n=200)81.5a61.0a37.0a-0.84-42.8b-3.7
Wk 12 responder (n=57)56.136.812.3-0.71-34.3-3.3
ACR 20      
Wk 6 responder (n=178)83.1a66.7a39.0a-0.87c-44.8a-3.8
Wk 12 responder (n=87)66.734.516.1-0.69-34.3-3.2
a p<0.001; b p<=0.01; c p<=0.05 vs Wk 12 responders (adjusted mean difference in change from BL).

Conclusion:

A faster response to treatment is associated with improved long-term outcomes at 52 wks in active RA patients treated with CZP + MTX. Rapid (Wk 6) responders demonstrated significantly greater ACR responder rates and greater improvements in physical function and pain relief than later (Wk 12) responders. Largely independent of whether ACR20 or DAS28 change >=1.2 is used to assess response, these observations highlight the importance of a rapid, 6-wk response in RA outcomes over 1 year.

To cite this abstract, please use the following information:
Keystone, Edward C., Curtis, Jeffrey R., Fleischmann, Roy, Mease, P., Khanna, D., Smolen, J. S., et al; A Faster Clinical Response to Certolizumab Pegol (CZP) Treatment Is Associated with Better 52-Week Outcomes in Patients with Rheumatoid Arthritis (RA) [abstract]. Arthritis Rheum 2009;60 Suppl 10 :989
DOI: 10.1002/art.26066

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